Hepatitis C Virus (HCV) Genotyping, Nonreflex

CPT: 87902
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Test Details

Synonyms

  • HCV Subtype

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.

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.

Methodology

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

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

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.

Storage Instructions

Freeze (preferred) or refrigerate.

Stability Requirements

Temperature

Period

Room temperature

1 day

Refrigerated

3 days

Frozen

3 months

Causes for Rejection

Incorrect anticoaglulant; PPT™ not centrifuged

Clinical Information

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.

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
550475 HCV Genotyping Non Reflex 32286-7 550474 Please note: 77202-0
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

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CPT Statement/Profile Statement

The LOINC® codes are copyright © 1994-2018, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf