American Proﬁciency - api-pt.com · analytes. API programs are also accepted by CMS, COLA, TJC,...

AmericanProficiencyInstitute

2020CATALOG OF PROGRAMSACCEPTED BY: CAP, CMS, COLA, TJCISO Accredited by A2LA: Cer t. #3094.01 - see p. 5

Innovative Solutions.

Technical Excellence.

Technical expertise. Responsive service. Constant innovation. We’re proficient at all of them.

When it comes to proficiency testing, reliability is everything. You need a provider that fully supports you with technical expertise and prompt, personal service.

At API, we work with over 20,000 laboratories, covering all areas of laboratory medicine. Impressive numbers, for sure. But our reputation as a leader has

grown because we are committed to providing the best customer service in the industry. We handle each contact promptly and professionally, so you don’t wait for answers. Our technical experts fully understand the laboratory so they can assist you with a wide range of needs. We also provide automated result transmission, creative online services, and free Continuing Education credits.

The end result? With API, you have people and results you can rely on to meet all your proficiency testing needs.

Enrollment Information 4

Highlights for 2020 5

Proficiency Testing Programs

Chemistry 6 - 27

Hematology 28 - 40

Andrology 41 - 43

Coagulation 44 - 51

Urinalysis, Microscopy, & Miscellaneous Tests 52 - 58

Microbiology 59 - 89

Immunology 90 - 101

Immunohematology 102 - 107

Additional Programs

Remedial Proficiency Testing 108

Troubleshooting Samples 108

Verification Programs (for secondary instruments or methods) 108

Continuing Education Credit 108

Index 110 - 113

Table of Contents

Enrollment1. Use this catalog to select the programs you need and record the selections on the order form. Please follow the instructions below to complete the form. Make sure to include:

3. To Order:

4. After processing your order, we will send you an “Order Confirmation” showing products ordered and pre-set shipping dates:

2. Ensure the “TOTAL” includes the $103 Shipping and Processing fee which covers shipping, administrative costs of setting up customer files, data processing, and reports.

Partial Year OrdersAPI makes every effort to accommodate new orders or order changes throughout the year. Except for the shipping and processing fee, we will prorate the prices for orders received after the first shipment.

CancellationsWe will credit any charges for unshipped specimens if we receive notification four weeks prior to the next shipment. In accordance with our cancellation policy, all credits expire within 120 days of the credit memo date. The shipping and processing fee is nonrefundable.

International and Non-Continental U.S. CustomersAPI is able to service many international locations and non-continental U.S. customers. Some locations, including the state of Hawaii, U.S. territories and commonwealths, as well as international locations, may require import permits for API shipments. Local authorities can assist you in determining if any permits are required for your location. Please note: It is the responsibility of the testing facility to obtain any required import permits.

Additional shipping charges for international and non-continental U.S. locations may apply. Please contact Customer Service at [email protected] for more information.

2020 Shipping ScheduleBelow is a general shipping schedule. A printable shipping and reporting schedule is available on our website. Shipping dates will also be printed on your order confirmation.

1st Event 2nd Event 3rd Event

Chemistry - Core January 13 May 18 August 24

Chemistry - Miscellaneous April 20 - October 12

Hematology/Coagulation/Urinalysis March 9 July 6 November 2

Immunology/Immunohematology March 30 August 3 November 30

Microbiology February 10 June 15 September 21

Enrollment Information

a. Email your order to [email protected]. Fax the order form to us at 855-900-6119c. Call us at 800-333-0958 and speak with a Customer Service Representatived. Mail orders to: American Proficiency Institute Department 9526 P.O. Box 30516 Lansing, MI 48909-8016

a. Shipping Addressb. Billing Address (if different than shipping address)c. Regulatory Information (CLIA number, CAP, TJC, or COLA, etc. )d. Payment Method If paying by check, mail to: American Proficiency Institute Department 9526 P.O. Box 30516 Lansing, MI 48909-8016

a. Mark your calendar with the shipment dates. If your kit does not arrive within 3 business days after the shipment date, call us so we can track the kit or issue a replacement.b. Inspect your kit immediately upon receipt. Call us within 3 days if any sample is missing or damaged to request a replacement. Please call prior to discarding any damaged samples or refusing a kit.

Enrollment (continued)c. Read the instructions carefully before beginning a test. Some samples require special handling before testing.d. Keep a copy of any result forms mailed to API.

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API Proficiency Testing Programs are CAP Accepted!We are pleased to report that the College of American Pathologists continues to accept proficiency testing programs from the American Proficiency Institute. This means CAP accredited laboratories can use API’s proficiency testing programs. Please refer to the index on pages 106 through 109 for a complete listing of CAP accepted analytes. API programs are also accepted by CMS, COLA, TJC, and state regulatory agencies including New York state.

Track Proficiency Performance using API DataDashboardWith API’s DataDashboard, laboratories can quickly and easily view proficiency testing performance over the most recent six test events. The dashboard includes trend data by analyte, percentage of acceptable results compared to all API labs, failure count by test event, and analytes with unsatisfactory performance. Customers can log in to their API Paperless PT account to access their dashboard. Contact us at [email protected] or call us if you need assistance.

Automated Proficiency Results with API DataDirectUsing their laboratory information system (LIS) or middleware, laboratories may now transmit proficiency testing results directly to API, a process that revolutionizes proficiency testing for clinical laboratories. No more manual data entry, no more clerical errors, no new technology systems to purchase, and no additional fees! DataDirect is easy to use and saves time! Contact us at [email protected] or call us for a demonstration and free Test Drive.

New 2020 Programs!

• Carbapenem-resistant Organisms - catalog #380 on page 63.• Coagulation, Supplemental - add on option to 217 - catalog #283 on page 45.• Extended Bacteriology - Educational - catalog #383 on page 65.• Molecular Virology - catalog #381 on page 84.• Mycoplasma genitalium (molecular) - catalog #384 on page 70.• Norovirus - catalog #379 on page 84.• Rapid Malaria - catalog #382 on page 80.• SARS-CoV2 - catalog #385 on page 85.• Strep Pharyngeal (molecular) (Verification) - catalog #C64 on page 72.

If you have any questions or need assistance with ordering, please email [email protected] or call us at 800-333-0958. Visit our website, api-pt.com, to view our catalog and shipping schedule.

2020 Highlights

API is ISO Accredited!We are proud to be accredited as a proficiency testing provider to the requirements of ISO/IEC 17043:2010. We are accredited by the American Association for Laboratory Accreditation (A2LA) under certificate number 3094.01 (www.A2LA.org). A2LA is a signatory to all existing International Accreditation Forum (IAF) international recognition agreements. Programs included under the scope of this accreditation are marked with a in this catalog.* Evaluations for accredited analytes can be used by ISO 15189-accredited laboratories to fulfill PT requirements.

*Printed versions of the catalog may not have the most current scope information; please see online catalog for current status.

Enhanced 2020 Programs!

• Body Fluid Cell Count - C - MN, PMN, TC-BF added - catalog #206 on page 35.• Comprehensive Bacteriology - Stool Culture now includes reporting for Aeromonas, Plesiomonas, Vibrio, and Yersinia - catalog #328 on page 64.• Comprehensive Chemistry - Cholinesterase added - catalog #122 & A22 on page 7.• Pneumonia Panel - now includes 5 samples - catalog #378 on page 88.• Sedimentation Rate - E - now offering 3 samples 3 times per year - catalog #280 on page 40.

New 5 sample options for 2020!

The following programs are now available as 5 samples, 3 times per year, for laboratories preparing for potential regulatory changes.

• High Sensitivity CRP - 5 - catalog #443 on page 94.• Immunoassay - 5 - catalog #180 on page 17.• Immunoassay - Special - 5 - catalog #182 on page 17.• Tumor Markers - 5 - catalog #183 on page 23.

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Basic Chemistry

Program Description5 mL serum - Cholestech users see catalog #176/976 - Lipid Plus on page 19. For quantitative HCG, see catalog #409 - Serum HCG on page 21.

Analytes

ALT (SGPT)

Bilirubin, total

Cholesterol

Glucose

Potassium

Urea Nitrogen (BUN)

AST (SGOT)

Calcium

CO2

HDL Cholesterol

Sodium

Uric Acid

Bilirubin, direct

Chloride

Creatinine

LDL, calculated and measured

Triglycerides

Format5 samples x 3 shipments

Shipping DatesJan. 13, May 18, Aug. 24

Program Information121 Basic Chemistry A21 Basic Chemistry - Verification Program141 Additional Sample Volume

CHEMISTRY

Chemistry - Endocrinology

Program Description5 mL serum - OCD Vitros labs performing thyroid tests, see catalog #175 - Thyroid - Special on page 22. For quantitative HCG, see catalog #409 - Serum HCG on page 21.

Analytes

Alpha-fetoprotein

Free T4

Triiodothyronine (T3)

Cortisol

T Uptake

TSH

Free T3

Thyroxine (T4)



Program Information125 Chemistry - Endocrinology

All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.

Program is included in our A2LA scope of accreditation.


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Comprehensive Chemistry

Program Description5 mL serum - OCD Vitros labs performing thyroid tests, see catalog #175 - Thyroid - Special on page 22. Cholestech users see catalog #176/976 - Lipid Plus on page 19. For quantitative HCG, see catalog #409 - Serum HCG on page 21.

Program Information122 Comprehensive Chemistry A22 Comprehensive Chemistry - Verification Program141 Additional Sample Volume

Analytes

Albumin

ALT (SGPT)

Bilirubin, direct

Calcium, ionized

Cholinesterase NEW

Creatine Kinase (CK)

Glucose

Lactic Acid

Lipase

Phosphorus

T Uptake

TIBC, measured

Total Protein

TSH

Uric Acid

Alkaline Phosphatase

Amylase

Bilirubin, total

Chloride

CO2

Creatinine

HDL Cholesterol

LDH

Magnesium

Potassium

Thyroxine (T4)

Free T3

Triglycerides

UIBC, measured

Alpha-fetoprotein

AST (SGOT)

Calcium

Cholesterol

Cortisol

GGT

Iron

LDL, calc. and measured

Osmolality

Sodium

TIBC (iron based calculation)

Free T4


Urea Nitrogen (BUN)




Analyte is not CAP accepted. Program is included in our A2LA scope of accreditation.

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Program Description5 mL serum - For waived methods. Cholestech users see catalog #976 - Lipid Plus - 2 samples on page 19.



Program Information144 Chemistry - waived A44 Chemistry - waived - Verification Program

Analytes

Albumin

Amylase

Calcium

CO2

GGT

LDL, calc. and measured

Sodium

Urea Nitrogen (BUN)


AST (SGOT)

Chloride

Creatine Kinase (CK)

Glucose

Phosphorus

Total Protein

Uric Acid

ALT (SGPT)

Bilirubin, total & direct

Cholesterol

Creatinine

HDL Cholesterol

Potassium

Triglycerides

Alcohol

Program Description2 mL serum - For quantitative alcohol and qualitative acetone (ketone) testing, such as Bayer Acetest. For quantitative Beta-hydroxybutyrate testing, see catalog #174 - B-Ketone on page 10.

Program Information137 Alcohol A37 Alcohol - Verification Program

Analytes

Acetone Alcohol






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Ammonia

Program Description2 mL serum

Program Information138 Ammonia A38 Ammonia - Verification Program

Analytes

Ammonia


Shipping DatesApr. 20, Oct. 12

Amniotic Fluid pH

Program Description0.5 mL simulated amniotic fluid - For Nitrazine methods.



AnalytespH (nitrazine) pH (interpretation)

Program Information166 Amniotic Fluid pH

Apolipoproteins




AnalytesApolipoprotein A1 Apolipoprotein B Lipoprotein (a)

Program Information130 Apolipoproteins



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Program Description1 mL liquid - For quantitative Beta-hydroxybutyrate testing performed on chemistry analyzers or whole blood glucometers. For qualitative testing using Bayer Acetest, see catalog #137 - Alcohol on page 8.



AnalytesBeta-hydroxybutyrate

Program Information174 B-Ketone

Blood Gas

Program Description3 mL ampule - For i-STAT see catalog #145 - i-STAT Chemistry on page 18.

Program Information111 Blood Gas A11 Blood Gas - Verification Program

Analytes

pCO2 pH pO2






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Blood Gas Plus

Program Description3 mL ampule - For combination blood gas/electrolyte analyzers with or without hematocrit option. For i-STAT see catalog #145 - i-STAT Chemistry on page 18.

Program Information112 Blood Gas Plus A12 Blood Gas Plus - Verification Program

Analytes



pCO2

BUN

Creatinine

Hemoglobin, calculated

Potassium

pH

Calcium, ionized

Glucose

Lactate

Sodium

pO2

Chloride

Hematocrit

Magnesium, ionized

tCO2


Blood Lead - 5

Program Description1 mL hemolysate - Designed for LeadCare I, Plus, and Ultra.

Program Information172 Blood Lead - 5

Analytes

Lead




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Program Description1 mL hemolysate - Designed for the LeadCare II.

Program Information173 Blood Lead - waived

Analytes

Lead



Blood Oximetry

Program Description2 mL ampule - Hemoglobin source is bovine.

Program Information114 Blood Oximetry A14 Blood Oximetry - Verification Program

Analytes

Carboxyhemoglobin

Methemoglobin

Hematocrit, calculated

Oxyhemoglobin

Hemoglobin, total





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Cardiac Markers - 5

Program Description1.5 mL liquid - CAP accredited labs must test five samples for all Cardiac Markers except D-dimer, Myoglobin, and waived BNP.

Program Information140 Cardiac Markers - 5 A40 Cardiac Markers - Verification Program165 Additional Sample Volume



Analytes

BNP

D-dimer

Troponin I

CK, total

Myoglobin

Troponin T ( qualitative)

CK-MB

NT pro-BNP

Cardiac Markers - 2

Program Description1.5 mL liquid - CAP accredited labs must test five samples for all Cardiac Markers except D-dimer, Myoglobin, and waived BNP.

Program Information920 Cardiac Markers - 2 J20 Cardiac Markers - Verification Program

Analytes

BNP ( non-waived)

NT pro-BNP

D-dimer

Troponin I

Myoglobin

Troponin T






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Program Information170 Cystatin C

Analytes

Cystatin C



Program Information142 Fetal Fibronectin

Fetal Fibronectin

Program Description1 mL liquid

Analytes

Fetal Fibronectin



Program Information131 Fetal ROM

Fetal ROM

Program Description0.5 mL simulated amniotic fluid for ROM methods. Compatible with Actim Prom, AmniSure ROM, and Clinical Innovations ROM Plus.

Analytes

Fetal Membranes Rupture Test





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Program Information135 Fructosamine

Fructosamine


Analytes

Fructosamine



Glycohemoglobin

Program Description0.7 mL hemolysate - CAP accredited labs using a non-waived method must test five samples for glycohemoglobin. For Afinion see catalog #134 - Glycohemoglobin - whole blood on page 16.

Program Information126 Glycohemoglobin - 5 samples 179 Glycohemoglobin - Additional Sample Volume - 5 samples127 Glycohemoglobin - 2 samples 167 Glycohemoglobin - Additional Sample Volume - 2 samplesA27 Glycohemoglobin - Verification Program - 2 samples

Analytes

Glycohemoglobin (as HbA1c)

Format3 shipments



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Program Information134 Glycohemoglobin - whole blood

Glycohemoglobin - whole blood

Program Description0.5 mL liquid - For laboratories using Afinion analyzers for HbA1c testing.

