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- HCV Subtype
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.
Expected 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.
Related Documents
For more information, please view the literature below.
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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 anticoagulant; PPT™ not centrifuged
|
Incorrect anticoagulant; PPT™ not centrifuged Incorrect anticoagulant; PPT™ not centrifuged |
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Incorrect anticoagulant; PPT™ not centrifuged Incorrect anticoagulant; PPT™ not centrifuged |
Test Details
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.
This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.
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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. <tion. |
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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. |
Methodology
Polymerase chain reaction (PCR) amplification and solid-phase electrochemical detection
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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