Test Details
Methodology
HCV quantitative RT PCR: cobas® HCV
HCV genotyping: Sanger sequencing
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: This test determines 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: This test is used for 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.
HCV NS5A drug resistance assay: This test is used for assessment of drug susceptibility by nucleic acid sequencing of a patient's Hepatitis C Virus (HCV) to the NS5A inhibitors, and it detects resistance associated variants at positions 28, 30, 31 and 93 in genotype 1a HCV.
Special Instructions
A separate frozen specimen is required for each frozen test ordered. If reflex test(s) is performed, additional charges/CPT code(s) may apply.
Limitations
The quantifiable range of the HCV Quantitative RT PCR assay is 15 IU/mL to 100,000,000 IU/mL. HCV genotyping may not be successful when the HCV viral load is <2,500 IU/mL in serum/plasma. Mixed genotype infections results may not be detected. The predominant genotype detected is most likely to be reported. The HCV NS5A drug resistance assay will only be performed when the HCV genotype is 1a.
Custom Additional Information
The HCV genotype will only reflex when the viral load is >2,500 IU/mL, and the HCV NS5A drug resistance test will only reflex when the HCV genotype results as 1a.
Specimen Requirements
Specimen
Plasma (preferred) or serum, frozen
Volume
6 mL
Minimum Volume
3 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
References
Zepatier™ (elbasvir and grazoprevir) tablets, for oral use [package insert]. Initial US Approval: 2016. Whitehouse Station, NJ: Merck and Co Inc; 2016.
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 550887 | HCV Quant GT1a NS5A Profile | 50023-1 | 550028 | Hepatitis C Quantitation | IU/mL | 11011-4 |
| 550887 | HCV Quant GT1a NS5A Profile | 50023-1 | 550051 | HCV log10 | log10 IU/mL | 38180-6 |
| 550887 | HCV Quant GT1a NS5A Profile | 50023-1 | 550306 | Test Information: | 77202-0 | |
| 550887 | HCV Quant GT1a NS5A Profile | 50023-1 | 550708 | HCV Genotype Reflex NS5A | N/A | |
| Order Code | 550887 | |||||
| Order Code Name | HCV Quant GT1a NS5A Profile | |||||
| Order Loinc | 50023-1 | |||||
| Result Code | 550028 | |||||
| Result Code Name | Hepatitis C Quantitation | |||||
| UofM | IU/mL | |||||
| Result LOINC | 11011-4 | |||||
| Order Code | 550887 | |||||
| Order Code Name | HCV Quant GT1a NS5A Profile | |||||
| Order Loinc | 50023-1 | |||||
| Result Code | 550051 | |||||
| Result Code Name | HCV log10 | |||||
| UofM | log10 IU/mL | |||||
| Result LOINC | 38180-6 | |||||
| Order Code | 550887 | |||||
| Order Code Name | HCV Quant GT1a NS5A Profile | |||||
| Order Loinc | 50023-1 | |||||
| Result Code | 550306 | |||||
| Result Code Name | Test Information: | |||||
| UofM | ||||||
| Result LOINC | 77202-0 | |||||
| Order Code | 550887 | |||||
| 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 | 550040 | HCV RNA (International Units) | 550029 | HCV RNA (International Units) | IU/mL | 11011-4 |
| Reflex 1 | ||||||
| Order Code | 550040 | |||||
| Order Name | HCV RNA (International Units) | |||||
| Result Code | 550029 | |||||
| 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 | 550040 | HCV RNA (International Units) | 550032 | HCV log10 | log10 IU/mL | 38180-6 |
| Reflex 1 | ||||||
| Order Code | 550040 | |||||
| Order Name | HCV RNA (International Units) | |||||
| Result Code | 550032 | |||||
| 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 | 550683 | HCV Genotype Reflex NS5A | 144054 | Hepatitis C Genotype | 92731-9 | |
| Reflex 2 | 550326 | HCV NS5A Drug Resistance Assay | 550316 | HCV NS5A Resistance Assay PDF | 72862-6 | |
| Reflex 1 | ||||||
| Order Code | 550683 | |||||
| Order Name | HCV Genotype Reflex NS5A | |||||
| Result Code | 144054 | |||||
| Result Name | Hepatitis C Genotype | |||||
| UofM | ||||||
| Result LOINC | 92731-9 | |||||
| Reflex 2 | ||||||
| Order Code | 550326 | |||||
| Order Name | HCV NS5A Drug Resistance Assay | |||||
| Result Code | 550316 | |||||
| Result Name | HCV NS5A Resistance Assay PDF | |||||
| UofM | ||||||
| Result LOINC | 72862-6 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 550683 | HCV Genotype Reflex NS5A | 144054 | Hepatitis C Genotype | 92731-9 | |
| Reflex 2 | 550326 | HCV NS5A Drug Resistance Assay | 550317 | HCV NS5A Drug Resistance Assay | 73655-3 | |
| Reflex 1 | ||||||
| Order Code | 550683 | |||||
| Order Name | HCV Genotype Reflex NS5A | |||||
| Result Code | 144054 | |||||
| Result Name | Hepatitis C Genotype | |||||
| UofM | ||||||
| Result LOINC | 92731-9 | |||||
| Reflex 2 | ||||||
| Order Code | 550326 | |||||
| Order Name | HCV NS5A Drug Resistance Assay | |||||
| Result Code | 550317 | |||||
| Result Name | HCV NS5A Drug Resistance Assay | |||||
| UofM | ||||||
| Result LOINC | 73655-3 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 550683 | HCV Genotype Reflex NS5A | 144054 | Hepatitis C Genotype | 92731-9 | |
| Reflex 2 | 550326 | HCV NS5A Drug Resistance Assay | 550318 | HCV NS5A Resist Assay Interp | 49549-9 | |
| Reflex 1 | ||||||
| Order Code | 550683 | |||||
| Order Name | HCV Genotype Reflex NS5A | |||||
| Result Code | 144054 | |||||
| Result Name | Hepatitis C Genotype | |||||
| UofM | ||||||
| Result LOINC | 92731-9 | |||||
| Reflex 2 | ||||||
| Order Code | 550326 | |||||
| Order Name | HCV NS5A Drug Resistance Assay | |||||
| Result Code | 550318 | |||||
| Result Name | HCV NS5A Resist Assay Interp | |||||
| UofM | ||||||
| Result LOINC | 49549-9 | |||||