Specialty Sub Specialty Test/Analyte Method Matrix · LABORATORY CORPORATION OF AMERICA 69 First...

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(A2LA Cert. No. 4119.01) 01/18/2018 Page 1 of 18 SCOPE OF ACCREDITATION TO ISO 15189:2012 LABORATORY CORPORATION OF AMERICA 69 First Avenue Raritan, NJ 08869 Dr. Araceli Reyes 908 526 2400 Ext. 2117 CLINICAL Valid To: January 31, 2021 Certificate Number: 4119.01 In recognition of the successful completion of the A2LA evaluation process, accreditation is granted to this laboratory to perform the following types of testing on human samples, including: Plasma (P), Serum (S), Sputum (SP), Sterile Swabs (SS), Stool (ST), Urine (U), Wounds (W), Whole Blood (WB), Semen, Pathology Tissue, Nasal Fluid, Heparin, Blood Smear and other bodily fluids/tissues including Dried Blood Spot/Dried Serum Spot (DBS). Specialty Sub Specialty Test/Analyte Method Matrix Pathology Histopathology Routine Processing Manual, Microscopy Pathology Tissue Gross Evaluation, Non- Pathologist Manual, Microscopy Pathology Tissue Gross Evaluation, Pathologist Manual, Microscopy Pathology Tissue Immunofluorescence Stain, Tissue Biopsy Staining, Microscopy Pathology Tissue Immunohistochemistry Staining IHC, Microscopy Pathology Tissue Microscopic Evaluation, Surgical Pathology Microscopy Pathology Tissue Oral Pathology (Oral Specimen Exam) Microscopy Pathology Tissue Pathologist Interpretation, FNA Microscopy Body Fluid Skin Scrapings for Parasites, Surgical Pathology Microscopy Pathology Tissue Special Stains – Histochemistry Staining, Microscopy Pathology Tissue

Transcript of Specialty Sub Specialty Test/Analyte Method Matrix · LABORATORY CORPORATION OF AMERICA 69 First...

Page 1: Specialty Sub Specialty Test/Analyte Method Matrix · LABORATORY CORPORATION OF AMERICA 69 First Avenue Raritan, ... Ion–Exchange High ... (HEL/SUP) FLOW WB

(A2LA Cert. No. 4119.01) 01/18/2018 Page 1 of 18

SCOPE OF ACCREDITATION TO ISO 15189:2012

LABORATORY CORPORATION OF AMERICA 69 First Avenue

Raritan, NJ 08869 Dr. Araceli Reyes 908 526 2400 Ext. 2117

CLINICAL Valid To: January 31, 2021 Certificate Number: 4119.01

In recognition of the successful completion of the A2LA evaluation process, accreditation is granted to this laboratory to perform the following types of testing on human samples, including: Plasma (P), Serum (S), Sputum (SP), Sterile Swabs (SS), Stool (ST), Urine (U), Wounds (W), Whole Blood (WB), Semen, Pathology Tissue, Nasal Fluid, Heparin, Blood Smear and other bodily fluids/tissues including Dried Blood Spot/Dried Serum Spot (DBS).

Specialty Sub Specialty Test/Analyte Method Matrix

Pathology Histopathology Routine Processing Manual, Microscopy Pathology

Tissue Gross Evaluation, Non-

Pathologist Manual, Microscopy Pathology

Tissue Gross Evaluation,

Pathologist Manual, Microscopy Pathology

Tissue Immunofluorescence

Stain, Tissue Biopsy Staining, Microscopy Pathology

Tissue Immunohistochemistry

Staining IHC, Microscopy Pathology

Tissue Microscopic Evaluation,

Surgical Pathology Microscopy Pathology

Tissue Oral Pathology (Oral

Specimen Exam) Microscopy Pathology

Tissue Pathologist

Interpretation, FNA Microscopy Body Fluid

Skin Scrapings for Parasites, Surgical Pathology

Microscopy Pathology Tissue

Special Stains – Histochemistry

Staining, Microscopy Pathology Tissue

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Specialty Sub Specialty Test/Analyte Method Matrix

Pathology Cytology Automated PAP

Screening / Re–Screening

Microscopy

BF

FNA Accessioned & Processed in Cytology

Microscopy

BF

Interpretation, FNA Microscopy BF

Interpretation, Non-Gyn Cytology

Microscopy

BF

Liquid Based Preparation

Microscopy

BF

Pathologist Interpretation, Gynecologic Cytology, FNA, Non-Gyn Cytology

Microscopy

BF / Tissue

Screening by Cytotech, Gynecologic Cytology

Microscopy

BF

Screening by Cytotech, Non-Gynecologic Cytology

Microscopy

BF

Chemistry General Chemistry Albumin Colorimetric– Bromcresol S or P Alk Phos Enzymatic– Colorimetric S or P ALT Enzymatic– Colorimetric S or P Ammonia Enzymatic EDTA Amylase Enzymatic–Colorimetric S or P AST Enzymatic–Colorimetric S or P Bilirubin, Direct Colorimetric– Diazo S or Heparin Bilirubin, Direct

(Neonatal)Colorimetric– Diazo S or Heparin

Bilirubin, Total Colorimetric– Diazo S or Heparin Calcium NM–BAPTA Photometric S or Heparin,

Urine, BF Calcium, Ionized Ion Selective Electrode Serum Chloride ISE S or Heparin,

U

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Specialty Sub Specialty Test/Analyte Method Matrix

Chemistry General Chemistry Cont. Cholesterol Enzymatic– Colorimetric S or EDTA CK–MB ECLIA S CO2 Colorimetric (PEPC) S or Heparin C-Reactive Protein,

QuantitativeImmuno–Turbidimetric S or EDTA

Creatine Kinase (CK) Enzymatic– Colorimetric S or Heparin Creatinine JAFFE–Picrate, Rate S or EDTA,

BF, U Cryoglobulin Manual S

Fetal Fibronectin Immunoassay Cervicovaginal Fluid

G–6–PD Screen Kinetic WB GGT Enzymatic–Colorimetric S or EDTA Glucose Enzymatic Glucose

Endpoint–Hexokinase S or P Gray, BF, U

Beta Hcg, Quantitative ECLIA S HDL Cholesterol Enzymatic– Colorimetric S or EDTA Iron Colorimetric– Ferrozine S LD Enzymatic– Colorimetric S or EDTA LDL Cholesterol, Direct Enzymatic– Colorimetric S Lipase Enzymatic– Colorimetric S Magnesium Xylidyl Blue,

PhotometricS or U

Myoglobin ECLIA S pH Electrochemical BF, U Phosphorus Endpoint S or EDTA,

U Potassium ISE S or U, BF Protein, Total Turbidmetric S or U, BF Sodium ISE S or U, BF Triglycerides Enzymatic– Colorimetric S or BF UIBC Colorimetric– Ferrozine S Urea UREASE–Rate S or Urine,

BF Uric Acid Enzymatic–Colorimetric S or BF Uric Acid Uricase– Colorimetric UChemistry Special Chemistry ACTH ECLIA EDTA Aldolase ECLIA S Alpha–1–Antitrypsin Immuno–Turbidimetric S or EDTA Alpha–Fetoprotein,

Tumor MarkerECLIA S

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Specialty Sub Specialty Test/Analyte Method Matrix

Chemistry Special Chemistry Cont. Amikacin FPIA S Angiotensin Converting

Enzymer (ACE)Kinetic S

Apolipoprotein A1 Immuno–Turbidimetric S or EDTA Apolipoprotein B Immuno–Turbidimetric S or EDTA ASO, Quantitative Latex Turbidimetry S Bence Jones Protein Electrophoresis U BNP ICMA EDTA

Plasma CA 15–3 ECLIA S CA 19–9 ECLIA S CA 27–29 ICMA S CA–125 ECLIA S Carbamazepine FPIA S CEA ECLIA S Ceruloplasmin Immuno–Turbidimetric S CK Isozymes

(CK1, CK2, CK3) Electro S

Complement C3 Immuno–Turbidimetric S or Heparin Complement C4 Immuno–Turbidimetric S or Heparin

Complement, Other Than C3 and C4, including CH50

Immuno–Turbidimetric S

Cortisol ECLIA S C-Peptide ECLIA S C-Reactive Protein,

High Sensitivity (Hscrp) Turbidmetric S

Cyclosporine ICMA S or P (Heparin)

DHEA Sulfate ECLIA S Digoxin ICMA S Erythropoietin ICMA S Estradiol ECLIA S Ferritin ECLIA S Folate ECLIA S Follicle Stimulating

