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Hepatitis C Virus (HCV) Genotyping, Nonreflex

CPT 87902
Synonyms
  • HCV Subtype

Test Details

Methodology

Polymerase chain reaction (PCR) amplification and solid-phase electrochemical detection

Result Turnaround Time

3 - 5 days

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

Use

This assay, for in vitro use, is intended for the genotyping of hepatitis C virus (HCV) in human serum and plasma. This test allows genotyping of the six major HCV types and their most common subtypes.

Special Instructions

A separate frozen specimen is required for each frozen test ordered. Only submit samples that contain an HCV viral load >1000 IU/mL in serum or plasma.

Limitations

This procedure may not be successful when the HCV viral load is <1000 IU/mL in serum or plasma.

Mixed genotype assay results may be reported for the following combinations (genotypes 1 and 2; genotypes 1 and 3; genotypes 1 and 4) when viral concentrations are near equivalence. The assay may not report lower concentration genotypes.

Greater than (>) 99% of samples containing sufficient HCV RNA can be resolved to the genotype level using the primary test methodology. Failure to generate a genotype under such circumstances is most commonly caused by inter-probe competition leading to ambiguous results. Such samples are automatically subjected to an HCV genotype-specific PCR assay for resolution.

This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.

Specimen Requirements

Specimen

Serum or plasma, frozen

Volume

3 mL

Minimum Volume

300 µL (Note: This volume does not allow for repeat testing)

Container

Gel-barrier tube, lavender-top (EDTA) tube, or plasma preparation tube (PPT™)

Collection Instructions

Centrifuge sample within 24 hours of collection. Transfer serum/plasma to a screw-cap polypropylene transport tube. Ship frozen (preferred). Plasma from a PPT™ can be frozen and shipped in situ. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.

Stability Requirements

Temperature

Period

Room temperature

1 day

Refrigerated

3 days

Frozen

3 months

Storage Instructions

Freeze (preferred) or refrigerate.

Causes for Rejection

Incorrect anticoagulant; PPT™ not centrifuged

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
550475 HCV Genotyping Non Reflex 32286-7 550511 Hepatitis C Genotype 32286-7
Order Code550475
Order Code NameHCV Genotyping Non Reflex
Order Loinc32286-7
Result Code550511
Result Code NameHepatitis C Genotype
UofM
Result LOINC32286-7
Reflex Table for Hepatitis C Genotype
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550614 Hepatitis C Genotype 550614 Hepatitis C Genotype 32286-7
Reflex 1
Order Code550614
Order NameHepatitis C Genotype
Result Code550614
Result NameHepatitis C Genotype
UofM
Result LOINC32286-7