Analytes

Glycohemoglobin (as HbA1c)



Program Information128 HemoCue - 5 samples 928 HemoCue - 2 samples J28 HemoCue - Verification Program - 2 samples

HemoCue

Program Description2.5 mL whole blood - For HemoCue 201 Series and HemoCue 301 analyzers.

Analytes

Glucose Hemoglobin

Format3 shipments



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Immunoassay


Program Information180 Immunoassay - 5 samples

133 Immunoassay - 2 samples A33 Immunoassay - Verification Program - 2 samples

Analytes

CEA

Estriol

Folate

LH

Progesterone

Testosterone

Vitamin B12

DHEA-S

FSH

Growth Hormone NEW

PAP

Prolactin

TIBC (transferrin based calc)

Estradiol

Ferritin

Homocysteine

Prealbumin

PSA, total

Transferrin

Format3 shipments



Immunoassay - Special

Program Description2 mL lyophilized serum

Program Information182 Immunoassay - Special - 5 samples NEW

160 Immunoassay - Special - 2 samples A60 Immunoassay - Special - Verification Program

Analytes

25-OH Vitamin D

Insulin

C-peptide

PTH

Gastrin

Format3 shipments



Enhanced!!

Enhanced!!

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i-STAT Chemistry - waived

Program Description3 mL ampule - For i-STAT analyzers for waived testing or non-scored analytes.

Program Information945 i-STAT Chemistry - waived J45 i-STAT Chemistry - waived - Verification Program

Analytes

Calcium, ionized

Glucose

Lactate

tCO2

Chloride

Hematocrit

Potassium

Urea Nitrogen (BUN)

Creatinine

Hemoglobin

Sodium



i-STAT Chemistry

Program Description3 mL ampule - For ACT testing see catalog #215 - i-STAT ACT on page 49. For BNP, CK-MB, & Troponin I, see catalog #140/920 - Cardiac Markers programs on page 13. For quantitative hCG see catalog #409 - Serum HCG on page 21.

Program Information145 i-STAT Chemistry A45 i-STAT Chemistry - Verification Program

Analytes

pCO2

Calcium, ionized

Glucose

Lactate

tCO2

pH

Chloride

Hematocrit

Potassium

Urea Nitrogen (BUN)

pO2

Creatinine

Hemoglobin

Sodium






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Lipid Plus

Program Description1 mL serum - For laboratories using the Cholestech analyzer. Catalog #976 is not scored for CMS.

Program Information176 Lipid Plus - 5 samples 976 Lipid Plus - 2 samples

Analytes

Cholesterol

LDL Cholesterol, calc.

Glucose

Triglycerides

HDL Cholesterol

Format3 shipments



Program Information208 Lamellar Body Count

Lamellar Body Count

Program Description2 mL liquid - For lamellar body counts performed on Hematology analyzers.

Analytes

Lamellar Body Count





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Program Information169 Procalcitonin

Procalcitonin

Program Description1 mL lyophilized samples

Analytes

Procalcitonin





Neonatal Bilirubin

Program Description1 mL serum - Bilirubin levels targeted to be representative for those seen in newborns. Catalog #129 is not scored for CMS.

Program Information147 Neonatal Bilirubin - 5 samples 129 Neonatal Bilirubin - 2 samples A29 Neonatal Bilirubin - Verification Program - 2 samples

Analytes

Bilirubin, direct Bilirubin, total

Format3 shipments



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Serum HCG

Program Description1 mL serum - For quantitative and qualitative serum HCG methods. Due to CLIA regulations, to report results for both quantitative and qualitative serum HCG, order catalog #409 and #D09.

Program Information409 Serum HCG D09 Serum HCG - Verification Program

Analytes

HCG





Program Information171 SHBG and Testosterone

SHBG and Testosterone

Program Description2 mL lyophilized samples

Analytes

Sex Hormone Binding Globulin

Testosterone, free ( measured)

Testosterone, bioavailable Testosterone, total




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Program Information175 Thyroid - Special

Thyroid - Special

Program Description0.75 mL serum - Designed for the OCD Vitros analyzers.

Analytes

Free T3


Free T4

TSH

Thyroxine (T4)

T Uptake




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Program Information132 Therapeutic Drugs 136 Therapeutic Drugs - add on option to #121 or 122 A36 Therapeutic Drugs - Verification Program

Analytes

Acetaminophen

Digoxin

Lithium

Salicylates

Valproic Acid

Amikacin

Gentamicin

Phenobarbital

Theophylline

Vancomycin

Carbamazepine

Lidocaine

Phenytoin

Tobramycin




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Tumor Markers


Analytes

Beta-2 Microglobulin

CA 19-9

PSA, free

Thyroglobulin

CA 125

CA 27.29

PSA, total

CA 15-3

CEA

PSA, complexed

Format3 shipments


Program Information183 Tumor Markers - 5 samples NEW

150 Tumor Markers - 2 samples


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Enhanced!!

Whole Blood Glucose

Program Description2 mL whole blood - For waived blood glucose meters. Per CMS, only one set of proficiency results may be reported. Facilities using more than one meter should also enroll in X23, A23, X18, or J18.

Program Information123 Whole Blood Glucose - 5 samples X23 Extra results Whole Blood Glucose - Verification Program - report results for up to 20 additional meters using #123 samples A23 Whole Blood Glucose - Verification Program - report up to 20 results - 5 samples918 Whole Blood Glucose - 3 samples X18 Extra results Whole Blood Glucose - Verification Program - report results for up to 20 additional meters using #918 samplesJ18 Whole Blood Glucose - Verification Program - report up to 20 results - 3 samples

Analytes

Glucose

Format2 shipments



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CSF & Body Fluid Chemistry

Program DescriptionCSF Chemistry - 3 samples; Body Fluid Chemistry - 3 samples. For Manual Cell Count and Body Fluid Crystals see catalog #277 - Cell Count & Body Fluid Crystals on page 36.

Analytes - CSF Chemistry

Analytes - Body Fluid Chemistry

Albumin

IgG

Sodium

Chloride

Lactic Acid

Total Protein

Glucose

LDH

Albumin

Bilirubin, total

Cholesterol

LDH

Potassium

Triglycerides


Calcium

Creatinine

Lipase

Sodium

Urea Nitrogen

Amylase

Chloride

Glucose

pH

Total Protein

Uric Acid



Program Information177 CSF & Body Fluid Chemistry


Program Information148 Ethyl Glucuronide

Ethyl Glucuronide

Program Description5 mL urine - For qualitative testing.

Analytes

Ethyl glucuronide (EtG)




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Micro

Program Information236 Microalbumin

Microalbumin

Program Description3 mL urine - For semi-quantitative dipstick or quantitative analysis. Recommended for Afinion users. If your lab is also performing other urine chemistry tests, see catalog #143 - Urine Chemistry on page 26.

Analytes

Microalbumin Urine Creatinine



Program Information163 Sweat Analysis

Sweat Analysis

Program Description5 mL liquid - For sweat analysis.

Analytes

Chloride (qualitative)

Osmolality

Chloride (quantitative)

Sodium

Conductivity



Analyte is not CAP accepted.


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Urine Chemistry

Program Description10 mL urine - For quantitative analysis. If your lab is performing only microalbumin and/or creatinine, or for the Afinion microalbumin, see catalog #236 - Microalbumin on page 25.

Analytes

Amylase

Creatinine

Microalbumin

Potassium

Urea

Calcium

Glucose

Osmolality

Sodium

Uric Acid

Chloride

Magnesium

Phosphorus

Total Protein



Program Information143 Urine Chemistry

Program Information146 Urine Adulteration Test

Urine Adulteration Test

Program Description10 mL urine - Qualitative or quantitative tests for urine adulteration. For Urine Drug Screen see catalog #139 on page 27.

Analytes

Creatinine

pH

Nitrite

Specific Gravity

Oxidants





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Urine Drug Screen

Program Description10 mL urine - Qualitative or quantitative tests for urine drug screen.

Program Information139 Urine Drug Screen (qual)

A39 Urine Drug Screen - Verification Program

Analytes

6-Acetylmorphine

Amphetamines

Buprenorphine

Cocaine Metabolites

Fentanyl

MDMA

Methamphetamines

Oxycodone

Tramadol

Acetaminophen

Barbiturates

Cannabinoids

Cotinine

Hydrocodone

Meperidine

Methaqualone

Phencyclidine

Tricyclic Antidepressants

Alcohol

Benzodiazepines

Carisoprodol

EDDP

LSD

Methadone

Opiates

Propoxyphene

Zolpidem



Only qualitative testing is included in our A2LA scope of accreditation.

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HEMATOLOGY - 2 & 3-PART DIFFERENTIAL PROGRAMS

Hematology - 3

Program Description2 mL simulated whole blood - For automated techniques, including 2 and 3-part differentials or manual techniques for hematocrit, WBC (ammonium oxalate only), and platelet count.


Shipping DatesMar. 9, Jul. 6, Nov. 2

Program Information221 Hematology - 3 B21 Hematology - 3 - Verification Program

Analytes

Automated Differential

MCH

MPV

RDW

Hematocrit

MCHC

Platelet Count

WBC

Hemoglobin

MCV

RBC

Hematology - 3S

Program Description2 mL simulated whole blood - For the CDS Medonic M-Series, Sysmex KX Series, pocH-100i, and XP-300.



Program Information227 Hematology - 3S B27 Hematology - 3S - Verification Program

Analytes


MCH

MPV

RDW-CV

Hematocrit

MCHC

Platelet Count

RDW-SD

Hemoglobin

MCV

RBC

WBC



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Program Information222 QBC Hematology

QBC Hematology

Program Description1.4 mL simulated whole blood - For use with QBC analyzers.



Analytes

Granulocytes

Lymph/Mono

Hematocrit

Platelet count

Hemoglobin

WBC

5-PART DIFFERENTIAL PROGRAMS

Hematology - 5A

Program Description2.5 mL simulated whole blood - For the Horiba Medical Pentra 60, 60+, 80, 120 and the Coulter AcT 5-Diff.



Program Information231 Hematology - 5A B31 Hematology - 5A - Verification Program

Analytes


MCH

MPV

RDW

Hematocrit

MCHC

Platelet Count

WBC

Hemoglobin

MCV

RBC


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Hematology - 5B

Program Description4 mL simulated whole blood - For the Siemens Advia 120, 2120, and 2120i.



Program Information240 Hematology - 5B B40 Hematology - 5B - Verification Program

Analytes


MCH

MPV

RDW

Hematocrit

MCHC

Platelet Count

WBC

Hemoglobin

MCV

RBC

Hematology - 5C

Program Description2 mL simulated whole blood - For the Coulter UniCel DxH600, DxH800, DxH900, and LH750, LH755, LH780, LH785.



Program Information230 Hematology - 5C B30 Hematology - 5C - Verification Program

Analytes


IRF

MCV

Platelet Count

RDW-SD

Hematocrit

MCH

MPV

RBC

Reticulocyte Count

Hemoglobin

MCHC

nRBC

RDW-CV

WBC



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Hematology - 5C2

Program Description2 mL simulated whole blood - For the Coulter LH500 and HmX.



Program Information220 Hematology - 5C2 B20 Hematology - 5C2 - Verification Program

Analytes


MCH

MPV

RDW-CV

Hematocrit

MCHC

Platelet Count

WBC

Hemoglobin

MCV

RBC

Hematology - 5D

Program Description3 mL simulated whole blood - For the Abbott Cell-Dyn 3000-3700, 4000, Ruby, Sapphire, and the Diatron Abacus 5.



Program Information242 Hematology - 5D B42 Hematology - 5D - Verification Program

Analytes


IRF

MCV

Platelet Count

Reticulocyte Count

Hematocrit

MCH

MPV

RBC

WBC

Hemoglobin

MCHC

nRBC

RDW



HE

MA

TO

LO

GY

32 800.333.0958 | www.api-pt.com


Hematology - 5M

Program Description3 mL simulated whole blood - For the Mindray 5000 series analyzers.



Analytes


MCH

MPV

RDW-CV

Hematocrit

MCHC

Platelet Count

RDW-SD

Hemoglobin

MCV

RBC

WBC

Program Information226 Hematology - 5M

Hematology - 5H

Program Description2.5 mL simulated whole blood - For the Coulter DxH500 and DxH520.



Program Information279 Hematology - 5H

Analytes


MCH

MPV

RDW-CV

Hematocrit

MCHC

Platelet Count

RDW-SD

Hemoglobin

MCV

RBC

WBC



HE

MA

TO

LO

GY

33800.333.0958 | www.api-pt.com


Hematology - 5S

Program Description2 mL simulated whole blood - For all Sysmex XE, XN, XS, and XT analyzers.



Analytes


IG# and IG%

MCH

MPV

RBC

RET-He

Hematocrit

IPF

MCHC

nRBC

RDW-CV

Reticulocyte Count

Hemoglobin

IRF

MCV

Platelet Count

RDW-SD

WBC

Program Information238 Hematology - 5S B38 Hematology - 5S - Verification Program


HE

MA

TO

LO

GY

34 800.333.0958 | www.api-pt.com


BLOOD CELL IDENTIFICATION

For laboratories that perform both Blood Cell Identification and Automated Differentials:CMS allows for the transmission of only one of these scores each test event. Results for both tests are graded and will appear on your evaluation, but only one score can be sent to CMS. If you would like your score for Blood Cell ID to be sent to CMS, enroll in catalog #224. If you would like your score for auto differential to be sent to CMS, enroll in catalog #225.

Blood Cell Identification

Program DescriptionTwo virtual Wright stained peripheral blood smears for blood cell identification. One case study will include 5 annotated cells/objects for identification and will be graded. The second case study is educational and will include 5 annotated cells/objects for identification and a manual 100 WBC differential. This is a virtual program only and will not include printed photographs. If laboratories would like to receive printed photographs, add on catalog #286.

Format10 photographs x 3 shipments


AnalytesBlood Cell Identification Educational Blood Cell ID Manual Differential

Program Information224 Blood Cell ID (CMS Scored) (Virtual) 225 Blood Cell ID (Not CMS Scored) (Virtual) 286 Add-on Blood Cell ID Photographs

Program Information259 Advanced Blood Cell ID (Virtual)

Advanced Blood Cell ID (Virtual)

Program DescriptionOne virtual Wright stained peripheral blood smear for blood cell identification. The case study will include seven cells/objects chosen for ID and an educational commentary. This option is designed to offer case studies that are more challenging and complex. Not CMS scored or reported to CAP.



Analytes

Blood Cell Identification



HE

MA

TO

LO

GY

35800.333.0958 | www.api-pt.com

Program Information206 Body Fluid Cell Count - C

MISCELLANEOUS HEMATOLOGY

Body Fluid Cell Count - C

Program Description3 mL liquid - For Abbott, Coulter, Sysmex and Advia analyzers. For manual cell counts see catalog #277 - Cell Count & Body Fluid Crystals on page 36.

Format1 sample x 3 shipments


Analytes

Body Fluid Cell Count - I

Program Description4 mL liquid - For Iris IQ®. For manual cell counts see catalog #277 - Cell Count & Body Fluid Crystals on page 36.



Analytes

RBC Nucleated Cells

Program Information207 Body Fluid Cell Count – I



MN NEW

TC-BF NEW

PMN NEW

WBC

RBC

Enhanced!!

HE

MA

TO

LO

GY

36 800.333.0958 | www.api-pt.com

Program Information168 Body Fluid Microscopy (Virtual) 181 Add-on Body Fluid Microscopy Photographs

Program Information277 Cell Count & Body Fluid Crystals

Body Fluid MicroscopyProgram DescriptionThree online images for the identification of crystals and other formed elements/cells in various body fluids. This program includes 2 shipments per year. This is a virtual program only and will not include printed photographs. If laboratories would like to receive printed photographs, add on catalog #181.


