CH40-650A01 Cobas Pro Reporting Chart CRH GPRH RDH ...

** Enzymes are not reported to endpoint, but require dilution to endpoint (with saline) in order to dilute out any potential interferences. They continue to be reported with the high

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CH40-650A01 Cobas Pro Reporting Chart – CRH GPRH RDH

Reference Intervals and Critical Values

Refer to CH02-050 Reference Intervals - Critical Values Reference Intervals – Cobas Pro – Meditech Epic for reference intervals, therapeutic ranges and critical values

Delta Limits Assay Value (Absolute) or % Hours Assay Value (Absolute) or % Hours

ALB 5 g/L 24 GLU 5 mmol/L 24

BILT 5 µmol/L 72 MG 0.10 mmol/L 24

CA 0.10 mmol/L 24 NA 10 mmol/L 24

CL 8 mmol/L 24 PHOS 0.15 mmol/L 24

CO2 4 mmol/L 24 K 0.5 mmol/L 24

CREA 50 % 24 UREA 2.5 mmol/L 24

NOTES:

Gender Unknown

GENDER X,U – pertains only to Connect Care sites LAB CHEM GENDER X,U: Patient identifies as gender X, or gender is unknown. The reference interval provided encompasses male and female ranges. Result should be interpreted in the context of the clinical history. PathNet and Meditech: Unknown genders (U) assigned Male reference intervals.

Dilutions: **Enzyme Dilution Protocol for ALT, ALP, AST, GGT, LD and LIPASE: These enzymes are not reported to endpoint, but require dilution to endpoint (with saline) in order to dilute out any potential interferences. They continue to be reported with the high alpha result Manual Dilutions using 0.9% NaCl. DO NOT USE ROCHE PRODUCT OR CASSETTE. Use 0.9% Sodium Chloride, i.e. Irrigation Solution (Baxter) or alternate manufacture product.

Linear Ranges

Alpha Responses do not always match Linear Range of analyte. Linear range is managed through Infinity and may not match package insert

Fluids Infinity Panic Low and Panic Highs do not pertain to fluids

Specimen Types

Analytes listed as Blood = Serum/Plasma If no specimen type is specified, assume specimen type is serum/plasma

Comments Comments are listed with Epic Mnemonic names. Meditech comments were built to match Epic comments


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BLOOD AND FLUIDS

Analyte Linear Range

/ Units

Automatic Dilution (decrease volume)

Manual Dilution

Infinity Review Ranges

Alpha Responses

Rerun Dilution

Rerun Range

Report to Endpoint / Approved

Diluent

Age Range

Panic Low

Review Low

Review High

Panic High

Low Alpha

High Alpha

Acetaminophen

33 - 1324 µmol/L

x 5 6620 Yes

0.9% NaCl All < 33 > 130 > 250 < 33

Auto appended to all results: PADIS Consult Poison and Drug Information Service (PADIS) at 1-800-332-1414 if appropriate.

Alanine Aminotransaminase

5 - 700 U/L x 10 7000 Dilute** All < 5 > 700 < 5 > 7000

Manual Comment: ALTPOISON Alanine Aminotransferase: _ U/L Alanine Aminotransferase (ALT) diluted to endpoint as per Poison and Drug Information Service (PADIS)

Albumin – Blood or Fluid

2 - 100 g/L x 5 500 No All < 18 > 50 < 2 > 100

Alkaline Phosphatase

5 - 1200 U/L x 5 6000 Dilute** All < 20 > 1500 < 5 > 6000

Ammonia 10-1000 µmol/L

X 2 2000 Yes

CLRW

0-16 y < 12 > 47 > 110 <10

>16 y < 12 > 47 > 200

Anion Gap

Calculation (mmol/L) All < 0 < 1 > 20

To order repeat electrolytes and AGAP in Infinity, highlight EP/AGAP and select REPEAT Refer to CH40-675 Cobas Calculations - CRH GPRH RDH for < or > Na, Cl or CO2 results, Anion Gap <1 or Anion Gap >35

Aspartate Aminotransferase – Blood

5 - 700 U/L X 10 7000 Dilute** All < 8 > 700 < 5 > 7000


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Manual Dilution


Alpha Responses

Rerun Dilution

Rerun Range


Diluent

Age Range

Panic Low

Review Low

Review High

Panic High

Low Alpha

High Alpha

Beta HCG, Quantitative – Blood

1 - 10000 IU/L X 100 1 000 000 Yes

Universal Diluent

< 0 > 10000 < 1

Autoappended to all results: Roche method has been standardized against the 4th International Standard from National Institute for Biological Standards and Control (75/589). WARNING: Different methods give potentially significantly different numerical values. Do not compare results from method to method. Testing by the same method is required for serial monitoring (e.g. graphical comparison displays). Biotin taken in doses >1 mg/day may interfere, causing falsely decreased results. Autoappended if female >40 yrs: Low concentration of hCG can be found in peri- and postmenopausal women that is of pituitary origin. Consider repeat b-hCG in 2-7 days if clinically appropriate.