Hormone (FSH) ECLIA S

Fructosamine Colormetric S or EDTA Gentamicin FPIA S Glomerular Filtration

Rate Calculation S

Haptoglobin Immuno–Turbidmetric S or EDTA HAV Antibody, Igm ICMA S

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Specialty Sub Specialty Test/Analyte Method Matrix

Chemistry Special Chemistry Cont. HAV Antibody, Total ICMA S Hbc Antibody, Igm ICMA S Hbc Antibody, Total ICMA S Hbe Antibody EIA S Hbeag ICMA S Hbs Antibody,

QualitativeICMA S

Hbs Antibody, Quantitative

ICMA S

Hbsag ICMA S HCV Antibody ICMA S Hemoglobin A1C Colormetric P (Lav) HIV–1/2 Antibody

Rapid Test Immuno–Chromographic S

HIV–1/2 Antibody/P24 Antigen, Non–Rapid, Immunoassay

ICMA S

Homocysteine Enzymatic Kinetic S Iga, Quantitative Immuno–Turbidimetric S Igg, Quantitative Immuno–Turbidimetric S Igm, Quantitative Immuno–Turbidimetric S Immunofixation

ElectrophoresisElectrophoresis S, U

Insulin ECLIA S Kappa Light Chain,

Free, QuantitativeImmunologic S

Kappa/Lambda Ratio Immunologic S Lambda Light Chain,

Free, QuantitativeCalculation S

Lamellar Body Count (Impedance Cell Counting) (LDT)

Optical Impedance Amniotic Fluid

LD Isoenzymes (LD1, LD2, LD3, LD4, LD5)

Electrophoresis S

Lead Graphic Furnace AAS WB Lipoprotein (A) Immuno–Turbidimetric S Lithium ISE S Luteinizing Hormone

(LH) ECLIA S

N–Acetylprocainamide (NAPA)

FPIA S or P (Heparin)

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Specialty Sub Specialty Test/Analyte Method Matrix

Chemistry Special Chemistry Cont. Paraprotein

Identification (M–Protein)

Electrophoresis S

Parathyroid Hormone (PTH)

ECLIA S or P (Heparin)

Phenobarbital FPIA S or P (Heparin)

Phenytoin FPIA S or P (Heparin)

Prealbumin Immuno–Turbidmetric S Procainamide FPIA S or P

(Heparin) Progesterone ECLIA S Prolactin ECLIA S Prostate Specific

Antigen (PSA)ECLIA S

Prostate Specific Antigen (PSA), Free

ECLIA S

Protein Electrophoresis Electrophoresis S, U Quinidine FPIA S or P

(Heparin) RBC Folate ECLIA WB Rheumatoid Factor,

Quantitative

Immuno–Turbidimetric S or P (Heparin)

Salicylate Enzymatic S or P (Heparin)

Sex Hormone–Binding Globulin (SHBG)

ECLIA S

T3, Uptake ECLIA S T3, Free ECLIA S T3, Total ECLIA S T4, Free ECLIA S T4, Total ECLIA S Tacrolimus ICMA WB Testosterone, Free EIA S Testosterone, Total ECLIA S Theophylline FPIA S or P

(Heparin) Therapeutic Drug

MonitoringFPIA S or P

(Heparin) Thyroglobulin

ICMA S

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Specialty Sub Specialty Test/Analyte Method Matrix

Chemistry Special Chemistry Cont. Tobramycin FPIA S or P

(Heparin) Transferrin Immuno–Turbidimetric S or P

(Heparin) Troponin I ICMA S TSH ECLIA S Valproic Acid FPIA S or P

(Heparin) Vancomycin FPIA S or P

(Heparin) Vitamin B12 ECLIA S

Vitamin D, 25–Hydroxy ECLIA S

Zinc Protoporphyins Hematofluorometer WBChemistry Toxicology Forensic Alcohol/Volatiles, Legal GC Headspace U, Blood Clinical and

Forensic Alcohol/Volatiles, Medical

ADH U

Forensic Nicotine/Cotinine Rapid Test

Immunoassay U

Clinical and Forensic

Specimen Integrity Testing, Creatinine

Jaffe Reaction U

Clinical and Forensic

Specimen Integrity Testing, pH

End Point Colorimetric U

Forensic Specimen Integrity Testing, pH Workplace Forensic

pH Meter U

Clinical Specimen Integrity Testing, Nitrite

End Point Colorimetric U

Clinical and Forensic

Specimen Integrity Testing, Spec Gravity

End Point Colorimetric U

Forensic Specimen Integrity Testing, Spec Gravity Workplace Forensic

Refractometer U

Forensic Urine Drug Screening, Pre–Employment

GCMS, LCMSMS U

Forensic Urine Drug Screening, Workplace

GCMS, LCMSMS U

Clinical Urine Toxicology, Oral Immunoassay U Forensic Urine Toxicology,

Quantitative GCMS, LCMSMS U

Clinical Oral Fluid Toxicology, Qualitative

ELISA Oral Fluid

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Specialty Sub Specialty Test/Analyte Method Matrix

Chemistry Toxicology Cont. Clinical Oral Fluid Toxicology,

Quantitative GC/MS Oral Fluid

Chemistry Urinalysis Hcg Immunoassay U Specific Gravity Refractometer U Urinalysis Dipstick,

Automated Reflectance Spectrophotometry

U

Urinalysis Dipstick, Manual

Reagent Strips U

Urine Sediment Microscopy (Including Crystal ID)

Automated Microscopy (Particle Imaging)

U

Hematology Hematology Abn. Hb Detection

(All Methods Except Solubility)

Ion–Exchange High Performance Liquid Chromatography

WB

Body Fluid Cell Count, Automated

Fluorescent Flow Cytometry

BF

Body Fluid Cell Count, Manual

Manual Microscopic Exam

BF

Body Fluid Differential Manual Microscopic Exam

BF

CD3/CD4/CD8 (HEL/SUP/T.LYMPH)

FLOW WB

CD4 (HEL) FLOW WB CD4/CD8 (HEL/SUP) FLOW WB CD8–/CD57+ FLOW WB Crystal Identification Manual Microscopic

ExamBF

D–Dimer, Quantitative Latex Immuno–Agglutination Assay (LIA)

P

DIFF. PANEL (3/4/8/19) (T.LYM/H/S/B)

FLOW WB

Eosinophil Count Mixed Technology WB Eosinophils,

Nasal Smear Wright –Giemsa Stain Nasal Fluid

ESR, Automated Photometrical Capillary Optical Clot Detection

WB

ESR, Manual Manual WB

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Specialty Sub Specialty Test/Analyte Method Matrix

Hematology Hematology Cont. Fibrinogen Optical Clot Detection P Flow Activation Panel

CD56+16+/3/3+25+ CD3/4/8/3+25+/8+57+

FLOW WB

Semen Fructose Manual Semen Hematocrit Mixed Technology WB Hemoglobin A2

Quantitation, Non–Electrophoresis

Ion–Exchange High Performance Liquid Chromatography

WB

Hemoglobin F Quantitation (Hemoglobinopathy)

Ion–Exchange High Performance Liquid Chromatography

WB

Hemoglobin Solubility (Sickling Test)

Sodium Hydrosulfite Reduction

WB

Hemoglobin, Non–Waived

Mixed Technology WB

INR Optical Clot Detection P Leukocyte Alkaline

Phosphatase Score Naphthol Stain–Bright Field Microscopy

Blood Smear

Lymphocyte Phenotyping

FLOW WB

Mucin Clot Manual BF NK Only (CD 56) FLOW WB Nrbc Count, Automated Mixed Technology WB Parasite ID, Blood,

Other Than Malaria Manual Microscopic Exam

WB

Parasite ID, Malaria Manual Microscopic Exam

WB

Platelet Count (PLT) Mixed Technology P PT Optical Clot Detection P PTT Optical Clot Detection P RBC Count Mixed Technology WB RBC Indices (E.G.