Shipping DatesMar. 9, Nov. 2

Analytes

Identification of formed elements

Cell Count & Body Fluid Crystals

Program DescriptionManual Cell Count - 2 samples; Body Fluid Crystals - 2 samples. For CSF and Body Fluid Chemistry, see catalog #177 - CSF & Body Fluid Chemistry on page 24.



Analytes

Crystals

WBC Differential

RBC WBC



HE

MA

TO

LO

GY

37800.333.0958 | www.api-pt.com

Program Information229 Flow Cytometry

Flow Cytometry

Program Description2.5 mL simulated whole blood - For lymphocyte phenotyping.



Analytes

CD3 (T Cells)

CD19 (B Cells)

CD4 (T Helper)

CD45 (Leukocytes)

CD8 (T Cytotoxic)

CD56 / CD16+56 (NK Cells)


Program Information210 Fetal Hemoglobin

Fetal HemoglobinProgram Description1.2 mL simulated gastric fluid - For qualitative fetal hemoglobin. For Whole Blood Fetal Screen see catalog #515 - Fetal RBC on page 107.



Analytes

Fetal Hemoglobin (gastric fluid)

HE

MA

TO

LO

GY

38 800.333.0958 | www.api-pt.com

Program Information223 Reticulocyte Count

Reticulocyte Count

Program Description1 mL simulated whole blood - For manual (new methylene blue stain only) and automated reticulocyte techniques.



Analytes

Reticulocyte Count


HemoCue White Blood Cell Count

Program Description2 mL simulated whole blood - For HemoCue WBC System.



Analytes

WBC

Program Information209 HemoCue White Blood Cell Count



HE

MA

TO

LO

GY

39800.333.0958 | www.api-pt.com

Program Information202 Sedimentation Rate - C

Sedimentation Rate - C

Program Description6 mL simulated whole blood - For HemaTechnologies ESR STAT Plus and ESR STAT 6.



Analytes

Sedimentation Rate

Program Information201 Sedimentation Rate - B

Sedimentation Rate - B

Program Description6 mL simulated whole blood - For Polymedco Sedimat 15, 15 Plus.



Analytes

Sedimentation Rate

Program Information228 Sedimentation Rate - A

Sedimentation Rate - A

Program Description5 mL simulated whole blood - For manual methods and most automated methods.



Analytes

Sedimentation Rate




HE

MA

TO

LO

GY

40 800.333.0958 | www.api-pt.com

Sedimentation Rate - D

Program Description4.5 mL simulated whole blood - For the Alcor i-SED and Alcor miniiSED.



Analytes

Sedimentation Rate

Program Information203 Sedimentation Rate - D

Sedimentation Rate - E

Program Description3 mL simulated whole blood - For Alifax ESR analyzers.

Shipping3 samples x 3 shipments


Analytes

Sedimentation Rate

Program Information280 Sedimentation Rate - E

Program Information237 Sickle Cell Screen

Sickle Cell Screen

Program Description2.5 mL simulated whole blood - For screening kits and electrophoresis screening methods.



Analytes

Sickle Cell Screen



Enhanced!!

HE

MA

TO

LO

GY

41800.333.0958 | www.api-pt.com

Program Information154 Antisperm Antibody

Program Information185 Automated Post-Vasectomy Sperm Analysis

ANDROLOGY

Antisperm Antibody

Program Description0.5 mL serum - Human serum for antisperm antibody.



Analytes Antisperm Antibody

Automated Post-Vasectomy Sperm Analysis

Program Description1.0 mL stabilized sperm - Designed for automated sperm analyzers.



Analytes

Sperm Count Sperm, presence/absence


Program Information184 Automated Sperm Count

Automated Sperm Count

Program Description1.0 mL stabilized sperm - Designed for automated sperm analyzers.



Analytes

Sperm Count


AN

DR

OL

OG

Y

NEW!!

NEW!!

42 800.333.0958 | www.api-pt.com

Program Information162 Post-Vasectomy Sperm Analysis

Post-Vasectomy Sperm Analysis

Program Description0.3 mL stabilized sperm sample



Analytes

Sperm Count Sperm, presence/absence


Program Information151 Sperm Count

Sperm Count

Program Description0.3 mL stabilized sperm sample



Analytes

Sperm Count


Sperm Morphology

Program Description1 unstained semen smear and 1 virtual image (online only) for specific sperm morphology.



Analytes

Sperm Morphology

Program Information152 Sperm Morphology

AN

DR

OL

OG

Y

43800.333.0958 | www.api-pt.com

Program Information161 Sperm Motility (Virtual)

Sperm Motility (Virtual)

Program DescriptionWeb based video footage for sperm motility and progressive motility.



AnalytesSperm Motility Sperm Progressive Motility

Program Information153 Sperm Viability

Sperm Viability

Program DescriptionGlass slides - Eosin-Nigrosin stained smears.



Analytes

Sperm Viability

AN

DR

OL

OG

Y

44 800.333.0958 | www.api-pt.com

COAGULATION

Program Description3 mL lyophilized samples - For the Hemochron Response, 801, Helena Laboratories Actalyke, and Cascade POC.

Format3 shipments


Analytes

Activated Clotting Time

Program Information211 Activated Clotting Time - 5 samples916 Activated Clotting Time - 2 samplesJ16 Activated Clotting Time - Verification Program - 2 samples

Activated Clotting Time (Hemochron/Helena)

Program Description3 mL lyophilized samples - For the Medtronic ACT and HMS Plus.

Analytes


Program Information212 Activated Clotting Time - 5 samples917 Activated Clotting Time - 2 samplesJ17 Activated Clotting Time - Verification Program - 2 samples

Activated Clotting Time (Medtronic)

Format3 shipments


CO

AG

UL

AT

ION

45800.333.0958 | www.api-pt.com

CO

AG

UL

AT

ION

Program Description1 mL lyophilized plasma - For plasma-based coagulation analyzers.



Analytes

APTT

Prothrombin Time

Fibrinogen INR

Program Information217 Coagulation B17 Coagulation - Verification Program

Coagulation

Program Description1 mL lyophilized plasma



Analytes

Antithrombin III Activity

Factor VII Activity

Factor X Activity

Plasminogen

Thrombin Time

Factor II Activity

Factor VIII Activity

Factor XI Activity

Protein C

Factor V Activity

Factor IX Activity

Factor XII Activity

Protein S

Program Information281 Coagulation, Supplemental282 Additional Sample Volume283 Coagulation, Supplemental - add on to 217 NEW

Coagulation, Supplemental


Enhanced!!


46 800.333.0958 | www.api-pt.com

Program Information245 D-dimer - Qualitative

Program Description0.5 mL plasma - For qualitative D-dimer methods.



Analytes

D-dimer

D-dimer - Qualitative

Program Description0.5 mL plasma - For quantitative D-dimer methods.



Analytes

D-dimer

Program Information246 D-dimer - Quantitative B46 D-dimer - Quantitative - Verification Program

D-dimer - Quantitative

Program Description0.7 mL lyophilized samples - For the Hemochron Jr., Signature, Signature +, Signature Elite, and IL Gem PCL. For use with ACT + Cuvette.



Analytes


Program Information248 Hemochron Jr. ACT +B48 Hemochron Jr. ACT + - Verification Program

Hemochron Jr. ACT +



CO

AG

UL

AT

ION

47800.333.0958 | www.api-pt.com

CO

AG

UL

AT

ION

Program Description0.7 mL lyophilized samples - For the Hemochron Jr., Signature, Signature +, Signature Elite, and IL Gem PCL. For use with ACT-LR cuvette.



AnalytesActivated Clotting Time

Program Information247 Hemochron Jr. ACT - LRB47 Hemochron Jr. ACT - LR - Verification Program

Hemochron Jr. ACT - LR

Program Information252 Hemochron Jr. Citrate APTT

Program Description0.7 mL lyophilized samples - For the Hemochron Jr. II, Signature, Signature +, Signature Elite. For use with Citrate cuvette.



Analytes

APTT

Hemochron Jr. Citrate APTT


48 800.333.0958 | www.api-pt.com


Program Description0.7 mL lyophilized samples - For the Hemochron Jr. Signature, Signature +, Signature Elite, IL Gem PCL, and Gem PCL Plus. For use with whole blood cuvette.



Analytes

INR Prothrombin Time

Program Information250 Hemochron Jr. PT

Hemochron Jr. PT

Program Information249 Hemochron Jr. Citrate PT

Program Description0.7 mL lyophilized samples - For the Hemochron Jr. II, Signature, Signature +, Signature Elite. For use with Citrate cuvette.



Analytes


Hemochron Jr. Citrate PT

CO

AG

UL

AT

ION

49800.333.0958 | www.api-pt.com

CO

AG

UL

AT

ION

Program Information278 Heparin Assay

Program Description1.0 mL lyophilized plasma - For testing Low Molecular Weight Heparin (LMWH) and Unfractionated Heparin (UFH) levels. Not CMS scored or reported to CAP.



AnalytesAnti-Xa

Prothrombin Time

APTT

Thrombin Time

INR

Heparin Assay

Program Description1 mL lyophilized samples - For the i-STAT analyzer.



Analytes


Program Information215 i-STAT ACT B15 i-STAT ACT - Verification Program

i-STAT ACT

Program Information255 Platelet Function - Aspirin Test

Program DescriptionPellet - For aspirin-induced inhibition. Designed for use with the Accumetrics VerifyNow System.



AnalytesAspirin induced inhibition

Platelet Function - Aspirin Test



50 800.333.0958 | www.api-pt.com

Program Information256 Platelet Function - PRUTest

Program DescriptionPellet - For P2Y12 inhibition (Plavix® and Effient®). Designed for use with Accumetrics VerifyNow System.



AnalytesP2Y12 inhibition

Platelet Function - PRUTest

Program DescriptionLyophilized plasma - Point of Care coagulation for CoaguChek XS (INR only), XS Plus, and XS Pro. Catalog #914 is not CMS scored or reported to CAP.

Format3 shipments


Analytes


Program Information214 POC Coagulation A - 5 samplesB14 POC Coagulation A - Verification Program - 5 samples914 POC Coagulation A - 2 samplesJ14 POC Coagulation A - Verification Program - 2 samples

POC Coagulation A

CO

AG

UL

AT

ION


51800.333.0958 | www.api-pt.com


CO

AG

UL

AT

ION

Program Description1 mL lyophilized samples - Point of Care coagulation for i-STAT PCA, i-STAT I, and Coag-Sense (CoaguSense).



AnalytesINR Prothrombin Time

Program Information216 POC Coagulation B B16 POC Coagulation B - Verification Program

POC Coagulation B

Program Information244 Thromboelastogram

Program Description1 mL lyophilized samples - For the Haemonetics Thromboelastograph® and TEM International ROTEM® analyzers.



AnalytesThromboelastometry

Thromboelastogram


52 800.333.0958 | www.api-pt.com

URINALYSIS, MICROSCOPY, & MISCELLANEOUS TESTS

Program Information270 Automated Urine Microscopy - I

Program Description10 mL simulated urine - Designed for IRIS instruments.



AnalytesCrystals

WBC

Non-Squamous Epithelial Cells

RBC

Automated Urine Microscopy - I

Program Description10 mL simulated urine - Designed for Sysmex and the Arkray Aution AU-4050.



AnalytesBacteria

Epithelial Cells

Casts

RBC

Crystals

WBC

Automated Urine Microscopy - S

Program Information271 Automated Urine Microscopy - S

Program Information261 Fecal Lactoferrin

Program Description0.5 mL simulated stool samples - For qualitative detection of fecal lactoferrin.



AnalytesFecal Lactoferrin

Fecal Lactoferrin




UR

INA

LYS

IS,

MIC

RO

SC

OP

Y,

& M

ISC

EL

LA

NE

OU

S T

ES

TS

53800.333.0958 | www.api-pt.com

UR

INA

LYS

IS, M

ICR

OS

CO

PY,

& M

ISC

EL

LA

NE

OU

S T

ES

TS

Program Description1.5 mL simulated stool samples - For Guaiac or Immunoassay methods.



AnalytesFecal Occult Blood

Program Information284 Fecal Occult Blood 285 Fecal Occult Blood - add on option to #232 or 272 B84 Fecal Occult Blood - Verification Program

Fecal Occult Blood

Program Description2 mL simulated gastric samples - For gastric occult blood and pH.



AnalytesGastric Occult Blood pH

Program Information239 Gastric Occult Blood B39 Gastric Occult Blood - Verification Program

Gastric Occult Blood



54 800.333.0958 | www.api-pt.com

Program DescriptionOnline images for microscopy. For KOH preparations of skin, hair, or nails, see catalog #333 - KOH Preparation on page 78. This program includes two challenges for urine sediment and one challenge for all others. This is a virtual program only and does not include printed photographs. If laboratories would like to receive printed photographs, add on catalog #287.

Format3 shipments


Analytes

Fecal WBC

Pinworm Preparation

Vaginal Wet Prep

Fern Test

Sperm, pos/neg ( post-vas)

Vaginal Wet Prep (KOH)

Nasal Smear

Urine Sediment

Program Information233 Microscopy Package (Virtual) 287 Add-on Microscopy PhotographsB33 Microscopy Package (Virtual) - Verification Program

Microscopy Package

Program Information260 Rapid Urease

Program DescriptionSimulated gastric biopsy samples - For use with CLOtest, PyloriTek, or similar methods.


Shipping DatesFeb. 10, Sep. 21

AnalytesUrease

Rapid Urease



UR

INA

LYS

IS,

MIC

RO

SC

OP

Y,

& M

ISC

EL

LA

NE

OU

S T

ES

TS

55800.333.0958 | www.api-pt.com

UR

INA

LYS

IS, M

ICR

OS

CO

PY,

& M

ISC

EL

LA

NE

OU

S T

ES

TS

Program Description10 mL urine - For dipstick analysis. HCG is intended for waived methods. For automated urine microscopy see catalog #270 and 271 on page 52. For Iris dipsticks, see catalog #272 - Urinalysis & HCG - I on page 55. For Fecal Occult Blood testing see catalog #285 - Fecal Occult Blood - add on, on page 53.



AnalytesBilirubin

Creatinine

Ketones

pH

Reducing Substance

Bilirubin, confirmatory

Glucose

Leukocyte Esterase

Protein

Specific Gravity

Blood/Hemoglobin

HCG

Nitrite

Protein, confirmatory

Urobilinogen

Program Information232 Urinalysis & HCG B32 Urinalysis & HCG - Verification Program

Urinalysis & HCG

Program Information272 Urinalysis & HCG - I

Program Description10 mL urine - For Iris iChem, iVelocity, and vChem dipstick analysis. HCG is intended for waived methods. For automated urine microscopy see catalog #270 and 271 on page 52. For Fecal Occult Blood testing see catalog #285 - Fecal Occult Blood - add on, on page 53.



AnalytesBilirubin

Glucose

Leukocyte Esterase

Protein

Specific Gravity

Bilirubin, confirmatory

HCG

Nitrite

Protein, confirmatory

Urobilinogen

Blood/Hemoglobin

Ketones

pH

Reducing Substance

Urinalysis & HCG - I



56 800.333.0958 | www.api-pt.com

Program Information273 Urine Crystals

Program Description1.5 mL urine - For identification of urine crystals.



AnalytesUrine Crystal Identification

Urine Crystals

Program Information258 Urine Eosinophils (Virtual) 289 Add-on Urine Eosinophils Photographs

Program DescriptionOne online image for the presence or absence of urine eosinophils. This is a virtual program only and will not include printed photographs. If laboratories would like to receive printed photographs, add on catalog #289.