Bilirubin, Direct (Conjugated)

1 - 236 µmol/L

X 2 472 Yes

0.9% NaCl All < 1 > 100 < 1 > 900

Direct Bilirubin is Greater than Total Bilirubin

Occasionally, a specimen whose total bilirubin is nearly all direct reacting, may give a direct bilirubin result slightly greater than the total bilirubin result.

In such cases, the total bilirubin result should be reported for both assays. o Ensure specimen is ultracentrifuged if lipemic o Repeat BILT and BILD on an alternate analyzer. o Report the BILT result for both BILT and BILD

Bilirubin, Total - Blood Bilirubin, Total -Fluid

2.5 - 650 µmol/L

X2 1300 Yes

0.9% NaCl

< 31 d < 100 > 300 > 300

< 2 > 3000 ≥ 31 d to

≤ 1 y < 100 > 300

> 1 y < 0 > 600

Biliary Atresia Protocol

Refer to Guidelines for Biliary Atresia Testing for Meditech Sites (PCCGNP00001)

Refer CH40-675 Cobas Calculations - CRH GPRH RDH for calculation LAB CHEM CBIL >20%: In infants, conjugated hyperbilirubinemia (conjugated bilirubin >=20% of the total bilirubin) is pathologic. Prompt evaluation is necessary, especially to assess for biliary atresia. Consider referral to a Pediatric Gastroenterologist.


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Manual Dilution


Alpha Responses

Rerun Dilution

Rerun Range


Diluent

Age Range

Panic Low

Review Low

Review High

Panic High

Low Alpha

High Alpha

Neonatal Bilirubin result less than 100 µmol/L

If Then

The Neonatal Bilirubin result on a neonate (less than 15 days old) is <100 µmol/L

In Infinity, a comment icon will appear instructing the technologist to “Check that sample volume and integrity are acceptable.”

Check the integrity of the specimen (i.e. icteric, low volume, clots)

Check for previous results (delta)

If adequate volume, repeat the specimen, preferably on the opposite analyzer.

The integrity has been checked, previous results have been checked and the specimen has been repeated (if possible)

Manually enter internal comment in LIS: ”Sample volume and Integrity acceptable” (Epic add a FYI notes)

In Infinity, release the BILT result.

Low volume specimen on Bilirubin order babies up to 30 days old

Program the specimen on the instrument without the container letter so that serum indices will not run.

Analyze and obtain the result from the Cobas Pro

Infinity o Select RELEASE TEST BY SAMPLE. o Select SAMPLE ID from the default filter. o Enter the accession number and APPLY. o Select the assay and if no result is present, select “MORE” then “EDIT.” o Edit in the Bilirubin result and select the instrument that it was tested on. o Select MORE again. o Select OVERRULE SI, so Infinity does not wait for the indices to be tested. o Release all. o The bilirubin result will now cross into LIS without indices.

NOTE: It is best to include indices whenever possible. (Visually inspect for hemolysis and lipemia and add appropriate

comment(s) in LIS)


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Manual Dilution


Alpha Responses

Rerun Dilution

Rerun Range


Diluent

Age Range

Panic Low

Review Low

Review High

Panic High

Low Alpha

High Alpha

Autoappended: LAB CHEM NBIL >250, <2 DAYS OLD: Bilirubin levels of >250 umol/L in the first 48 hours of life require pediatric consultation and further investigation. LAB CHEM NBIL <250, >2 -7 DYS OLD: Values <250, not associated with rising bilirubin values, may be considered normal for this age group. LAB CHEM NBIL >300-350, >2-7 DYS OLD: Bilirubin levels of >= 300 umol/L require medical reassessment. RE: Possibility of blood group incompatibility, excessive weight loss or inadequate feeding pattern. In presence of blood group incompatibility, the initiation of phototherapy could be considered. LAB CHEM NBIL >400, >2-7 DYS OLD: Bilirubin levels > 400 umol/L require prompt pediatric or neonatal consultation for potential need of exchange transfusion. LAB CHEM NBIL 250-300, >2-7 DYS OLD: Bilirubin levels >= 250 umol/L after the first 48 hours of life require follow-up monitoring. LAB CHEM NBIL 350-400, >2-7 DYS OLD: Bilirubin levels of >= 350 umol/L, the use of phototherapy would be prudent after appropriate assessment even when no blood group incompatibility exists. Pediatric consultation is recommended. LAB CHEM NBIL <7 DAYS OLD: Please interpret according to the Canadian Pediatric Society / AHS Guidelines for Phototherapy (https://extranet.ahsnet.ca/teams/policydocuments/1/clp-prov-womens-health-postpartum-hyperbilirubinemia-hcs-238-01.pdf#search=Hyperbilirubinemia) NBIL <30 days old: Please note: indicated reference intervals apply to neonates greater than or equal to 35 weeks gestational age