MCV, RDW) Mixed Technology WB

Reticulocyte Count Mixed Technology WB Sperm, Presence or

Absence (Post Vasectomy)

Manual Microscopic Exam

Semen

Sperm Count, Manual Manual Microscopic Semen T–Cell Act

(CD3/4/8/HLA/25/38) FLOW WB

WBC Count, Automated Mixed Technology WB

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Specialty Sub Specialty Test/Analyte Method Matrix

WBC Differential, Automated

Mixed Technology WB

WBC Differential, Manual

Manual Microscopic Exam

WB

Diagnostic Immunology General Immunology Anti–Cardiolipin Iga EIA S Anti–Cardiolipin Igg EIA S Anti–Cardiolipin Igm EIA S Anti–Centromere

Antibody Multiplex Bead Assay S

Anti–Chromatin Antibody

Multiplex Bead Assay S

Anti–DNA Multiplex Bead Assay S Anti–ENA Multiplex Bead Assay S Antigliadin Antibody

Iga EIA S

Antigliadin Antibody Igg

EIA S

Anti–JO–1 Multiplex Bead Assay S Antimitochondrial M2

Antibody (AMA–M2) EIA S

Antinuclear Antibody, Qualitative

Multiplex Bead Assay S

Antinuclear Antibody, Qualitative

IFA S

Anti–Parietal Cell Antibody

EIA S

Anti–Reticulin IFA S Anti–Ribosomal P

AntibodyMultiplex Bead Assay S

Anti–RNP Antibody Multiplex Bead Assay S Anti-SCL-70 Multiplex Bead Assay S Anti-Sm Antibody Multiplex Bead Assay S Anti–Smooth Muscle

Antibody EIA S

Anti–SS–A Antibody Multiplex Bead Assay S Anti–SS–B Antibody Multiplex Bead Assay S Anti–Thyroglobulin

Antibody ICMA

S

Antithyroid Peroxidase (Antimicrosomal Antibody)

ECLIA

S

Antitissue Transglutaminase Antibody

EIA S

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Specialty Sub Specialty Test/Analyte Method Matrix

Diagnostic Immunology General Immunology Cont. Borrelia burgdorferi

Antibody EIA S

Borrelia burgdorferi Antibody–Confirmatory

WB – Line Blot S

CMV Antibody, Igg CLIA S CMV Antibody, Igm CLIA S Cold Agglutinin Agglutination S EBNA, Antibody CLIA S EBV Antibody CLIA S EBV–VCA, Antibody CLIA S FTA–ABS IFA S Helicobacter pylori

AntibodyIgg = CLIA Iga/Igm = EIA

S

HSV Antibody HSV 1/2 Type Specific = CLIA HSV1/2 Igm = EIA

S

HSV-2 Antibody, Confirm

Rapid Immunoassay S

Infectious Mononucleosis

Agglutination S

Mumps Antibody CLIA S Mycoplasma

Pneumoniae AntibodyEIA S

Parvovirus B19

AntibodyIgg/Igm=EIA S

RPR Flocculation S Rubella Antibody,

IgG/IgM, QualitativeCLIA S

Rubeola Antibody CLIA S Syphilis Antibodies, Igg Multiplex Bead Assay S Toxoplasma Antibody Igg/Igm = CLIA S Varicella–Zoster

Antibody

Igm = EIA Igg = CLIA

S

Microbiology Bacteriology Antimicrobial

Susceptibility, Aerobes Broth Microdilution; Disk Diffusion

Other –Isolate

Antimicrobial Susceptibility, Anaerobes

Broth Microdilution Other –Isolate

Antimicrobial Susceptibility, Urine

Broth Microdilution Other –Isolate

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Specialty Sub Specialty Test/Analyte Method Matrix

Bact. ID Other, Nucleic Acid Amplification. (Not FDA–App)

NAA SS

Bacterial ID, Respiratory Panel, (FDA App)

PCR Other – NP Swab

Bacterial Identification, Other

Culture; Biochemical Malditof

SS, W, SP, ST, U, WB, Other – Isolate

Bacterial Identification/Isolation, Anaerobic

Culture; Biochemical

SS, W, Other - Isolate

Bacterial Identification/ Presumptive ID Gonococcus

Culture; Biochemical SS, Other – Isolate

Bacterial Identification/ Presumptive ID, Throat

Culture; Biochemical SS, Other – Isolate

Bacterial Identification/ Presumptive ID, Urine

Culture; Biochemical U, Other – Isolate

Bacterial Vaginosis Rapid Test

Chromogenic Assay SS

Clostridium difficile Detection (Non–Molecular)

EIA ST

C. difficile Nucleic Acid Amplification (FDA–App)

NAA ST

Candida spp., Nucleic Acid Amplification (Not FDA–App)