Format1 photograph x 3 shipments


AnalytesUrine Eosinophils

Urine Eosinophils



UR

INA

LYS

IS,

MIC

RO

SC

OP

Y,

& M

ISC

EL

LA

NE

OU

S T

ES

TS

57800.333.0958 | www.api-pt.com

UR

INA

LYS

IS, M

ICR

OS

CO

PY,

& M

ISC

EL

LA

NE

OU

S T

ES

TS

Program Description1 mL simulated urine - For non-waived methods such as latex agglutination or FIA. Also may be ordered by laboratories that wish to test 5 samples.



AnalytesHCG

Program Information235 Urine HCG - Qualitative B35 Urine HCG - Qualitative - Verification Program

Urine HCG - Qualitative

Program DescriptionTwo online images for identification of formed elements in urine sediment. This is a virtual program only and will not include printed photographs. If laboratories would like to receive printed photographs, add on catalog #288.



Analytes

Urine Sediment

Identification of formed elements

Program Information234 Urine Sediment (Virtual) 288 Add-on Urine Sediment Photographs




58 800.333.0958 | www.api-pt.com

Program DescriptionFor waived methods and commonly performed microscopy procedures. HemoCue users see catalog #128/928 on page 16. For KOH preparations of skin, hair, or nails, see catalog #333 on page 78. The numbers shown to the right indicate the number of challenges per test event.

Format3 shipments


Analytes

Fecal Occult Blood (1)

Hematocrit (2)

Urine Sediment (2)

Whole Blood Glucose (2)

Group A Strep Antigen (2)

Hemoglobin (2)

Vaginal Wet Prep (1)

HCG (1)

Urinalysis (1)

Vaginal Wet Prep-KOH (1)

Program Information251 Waived & Microscopy Package X51 Extra Results WBG - Waived Package - Verification Program - report results for up to 20 additional glucose metersB51 Waived & Microscopy Package - Verification Program - for all analytes listed below

Waived & Microscopy Package


UR

INA

LYS

IS,

MIC

RO

SC

OP

Y,

& M

ISC

EL

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ES

TS

59800.333.0958 | www.api-pt.com

MIC

RO

BIO

LO

GY

Microbiology Enrollment Requirements

Programs listed that have fewer than five samples are to be used as add-on options to other programs in the same sub-specialty.

Susceptibility testing counts as one challenge regardless of the number of drugs reported.

Urine colony count is not a regulated test and cannot be included as one of the five challenges.

For assistance, please contact Technical Support at 800-333-0958 or [email protected].

CLIA requires laboratories performing microbiology tests that are regulated for proficiency testing to test five regulated challenges per test event in each sub-specialty where regulated testing is performed. The five sub-specialties are Bacteriology, Mycobacteriology, Mycology, Parasitology, and Virology. All non-waived tests in a sub-specialty can be combined to meet the five-challenge requirement. For molecular testing of direct specimens, CMS considers only bacteriology, virology, and yeast in blood cultures to be regulated tests. Regulated tests are indicated in bold type.

Challenges tested with waived methods (e.g., Rapid Group A Strep) cannot be included in the five regulated challenges. Furthermore, if one of your methods becomes waived or you change to a waived method mid-year, you are responsible for ensuring you maintain five challenges per test event for the remaining non-waived tests in that sub-specialty.

BACTERIOLOGY

Program Information324 Affirm VP

Program DescriptionSwab - For the BD Affirm VP III. For other rapid molecular methods see catalog #362 Trichomonas on page 80.


Shipping DatesFeb. 10, Jun. 15, Sep. 21

Affirm VP

AnalytesCandida sp. Gardnerella vaginalis Trichomonas vaginalis



60 800.333.0958 | www.api-pt.com


Program Information359 Bacterial Vaginosis

Program Description1 mL liquid - For OSOM BVBlue.



AnalytesBacterial Vaginosis Screen

Bacterial Vaginosis

Program DescriptionFor laboratories performing non-waived Group A Strep Antigen testing, Throat Cultures, and Urine Cultures. The numbers shown to the right of each analyte indicate the number of challenges per test event.



AnalytesGroup A Strep Antigen (2)

Urine Colony Count (1)

Susceptibility Testing (1)

Urine Culture (1)

Throat Culture (2)

Basic Bacteriology Package

Program Information321 Basic Bacteriology Package



MIC

RO

BIO

LO

GY

61800.333.0958 | www.api-pt.com


MIC

RO

BIO

LO

GY

Program Information361 Blood Culture

Program DescriptionPellet + 12 mL rehydration fluid - For aerobic and anaerobic Blood Cultures with susceptibility testing as indicated. Use as an add on to other Bacteriology programs.



Analytes

Blood Culture Susceptibility Testing

Blood Culture

Program Information363 Bordetella pertussis/parapertussis (molecular)

Program Description1 mL liquid - For molecular methods for Bordetella pertussis and Bordetella parapertussis. Use as an add on to other Bacteriology programs.



AnalytesBordetella pertussis Bordetella parapertussis

Bordetella pertussis/parapertussis (molecular)



62 800.333.0958 | www.api-pt.com


Program Description1 mL liquid - For C. difficile toxin / antigen test kits and molecular methods.

Format3 shipments


C. difficile Toxin/Antigen

Analytes

C. difficile Antigen C. difficile Toxin

Program Information350 C. difficile Toxin/Antigen - 5 samples 347 C. difficile Toxin/Antigen - Add on - 2 samples C47 C. difficile Toxin/Antigen - Verification Program - 2 samples

Program Information360 Campylobacter

Program DescriptionInocu-Swab II - For detection of Campylobacter sp. using antigen or culture methods. Use as an add on to other Bacteriology programs.



Campylobacter

AnalytesCampylobacter sp.



MIC

RO

BIO

LO

GY

63800.333.0958 | www.api-pt.com


MIC

RO

BIO

LO

GY

Program Information380 Carbapenem-resistant Organisms

Program DescriptionSwab - For detection of Carbapenem resistant organisms (CRO) using molecular methods.



Carbapenem-resistant Organisms

AnalytesIMP

OXA

KPC

VIM

NDM

NEW!!

Program Information311 Chlamydia/GC (molecular)

Program Description1 mL liquid - For nucleic acid probe or amplification methods.



Chlamydia/GC (molecular)

AnalytesChlamydia trachomatis Neisseria gonorrhoeae


64 800.333.0958 | www.api-pt.com


Program Description1 mL liquid - For Chlamydia antigen detection kits.

Format3 shipments


Chlamydia Antigen

AnalytesChlamydia Antigen

Program Information316 Chlamydia Antigen - 5 samples 930 Chlamydia Antigen - Add on - 2 samples


Program DescriptionFor laboratories performing a variety of bacteriology procedures. The numbers to the right of each analyte indicate the total number of challenges sent per year. Molecular methods for Group A Strep see catalog #364/964 - Strep Pharyngeal (molecular) on page 72.

Format3 shipments


Comprehensive Bacteriology

AnalytesBlood Culture (1)

Ear/Eye Culture (1)

GC/Group B Strep Culture (2)

Stool Culture (2)

Urine Culture (3)

Campylobacter Antigen (2)

Gram Stain (15)

Educational Culture & Susc. (3)

Susceptibility Testing (3)

Urine Colony Count (3)

CSF Culture (1)

Group A Strep Antigen (3)

Sputum Culture (2)

Throat Culture (1)

Wound Culture (aerobic & anaerobic) (2)

Program Information328 Comprehensive Bacteriology


MIC

RO

BIO

LO

GY

65800.333.0958 | www.api-pt.com


MIC

RO

BIO

LO

GY

Program Information383 Extended Bacteriology - Educational

Program DescriptionInocu-Swab II - Educational culture and susceptibility challenges for laboratories performing complete bacterial identification and susceptibility testing.



Extended Bacteriology - Educational

Analytes

Bacterial Identification Susceptibility Testing

NEW!!

Program Information320 Gram Stain 330 Additional Gram Stain Slides

Program DescriptionFixed unstained glass slides for Gram stain and morphology.



Gram Stain

Analytes

Gram Stain Gram Stain Morphology


66 800.333.0958 | www.api-pt.com

Program Information319 Gram Stain - Vaginitis (Virtual)

Program DescriptionVirtual images of Gram stained vaginal smears for the detection of bacterial vaginosis. Not CMS scored or reported to CAP.



Gram Stain - Vaginitis (Virtual)

AnalytesBacterial Vaginosis (Gram Stain) Nugent Score

Program Information329 Gram Stain - Direct Smears (Virtual)

Program DescriptionVirtual images of Gram stained direct smears from various sources such as blood, sputum, CSF, and wound. Not CMS scored or reported to CAP.



Gram Stain - Direct Smears (Virtual)

Analytes

Gram Stain

Stain Quality

Leukocytes Sputum Quality



MIC

RO

BIO

LO

GY

67800.333.0958 | www.api-pt.com

MIC

RO

BIO

LO

GY

Program DescriptionSwab - For molecular methods for Group B Strep.

Format3 shipments


Group B Strep (molecular)

AnalytesGroup B Strep

Program Information365 Group B Strep (molecular) - 5 samples 965 Group B Strep (molecular) - Add on - 2 samples

Program DescriptionSwab - For rapid Group A Strep antigen detection kits. For molecular methods see catalog #364/964 - Strep Pharyngeal (molecular) on page 72.

Format3 shipments


Group A Strep Antigen

AnalytesGroup A Strep Antigen

Program Information312 Group A Strep Antigen - 5 samples 913 Group A Strep Antigen - Add on option or waived methods - 3 samples 912 Group A Strep Antigen - Add on option or waived methods - 2 samples J12 Group A Strep Antigen - Verification Program - 2 samples




68 800.333.0958 | www.api-pt.com


Program Information351 H. pylori Antigen, Stool

Program Description0.5 mL fecal suspension - For detection of H. pylori antigen. Use as an add on to other Bacteriology programs.



H. pylori Antigen, Stool

Analytes

Helicobacter pylori Antigen

Program DescriptionInocu-Swab II - Culture for N. gonorrhoeae and Group B Strep. For molecular methods see catalog #365/965 - Group B Strep (molecular) on page 67.

Format3 shipments


GC/Group B Strep Culture

AnalytesN. gonorrhoeae Culture Group B Strep Culture

Program Information315 GC/Group B Strep Culture - 5 samples 929 GC/Group B Strep Culture - Add on - 2 samples


Program is included in our A2LA scope of accreditation.MIC

RO

BIO

LO

GY

69800.333.0958 | www.api-pt.com


MIC

RO

BIO

LO

GY

Program DescriptionSwab - For laboratories using culture methods for MRSA. Use as an add on to other Bacteriology programs. For molecular methods see catalog #366 - MRSA/Staph aureus (molecular) on page 70.



MRSA Culture

Analytes

Program Information356 MRSA Culture

Methicillin Resistant Staphylococcus aureus

Program Information340 Legionella Antigen

Program Description0.5 mL liquid - For Legionella antigen detection methods in urine. Use as an add on to other Bacteriology programs.



Legionella Antigen

AnalytesLegionella Antigen



70 800.333.0958 | www.api-pt.com


Program DescriptionSwab - For molecular detection of MRSA and Staphylococcus aureus. Use as an add on to other Bacteriology programs.



MRSA/Staph aureus (molecular)

Analytes

Program Information366 MRSA/Staph aureus (molecular)


Methicillin Resistant Staphylococcus aureus Staphylococcus aureus

MIC

RO

BIO

LO

GY Program Information

384 Mycoplasma genitalium (molecular)

Mycoplasma genitalium

Program Description1 mL liquid - For detection of Mycoplasma genitalium using molecular methods.



Mycoplasma genitalium (molecular)

Analytes

NEW!!

71800.333.0958 | www.api-pt.com


Program Information374 Mycoplasma pneumoniae (molecular)

Mycoplasma pneumoniae

Program Description1 mL liquid - For detection of Mycoplasma pneumoniae using molecular methods. Use as an add on to other Bacteriology programs.



Mycoplasma pneumoniae (molecular)

Analytes


MIC

RO

BIO

LO

GY

Program Information343 Shiga Toxin

Shiga Toxin 1 Shiga Toxin 2 Shiga Toxin 1 and/or 2

Program Description1 mL liquid - For detection of Shiga Toxins 1 and 2 using rapid kits.



Shiga Toxin

Analytes


72 800.333.0958 | www.api-pt.com


Program DescriptionSwab - For detection of Group A and Group C/G Strep by molecular methods.

Format3 shipments


Strep Pharyngeal (molecular)

Analytes

Group A Strep Group C/G Strep

Program Information364 Strep Pharyngeal (molecular) - 5 samples 964 Strep Pharyngeal (molecular) - Add on - 2 samples C64 Strep Pharyngeal (molecular) - Verification Program - 2 samples NEW


Enhanced!!

MIC

RO

BIO

LO

GY

Program Information341 S. pneumoniae Antigen

Program Description0.5 mL liquid - For S. pneumoniae antigen detection methods in urine. Use as an add on to other Bacteriology programs.



S. pneumoniae Antigen

AnalytesS. pneumoniae Antigen


73800.333.0958 | www.api-pt.com


Program DescriptionInocu-Swab II - For laboratories performing cultures for Group A Strep. For molecular methods see catalog #364/964 - Strep Pharyngeal (molecular) on page 72.

Format3 shipments


Throat Culture

AnalytesThroat Culture

Program Information313 Throat Culture - 5 samples 953 Throat Culture - Add on - 3 samples 952 Throat Culture - Add on - 2 samples


MIC

RO

BIO

LO

GY

Program DescriptionQuantitated pellet and dilution fluid - For culture (including screening tubes, paddles, and agar plates) for bacterial colony count and/or ID. Antimicrobial susceptibility testing can be performed on one sample per test event.

Format3 shipments


Urine Culture

AnalytesSusceptibility Testing Urine Colony Count Urine Culture

Program Information314 Urine Culture - 5 samples 924 Urine Culture - Add on - 2 samples


74 800.333.0958 | www.api-pt.com


Program DescriptionSwab - For molecular methods for VRE. Use as an add on to other Bacteriology programs.



VRE (molecular)

AnalytesVancomycin Resistant Enterococci

Program Information367 VRE (molecular)

Program is included in our A2LA scope of accreditation.MIC

RO

BIO

LO

GY

Program Information357 VRE Culture

Program DescriptionSwab - For culture methods for VRE. Use as an add on to other Bacteriology programs. For molecular methods see catalog #367 - VRE (molecular) on page 74.



VRE Culture

AnalytesVancomycin Resistant Enterococci


75800.333.0958 | www.api-pt.com


Program Information335 Acid Fast Smears

MYCOBACTERIOLOGY

Program DescriptionFixed unstained glass slides - Shipped two times per year as allowed by CMS.


Shipping DatesMar. 2, Aug. 17

Acid Fast Smears

AnalytesAcid Fast Bacilli Smears


MIC

RO

BIO

LO

GY

Program Information372 M. tuberculosis (molecular)

Program Description1 mL liquid - For detection of M. tuberculosis and rifampin resistance using molecular methods.



M. tuberculosis (molecular)

AnalytesM. tuberculosis detection Rifampin resistance screen


76 800.333.0958 | www.api-pt.com


Program Information317 Candida Culture

Program DescriptionInocu-Swab II - For Candida culture.



Candida Culture

MYCOLOGY

AnalytesCandida Culture


MIC

RO

BIO

LO

GY

Program Information344 Mycobacteriology Culture

Program DescriptionLiquid samples and lyophilized samples - For culture and identification of mycobacteria. Shipped two times per year as allowed by CMS. Antimycobacterial susceptibility testing can be performed on one sample per test event.