Calcium – Blood Calcium – Fluid

0.20 - 5.00 mmol/L

No dilution -- No All 1.65 < 1.75 > 3.00 >3.25 < 0.20 > 5.00

Carbamazepine 8.5 - 85.0

µmol/L No dilution --

Yes Preciset TDM1

diluent x2 All < 17 > 50 >65 <9

Chloride – Blood Chloride – Fluid

60 - 140 mmol/L

No dilution -- No All < 88 > 115 < 60 > 140

Cholesterol, Total - Blood Cholesterol, Total - Fluid

0.1 - 20.7 X10 207 Yes

0.9% NaCl All < 2.00 > 10.00 < 0.10 >207.0

Autoappended on Blood: LAB CHEM TOTAL CHOL <18 YR: Acceptable limit relative to dyslipidemia and atherosclerosis risk is < 4.40 mmol/L LAB CHEM TOTAL CHOL >=18 YR: Desirable < 5.17 mmol/L High ≥ 6.21 mmol/L


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Manual Dilution


Alpha Responses

Rerun Dilution

Rerun Range


Diluent

Age Range

Panic Low

Review Low

Review High

Panic High

Low Alpha

High Alpha

CO2 Content – Blood CO2 Content – Fluid

2 - 50 mmol/L No dilution -- No All < 15 > 36 < 2 > 50

Complement C3 0.04 – 5.00

g/L X 2 10.00 No All < 0.31 > 1.99 <0.04 > 10.00

Complement C4 0.02 – 1.00

g/L X 2 2.00 No All <0.06 > 0.59 <0.02 > 2.00

C-Reactive Protein

0.6 - 350 mg/L

X 2 700 No All < 0.3 > 350 < 0.6 > 700.0

Creatine Kinase – Blood

7 - 2000 U/L X 11 22000 Yes

0.9% NaCl All < 15 > 2000 < 7

Creatinine – Blood Creatinine – Fluid

5 - 2700 µmol/L

X 4 10800 Yes

0.9% NaCl All < 15 > 900 < 5 > 6000

Digoxin

0.38 - 6.4 nmol/L

No -- Yes

TDM I Diluent All < 0.6 > 2.6 > 2.6 < 0.6

Autoappended to all: LAB DIGOXIN REF RANGE COMMENT Suggested Ranges: Heart Failure: 0.6-1.2 nmol/L Atrial Fibrillation: Not Defined Caution: Levels >1.5 nmol/L are associated with a higher risk of toxicity in heart failure patients.

Estradiol 30 – 11010

pmol/L No dilution --

Dilute to endpoint

Diluent

Estradiol/ Progesterone

All < 18.4 > 11010 < 30

Ethanol

2.2 - 108 mmol/L

X 2 216 Yes All < 0 > 17 > 65 < 2

Autoappended to all results: TOX ETHANOL COMMENT: These results should not be used or disclosed for potential medico-legal or other non-medical purposes.


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Manual Dilution


Alpha Responses

Rerun Dilution

Rerun Range


Diluent

Age Range

Panic Low

Review Low

Review High

Panic High

Low Alpha

High Alpha

Ferritin

0.50 - 2000 µg/L

x 50 100000 No All <5 >1000 < 1 >100000

Autoappended to all results: LAB CHEM FERRITIN ALL VALUES: Ferritin concentration should be interpreted within the context of the patient (eg. inflammation, acute illness) and values less than 30-45 ug/L are associated with iron deficiency.

Folate

1.36 - 45.4 nmol/L

No dilution -- No All < 1.5 > 45.4 <1.5 >45.4

Autoappended to all results: Most Albertans are folate sufficient. Folate deficiency is defined as <10 nmol/L based on WHO recommendations and should be assessed in a fasting state. Biotin taken in doses >1 mg/day may interfere.


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Manual Dilution


Alpha Responses

Rerun Dilution

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Diluent

Age Range

Panic Low

Review Low

Review High

Panic High

Low Alpha

High Alpha

Follicle stimulating Hormone (FSH)

0.3 -200.0 IU/L

No Dilution

-- No All <0.3 >200 < 0.3 > 200

Autoappended to all results: Biotin taken in doses >1 mg/day may interfere. Autoappended to F/M/U/X 11-<18yrs: Clinical correlation with puberty status suggested. Autoappended to all Females >=11y: Reference Interval: Follicular: 2.0-10.0 IU/L Luteal: 1.0-9.0 IU/L Midcycle: 3.0-33.0 IU/L Post-menopausal: 23.0 – 116.0 IU/L Autoappended to all Gender X/Unknown patients: Reference Interval: Female <2yrs: <8.0 IU/L Female 2-5yrs: <5.0 IU/L Female 6-10yrs: <4.0 IU/L Follicular: 2.0-10.0 IU/L Luteal: 1.0-9.0 IU/L Midcycle: 3.0-33.0 IU/L Post-menopausal: 23.0 – 116.0 IU/L Male <11y: <3.0 IU/L Male 11-12y: <9.0 IU/L Male >=13y: 1.0 – 18.0 IU/L Patient identifies as gender X, or gender is unknown. Interpret result based on an appropriate reference interval listed above.