NAA SS

Candida spp., Nucleic Acid Probe

DNA Probe SS

Chlamydia Trachomatis, Nucleic Acid Amplification

NAA SS, U, Other – Bodily Fluids/ Tissues

Culture Detection and Identification Anaerobic Cultures SS, W,

Other – Bodily Fluids/ Tissues

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Specialty Sub Specialty Test/Analyte Method Matrix

Bacterial Culture, Complete ID SS, W, Other – Bodily Fluids/ Tissues

Bacterial Culture, Partial ID SS, W, Other – Bodily Fluids/ Tissues

Blood Cultures WB Genital Cultures SS, Other –

Bodily Fluids/ Tissues

MRSA Screen, Culture SS Mycoplasma Culture SS, SP, Other

– Bodily Fluids/ Tissues

Respiratory Cultures SS, SP, Other – Bodily Fluids/ Tissues

Stool Cultures ST Trichomonas Culture SS, U, Other

– Bodily Fluids/ Tissues

Ureaplasma Culture SS, U, Other – Bodily Fluids/ Tissues

Urine Cultures U

VRE Screen, Culture SS, U, ST Wound Cultures SS, W, Other

– Bodily Fluids/ Tissues

DNA Probe Non–Amplified Methods (FDA–Approved)

DNA Probe/ Hybridization

SS, Other – Isolate

Fecal Fat Testing Microscopy ST Fecal Leukocytes Microscopy ST

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Specialty Sub Specialty Test/Analyte Method Matrix

Gardnerella vaginalis, Nucleic Acid Probe

DNA Probe/ Hybridization

SS

Gram Stain, Gonococcus

Microscopy SP, SS, ST, U, W, Other – Slide

Gram Stain, Other Microscopy SP, SS, ST, U, W, Other – Slide

H. pylori Antigen, EIA EIA ST HCV Viral Load NAA P, S HIV–RNA,

Quantitative, Nucleic Acid Amplification

NAA P

HPV, Signal Amplification (FDA–Approved)

Hybrid Capture Other – Liquid Pap Vial

HPV, Nucleic Acid Amplification (FDA–Approved)

NAA Other – Liquid Pap Vial

HPV, Genotyping (FDA–Approved)

NAA Other – Liquid Pap Vial

HSV, Nucleic Acid Amplification

NAA SS, Other – Bodily Fluids/ Tissues

Laboratory Developed Test – Bacterial Vaginosis Detection (PCR)

NAA SS

Laboratory Developed Test – Candida spp., Qualitative Detection (PCR)

NAA SS

Laboratory Developed Test – Mycoplasma spp. and Ureaplasma spp. Detection (PCR)

NAA SS, U

Legionella Antigen, Bronchoalveolar Lavage

DFA SP, Other – Bodily Fluids/ Tissues

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Specialty Sub Specialty Test/Analyte Method Matrix

Microbiology Bacteriology Cont. Modified IVD –

Chlamydia trachomatis Detection, Ocular (TMA)

NAA SS

Modified IVD – CT / GC Detection, Rectal / Pharyngeal (TMA)

NAA SS

Modified IVD – HSV 1 and 2 Detection (PCR)

NAA SS, Other – Bodily Fluids/ Tissues

Mycobacterium spp., Nucleic Acid Probe

DNA Probe/ Hybridization

SP, S, ST, U, W, WB, Other – Isolate

Mycobacterium Tuberculosis, Nucleic Acid Probe

DNA Probe/ Hybridization

SP, Other – Isolate

Neisseria gonorrhoeae, Nucleic Acid Amplification

NAA SS, U, Other

N. gonorrhoeae, Nucleic Acid Probe

DNA Probe Other – Isolate

Occult Blood, Fecal Immunoassay ST Occult Blood, Gastric Guaiac Other –

Bodily Fluids/ Tissues

pH, Gastric pH Indicator Other – Bodily Fluids/ Tissues

pH, Stool pH Indicator ST Salmonella and/or

Shigella Typing Latex Agglutination Other –

Isolate Shiga–Like Toxin, Stool EIA ST Strep A Rapid Antigen, Immunoassay SS Strep A, Nucleic Acid

Probe DNA Probe/ Hybridization

SS

Strep B, Nucleic Acid Amplification

NAA SS

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Specialty Sub Specialty Test/Analyte Method Matrix

TB, Whole Blood/Plasma, Immunoassay (Quantiferon)

EIA WB

Trichimonas, Nucleic Acid Amplification (FDA–Approved)

