Test Details
Methodology
Sanger sequencing for genotyping, and Polymerase chain reaction (PCR) amplification and DNA next generation sequencing for drug susceptibility
Result Turnaround Time
14 - 17 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
The HCV genotype detection assay 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 subtyping for HCV 1a and 1b and assessment of drug susceptibility by nucleic acid sequencing of a patient's hepatitis C virus (HCV) to the NS3/4A protease inhibitors. It also detects Q80K polymorphism.
Special Instructions
A separate frozen specimen is required for each frozen test ordered. Only submit samples that contain an HCV viral load >2,500 IU/mL in serum or plasma. If reflex test is performed, additional charges/CPT code(s) may apply.
Limitations
The HCV genotype procedure may not be successful when the HCV viral load is <2,500 IU/mL in serum or plasma.
Mixed genotype infections results may not be detected. The predominant genotype detected is most likely to be reported. The HCV NS3/4A drug resistance assay will only be performed when the HCV genotype is 1a.
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
Plasma (preferred) or serum, frozen
Volume
4 mL
Minimum Volume
2 mL (Note: This volume does not allow for repeat testing.)
Container
Gel-barrier tube or lavender-top (EDTA) tube
Collection Instructions
Centrifuge specimen within six hours of collection, remove serum/plasma, and transfer specimen to polypropylene screw-capped tubes and freeze. Ship frozen. 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 | Unacceptable |
| Refrigerated | Unacceptable |
| Frozen | 14 days |
| Freeze/thaw cycles | Stable x2 |
Storage Instructions
Freeze.
Causes for Rejection
Incorrect anticoagulant; unspun gel barrier tube or PPT™ tube; specimens received at room temperature or refrigerated; gross hemolysis; grossly lipemic; specimens with name/demographic discrepancies; heparinized plasma; specimen received in "pop-top" or "snap-cap" tube
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 550688 | HCV Genotype Reflex NS3/4A | 92731-9 | 144054 | Hepatitis C Genotype | 92731-9 | |
| Order Code | 550688 | |||||
| Order Code Name | HCV Genotype Reflex NS3/4A | |||||
| Order Loinc | 92731-9 | |||||
| Result Code | 144054 | |||||
| Result Code Name | Hepatitis C Genotype | |||||
| UofM | ||||||
| Result LOINC | 92731-9 |
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 550563 | Rfx to GenoSure(R) HCV NS3/4A | 550544 | HCV GenoSure(R) NS3/4A PDF | 32286-7 | |
| Reflex 1 | ||||||
| Order Code | 550563 | |||||
| Order Name | Rfx to GenoSure(R) HCV NS3/4A | |||||
| Result Code | 550544 | |||||
| Result Name | HCV GenoSure(R) NS3/4A PDF | |||||
| UofM | ||||||
| Result LOINC | 32286-7 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 550563 | Rfx to GenoSure(R) HCV NS3/4A | 550545 | HCV GenoSure(R) NS3/4A | 32286-7 | |
| Reflex 1 | ||||||
| Order Code | 550563 | |||||
| Order Name | Rfx to GenoSure(R) HCV NS3/4A | |||||
| Result Code | 550545 | |||||
| Result Name | HCV GenoSure(R) NS3/4A | |||||
| UofM | ||||||
| Result LOINC | 32286-7 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 550563 | Rfx to GenoSure(R) HCV NS3/4A | 550546 | HCV GenoSure(R) NS3/4A Interp | 77202-0 | |
| Reflex 1 | ||||||
| Order Code | 550563 | |||||
| Order Name | Rfx to GenoSure(R) HCV NS3/4A | |||||
| Result Code | 550546 | |||||
| Result Name | HCV GenoSure(R) NS3/4A Interp | |||||
| UofM | ||||||
| Result LOINC | 77202-0 | |||||