Free T3 (Triiodothyronine, Free) (FT3)

0.6 - 50.0 pmol/L

No dilution -- No All < 0.6 > 50.0 < 0.6 > 50.0

Auto appended to all results BIOTIN: Biotin taken in doses >1 mg/day may interfere. Auto appended to results in 7-12y, 12-19y, 19y+ age brackets PREGTHY: For interpretation of the test results in pregnancy refer to the care pathway at http://bit.ly/2BIWDIG


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Manual Dilution


Alpha Responses

Rerun Dilution

Rerun Range


Diluent

Age Range

Panic Low

Review Low

Review High

Panic High

Low Alpha

High Alpha

Free T4 (Thyroxine, Free) (FT4)

0.50 -100.0 pmol/L

No dilution -- No All < 9.0 > 29.0 <0.50 >100.0

Auto appended to all results BIOTIN: Biotin taken in doses >1 mg/day may interfere. Auto appended to 1month+ results PREGTHY: For interpretation of the test results in pregnancy refer to the care pathway at http://bit.ly/2BIWDIG

Gamma Glutamyl-Transferase

3 - 1200 U/L X 11 13200 Dilute** All < 8 > 1200 < 3 > 13200

Gentamicin

0.24- 12.0 mg/L

No dilution --

Yes Cedia

Antibiotic TDM low Cal diluent

Pre < 0.2 > 1.9 > 1.9

< 0.2 Post < 5.0 > 12.0 > 14.9

GENR < 0.2 > 12.0 > 14.9

GENT 8I < 0.2 > 12.0

Autoappended to all Predose Gentamicin: Note: If patient is receiving extended interval dosing the target trough is less than 0.5 mg/L. Dosing is 4 to 10 mg/kg and interval is 24h or more. Autoappended to Gentamicin 8 hour: Caution: Specimen should be collected 7-9 hours after the START of infusion for proper interpretation. Refer to Hartford Nomogram (applies only to 7 mg/kg dose; if other dose used, obtain pharmacokinetic consult). Refer to Aminoglycoside Dosing/Monitoring Guidelines, AHS Bugs and Drugs Online Document.

Glucose – Blood 0.11 - 41.6 mmol/L

X 2 83.2 Yes

0.9% NaCl

< 30 d < 2.0 < 2.0 > 24.9 > 24.9 < 0.5

> 30 d < 2.6 < 2.6 > 24.9 > 24.9

Autoappended to Glucose, Random >=11.1 mmol/L: A random glucose result of 11.1 mmol/L or greater is diagnostic of diabetes mellitus in a patient with symptoms of hyperglycemia. (2018 Diabetes Canada Guidelines)”

Autoappended depending on Glucose, Fasting result: 5.6 – 6.0 mmol/L: A fasting glucose result of 5.6 to 6.0 mmol/L indicates patient is at risk for diabetes mellitus. (2018 Diabetes Canada Guidelines) 6.1 – 6.9 mmol/L: A fasting glucose result of 6.1 to 6.9 mmol/L meets criteria for diagnosis of impaired fasting glucose (prediabetes). (2018 Diabetes Canada Guidelines) Append to all Glucose, Fasting results >= 7.0 mmol/L: A fasting glucose result of 7.0 mmol/L or greater meets part of the diagnostic criteria for diabetes mellitus. (2018 Diabetes Canada Guidelines)

Tolerances: Refer to CH40-650A04 Cobas Pro Tolerance Reporting

Glucose – Fluid 0.11 - 41.6

mmol/L X 2 83.2

Yes 0.9% NaCl

All < 2.0 > 24.9 < 0.5


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Diluent

Age Range

Panic Low

Review Low

Review High

Panic High

Low Alpha

High Alpha

Glucose – CSF 0.11 - 41.6

mmol/L X 2 83.2

Yes 0.9% NaCl

< 30 d > 1.4 > 4.3 < 0.5

> 30 d < 2.2 > 3.9

HDL Cholesterol

0.08 – 3.88 mmol/L

X 2 7.70 No All < 0.30 > 3.88 <0.08 >7.70

LOWHDL: Interpretations of Low HDL- Cholesterol include dysapolipoproteinemias, liver disease and interference due to monoclonal or polyclonal gammopathy." NHDL: For patients 30 years of age or older, the Framingham Risk Score (FRS), modified for family history, is recommended for risk assessment (2016 CCS Guideline, Can J Cardiol 2016): FRS Calculation Resource can be found at: https://myhealth.alberta.ca/Alberta/Pages/Heart-Disease-Risk-Calculator.aspx. Low Risk (FRS <10%) Treatment advised if LDL-C >=5.0 mmol/l, treatment target: >50% reduction LDL-C Intermediate Risk (FRS 10 - 19%) Treatment advised if LDL-C >=3.5 mmol/L OR Non-HDL-C >=4.3 mmol/L OR ApoB >= 1.2 g/L; Consider treatment for men >=50 and women >= 60 yrs with one additional CV risk factor. Treatment targets: LDL-C <2.0 mmol/L OR decrease by >50% OR Non-HDL-C <2.6 mmol/L OR ApoB <0.8 g/l. High Risk (FRS >=20% or presence of high risk features) Treatment advised in all patients. Treatment targets: LDL-C <2.0 mmol/L OR decrease by >50% OR Non-HDL-C <2.6 mmol/L OR ApoB <0.8 g/L NHDLCHILD: Lipid Profile acceptable limits relative to dyslipidemia and atherosclerosis risk: Total Cholesterol Acceptable <4.40 mmol/L HDL-C Acceptable >1.16 mmol/L LDL-C Acceptable <2.84 mmol/L Triglycerides Acceptable <0.85 mmol/L (0-9 years) OR <1.02 mmol/L (10-17 years)

