Test Details
Methodology
HCV quantitative RT PCR: Cobas® AmpliPrep/Cobas® TaqMan® HCV Test v2.0; HCV genotyping: Polymerase chain reaction (PCR) amplification and solid-phase electrochemical detection; HCV NS5A drug resistance assay: Polymerase chain reaction (PCR) amplification and DNA next generation sequencing (NGS)
Result Turnaround Time
13 - 21 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 GT1a NS5A profile is intended for baseline determination of HCV viral load, HCV genotype, and HCV NS5A drug resistance in patients with documented HCV infection and HCV genotype 1a. HCV quantitative RT PCR: Determine the number of international units (IU) of hepatitis C virus (HCV) RNA per milliliter in serum or plasma in known HCV-positive patients. HCV genotyping: Genotyping of the six major HCV types and their most common subtypes. HCV NS5A drug resistance assay: Assessment of drug susceptibility by nucleic acid sequencing of a patient's hepatitis C virus (HCV) to the NS5A inhibitors. Detects resistance associated variants at positions 28, 30, 31, and 93 in genotype 1a HCV.
Limitations
HCV quantitative RT PCR: The quantifiable range of the assay is 15 IU/mL to 100,000,000 IU/mL. HCV genotyping may not be successful when the HCV viral load is <1000 IU/mL serum/plasma. The HCV NS5A drug resistance assay may not be successful when the HCV viral load is <500 IU/mL.
Specimen Requirements
Specimen
Plasma (preferred) or serum, frozen
Volume
4 mL
Minimum Volume
3 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, yellow-top (ACD) tubes, or lavender-top (EDTA) tubes. Do not use green-top (heparin) tubes. Centrifuge specimen within six hours of collection, remove serum/plasma, and 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
Hemolysis; green-top (heparin) tube; specimen not frozen on date of collection; PPT™ not centrifuged; specimen received in "pop-top" or "snap-cap" tube; specimen shipped at room temperature
References
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 550705 | HCV Quant GT1a NS5A Profile | 50023-1 | 550073 | Hepatitis C Quantitation | IU/mL | 11011-4 |
| 550705 | HCV Quant GT1a NS5A Profile | 50023-1 | 550074 | HCV log10 | log10 IU/mL | 38180-6 |
| 550705 | HCV Quant GT1a NS5A Profile | 50023-1 | 550308 | Test Information: | N/A | |
| 550705 | HCV Quant GT1a NS5A Profile | 50023-1 | 550708 | HCV Genotype Reflex NS5A | N/A | |
| Order Code | 550705 | |||||
| Order Code Name | HCV Quant GT1a NS5A Profile | |||||
| Order Loinc | 50023-1 | |||||
| Result Code | 550073 | |||||
| Result Code Name | Hepatitis C Quantitation | |||||
| UofM | IU/mL | |||||
| Result LOINC | 11011-4 | |||||
| Order Code | 550705 | |||||
| Order Code Name | HCV Quant GT1a NS5A Profile | |||||
| Order Loinc | 50023-1 | |||||
| Result Code | 550074 | |||||
| Result Code Name | HCV log10 | |||||
| UofM | log10 IU/mL | |||||
| Result LOINC | 38180-6 | |||||
| Order Code | 550705 | |||||
| Order Code Name | HCV Quant GT1a NS5A Profile | |||||
| Order Loinc | 50023-1 | |||||
| Result Code | 550308 | |||||
| Result Code Name | Test Information: | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||
| Order Code | 550705 | |||||
| Order Code Name | HCV Quant GT1a NS5A Profile | |||||
| Order Loinc | 50023-1 | |||||
| Result Code | 550708 | |||||
| Result Code Name | HCV Genotype Reflex NS5A | |||||
| UofM | ||||||
| Result LOINC | N/A |
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 550075 | HCV RNA (International Units) | 550078 | HCV RNA (International Units) | IU/mL | 11011-4 |
| Reflex 1 | ||||||
| Order Code | 550075 | |||||
| Order Name | HCV RNA (International Units) | |||||
| Result Code | 550078 | |||||
| Result Name | HCV RNA (International Units) | |||||
| UofM | IU/mL | |||||
| Result LOINC | 11011-4 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 550075 | HCV RNA (International Units) | 550081 | HCV log10 | log10 IU/mL | 38180-6 |
| Reflex 1 | ||||||
| Order Code | 550075 | |||||
| Order Name | HCV RNA (International Units) | |||||
| Result Code | 550081 | |||||
| Result Name | HCV log10 | |||||
| UofM | log10 IU/mL | |||||
| Result LOINC | 38180-6 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 550709 | HCV Genotype Reflex NS5A | 550617 | Hepatitis C Genotype | 32286-7 | |
| Reflex 1 | ||||||
| Order Code | 550709 | |||||
| Order Name | HCV Genotype Reflex NS5A | |||||
| Result Code | 550617 | |||||
| Result Name | Hepatitis C Genotype | |||||
| UofM | ||||||
| Result LOINC | 32286-7 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 550709 | HCV Genotype Reflex NS5A | 550617 | Hepatitis C Genotype | 32286-7 | |
| Reflex 1 | ||||||
| Order Code | 550709 | |||||
| Order Name | HCV Genotype Reflex NS5A | |||||
| Result Code | 550617 | |||||
| Result Name | Hepatitis C Genotype | |||||
| UofM | ||||||
| Result LOINC | 32286-7 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 550709 | HCV Genotype Reflex NS5A | 550617 | Hepatitis C Genotype | 32286-7 | |
| Reflex 1 | ||||||
| Order Code | 550709 | |||||
| Order Name | HCV Genotype Reflex NS5A | |||||
| Result Code | 550617 | |||||
| Result Name | Hepatitis C Genotype | |||||
| UofM | ||||||
| Result LOINC | 32286-7 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 550709 | HCV Genotype Reflex NS5A | 550617 | Hepatitis C Genotype | 32286-7 | |
| Reflex 1 | ||||||
| Order Code | 550709 | |||||
| Order Name | HCV Genotype Reflex NS5A | |||||
| Result Code | 550617 | |||||
| Result Name | Hepatitis C Genotype | |||||
| UofM | ||||||
| Result LOINC | 32286-7 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 550709 | HCV Genotype Reflex NS5A | 550618 | Please note: | 77202-0 | |
| Reflex 1 | ||||||
| Order Code | 550709 | |||||
| Order Name | HCV Genotype Reflex NS5A | |||||
| Result Code | 550618 | |||||
| Result Name | Please note: | |||||
| UofM | ||||||
| Result LOINC | 77202-0 | |||||