NAA SS, U, Other – Liquid Pap Vials

Trichomonas, Nucleic Acid Probe

DNA Probe/ Hybridization

SS

Urine Colony Count Culture U Vaginal Wet Mount Microscopy SS, Other Wet Mount for Yeast Microscopy SS, OtherMicrobiology Mycobacteriology Acid Fast Bacillus

Smear Microscopy SP, SS, W,

U, Other – Slide

Antimycobacterial Susceptibility

MGIT 960, Agar Proportion

Other – Isolate

Mycobacterial Identification

Culture, DNA Probe/ Hybridization

SP, SS, U, W, ST, WB, Other –Isolate

Microbiology Mycology Mycology Culture,

Screen for Growth Only Culture SS, ST, SP,

U, W, WB, Other

Dermatophyte Identification

Culture; Microscopic and Macroscopic Observation

SS, W, Other

KOH Prep Microscopy SS, ST, SP, U, W, Other – Bodily Fluids/ Tissues

Calcofluor White Fluorescent Statin

Microscopy SS, ST, SP, U, W, Other – Bodily Fluids/Tissues

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Specialty Sub Specialty Test/Analyte Method Matrix

Candida spp., ID / Presumptive ID from Culture

Culture; Microscopic Observation; Biochemical

SS, ST, SP, U, W, WB, Other – Isolate

Mold and/or Yeast Culture, Screen for Growth Only

Culture SS, ST, SP, U, W, WB, Other – Bodily Fluids/ Tissues

Mold Identification Culture; Microscopic and Macroscopic Observation; Biochemical

SS, ST, SP, U, W, WB, Other – Bodily Fluids/ Tissues

Yeast Identification Culture; Microscopic Observation; Biochemical

SS, ST, SP, U, W, WB, Other – Bodily Fluids/ Tissues

Microbiology Parasitology Cryptosporidium

Antigen, Preserved Specimen

EIA ST

Giardia Antigen, Preserved Specimen

EIA ST

Modified Acid Fast Stain for Intestinal Parasites

Microscopy ST, Other – Slide

Ova and Parasite Exam Microscopy ST, U Parasitology,

Complete IDMicroscopy ST, U

Parasite ID, Arthropod Microscopy Other – Parasite

Parasite ID, Fecal Microscopy Other – Parasite

Parasite ID, Other Microscopy Other – Parasite

Pinworm Prep Microscopy Other – Scotch Tape Prep

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(A2LA Cert. No. 4119.01) 01/18/2018 Page 18 of 18

Specialty Sub Specialty Test/Analyte Method Matrix

Microbiology Virology Chlamydia Culture Culture SS Herpes Culture Culture SS Influenza Antigen, Non–

Waived EIA SS, Other -

NP Aspirate, Wash

Influenza, Nucleic Acid Amplification FDA Approved

NAA SS, Other – NP Aspirate, Wash

Rota Virus Antigen, Non–DFA Method

EIA ST

RSV Antigen, Non–DFA Method, Non–Waived

EIA SS, Other – NP Aspirate, Wash

Viral ID, Respiratory Panel, (FDA App)

PCR Other – NP Swab

Immunohematology Immunohematology ABO Blood Grouping Agglutination WB Antibody Screen Agglutination WB Antibody Identification Agglutination WB Direct Antiglobulin Test

(DAT) Agglutination

WB

Rh Type (Includes Weak D)

Agglutination

WB

Page 19: Specialty Sub Specialty Test/Analyte Method Matrix · LABORATORY CORPORATION OF AMERICA 69 First Avenue Raritan, ... Ion–Exchange High ... (HEL/SUP) FLOW WB

ISO 15189:2012 Internationally-Recognized

Accredited Laboratory

A2LA has accredited LABORATORY CORPORATION

OF AMERICA Raritan, NJ

for technical competence in the field of

Clinical Testing

This laboratory is accredited in accordance with the recognized International Standard ISO 15189:2012 Medical laboratories - Requirements for quality and

competence. This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system (refer to joint

ISO-ILAC-IAF Communiqué dated January 2015).

Presented this 18th day of January 2019.

_______________________

Senior Director, Accreditation Services For the Accreditation Council Certificate Number 4119.01 Valid to January 31, 2021

For the tests to which this accreditation applies, please refer to the laboratory’s Clinical Scope of Accreditation.