Immunoglobulin A 0.50 - 8.00

g/L X 8 high X10 low

64.0 0.05

Yes 0.9% NaCl

All < 0.50 > 8.0 < 0.05 > 8.00

Immunoglobulin A, Pediatric

0.05 – 4.00 g/L

X 2.5 low 0.05 No All < 0.50 > 8.0 < 0.05 > 8.00


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Review Low

Review High

Panic High

Low Alpha

High Alpha

Immunoglobulin G 3.0 - 50.0 g/L X 5.6 high X 7.5 low

2800.4 Yes

0.9% NaCl All < 0.5 > 5 0 < 0.05

Immunoglobulin M 0.25 - 6.5 g/L X 9 high X 5 low

58.50.05 Yes

0.9% NaCl All < 0.25 > 6.50 < 0.25

Immunoglobulin M, Pediatric

0.04 - 1.50 g/L

X 5 low 0.01 No All < 0.25 > 6.50 < 0.05

Iron

0.9 - 179 µmol/L

X 2.1 376 No < 12 y < 1 > 50 > 54

< 1 > 376 > 12 y < 1 > 50

Autoappended to all results: LAB CHEM IRON ALL VALUES: Blood iron levels alone cannot be used to determine iron stores. Ferritin is the preferred marker to screen for iron deficiency. Iron saturation index and ferritin are the preferred screening tests for iron overload. Autoappended to results > 55 µmol/L: LAB CHEM IRON >55: CAUTION: Iron level monitoring during therapy with iron chelating agents (e.g. deferoxamine, deferasirox, deferiprone) is not recommended. If required, testing may resume >24 hours after cessation of therapy.

Lactate – Blood 0.2 - 15.5 mmol/L

X 10 155 No All < 0.5 > 2.2 > 4.0 < 0.2 > 155.0

Lactate – CSF 0.2 - 15.5 mmol/L

X 10 155 No

0-2 d

< 1.1

> 6.7

< 0.2 > 155.0 2-10 d > 4.4

>10 d > 2.4

Lactate Dehydrogenase – Blood & CSF Lactate Dehydrogenase – Fluid

10 - 1000 U/L X 2.5 2500 Dilute** All < 100 > 700 < 10 > 2500

CSF Fluid auto appended comment: Test performance not validated for this specimen type. Interpret with caution; clinical correlation is advised.

Lipase - Blood Lipase – Fluid

3 - 300 U/L X 10 3000 Dilute** All < 12 > 200 < 3 > 3000


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Alpha Responses

Rerun Dilution

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Diluent

Age Range

Panic Low

Review Low

Review High

Panic High

Low Alpha

High Alpha

Lithium

0.05 - 3.00 mmol/L

X 2 6.00 Yes

Water All < 0.10 > 0.60 < 0.10

Autoappended to all results: LAB LITHIUM REF RANGE COMMENT: Acute mania therapy: 1.00 - 1.50 mmol/L Bipolar maintenance therapy: 0.60 - 1.20 mmol/L Depression: 0.30 - 0.60 mmol/L

Luteinizing Hormone (LH)

0.3 - 200.0 IU/L

No dilution -- No All < 0.3 > 200.0 <0.3 >200

Autoappended to all results BIOTIN: Biotin taken in doses >1 mg/day may interfere. Autoappended to F/M/U/X 11-<18yrs: Clinical correlation with puberty status suggested. Autoappended to all Females >=11y: Reference Interval: Follicular: 1.0-13.0 IU/L Luteal: 1.0-17 .0IU/L Midcycle: 8.0-76.0 IU/L Post-menopausal: 16.0-54.0 IU/L Autoappended to Gender X/Unknown patients >=11y: Reference Interval: Follicular: 1.0-13.0 IU/L Luteal: 1.0-17.0 IU/L Midcycle: 8.0-76.0 IU/L Post-menopausal: 16.0-54.0 IU/L Male 11-70y: 1.0-9.0IU/L Male >=71y: 3.0-35.0 IU/L Patient identifies as gender X, or gender is unknown. Interpret result based on an appropriate reference interval listed above.

Magnesium- Blood

0.10 - 2.00 mmol/L

X 2 4.00 Yes

0.9% NaCl All < 0.40 < 0.50 > 1.50 > 1.90 < 0.10


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Diluent

Age Range

Panic Low

Review Low

Review High

Panic High

Low Alpha

High Alpha

NT-proBNP

5 - 35000 ng/L

X 2 70000 Yes

Universal Diluent

All < 0 > 300 < 5 > 70000

Autoappended to >=18 years: LAB CHEM NT PRO BNP RR In an acute setting, Heart Failure is unlikely if NT-proBNP <300 ng/L Heart Failure is likely if: NT-proBNP >450 ng/L for patients <50 years of age NT-proBNP >900 ng/L for patients 50-75 years of age NT-proBNP >1800 ng/L for patients >75 years of age 2017 CCS HF Guidelines, CJC 2017