Shipping DatesMar. 2, Aug. 17

Mycobacteriology Culture

AnalytesMycobacteriology Susceptibility TestingMycobacteriology Identification


77800.333.0958 | www.api-pt.com


Program Description1 mL liquid - For Cryptococcal antigen detection.



Cryptococcal Antigen

AnalytesCryptococcal Antigen

Program Information345 Cryptococcal Antigen

Program Information332 Dermatophyte Culture

Program DescriptionInocu-Swab II - For culture methods for dermatophytes.



Dermatophyte Culture

AnalytesDermatophyte Culture



MIC

RO

BIO

LO

GY

78 800.333.0958 | www.api-pt.com


MIC

RO

BIO

LO

GY

Program Information339 India Ink

Program Description1 mL liquid - For presence or absence of encapsulated yeast using India Ink methods.



India Ink

AnalytesIndia Ink

Program Information333 KOH Preparation

Program DescriptionGlass slide prepared to represent a KOH examination of skin, nail or hair.



KOH Preparation

AnalytesKOH Preparation

Program Information331 Mycology Culture

Program DescriptionInocu-Swab II - For culture and identification of yeasts, molds, and aerobic actinomycetes.



Mycology Culture

Analytes

Mycology Culture




79800.333.0958 | www.api-pt.com


Program DescriptionTwo virtual blood smears plus three Giemsa-stained thick and/or thin blood smears for the identification of blood parasites.



Blood Parasites

PARASITOLOGY

AnalytesBlood Parasite Identification

Program Information336 Blood Parasites

Program Description1 mL liquid - For EIA & DFA test methods.

Format3 shipments


Giardia & Cryptosporidium Antigens

AnalytesCryptosporidium Antigen Giardia Antigen

Program Information342 Giardia & Cryptosporidium Antigens - 5 samples 932 Giardia & Cryptosporidium Antigens - Add on - 2 samples



MIC

RO

BIO

LO

GY

80 800.333.0958 | www.api-pt.com


MIC

RO

BIO

LO

GY

Program Information334 Parasitology

Program DescriptionPhotographs, formalin concentrates for direct examination and modified acid fast stain, and a zinc-based PVA slide. For labs performing a variety of parasitology tests. The numbers shown to the right of each analyte indicate the number of challenges per test event. For Cryptosporidium antigen see catalog #342/932 - Giardia & Cryptosporidium Antigens on page 79. For Blood Parasites see catalog #336 on page 79.



Parasitology

AnalytesBlood Smear Photo (1)

Stool Prep Photo (1)

Formalin Concentrates (2)

PVA Slide (1)

Program Information382 Rapid Malaria

Program Description0.5 mL stabilized whole blood - For rapid malaria detection. Compatible with methods that detect Plasmodium falciparum specific histidine-rich protein 2 (HRP2).



Rapid Malaria

AnalytesRapid malaria detection


NEW!!

81800.333.0958 | www.api-pt.com


Program Information362 Trichomonas

Program Description2 mL liquid - For molecular methods and Sekisui OSOM Rapid Trichomonas test. For laboratories using the BD Affirm VP III see catalog #324 - Affirm VP on page 59.



Trichomonas

AnalytesTrichomonas vaginalis


Program Description1 mL liquid - For detection of high risk HPV using molecular methods.



HPV (molecular) - 5

VIROLOGY

AnalytesHPV HPV genotyping (16, 18, & 18/45)

Program Information375 HPV (molecular) - 5 samples


MIC

RO

BIO

LO

GY

82 800.333.0958 | www.api-pt.com


MIC

RO

BIO

LO

GY

Program Description1 mL liquid - For detection of high risk HPV using molecular methods. Use as an add on to other Virology programs.



HPV (molecular) - 2

AnalytesHPV HPV genotyping (16, 18, & 18/45)

Program Information975 HPV (molecular) - 2 samples

Program Information373 HSV 1 & 2 (molecular)

Program Description1 mL liquid - For detection of HSV 1 and 2 using molecular methods.



HSV 1 & 2 (molecular)

AnalytesHerpes Simplex Virus Type 1 Herpes Simplex Virus Type 2



83800.333.0958 | www.api-pt.com


Program DescriptionSwab - For Silaris Influenza A&B Test kits. For other methods see catalog #322/942 - Virology Package on page 86. Not CMS scored; results are reported to CAP as waived.



Influenza A&B (Silaris) - 5

AnalytesInfluenza A Influenza B

Program Information377 Influenza A&B (Silaris) - 5 samples

Program DescriptionSwab - For Silaris Influenza A&B Test kits. For other methods see catalog #933 - Virology Package - waived on page 86.



Influenza A&B (Silaris) - 3

Analytes Influenza A Influenza B

Program Information977 Influenza A&B (Silaris) - 3 samples


MIC

RO

BIO

LO

GY

84 800.333.0958 | www.api-pt.com


Program Description1 mL liquid - For detection of Norovirus using molecular methods. Use as an add on to other Virology programs.



Norovirus

AnalytesNorovirus

Program Information379 Norovirus

NEW!!

MIC

RO

BIO

LO

GY

Program Description1 mL liquid - For detection of Cytomegalovirus (CMV), Enterovirus, Human Metapneumovirus (hMPV), and Varicella-zoster virus (VZV) using molecular methods. Use as an add-on option - 1 analyte per sample.



Molecular Virology

AnalytesCMV

VZV

Enterovirus hMPV

Program Information381 Molecular Virology

NEW!!

85800.333.0958 | www.api-pt.com


MIC

RO

BIO

LO

GY

Program Description1 mL liquid - For detection of Rotavirus antigen.

Format3 shipments


Rotavirus

AnalytesRotavirus Antigen

Program Information348 Rotavirus - 5 samples 349 Rotavirus - Add on - 3 samples


Program Description1.5 mL liquid - For detection of SARS-CoV2 (COVID-19) using molecular methods. Compatible with methods targeting CDC/WHO consensus genomic RNA sequences (ORF1a, RdRp, E gene, N gene, and S gene).


Shipping DatesMay 4, Jul. 20, Oct. 26

SARS-CoV2 (molecular)

AnalytesSARS-CoV2

Program Information385 SARS-CoV2 (molecular)

NEW!!

86 800.333.0958 | www.api-pt.com


MIC

RO

BIO

LO

GY

Program Description1 mL liquid - For waived Influenza A and/or B, RSV, and Adenovirus. Compatible with antigen detection kits and most molecular methods. For Silaris Influenza A&B, see catalog #377/977 - Influenza A&B (Silaris) on page 83.



Virology Package - waived

Analytes

Adenovirus Influenza A or B RSV

Program Information933 Virology Package - waived methods J33 Virology Package - waived methods - Verification Program


Program Description1 mL liquid - For Influenza A and/or B, RSV, and Adenovirus. Compatible with antigen detection kits and most molecular methods. For Silaris Influenza A&B, see catalog #377/977 - Influenza A&B (Silaris) on page 83.

Format3 shipments


Virology Package

AnalytesAdenovirus Influenza A or B RSV

Program Information322 Virology Package - 5 samples C22 Virology Package - Verification Program - 5 samples942 Virology Package - Add on - 2 samples


87800.333.0958 | www.api-pt.com


Program Information369 GI Panel

Program Description1 mL liquid - For molecular multiplex panels.



GI Panel

Analytes


Identification of Bacteria

Identification of Viruses

Identification of Bacterial Toxins Identification of Parasites

MIC

RO

BIO

LO

GY




Blood Pathogen Panel

AnalytesIdentification of Bacteria Identification of Yeasts Resistance Genes

Program Information368 Blood Pathogen Panel


MOLECULAR MULTIPLEX PROGRAMS

For molecular testing of direct specimens, CMS considers bacteriology, virology, and yeast in blood cultures to be regulated tests. If the only regulated bacteriology, virology or mycology testing you perform is using a multiplex analyzer, you are required to participate in five challenges, three times a year for compliance with CLIA. Technical Support is available at 800-333-0958.

88 800.333.0958 | www.api-pt.com

Program Information371 Meningitis Panel




Meningitis Panel

AnalytesIdentification of Bacteria Identification of Viruses Identification of Yeasts


Program Information378 Pneumonia Panel

Program Description0.5 mL liquid - For molecular multiplex panels.



Pneumonia Panel

AnalytesIdentification of Bacteria Identification of Viruses Resistance Genes

Enhanced!!


MIC

RO

BIO

LO

GY

89800.333.0958 | www.api-pt.com

Program Information370 Respiratory Panel




Respiratory Panel

AnalytesIdentification of Bacteria Identification of Viruses


Program Information376 Vaginal Panel

Program Description0.5 mL liquid - For detection of vaginitis/vaginosis using molecular multiplex panels.



Vaginal Panel

AnalytesIdentification of Bacteria Identification of Candida Identification of Trichomonas


MIC

RO

BIO

LO

GY

90 800.333.0958 | www.api-pt.com


Program Description0.5 mL serum - Qualitative reporting only. Designed for ANA methods other than latex agglutination. Latex agglutination methods see catalog #429 - ANA (latex kits) on page 90.


Shipping DatesMar. 30, Aug. 3, Nov. 30

ANA

IMMUNOLOGY

AnalytesANA

Anti-SSA

Anti-DNA (ds, ss)

Anti-SSB

Anti-RNP

Anti-Sm

Program Information421 ANA

Program Information429 ANA (latex kits)

Program Description0.5 mL serum - Designed for latex agglutination methods.



ANA (latex kits)

Analytes

ANA


IMM

UN

OL

OG

Y

91800.333.0958 | www.api-pt.com


IMM

UN

OL

OG

Y

Program Information423 Anti-CCP

Program Description1 mL serum - For qualitative, quantitative, and semi-quantitative testing.



Anti-CCP

AnalytesAnti-Cyclic Citrullinated Peptide

Program Information424 ASO

Program Description1 mL serum - For qualitative, quantitative, and semi-quantitative (titer) methods.



ASO

AnalytesAnti-Streptolysin O

Program Description10 mg extracted DNA specimens



BRCA1/2 Sequencing

Analytes

Program Information441 BRCA1/2 Sequencing

BRCA1/2 duplication/deletion analysis BRCA1/2 DNA sequencing & variant interpretation




92 800.333.0958 | www.api-pt.com


Program Description0.5 mL serum - For qualitative and quantitative CRP procedures that measure levels >1.0 mg/dL.



C-Reactive Protein

AnalytesC-Reactive Protein

Program Information431 C-Reactive Protein


Program Description2 mL serum - For quantitative IgE and specific allergens. Specific allergens may be reported qualitatively or quantitatively.



Diagnostic Allergy

AnalytesSpecific Allergens Total IgE

Program Information419 Diagnostic Allergy 437 Additional Sample Volume


IMM

UN

OL

OG

Y

93800.333.0958 | www.api-pt.com

IMM

UN

OL

OG

Y


Program Information420 H. pylori Antibody

Program Description0.5 mL serum - For kits that detect Helicobacter pylori antibody. For H. pylori antigen see catalog #351 - H. pylori Antigen, Stool on page 68.



H. pylori Antibody

AnalytesH. pylori Antibody


Program Information442 HBV Viral Load

Program Description1.5 mL plasma - For molecular quantification of HBV DNA. Program is shipped frozen on dry ice.



HBV Viral Load

Analytes HBV Viral Load


94 800.333.0958 | www.api-pt.com

Program Information439 HCV Viral Load

Program Description1.5 mL plasma - For molecular detection and quantification of HCV. Program is shipped frozen on dry ice.



HCV Viral Load

Analytes HCV, qualitative HCV genotyping HCV viral load

Program Description0.5 mL serum - For hsCRP procedures that measure levels between 0-1.5 mg/dL.

Format3 shipments


High Sensitivity CRP

AnalyteshsCRP

Program Information440 HIV Viral Load

Program Description1.5 mL plasma - For molecular quantification of HIV-1 RNA Viral Load. Program is shipped frozen on dry ice.



HIV Viral Load

Analytes

HIV-1 RNA Viral Load




Program Information443 High Sensitivity CRP - 5 samples NEW

425 High Sensitivity CRP - 2 samples

Enhanced!!

IMM

UN

OL

OG

Y

95800.333.0958 | www.api-pt.com

IMM

UN

OL

OG

Y

Program Information430 HSV-2 Antibody

Program Description0.5 mL serum - For the Biokit HSV-2 rapid test.



HSV-2 Antibody

AnalytesHSV-2 Antibody

Program Information407 Immunology Package

Program DescriptionSerum samples - Cost savings for sites that perform all of the included tests. ASO, Rubella, and Rheumatoid Factor may be reported as qualitative, quantitative, or as a titer.

Format3 shipments


Immunology Package

AnalytesAnti-Streptolysin O

Rubella

Infectious Mononucleosis

Rheumatoid Factor




96 800.333.0958 | www.api-pt.com


Program Description1 mL serum - For quantitative testing.



Immunoproteins/C3 & C4

AnalytesAlpha-1-Antitrypsin

Haptoglobin

IgG

Complement C3

IgA

IgM

Complement C4

IgE

Program Information436 Immunoproteins/C3 & C4

Program Description0.5 mL lyophilized defibrinated plasma samples - 1 analyte per sample. Not CMS scored.



Infectious Disease Serology

Analytes

Program Information438 Infectious Disease Serology

CMV (IgG & IgM)

Rubeola Virus IgG

Mumps Virus IgG

Toxoplasma gondii (IgG & IgM)

Rubella (IgG & IgM)

Varicella Zoster Virus (VZV) IgG



IMM

UN

OL

OG

Y

97800.333.0958 | www.api-pt.com


IMM

UN

OL

OG

Y

Program Description0.6 mL serum - For all Infectious Mononucleosis kits. Catalog #910 is not scored for CMS.

Format3 shipments


Infectious Mononucleosis

AnalytesInfectious Mononucleosis

Program Information410 Infectious Mononucleosis - 5 samples 910 Infectious Mononucleosis - waived - 2 samples

Program Information411 Infectious Mononucleosis & Rheumatoid Factor

Program DescriptionSerum samples - Cost savings for labs that perform both tests. Rheumatoid Factor results may be reported as qualitative, quantitative, or as a titer.

Format3 shipments


Infectious Mononucleosis & Rheumatoid Factor

AnalytesInfectious Mononucleosis Rheumatoid Factor



98 800.333.0958 | www.api-pt.com

Program Information418 Lyme Disease

Program Description0.6 mL serum - For IgG and IgM antibody detection to Borrelia burgdorferi.



Lyme Disease

Analytes

Lyme Disease Antibody

Program Information428 Mycoplasma Antibody

Program Description0.5 mL serum - For kits that detect Mycoplasma pneumoniae antibody.



Mycoplasma Antibody

Analytes

Mycoplasma Antibody



IMM

UN

OL

OG

Y


99800.333.0958 | www.api-pt.com

IMM

UN

OL

OG

Y

Program DescriptionFor laboratories using a rapid method to test for anti-HIV and/or HIV-1 p24 antigen. For other antigen/antibody methods, see Viral Markers alo #

Rapid HIV

AnalytesAnti-HIV-1/2 HIV-1 p24 Antigen

Program Information432 Rapid HIV - 5 samples 433 Rapid HIV - waived methods - 2 samples D33 Rapid HIV - waived methods - Verification Program - 2 samples

Program Description1 mL serum - For laboratories using a rapid method to test for anti-HIV and/or HIV-1 p24 antigen. Other antigen/antibody methods see catalog #417 - Viral Markers on page 101. Catalog #433 is not scored for CMS.

