Test Details
Methodology
Sanger sequencing
Use
This 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.
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.
Limitations
This 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.
This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.
Custom Additional Information
Hepatitis C viral RNA is tested using RT-PCR to detect a portion of the NS5B gene of the HCV genome. The nucleic acid is sequenced using dye-terminator (Sanger) chemistry. Sequence data is compared to a genomic database and genotypes 1-6 are reported with subtype 1a and 1b differentiation.
Specimen Requirements
Specimen
Serum or plasma, frozen
Volume
3 mL
Minimum Volume
1 mL (Note: This volume does not allow for repeat testing.)
Container
Gel-barrier tube or lavender-top (EDTA) tube
Collection Instructions
Centrifuge sample within 24 hours of collection. Transfer serum/plasma to a screw-cap polypropylene transport tube. Ship frozen (preferred). 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 | 6 days |
| Frozen | 14 days |
| Freeze/thaw cycles | Stable x2 |
Storage Instructions
Freeze (preferred) or refrigerate.
Causes for Rejection
Incorrect anticoagulant; unspun gel barrier tube or PPT™ tube; specimens received at room temperature; gross hemolysis; grossly lipemic; specimens with name/demographic discrepancies
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 144052 | HCV Genotyping, Sequencing | 92731-9 | 144054 | Hepatitis C Genotype | 92731-9 | |
| Order Code | 144052 | |||||
| Order Code Name | HCV Genotyping, Sequencing | |||||
| Order Loinc | 92731-9 | |||||
| Result Code | 144054 | |||||
| Result Code Name | Hepatitis C Genotype | |||||
| UofM | ||||||
| Result LOINC | 92731-9 |