Phenobarbital 10.3 - 258.6

µmol/L No

Dilution --

Yes Preciset TDM

I Diluent All < 65 > 170 > 190 < 10.0

Phenytoin, Total 3.2 - 158.4

µmol/L No

Dilution --

Yes Preciset TDM

I Diluent

0-3 m < 25 > 55 > 80 < 4

> 3 m < 25 > 55 > 120 < 4

Phosphate – Blood Phospate – Fluid

0.10 - 6.46 mmol/L

X 2 12.92 No

All < 0.40 < 0.40 > 3.10 < 0.10 > 10.00

4 m – 150 y

< 40 > 80 > 120

Potassium – Blood Potassium – Fluid

1.5 - 10.0 mmol/L

No Dilution

-- No

<29 d < 3.0

< 2.5 > 6.0

> 6.4

< 1.5 > 9.9 29 d – 18 y

< 3.0 > 6.0

> 18 y < 2.6 > 6.2

Progesterone 0.2 – 1.91

nmol/L No

Dilution --

Yes Diluent

Estradiol/ Progesterone

All <0.2 > 191 <0.2

Prolactin 2-10000 IU/L X10 100000

Yes Universal Diluent

Male

< 1.00 > 50.0

<1 Female or U

< 1.00 >250.0

Autoappended to all results BIOTIN: Biotin taken in doses >1 mg/day may interfere.


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Review Low

Review High

Panic High

Low Alpha

High Alpha

Protein, Total – Blood Protein, Total – Fluid

2 - 120 g/L X 3 360 No All < 40 > 100 < 2 > 300

Protein, Total – CSF

0.04 - 2.00 g/L

X 3 6.00 Yes

0.9% NaCl

0-30 d

< 0.14 > 1.12 < 0.04

< 30 d < 0.15 > 0.45

Rheumatoid Factor, Quantitative

10 – 120 IU/mL

X 5 650 Yes

0.9% NaCl All < 10 > 650 < 10

Salicylate 0.04 - 5.07

mmol/L No

Dilution --

Yes 0 Calibrator

All < 0.07 > 1.8 > 2.20 < 0.30

Sodium – Blood Sodium – Fluid

80 - 180 mmol/L

No Dilution

-- No All < 120 < 120 > 155 > 155 < 80 > 180

Thyroid Stimulating Hormone

0.10 – 100 mU/L

X 10 1000 No All <0.05 > 100 < 0.01 > 1000

Tobramycin 0.33 - 10

mg/L No

Dilution --

Yes TDM diluent

TOBI

< 0.4 > 10.0 <0.4

TOBT < 0.4 > 1.9

Triglycerides – Blood Triglycerides – Fluid

0.10 - 10.00 mmol/L

X 5 50.00 No All < 0.30 > 10.0 < 0.10 > 50.00

Autoappended to < 18 y: LAB CHEM TRIG <18 YR: Acceptable limit relative to dyslipidemia and atherosclerosis risk < 0.85 mmol/L (0-9 years) OR < 1.02 mmol/L (10-17 years).

Troponin T, High Sensitivity

3 - 10000 ng/L

x 10 100000 Yes

Diluent Multiassay

All < 1 > 13 > 52 < 3


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Acute Care Reporting

Comments

NOTE: These subsequent comments are for manual entry during Infinity downtime (they will otherwise be entered via Infinity) - only for patients 120 days old to 150 years: (Refer to Downtime documents)

TNT<5: For patients with a non-ischemic ECG, a Troponin T, High Sensitivity of 4 ng/L or less on presentation is highly sensitive for excluding acute myocardial infarction, provided the specimen was collected more than 3-hours from symptom onset. However, for patients with symptoms less than 3-hours duration or concerning clinical presentations, repeat troponin testing at 2-hours after the initial sample is recommended. Please note that patients with ischemic ECG changes and/or high-risk clinical presentations should be considered for further evaluation irrespective of troponin results.

TNT5-13: Troponin T, High Sensitivity is below the upper reference limit (14 ng/L) and results are not consistent with myocardial infarction or injury. However, patients with acute symptoms (less than 6-hours) or concerning clinical presentations should undergo repeat troponin testing at 2-hours after the initial sample.

A 2-hour change of 3 ng/L or less is highly sensitive for excluding acute myocardial infarction.

A 2-hour change of 4 - 9 ng/L may indicate acute myocardial injury. Repeat clinical evaluation, ECG and troponin at 4-hours after the initial sample is recommended.

A 2-hour change of 10 ng/L suggests an acute myocardial injury and may represent acute myocardial infarction in the appropriate clinical scenario.

Please note that patients with ischemic ECG changes and/or high risk clinical presentations should be considered for further evaluation irrespective of troponin results.

TNT14-52: Troponin T, High Sensitivity has a non-specific/non-diagnostic elevation. Interpretation is highly dependent on clinical presentation and patient history. New elevations are concerning; however, many patients have chronic elevations in troponin and measured concentrations near the patient's baseline are reassuring. Patients with acute symptoms (less than 6 hours) or concerning clinical presentations should undergo repeat troponin testing at 2-hours after the initial sample.

A 2-hour change of 3 ng/L or less suggests acute myocardial infarction is unlikely.

A 2-hour change of 4-9 ng/L may indicate acute myocardial injury. Repeat clinical evaluation, ECG and troponin at 4-hours after the initial sample is recommended.

A 2-hour change of 10 ng/L suggests an acute myocardial injury and may represent acute myocardial infarction in the appropriate clinical scenario.

Please note that patients with ischemic ECG changes and/or high-risk clinical presentations should be considered for further evaluation irrespective of troponin results.


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TNT>52: Clear elevation of Troponin T, High Sensitivity consistent with acute myocardial injury or infarction in the appropriate clinical context. Repeat troponin testing at 2-hours after the initial sample may be helpful to assess for ongoing myocardial injury.

TNTHS1 (applied to all first hemolyzed troponins for patients >4 months): Unable to report Troponin T, High Sensitivity results due to specimen hemolysis or myoglobinemia. Hemolysis is known to severely decrease Troponin T, High Sensitivity results. Reorder and recollection is suggested.

TNTHSRRL8 2nd (and subsequent) Hemolyzed hsTnT <5 ng/L: The Level of Troponin T, High Sensitivity reported is decreased due to interference by hemolysis or myoglobinemia. The extent of negative interference is not known. This Troponin T, High Sensitivity value was reported to aid clinical interpretation following receipt of two consecutive Troponin T, High Sensitivity samples with hemolysis. For patients with a non-ischemic ECG, a Troponin T, High Sensitivity of 4 ng/L or less on presentation is highly sensitive for excluding acute myocardial infarction, provided the specimen was collected more than 3-hours from symptom onset. However, for patients with symptoms less than 3-hours duration or concerning clinical presentations, repeat troponin testing at 2-hours after the initial sample is recommended. Please note that patients with ischemic ECG changes and/or high-risk clinical presentations should be considered for further evaluation irrespective of troponin results.

TNTHSRRL6 2nd (and subsequent) Hemolyzed hsTnT 5-13 ng/L: The Level of Troponin T, High Sensitivity reported is decreased due to interference by hemolysis or myoglobinemia. The extent of negative interference is not known. This Troponin T, High Sensitivity value was reported to aid clinical interpretation following receipt of two consecutive Troponin T, High Sensitivity samples with hemolysis. Troponin T, High Sensitivity is below the upper reference limit (14 ng/L) and results are not consistent with myocardial infarction or injury. However, patients with acute symptoms (less than 6-hours) or concerning clinical presentations should undergo repeat troponin testing at 2-hours after the initial sample. • A 2-hour change of 3 ng/L or less is highly sensitive for excluding acute myocardial infarction. • A 2-hour change of 4-9 ng/L may indicate acute myocardial injury. Repeat clinical evaluation, ECG and troponin at 4-hours after the initial sample is recommended. • A 2-hour change of 10 ng/L suggests an acute myocardial injury and may represent acute myocardial infarction in the appropriate clinical scenario. Please note that patients with ischemic ECG changes and/or high-risk clinical presentations should be considered for further evaluation irrespective of troponin results.


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TNTHSRRL7 2nd (and subsequent) Hemolyzed hsTnT 14-52 ng/L: The Level of Troponin T, High Sensitivity reported is decreased due to interference by hemolysis or myoglobinemia. The extent of negative interference is not known. This Troponin T, High Sensitivity value was reported to aid clinical interpretation following receipt of two consecutive Troponin T, High Sensitivity samples with hemolysis. Troponin T, High Sensitivity has a non-specific/non-diagnostic elevation. Interpretation is highly dependent on clinical presentation and patient history. New elevations are concerning; however, many patients have chronic elevations in troponin and measured concentrations near the patient’s baseline are reassuring. Patients with acute symptoms (less than 6 hours) or concerning clinical presentations should undergo repeat troponin testing at 2-hours after the initial sample. • A 2-hour change of 3 ng/L or less suggests acute myocardial infarction is unlikely. • A 2-hour change of 4-9 ng/L may indicate acute myocardial injury. Repeat clinical evaluation, ECG and troponin at 4-hours after the initial sample is recommended. • A 2-hour change of 10ng/L suggests an acute myocardial injury and may represent acute myocardial infarction in the appropriate clinical scenario. Please note that patients with ischemic ECG changes and/or high-risk clinical presentations should be considered for further evaluation irrespective of troponin results.

TNTHSRRL5 2nd (and subsequent) Hemolyzed hsTnT >/=53 ng/L: The Level of Troponin T, High Sensitivity reported is decreased due to interference by hemolysis or myoglobinemia. The extent of negative interference is not known. This Troponin T, High Sensitivity value was reported to aid clinical interpretation following receipt of two consecutive Troponin T, High Sensitivity samples with hemolysis. Clear elevation of Troponin T, High Sensitivity consistent with acute myocardial injury or infarction in the appropriate clinical context. Repeat troponin testing at 2-hours after the initial sample may be helpful to assess for ongoing myocardial injury.


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Community Reporting

Comments

All results autoappend TNTBIO biotin comment for troponin (not this may be removed with new formulation): Biotin intake >1 mg/day may cause falsely low Troponin T High Sensitivity.