Format3 shipments


Rapid HIV

Program Information408 Rheumatoid Factor




Rheumatoid Factor

AnalytesRheumatoid Factor




100 800.333.0958 | www.api-pt.com


Program Information415 Rubella




Rubella

AnalytesRubella

Program Information416 Syphilis Serology

Program Description1 mL serum - For qualitative and semi-quantitative (titer) methods for serum and CSF. Designed for RPR, VDRL, FTA, and Treponemal Antibody methods.



Syphilis Serology

AnalytesSyphilis



IMM

UN

OL

OG

Y

101800.333.0958 | www.api-pt.com


IMM

UN

OL

OG

Y

Program Information164 Thyroid Antibodies

Program Description0.5 mL serum



Thyroid Antibodies

Analytes

Thyroglobulin antibody (Anti-TG) Thyroid microsomal antibody (Anti-TPO)

Program Description3 mL plasma - For anti-HIV, HIV antigen and/or Hepatitis testing. Anti-HIV and HIV-1 p24 antigen is for standard or confirmatory methods only. Rapid HIV antibody and antigen methods see catalog #432/433 - Rapid HIV on page 99.



Viral Markers

AnalytesAnti-HAV (total & IgM)

Anti-HBs, qualitative & quantitative

Anti-HIV-2

Anti-HIV-1/2, p24 Antigen

Anti-HAV (IgG)

Anti-HCV

Anti-HIV-1/2

HBsAg

Anti-HBc (total & IgM)

Anti-HIV-1

Anti-HIV-1/2 Confirmatory

HBsAg Confirmatory

Program Information417 Viral Markers



102 800.333.0958 | www.api-pt.com


Program Information511 ABO/Rh

Program Description3 mL - 4% cell suspensions for ABO/Rh testing.



IMMUNOHEMATOLOGY

ABO/Rh

AnalytesABO Group ABO Subgroup D (Rho) Type

Program Information516 Antibody Elution

Program Description2 mL - 50% cell suspensions for antibody elution for non-ABO antibody testing.



Antibody Elution

AnalytesAntibody Elution



IMM

UN

OH

EM

AT

OL

OG

Y

103800.333.0958 | www.api-pt.com

IMM

UN

OH

EM

AT

OL

OG

Y

Program Information520 Antibody Titer - D

Program Description2 mL serum - For anti-D titer, one 3 mL red cell sample (4% suspension) to be used as titer cell.



Antibody Titer - D

AnalytesAnti-D titer

Program Description2 mL serum - One sample each for anti-A and anti-D titer and one 3 mL red cell sample (4% suspension) to be used as titer cell.



Antibody Titer - AD

Analytes

Anti-A (IgM and IgG) titer Anti-D titer

Program Information521 Antibody Titer - AD

Program Information519 Antibody Titer - A

Program Description2 mL serum - For anti-A titer, one 3 mL red cell sample (4% suspension) to be used as titer cell.



Antibody Titer - A

AnalytesAnti-A (IgM and IgG) titer




104 800.333.0958 | www.api-pt.com

Program DescriptionIncludes five 4 mL tubes of CPD anticoagulated whole blood. One 2 mL donor red cell suspension is included for compatibility testing and antigen typing which are compatible with Bio-Rad, Grifols, Immucor, and Ortho blood bank analyzers.

Format3 shipments


Automated Blood Bank

AnalytesABO Group

Antibody Screen

D (Rho) Type

ABO Subgroup

Antigen Typing

Antibody Identification

Compatibility Testing

Program Information517 Automated Blood Bank E17 Automated Blood Bank - Verification Program

Program Information537 Automated Blood Bank with Electronic Crossmatch

Program DescriptionIncludes five 4 mL tubes of CPD anticoagulated whole blood. One 2 mL donor red cell suspension is included for compatibility testing and antigen typing which are compatible with Bio-Rad, Grifols, Immucor, and Ortho blood bank analyzers. In addition, two donor red cell suspensions with corresponding simulated ISBT donor unit labels are included for electronic crossmatch.

Format3 shipments


Automated Blood Bank with Electronic Crossmatch

AnalytesABO Group

Antibody Screen

D (Rho) Type

ABO Subgroup

Antigen Typing

Electronic Crossmatch





IMM

UN

OH

EM

AT

OL

OG

Y


105800.333.0958 | www.api-pt.com


IMM

UN

OH

EM

AT

OL

OG

Y

Program DescriptionIncludes five 2 mL samples of a 4% red cell suspension and five 3 mL samples of corresponding serum. One 2 mL donor red cell suspension is included for compatibility testing and antigen typing. For Automated Blood Bank see catalog #517/E17 on page 104.

Format3 shipments


Blood Bank

AnalytesABO Group

Antibody Screen

D (Rho) type

ABO Subgroup

Antigen Typing



Program Information512 Blood Bank E12 Blood Bank - Verification Program

Program DescriptionIncludes five 2 mL samples of a 4% red cell suspension and five 3 mL samples of corresponding serum. One 2 mL donor red cell suspension is included for compatibility testing and antigen typing. In addition, two donor red cell suspensions with corresponding simulated ISBT donor unit labels are included for electronic crossmatch. For Automated Blood Bank with Electronic Crossmatch see catalog #537 on page 104

Format3 shipments


Blood Bank with Electronic Crossmatch

AnalytesABO Group

Antibody Screen

D (Rho) Type

ABO Subgroup

Antigen Typing

Electronic Crossmatch



Program Information532 Blood Bank with Electronic Crossmatch



106 800.333.0958 | www.api-pt.com

Program Description1 mL - 4% cell suspensions for DAT.



DAT

Analytes

Direct Antiglobulin Testing

Program Information514 DAT E14 DAT - Verification Program

Program Information534 DAT - Automated

Program Description4 mL - 15% red cell suspensions for automated DAT methods.



DAT - Automated

AnalytesDirect Antiglobulin Testing



IMM

UN

OH

EM

AT

OL

OG

Y

107800.333.0958 | www.api-pt.com

IMM

UN

OH

EM

AT

OL

OG

Y

Program Description0.5 mL - 35-45% cell suspensions for sites that use slide methodology or Eldoncards for Rh typing.



Rh Slide Test

AnalytesD (Rho) Type

Program Information513 Rh Slide Test


Program Description2 mL simulated whole blood - For fetal screen, Kleihauer-Betke, and flow cytometry.



Fetal RBC

Analytes F Cell Value (by flow cytometry) Fetal Screen Hemoglobin F, quantitative

Program Information515 Fetal RBC


Program Information518 Educational Blood Bank

Program DescriptionOne case study - Sample volume varies by event. 1-2 serum samples and/or 1-2 red cell samples for special challenges in antibody detection and identification.

Format3 shipments


Educational Blood Bank

AnalytesAntibody Identification



108 800.333.0958 | www.api-pt.com

Free Continuing Education CreditsPhysicians, medical technologists, and technicians enrolled with API are eligible to earn FREE continuing education credit through online self-assessment activities offered in conjunction with the American Society for Clinical Pathology (ASCP). The number of credits that can be earned depends on individual participation.

For more information, go to our website at api-pt.com and select “Learn More” under the Continuing Education heading, or call us at 800-333-0958 to speak with a Customer Service Representative.

API DataDirectUsing their own laboratory information system (LIS) or middleware, laboratories may now transmit proficiency testing results directly to American Proficiency Institute (API), a process that revolutionizes proficiency testing for clinical laboratories. No more manual data entry, no more clerical errors, no new technology systems to purchase, and no additional fees! DataDirect is easy to use and saves time! Contact us at [email protected] or call us for a demonstration.

Remedial Proficiency TestingRemedial proficiency testing is a service API offers to those who need to test specimens in addition to regular proficiency testing. This is usually required when a laboratory has had poor performance on a particular analyte in two of three test events. If your laboratory encounters a need for this service (which includes a written performance evaluation), call to speak with a Technical Specialist for more details. Remedial evaluations are not ISO accredited.

Troubleshooting SamplesOccasionally, laboratories wish to re-test a proficiency testing sample as part of a corrective action plan. Most API samples are available for this purpose at a nominal charge. Our Technical Specialists can give you further information.

Supplemental Products957 API 3 Ring Binder with Tabs958 API Binder Tabs

Verification Programs for Secondary InstrumentsCLIA regulations state that if a laboratory uses multiple methods to test an analyte they must designate one instrument/method as primary for the proficiency event and test the PT samples using that instrument/method. Laboratories are not to test proficiency samples during the PT event with more than one instrument unless that is how they test all patient specimens. This restriction also applies to non-regulated analytes and to analytes categorized as waived under CLIA.

Laboratories may test proficiency samples with multiple instruments/methods after the PT due date. API’s Verification programs offer the convenience of using proficiency samples and statistics to verify secondary instruments and methods, while remaining compliant with CLIA regulations. Verification samples are shipped along with PT samples. Laboratories are directed to test and submit results for verification samples online after the PT due date. Verification evaluations are available online, when the evaluations for proficiency programs are released.

Where available, verification programs are listed in the main body of the catalog along with regular PT programs. Scores from verification programs are not reported to regulatory agencies such as CMS, CAP, or The Joint Commission. Verification programs are not included in our A2LA scope of accreditation.

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Outstanding Online Features and ServicesPaperless Proficiency Testing has unique features that can help you manage your proficiency testing more efficiently. Visit www.api-pt.com to learn more!

• Email is sent with shipping dates, package tracking information, and when your evaluation is ready.• Submit, review, and print results online.• DataDashboard trends performance over the most recent six test events.• Free Continuing Education credits.• Management reports for multiple labs.

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ABO group (◊ ABO Subgroup typing) 102, 104, 105

Acetaminophen 22, 27

◊ Acetone 8

6-Acetylmorphine 27

Acid Fast Smears 75

Activated Clotting Time 44, 46, 47, 49

Adenovirus 86

Affirm VP 59

Albumin ( CSF, ◊ body fluid) 7, 8, 24

Alcohol 8, 27

Alkaline Phosphatase (◊ body fluid) 7, 8, 24

Alpha-1-Antitrypsin 96

Alpha-fetoprotein 6, 7

ALT (SGPT) 6-8

Amikacin 22

◊ Ammonia 9

◊ Amniotic Fluid pH 9

Amphetamines 27

Amylase (◊ body fluid) 7, 8, 24, 26

ANA 90

◊ Antibody Elution 102

Antibody Identif ication and Screen 104, 105, 107

◊ Antibody Titer - A 103

◊ Antibody Titer - D 103

◊ Anti-CCP 91

Anti-DNA (ds, ss) 90

◊ Antigen Typing 104, 105

Anti-HAV (◊ total, IgG) 101

Anti-HBc (total and IgM) 101

Anti-HBs, qualitative (◊ quantitative) 101

Anti-HCV 101

Anti-HIV-1 and 2 101

Anti-HIV-1/2 / p24 Antigen 99, 101

Anti-HIV Confirmatory 101

Anti-RNP 90

Anti-Sm 90

◊ Anti-Xa 49

Antisperm Antibody 41

Anti-SSA and SSB 90

Anti-Streptolysin O (◊ titer) 91, 95

◊ Antithrombin III Activity 45

Apolipoprotein A1, B 9

APTT (◊ Heparin Assay) 45, 47, 49

AST (SGOT) 6-8

Automated Blood Bank 104

Automated Dif ferential 28-33

◊ Automated Urine Microscopy 52

◊ Bacterial Vaginosis 60, 66

Barbiturates 27

Benzodiazepines 27

Beta-2 Microglobulin 23

Beta-hydroxybutyrate 10

Bilirubin, urine (◊ confirmatory) 55, 58

Bilirubin, direct & total (◊ body fluid) 6-8, 20, 24

Blood Cell Identif ication (◊ Cat. #259 Advanced) 34

Blood Culture 61, 64

Blood Gas ( Magnesium, ionized, ◊ tCO2) 10, 11, 18

Blood/Hemoglobin, urine 55, 58

Blood Oximetry 12

Blood Parasites 79

Blood Pathogen Panel (◊ yeast, resistance genes) 87

BNP ( Cat. #920 - only accepted for wvd. methods) 13

◊ Body Fluid Cell Count 35

◊ Body Fluid Chemistry 24

◊ Body Fluid Crystals 36

◊ Body Fluid Dif ferential 36

◊ Body Fluid Microscopy 36

Bordetella pertussis/parapertussis 61

BRCA1/2 91

Buprenorphine 27

BUN (◊ body fluid) 6-8, 11, 18, 24

C. dif f icile Toxin or Antigen (◊ toxin) 62

CO2 6-8

CA 125 23

CA 15-3 23

CA 19-9 23

CA 27.29 23

Calcium (◊ body fluid)) 6-8, 24, 26

Calcium, ionized 7, 11, 18

Campylobacter 62, 64

Candida (◊ Cat. #376 Vaginal Panel) 59, 76, 89

Cannabinoids 27

Carbamazepine 22

◊ Carbapenem-resistant Organisms 63

Carboxyhemoglobin 12

Cardiac Markers 13

◊ Carisoprodol 27

CD3 (T Cells) 37

CD4 (T Helper) 37

CD8 (T Cytotoxic) 37

CD19 (B Cells) 37

CD45 (Leukocytes) 37

CD56 / CD16+56 (NK Cells) 37

CEA 17, 23

Chlamydia Antigen 64

Chlamydia trachomatis 63

Chloride (◊ CSF, body fluid) 6-8, 11, 18, 24, 26

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G

CAP accepted ◊ CAP-accepted PT not required Not CAP accepted

This list is not intended to replace CAP guidance on required analytes.

See the current catalog index online for updated information on CAP accepted analytes.

