Test Details
Methodology
Polymerase chain reaction (PCR) amplification and DNA next generation sequencing
Result Turnaround Time
10 - 14 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
Assessment of drug susceptibility by nucleic acid sequencing of a patient's hepatitis C virus (HCV) to the NS5A inhibitors. Assay should be used for patients with documented HCV genotype 1.
Special Instructions
Please indicate the patient's HCV genotype (1a or 1b) on the test request form. Submit a separate frozen specimen for each test ordered.
Limitations
This procedure may not be successful when the HCV viral load is <500 IU/mL. This assay requires an HCV genotype of either 1a or 1b.
This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.
References
Specimen Requirements
Specimen
Plasma (preferred) or serum, frozen
Volume
2 mL
Minimum Volume
1 mL
Container
Ship in plasma preparation tubes (PPT™) or screw-capped polypropylene frozen transport tubes.
Collection Instructions
Collect specimen in two PPT™ tubes, gel-barrier tubes, or lavender-top (EDTA) tubes. Do not use green-top (heparin) tubes. Centrifuge specimen within six hours of collection, remove serum/plasma, transfer specimen to polypropylene screw-capped tubes, and freeze. Specimens drawn into PPT™ tubes need to be centrifuged within six hours and frozen. Ship frozen. 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.
Causes for Rejection
PPT™ not centrifuged; insufficient volume; heparinized plasma; nonfrozen specimens; specimens exposed to repeated freeze/thaw cycles; 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 |
|---|---|---|---|---|---|---|
| 550325 | HCV NS5A Drug Resistance Assay | 550316 | HCV NS5A Resistance Assay PDF | 72862-6 | ||
| 550325 | HCV NS5A Drug Resistance Assay | 550317 | HCV NS5A Drug Resistance Assay | 73655-3 | ||
| 550325 | HCV NS5A Drug Resistance Assay | 550318 | HCV NS5A Resist Assay Interp | 49549-9 | ||
| Order Code | 550325 | |||||
| Order Code Name | HCV NS5A Drug Resistance Assay | |||||
| Order Loinc | ||||||
| Result Code | 550316 | |||||
| Result Code Name | HCV NS5A Resistance Assay PDF | |||||
| UofM | ||||||
| Result LOINC | 72862-6 | |||||
| Order Code | 550325 | |||||
| Order Code Name | HCV NS5A Drug Resistance Assay | |||||
| Order Loinc | ||||||
| Result Code | 550317 | |||||
| Result Code Name | HCV NS5A Drug Resistance Assay | |||||
| UofM | ||||||
| Result LOINC | 73655-3 | |||||
| Order Code | 550325 | |||||
| Order Code Name | HCV NS5A Drug Resistance Assay | |||||
| Order Loinc | ||||||
| Result Code | 550318 | |||||
| Result Code Name | HCV NS5A Resist Assay Interp | |||||
| UofM | ||||||
| Result LOINC | 49549-9 |