These subsequent comments are for manual entry during Infinity downtime (they will otherwise be entered via Infinity) - only for patients 120 days old to 150 years: (Refer to Downtime documents)

TNT 1-13: Troponin T, High Sensitivity is below the upper reference limit (14ng/L) and results are not consistent with myocardial infarction or injury, provided the specimen was collected more than 6-hours from the onset of symptoms. Patients with active symptoms, ischemic ECG changes and/or concerning clinical presentations should be considered for urgent evaluation irrespective of troponin results.

TNT 14-52: Troponin T, High Sensitivity has a non-specific/non-diagnostic elevation. Interpretation is highly dependent on clinical presentation and patient history. New elevations are concerning; however, many patients have chronic elevations in troponin and measured concentrations near the patient's baseline are reassuring. Patients with active symptoms, ischemic ECG changes and/or concerning clinical presentations should be considered for urgent evaluation irrespective of troponin results.

TNT >52: Clear elevation of Troponin T, High Sensitivity consistent with myocardial injury or infarction. Interpretation is highly dependent on clinical presentation and patient history. Many patients have chronic elevations in troponin and measured concentrations near the patient's baseline are reassuring. New troponin elevations are concerning and urgent assessment in an emergency department may be indicated in the appropriate clinical context.

If Specimen is Hemolyzed: Test cancelled. Specimen grossly hemolyzed, unsuitable for testing. Recollect if clinically indicated.

UIBC 3 -125 µmol/L No dilution -- No All < 3 > 125

Urate – Blood 12 – 1487

µmol/L X 2.5 3700 No All < 100 > 1450 < 12 > 3700

Urea – Blood 0.5 – 40.0

mmol/L X 3 120.0 No All < 1.0 > 40.0 < 0.8 > 100.0

Valproate Level 19.4 – 1040

µmol/L No dilution --

Yes TDM1 Diluent

All < 350 > 700 < 50

Vancomycin 4.0 – 80.0

µg/mL No dilution --

Yes TDM1 Diluent

All < 10 > 60 < 4.0

Vitamin B12 73.8 – 1476

pmol/L No -- No All < 74 > 1400 < 74 > 1476


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URINES Urine Electrolytes – Automatic reruns (decreased volume) will flag < > test. Disregard the flag. Validate the rerun value in the middleware.

24 Hour Urine tests with Creatinine Only:

If analyte is < or > reportable range: LAB CHEM UNABLE TO CALCULATE - ANALYTE: Unable to calculate. At least one calculation component is outside the measurable range.

If urine creatinine is <LOQ: LAB CHEM CREATININE CONTAINS <: Creatinine concentration is not consistent with normal human urine.

Recollection recommended. LAB CHEM UNABLE TO CALCULATE CREAT 24 UR: Specimen unsuitable due to low creatinine concentration. Recollection recommended." will

append to the urine creatinine component. The analyte portion is then removed (regardless of result)

Refer to CH40-675 Cobas Calculations - CRH GPRH RDH for Urine Analyte/Creatinine ratios or Urine Analyte, 24 hour calculations


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Albumin - Urine 3 - 400 mg/L X 11 4400 Yes

0.9% NaCl All < 3 > 400 < 3 >4400

Albumin, Timed - Urine

Refer to CH40-675 Cobas Calculations - CRH GPRH RDH

Calcium, Random - Urine

0.20 - 7.5 mmol/L

X 5 37.5 Yes

0.9% NaCl All < 0.2 > 37.5 <0.20 >37.5

Chloride – Urine 20 – 250 µmol/L

X 1.5 375 No All < 110 > 250 < 20 > 375

Creatinine – Urine (Random)

0.10 - 54.00 mmol/L

X 2.5 135.00

Yes 0.9% NaCl

If a < result, report < 0.10

All < 0.10

All <LOQ urine creatinine results: Creatinine concentration is not consistent with normal human urine. Recollection recommended. Automatically append to the other individual components at verification of those components: Specimen unsuitable due to low creatinine concentration. Recollection recommended.

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Magnesium - Urine

0.60 – 11.00 mmol/L

X 2 0.60 – 22.00 Do not dilute All < 0.60 > 22.00 < 0.60 > 22.00

Phosphate-Urine 1.1-92 mmol/L X 2 184 No manual

dilution All < 1.1 > 184 < 0.9 > 184.0

Potassium – Urine

1 - 100 mmol/L X 1.5 1-150 Do Not Dilute All < 0 >99999 < 3 > 150

Sodium – Urine 20- 250 mmol/L

X 1.5 20 - 375 Do Not Dilute All <0 >99999 < 20 > 375

Urate-Urine 0.131-16.4

mmol/L X 2.5 41

No manual dilution

All < 0.131 > 40.905 < 0.1 > 40.9

Urea-Urine 1-2000 mmol/L X 1.8 3600 No manual

dilution All < 1 > 3600 < 2 > 3600

RELATED DOCUMENTS CH40-650A04 Cobas Pro Tolerance Reporting CH40-675 Cobas Calculations - CRH GPRH RDH

CH40-650A01 Cobas Pro Reporting Chart CRH GPRH RDH ...

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