I

D

Chloride, sweat ( quant) 25

Cholesterol (◊ body fluid) 6-8, 19, 24

Cholinesterase 7

CK-MB (quantitative, qualitative) 13

CMV ( IgG, IgM) 84, 96

Cocaine Metabolites 27

Compatibility Testing (◊ Electronic Crossmatch) 104, 105

Complement C3 & C4 96

Conductivity, sweat 25

Cortisol 6, 7

Cotinine 27

C-Peptide 17

C-Reactive Protein (quantitative, qualitative) 92

C-Reactive Protein (hs) 94

Creatine Kinase (CK) 7, 8, 13

Creatinine (◊ body fluid, urine adult.) 6-8, 11, 18, 24-26, 55, 58

Cryptococcal Antigen 77

Cryptosporidium 79

CSF Chemistry ( CSF albumin, CSF IgG) 24

CSF Culture 64

◊ Cystatin C 14

D (Rho) Type 102, 104, 105, 107

D-dimer (◊ Qualitative) 13, 46

Dermatophyte Culture 77

DHEA-S 17

Digoxin 22

Direct Antiglobulin Testing (◊ automated) 106

Ear/Eye Culture 64

EDDP 27

◊ Electronic Crossmatch 104, 105

Enterovirus 84

Estradiol 17

Estriol 17

◊ Ethyl Glucuronide 24

F Cell Value (f low cytometry) 107

◊ Factor Activity 45

◊ Fecal Lactoferrin 52

◊ Fecal Occult Blood 53, 58

Fecal WBC 54

Fentanyl 27

Fern Test 54

Fetal Fibronectin 14

◊ Fetal Hemoglobin ( whole blood) 37, 107

◊ Fetal Membranes Rupture Test 14

Fetal Screen 107

Ferritin 17

Fibrinogen 45

Folate 17

Free T3 6, 7, 22

Free T4 6, 7, 22

◊ Fructosamine 15

FSH 17

◊ Gastric Occult Blood 53

Gastrin 17

GC/Group B Strep 64, 68

Gentamicin 22

GGT 7, 8

GI Panel (◊ toxins, parasites) 87

Giardia 79

Glucose (◊ body fluid) 6-8, 11, 18, 19, 24, 26, 55, 58

◊ Glucose, Whole Blood ( HemoCue) 16, 23, 58

Glycohemoglobin (HbA1c) 15, 16

Gram Stain (◊ morphology) 64, 65

◊ Gram Stain, Direct 66

◊ Gram Stain, Vaginitis 66

Granulocytes (◊ IG#, IG%) 29, 33

Group A Strep Antigen 58, 60, 64, 67

Group A, C/G Strep (molecular) 72

Group B Strep Culture 64, 68

Group B Strep (molecular) 67

Growth Hormone 17

H. pylori Antibody 93

H. pylori Antigen, Stool 68

Haptoglobin 96

HBsAg & HBsAg confirmatory 101

HBV Viral Load 93

HCG, urine 55, 57, 58

HCG, serum (qualitative, quantitative) 21

HCV Viral Load 94

HDL Cholesterol 6-8, 19

Hematocrit 11, 12, 18, 28-33, 58

Hemoglobin 11, 12, 16, 18, 28-33, 58

Hemoglobin F (quantitative, qualitative) 107

◊ Heparin Assay 49

HIV Viral Load 94

hMPV 84

Homocysteine 17

HPV (molecular) (◊ genotyping) 81, 82

HSV 1 & 2 (molecular) 82

HSV-2 Antibody 95

◊ Hydrocodone 27

ID of Bacteria (◊ Vaginal Panel) 87-89

ID of Viruses 87-89

IgA 96

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IgE 92, 96

IgG ( CSF) 24, 96

IgM, total 96

◊ IMP 63

◊ India Ink 78

Infectious Mononucleosis 95, 97

Influenza A or B ( Cat. #977) 83, 86

INR (◊ waived, Heparin Assay) 45, 48-51

Insulin 17

◊ IRF 30, 31, 33

Iron 7

Ketones (◊ serum qual) 8, 55, 58

KOH Preparation 78

◊ KPC 63

Lactate 11, 18

Lactic Acid 7, 24

◊ Lamellar Body Count 19

LDH (◊ body fluid) 7, 24

LDL (◊ calculated) 6-8, 19

Lead 11, 12

Legionella Antigen 69

Leukocyte Esterase 55, 58

LH 17

Lidocaine 22

Lipase (◊ body fluid) 7, 24

Lipoprotein (a) 9

Lithium 22

◊ LSD 27

◊ Lyme Disease Antibody 98

Lymph/Mono 29

Magnesium 7, 26

Magnesium, ionized 11

◊ MCH, MCHC, MCV, MPV 28-33

MDMA 27

Meningitis Panel (◊ yeast) 88

◊ Meperidine 27

Methadone 27

Methamphetamines 27

Methaqualone 27

Methemoglobin 12

Microalbumin 25, 26

◊ MN 35

Molecular multiplex panel (◊ parasites, vaginal, yeast) 87-89

MRSA 69, 70

◊ Mumps Virus IgG 96

◊ Mycobacterium tuberculosis, molecular 75

Mycobacteriology Culture 76

Mycology Culture 78

◊ Mycoplasma Antibody 98

Mycoplasma genitalium, molecular 70

Mycoplasma pneumoniae, molecular 71

Myoglobin (quantitative, qualitative) 13

N. gonorrhoeae 63, 64, 68

Nasal Smear 54

◊ NDM 63

Neonatal Bilirubin 20

Nitrite (◊ urine adulteration) 26, 55, 58

Norovirus, molecular 84

◊ nRBC 30, 31, 33

NT pro-BNP ( Cat. #920-CAP requires 5 samples) 13

Opiates 27

Osmolality (◊ sweat) 7, 25, 26

◊ OXA 63

◊ Oxidants 26

Oxycodone 27

Oxyhemoglobin 12

p24 Antigen 99, 101

PAP 17

Parasitology (◊ molecular) 79-81

Parathyroid Hormone (PTH) 17

pCO2 10, 11, 18

pH (◊ gastric, body, amn. fld, urine adult) 9-11, 18, 24, 26, 53, 55, 58

Phencyclidine 27

Phenobarbital 22

Phenytoin 22

Phosphorus 7, 8, 26

Pinworm Preparation 54

◊ Plasminogen 45

Platelet Count (◊ IPF) 28-33

◊ Platelet Function 49, 50

◊ PMN 35

Pneumonia Panel (◊ resistance genes) 88

pO2 10, 11, 18

Potassium (◊ body fluid) 6-8, 11, 18, 24, 26

Prealbumin 17

Procalcitonin 20

Progesterone 17

Prolactin 17

Propoxyphene 27

◊ Protein C 45

◊ Protein S 45

Protein, urine (◊ confirmatory) 55, 58

Prothrombin Time (◊ waived, Heparin Assay) 45, 48-51

PSA (complexed) 23

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S

CAP accepted ◊ CAP-accepted PT not required Not CAP accepted

This list is not intended to replace CAP guidance on required analytes.

See the current catalog index online for updated information on CAP accepted analytes.

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Z

PSA (total, free) 17, 23

◊ Rapid malaria detection 80

RBC (◊ automated body fluid & urine) 28-33, 35, 36, 52

◊ RDW 28-33

Reducing Substance 55, 58

Respiratory Panel 89

Reticulocyte Count (◊ RET He, IRF) 30, 31, 33, 38

Rheumatoid Factor (◊ titer) 95, 97, 99

Rotavirus Antigen 85

RSV 86

Rubella (◊ titer, Cat. #438 Inf. Disease Serology) 95, 96, 100

Rubeola Virus IgG 96

S. pneumoniae Antigen 72

Salicylates 22

◊ SARS-CoV2 85

◊ Sedimentation Rate 39, 40

SHBG 21

◊ Shiga Toxin 71

Sickle Cell Screen 40

Sodium (◊ CSF, body fluid, sweat) 6-8, 11, 18, 24-26

◊ Specific Allergens 92

Specific Gravity (◊ urine adulteration) 26, 55, 58

Sperm Count, automated (◊ post-vasectomy) 41

Sperm Count, manual 42

◊ Sperm, presence/absence (provider performed) 54

Sperm, presence/absence, post-vas ( Cat. #233) 41, 42, 54

◊ Sperm Morphology 42

◊ Sperm Motility 43

Sperm Viability 43

Sputum Culture 64

Stool Culture 64

Susceptibility Testing 60, 61, 64, 65, 73, 76

Sweat Analysis ( chloride, quan; ◊ osmolality and sodium) 25

Syphilis Serology (◊ CSF titer) 100

T Uptake 6, 7, 22

◊ TC-BF 35

◊ tCO2 11, 18

Testosterone 17, 21

◊ Testosterone, Bioavailable 21

◊ Testosterone, Free ( directly measured) 21

Theophylline 22

Therapeutic Drugs ( Lidocaine) 22

Throat Culture 60, 64, 73

◊ Thrombin Time 45, 49

◊ Thromboelastogram 51

Thyroglobulin 23

◊ Thyroid Antibodies, quantitative 101

Thyroxine (T4) 6, 7, 22

TIBC (◊ calculated) 7, 17

Tobramycin 22

Total Protein (◊ body fluid) 7, 8, 24, 26

Toxoplasma gondii IgG & IgM 96

Tramadol 27

Transferrin 17

Trichomonas (◊ Cat. #376 Vaginal Panel) 59, 81, 89

Tricyclic Antidepressants 27

Triglycerides (◊ body fluid) 6-8, 19, 24

Triiodothyronine (T3) 6, 7, 22

Troponin I ( Cat. #920-CAP requires 5 samples) 13

Troponin T, qualitative 13

Troponin T, quant ( Cat. #920-CAP requires 5 samples) 13

TSH 6, 7, 22

UIBC 7

Urea 26

Urea Nitrogen (BUN) (◊ body fluid) 6-8, 11, 18, 24

Urease 54

Uric Acid (◊ body fluid) 6-8, 24, 26

Urinalysis 55, 58

◊ Urine Adulteration Tests 26

Urine Chemistry 26

Urine Colony Count 60, 64, 73

◊ Urine Crystals 56

Urine Culture 60, 64, 73

Urine Drug Screen (◊ quantitative) 27

◊ Urine Eosinophils 56

◊ Urine Microscopy, Automated 52

Urine Sediment 54, 57, 58

Urobilinogen 55, 58

◊ Vaginal Panel 89

Vaginal Wet Preparation 54, 58

Valproic Acid 22

Vancomycin 22

◊ VIM 63

Vitamin B12 17

Varicella Zoster Virus (VZV) ( Cat. #438 IgG) 84, 96

Vitamin D 17

VRE 74

WBC Count (blood, manual CSF/BF) 28-33, 36

◊ WBC Count (auto CSF/BF, urine) 35, 52

WBC Dif ferential (◊ body fluid, manual blood) 28-36

WBC, HemoCue 38

Wound Culture 64

◊ Zolpidem 27

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Catalog #Catalog

Page Chemistry - Core Programs1st Event Ship Date

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3rd Event Ship Date

137 8 Alcohol January 13 May 18 August 24A37 8 Alcohol (Verification) January 13 May 18 August 24111 10 Blood Gas January 13 May 18 August 24A11 10 Blood Gas (Verification) January 13 May 18 August 24112 11 Blood Gas Plus ► January 13 May 18 August 24A12 11 Blood Gas Plus (Verification) January 13 May 18 August 24172 11 Blood Lead - 5 January 13 May 18 August 24173 12 Blood Lead (Waived) January 13 May 18 August 24114 12 Blood Oximetry January 13 May 18 August 24A14 12 Blood Oximetry (Verification) January 13 May 18 August 24140 13 Cardiac Markers - 5 January 13 May 18 August 24A40 13 Cardiac Markers - 5 (Verification) January 13 May 18 August 24920 13 Cardiac Markers - 2 ► January 13 May 18 August 24J20 13 Cardiac Markers - 2 (Verification) January 13 May 18 August 24165 13 Additional Volume Cardiac Markers January 13 May 18 August 24121 6 Chemistry - Basic January 13 May 18 August 24A21 6 Chemistry - Basic (Verification) January 13 May 18 August 24122 7 Chemistry - Comprehensive ► January 13 May 18 August 24A22 7 Chemistry - Comprehensive (Verification) January 13 May 18 August 24141 6, 7 Additional Volume Chemistry January 13 May 18 August 24125 6 Chemistry - Endocrinology January 13 May 18 August 24144 8 Chemistry - waived January 13 May 18 August 24A44 8 Chemistry - waived (Verification) January 13 May 18 August 24126 15 Glycohemoglobin - 5 January 13 May 18 August 24127 15 Glycohemoglobin - 2 January 13 May 18 August 24179 15 Additional Volume Glycohemoglobin - 5 January 13 May 18 August 24167 15 Additional Volume Glycohemoglobin - 2 January 13 May 18 August 24A27 15 Glycohemoglobin - 2 (Verification) January 13 May 18 August 24128 16 HemoCue - 5 January 13 May 18 August 24928 16 HemoCue - 2 January 13 May 18 August 24J28 16 HemoCue - 2 (Verification) January 13 May 18 August 24145 18 i-STAT Chemistry - 5 January 13 May 18 August 24A45 18 i-STAT Chemistry - 5 (Verification) January 13 May 18 August 24945 18 i-STAT Chemistry - 2 January 13 May 18 August 24J45 18 i-STAT Chemistry - 2 (Verification) January 13 May 18 August 24180 17 Immunoassay - 5 ► January 13 May 18 August 24133 17 Immunoassay - 2 ► January 13 May 18 August 24A33 17 Immunoassay - 2 (Verification) January 13 May 18 August 24182 17 Immunoassay - Special - 5 ► January 13 May 18 August 24160 17 Immunoassay - Special - 2 ► January 13 May 18 August 24A60 17 Immunoassay - Special - 2 (Verification) January 13 May 18 August 24176 19 Lipid Plus - 5 January 13 May 18 August 24976 19 Lipid Plus - 2 January 13 May 18 August 24147 20 Neonatal Bilirubin - 5 January 13 May 18 August 24129 20 Neonatal Bilirubin - 2 January 13 May 18 August 24A29 20 Neonatal Bilirubin - 2 (Verification) January 13 May 18 August 24409 21 Serum HCG January 13 May 18 August 24D09 21 Serum HCG (Verification) January 13 May 18 August 24132 22 Therapeutic Drugs ► January 13 May 18 August 24136 22 TDM - add on to Chemistry ► January 13 May 18 August 24A36 22 TDM (Verification) January 13 May 18 August 24175 22 Thyroid - Special January 13 May 18 August 24183 23 Tumor Markers - 5 ► January 13 May 18 August 24150 23 Tumor Markers - 2 ► January 13 May 18 August 24235 57 Urine HCG - Qualitative January 13 May 18 August 24B35 57 Urine HCG - 5 (Verification) January 13 May 18 August 24

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Catalog #Catalog

Page Chemistry - Miscellaneous Programs1st Event Ship Date

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138 9 Ammonia April 20 October 12A38 9 Ammonia (Verification) April 20 October 12166 9 Amniotic Fluid pH April 20 October 12130 9 Apolipoproteins April 20 October 12174 10 B-Ketone April 20 October 12177 24 CSF & Body Fluid Chemistry ► April 20 October 12170 14 Cystatin C April 20 October 12148 24 Ethyl Glucuronide April 20 October 12142 14 Fetal Fibronectin April 20 October 12131 14 Fetal ROM April 20 October 12135 15 Fructosamine April 20 October 12134 16 Glycohemoglobin - whole blood April 20 October 12208 19 Lamellar Body Count April 20 October 12236 25 Microalbumin April 20 October 12169 20 Procalcitonin April 20 October 12171 21 SHBG and Testosterone April 20 October 12163 25 Sweat Analysis ► April 20 October 12146 26 Urine Adulteration Test April 20 October 12143 26 Urine Chemistry April 20 October 12139 27 Urine Drug Screen April 20 October 12A39 27 Urine Drug Screen (Verification) April 20 October 12123 23 Whole Blood Glucose - 5 April 20 October 12918 23 Whole Blood Glucose - 3 April 20 October 12A23 23 Whole Blood Glucose - 5 (Verification) April 20 October 12J18 23 Whole Blood Glucose - 3 (Verification) April 20 October 12X23 23 Extra Results WBG - 5 (Verification) April 20 October 12X18 23 Extra Results WBG - 3 (Verification) April 20 October 12

Catalog #Catalog

Page Hematology Programs1st Event Ship Date

2nd Event Ship Date

3rd Event Ship Date

259 34 Advanced Blood Cell ID (Virtual) March 9 July 6 November 2224 34 Blood Cell ID (CMS Scored) (Virtual) March 9 July 6 November 2225 34 Blood Cell ID (Not CMS Scored) (Virtual) March 9 July 6 November 2286 34 Add-on Blood Cell ID Photographs March 9 July 6 November 2206 35 Body Fluid Cell Count - C March 9 July 6 November 2207 35 Body Fluid Cell Count - I March 9 July 6 November 2168 36 Body Fluid Microscopy (Virtual) March 9 July 6 November 2181 36 Add-on Body Fluid Microscopy Photographs March 9 July 6 November 2277 36 Cell Count & Body Fluid Crystals March 9 July 6 November 2210 37 Fetal Hemoglobin March 9 July 6 November 2229 37 Flow Cytometry ► March 9 July 6 November 2221 28 Hematology - 3 March 9 July 6 November 2B21 28 Hematology - 3 (Verification) March 9 July 6 November 2227 28 Hematology - 3S March 9 July 6 November 2B27 28 Hematology - 3S (Verification) March 9 July 6 November 2231 29 Hematology - 5A March 9 July 6 November 2B31 29 Hematology - 5A (Verification) March 9 July 6 November 2230 30 Hematology - 5C March 9 July 6 November 2B30 30 Hematology - 5C (Verification) March 9 July 6 November 2220 31 Hematology - 5C2 March 9 July 6 November 2B20 31 Hematology - 5C2 (Verification) March 9 July 6 November 2242 31 Hematology - 5D March 9 July 6 November 2B42 31 Hematology - 5D (Verification) March 9 July 6 November 2279 32 Hematology - 5H March 9 July 6 November 2238 33 Hematology - 5S March 9 July 6 November 2B38 33 Hematology - 5S (Verification) March 9 July 6 November 2226 32 Hematology - 5M March 9 July 6 November 2209 38 HemoCue White Blood Cell Count March 9 July 6 November 2222 29 QBC Hematology March 9 July 6 November 2223 38 Reticulocyte Count March 9 July 6 November 2

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Catalog #Catalog

Page Hematology Programs (cont.)1st Event Ship Date

2nd Event Ship Date

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228 39 Sedimentation Rate - A March 9 July 6 November 2201 39 Sedimentation Rate - B March 9 July 6 November 2202 39 Sedimentation Rate - C March 9 July 6 November 2203 40 Sedimentation Rate - D March 9 July 6 November 2280 40 Sedimentation Rate - E March 9 July 6 November 2237 40 Sickle Cell Screen March 9 July 6 November 2

Catalog #Catalog

Page Coagulation Programs1st Event Ship Date

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211 44 ACT (Hemochron/Helena) - 5 March 9 July 6 November 2916 44 ACT (Hemochron/Helena) - 2 March 9 July 6 November 2J16 44 ACT (Hemochron) - 2 (Verification) March 9 July 6 November 2212 44 ACT (Medtronic) - 5 March 9 July 6 November 2917 44 ACT (Medtronic) - 2 March 9 July 6 November 2J17 44 ACT (Medtronic) - 2 (Verification) March 9 July 6 November 2217 45 Coagulation March 9 July 6 November 2B17 45 Coagulation (Verification) March 9 July 6 November 2283 45 Coagulation, Supplemental - add on to 217 NEW March 9 July 6 November 2281 45 Coagulation, Supplemental March 9 July 6 November 2282 45 Additional Volume Coagulation, Supplemental March 9 July 6 November 2245 46 D-dimer - Qualitative March 9 July 6 November 2246 46 D-dimer - Quantitative March 9 July 6 November 2B46 46 D-dimer (quant) (Verification) March 9 July 6 November 2247 47 Hemochron Jr. ACT - LR March 9 July 6 November 2B47 47 Hemochron Jr. ACT-LR (Verification) March 9 July 6 November 2248 46 Hemochron Jr. ACT + March 9 July 6 November 2B48 46 Hemochron Jr. ACT+ (Verification) March 9 July 6 November 2252 47 Hemochron Jr. Citrate APTT March 9 July 6 November 2249 48 Hemochron Jr. Citrate PT March 9 July 6 November 2250 48 Hemochron Jr. PT March 9 July 6 November 2278 49 Heparin Assay March 9 July 6 November 2215 49 i-Stat ACT March 9 July 6 November 2B15 49 i-STAT ACT (Verification) March 9 July 6 November 2255 49 Platelet Function - Aspirin Test March 9 July 6 November 2256 50 Platelet Function - PRUTest March 9 July 6 November 2214 50 POC Coagulation A - 5 March 9 July 6 November 2914 50 POC Coagulation A - 2 March 9 July 6 November 2B14 50 POC Coagulation A - 5 (Verification) March 9 July 6 November 2J14 50 POC Coagulation A - 2 (Verification) March 9 July 6 November 2216 51 POC Coagulation B March 9 July 6 November 2B16 51 POC Coagulation B (Verification) March 9 July 6 November 2244 51 Thromboelastogram March 9 July 6 November 2

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Page Urinalysis, Microscopy, & Misc. Programs1st Event Ship Date

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270 52 Automated Urine Microscopy - I March 9 July 6 November 2271 52 Automated Urine Microscopy - S March 9 July 6 November 2261 52 Fecal Lactoferrin March 9 July 6 November 2284 53 Facal Occult Blood March 9 July 6 November 2285 53 Fecal Occult Blood - add on to #232 or #272 March 9 July 6 November 2B84 53 Fecal Occult Blood (Verification) March 9 July 6 November 2239 53 Gastric Occult Blood March 9 July 6 November 2B39 53 Gastric Occult Blood (Verification) March 9 July 6 November 2233 54 Microscopy Package (Virtual) March 9 July 6 November 2287 54 Add-on Microscopy Photographs March 9 July 6 November 2B33 54 Microscopy Package (Virtual) (Verification) March 9 July 6 November 2260 54 Rapid Urease February 10 - September 21273 56 Urine Crystals March 9 - November 2258 56 Urine Eosinophils (Virtual) March 9 July 6 November 2289 56 Add-on Urine Eosinophils Photograph March 9 July 6 November 2232 55 Urinalysis & HCG March 9 July 6 November 2B32 55 Urinalysis & HCG (Verification) March 9 July 6 November 2272 55 Urinalysis & HCG - I March 9 July 6 November 2

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Page Urinalysis, Microscopy, & Misc. Programs (cont.)1st Event Ship Date

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235 57 Urine HCG - Qualitative January 13 May 18 August 24B35 57 Urine HCG - 5 (Verification) January 13 May 18 August 24234 57 Urine Sediment (Virtual) March 9 July 6 November 2288 57 Add-on Urine Sediment Photographs March 9 July 6 November 2251 58 Waived & Microscopy Package March 9 July 6 November 2B51 58 Waived & Microscopy Pkg (Verification) March 9 July 6 November 2X51 58 Extra Results WBG-Wvd Pkg (Verification) March 9 July 6 November 2

Catalog #Catalog

Page Andrology Programs1st Event Ship Date

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3rd Event Ship Date

154 41 Antisperm Antibody ► March 9 - November 2185 41 Automated Post-Vasectomy Sperm Analysis March 9 - November 2184 41 Automated Sperm Count March 9 - November 2162 42 Post-Vasectomy Sperm Analysis March 9 - November 2151 42 Sperm Count March 9 - November 2152 42 Sperm Morphology March 9 - November 2161 43 Sperm Motility (Virtual) March 9 - November 2153 43 Sperm Viability March 9 - November 2

Catalog #Catalog

Page Immunology Programs1st Event Ship Date

2nd Event Ship Date

3rd Event Ship Date

421 90 ANA March 30 August 3 November 30429 90 ANA (latex kits) March 30 August 3 November 30423 91 Anti-CCP March 30 August 3 November 30424 91 ASO March 30 August 3 November 30441 91 BRCA1/2 Sequencing ► March 30 - November 30431 92 C-Reactive Protein March 30 August 3 November 30419 92 Diagnostic Allergy March 30 August 3 November 30437 92 Additional Volume Diagnostic Allergy March 30 August 3 November 30420 93 H. pylori Antibody March 30 August 3 November 30442 93 HBV Viral Load ► March 30 August 3 November 30439 94 HCV Viral Load ► March 30 August 3 November 30443 94 High Sensitivity CRP - 5 March 30 August 3 November 30425 94 High Sensitivity CRP - 2 March 30 August 3 November 30440 94 HIV Viral Load ► March 30 August 3 November 30430 95 HSV-2 Antibody March 30 August 3 November 30407 95 Immunology Package March 30 August 3 November 30436 96 Immunoproteins / C3 & C4 March 30 August 3 November 30438 96 Infectious Disease Serology ► March 30 - November 30411 97 Infectious Mono & Rheumatoid Factor March 30 August 3 November 30410 97 Infectious Mononucleosis - 5 March 30 August 3 November 30910 97 Infectious Mononucleosis - 2 March 30 August 3 November 30418 98 Lyme Disease March 30 August 3 November 30428 98 Mycoplasma Antibody March 30 August 3 November 30432 99 Rapid HIV - 5 March 30 August 3 November 30433 99 Rapid HIV - 2 March 30 August 3 November 30D33 99 Rapid HIV - 2 (Verification) March 30 August 3 November 30408 99 Rheumatoid Factor March 30 August 3 November 30415 100 Rubella March 30 August 3 November 30416 100 Syphilis Serology March 30 August 3 November 30164 101 Thyroid Antibodies March 30 August 3 November 30417 101 Viral Markers ► March 30 August 3 November 30

Catalog #Catalog

Page Immunohematology Programs1st Event Ship Date

2nd Event Ship Date

3rd Event Ship Date

511 102 ABO/Rh March 30 August 3 November 30516 102 Antibody Elution March 30 - November 30519 103 Antibody Titer - A March 30 - November 30520 103 Antibody Titer - D March 30 - November 30521 103 Antibody Titer - AD March 30 - November 30517 104 Automated Blood Bank March 30 August 3 November 30E17 104 Automated Blood Bank (Verification) March 30 August 3 November 30537 104 Auto Blood Bank with Electronic Crossmatch March 30 August 3 November 30

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Catalog #Catalog

Page Immunohematology Programs (cont.)1st Event Ship Date

2nd Event Ship Date

3rd Event Ship Date

512 105 Blood Bank March 30 August 3 November 30E12 105 Blood Bank (Verification) March 30 August 3 November 30532 105 Blood Bank with Electronic Crossmatch March 30 August 3 November 30514 106 DAT March 30 August 3 November 30E14 106 DAT (Verification) March 30 August 3 November 30534 106 DAT - Automated March 30 August 3 November 30518 107 Educational Blood Bank March 30 August 3 November 30515 107 Fetal RBC ► March 30 August 3 November 30513 107 Rh Slide Test March 30 August 3 November 30

Catalog #Catalog

Page Microbiology Programs1st Event Ship Date

2nd Event Ship Date

3rd Event Ship Date

335 75 Acid Fast Smears March 2 August 17 -324 59 Affirm VP February 10 June 15 September 21359 60 Bacterial Vaginosis February 10 June 15 September 21321 60 Basic Bacteriology Package February 10 June 15 September 21361 61 Blood Culture February 10 - September 21336 79 Blood Parasites February 10 June 15 September 21368 87 Blood Pathogen Panel February 10 June 15 September 21363 61 Bordetella pertussis/parapertussis (molecular) February 10 June 15 September 21350 62 C. difficile Toxin or Antigen - 5 February 10 June 15 September 21347 62 C. difficile Toxin or Antigen - 2 February 10 June 15 September 21C47 62 C. difficile Toxin or Antigen (Verification) February 10 June 15 September 21360 62 Campylobacter February 10 June 15 September 21317 76 Candida Culture February 10 June 15 September 21380 63 Carbapenem-resistant Organisms NEW February 10 June 15 September 21311 63 Chlamydia/GC (molecular) February 10 June 15 September 21316 64 Chlamydia Antigen - 5 February 10 June 15 September 21930 64 Chlamydia Antigen - 2 February 10 June 15 September 21328 64 Comprehensive Bacteriology February 10 June 15 September 21345 77 Cryptococcal Antigen February 10 June 15 September 21332 77 Dermatophyte Culture January 13 May 18 August 24383 65 Extended Bacteriology - Educational NEW February 10 June 15 September 21315 68 GC/Group B Strep Culture - 5 February 10 June 15 September 21929 68 GC/Group B Strep Culture - 2 February 10 June 15 September 21369 87 GI Panel February 10 June 15 September 21342 79 Giardia & Cryptosporidium Antigens - 5 February 10 June 15 September 21932 79 Giardia & Cryptosporidium Antigens - 2 February 10 June 15 September 21320 65 Gram Stain February 10 June 15 September 21330 65 Additional Gram Stain Slides February 10 June 15 September 21329 66 Gram Stain - Direct Smears (Virtual) February 10 June 15 September 21319 66 Gram Stain - Vaginitis (Virtual) February 10 - September 21312 67 Group A Strep Antigen - 5 February 10 June 15 September 21913 67 Group A Strep Antigen - 3 February 10 June 15 September 21912 67 Group A Strep Antigen - 2 February 10 June 15 September 21J12 67 Group A Strep Antigen - 2 (Verification) February 10 June 15 September 21365 67 Group B Strep (molecular) - 5 February 10 June 15 September 21965 67 Group B Strep (molecular) - 2 February 10 June 15 September 21351 68 H. pylori Antigen, Stool February 10 - September 21375 81 HPV (molecular) - 5 February 10 June 15 September 21975 82 HPV (molecular) - 2 February 10 - September 21373 82 HSV 1 & 2 (molecular) February 10 June 15 September 21339 78 India Ink February 10 June 15 September 21377 83 Influenza A&B (Silaris) - 5 February 10 June 15 September 21977 83 Influenza A&B (Silaris) - 3 ► February 10 - September 21333 78 KOH Preparation February 10 June 15 September 21340 69 Legionella Antigen February 10 June 15 September 21372 75 M. tuberculosis (molecular) February 10 June 15 September 21371 88 Meningitis Panel February 10 June 15 September 21381 84 Molecular Virology NEW February 10 June 15 September 21366 70 MRSA / Staph aureus (molecular) February 10 June 15 September 21356 69 MRSA Culture February 10 June 15 September 21344 76 Mycobacteriology Culture March 2 August 17 -331 78 Mycology Culture January 13 May 18 August 24

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Catalog #Catalog

Page Microbiology Programs (cont.)1st Event Ship Date

2nd Event Ship Date

3rd Event Ship Date

384 70 Mycoplasma genitalium (molecular) NEW February 10 June 15 September 21374 71 Mycoplasma pneumoniae (molecular) February 10 June 15 September 21379 84 Norovirus NEW February 10 - September 21334 80 Parasitology February 10 June 15 September 21378 88 Pneumonia Panel February 10 June 15 September 21382 80 Rapid Malaria NEW February 10 - September 21370 89 Respiratory Panel February 10 June 15 September 21348 85 Rotavirus - 5 February 10 June 15 September 21349 85 Rotavirus - 3 February 10 June 15 September 21341 72 S. pneumoniae Antigen February 10 June 15 September 21385 85 SARS-CoV2 (molecular) May 4 July 20 October 26343 71 Shiga Toxin February 10 - September 21364 72 Strep Pharyngeal (molecular) - 5 February 10 June 15 September 21964 72 Strep Pharyngeal (molecular) - 2 February 10 June 15 September 21C64 72 Strep Pharyngeal (molecular) (Verification) February 10 June 15 September 21313 73 Throat Culture - 5 February 10 June 15 September 21953 73 Throat Culture - 3 February 10 June 15 September 21952 73 Throat Culture - 2 February 10 June 15 September 21362 81 Trichomonas February 10 June 15 September 21314 73 Urine Culture - 5 February 10 June 15 September 21924 73 Urine Culture - 2 February 10 June 15 September 21376 89 Vaginal Panel February 10 June 15 September 21357 74 VRE Culture February 10 June 15 September 21367 74 VRE (molecular) February 10 June 15 September 21322 86 Virology Package - 5 February 10 June 15 September 21942 86 Virology Package - 2 February 10 June 15 September 21C22 86 Virology Package (Verification) February 10 June 15 September 21933 86 Virology Package - waived February 10 - September 21J33 86 Virology Package - waived (Verification) February 10 - September 21

► Some analytes within this program are not CAP accepted. See our online catalog for the most recent list of CAP accepted programs.

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American Proﬁciency - api-pt.com · analytes. API programs are also accepted by CMS, COLA, TJC,...

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