| Ordering Code | 5442R |
|---|---|
| Test Name | HCV Quant w/ Reflex to Genotype |
| Alias | Hepatitis C Virus Quantitative with Reflex to Hepatitis C Virus Genotype |
| Preferred Specimen | Serum |
| Preferred Container | SST (Gold) |
| Other Specimen/Container | Plasma in EDTA, K2 (Lavender), Serum in Plain (Red) |
| Optimum Volume | 6 mL |
| Collection Instructions | Draw 3 full SST tubes. |
| Handling Instructions | Separate serum from whole blood within 24 hours of collection. Use only polypropylene tubes for aliquot samples DO NOT thaw once serum/plasma is frozen. |
| Transport Requirements | Airline: Frozen |
| Specimen Stability | Refrigerated: 3 Days Frozen: 2 Months |
| Avail. Stat | NO |
| Analytic Time | Up to 7 Days for HCV Quant test; up to 4 days longer for additional testing. |
| Methodology | Real time PCR |
Reference range(s)
The reference ranges listed below are valid on this date of April 23, 2024.
| Component | Age | Male Norm | Male Critical Low | Male Critical High | Female Norm | Female Critical High | Female Critical Low | Units | Add'l info |
|---|---|---|---|---|---|---|---|---|---|
| HCV RNA, Quant | ALL | NOT DETECTED | NOT DETECTED | The linear... Note1 | |||||
| HCV RNA | ALL | <15 | <15 | IU/mL | |||||
| HCV RNA | ALL | <1.2 | <1.2 | Log IU/mL |
Note1:
The linear range for the cobas (R) HCV for EDTA plasma and serum is from 15 IU/mL to 1.00E+08 IU/mL and the accuracy of the test is within +/-0.24 log10. The lower limit of quantification (LLoQ) is 15 IU/mL
The limit of detection (LoD) of cobas (R) HCV was determined for WHO International Standard (genotype 1a) and for genotype 1b through 6. The overall LoD was 12.0 IU/mL for EDTA plasma and 13.7 IU/mL for serum
Reliable results depend on proper sample collection, storage and handling procedures. Quantitation of HCV RNA is dependent on the number of virus particles present in the samples and may be affected by sample collection methods, patient factors (i.e. age, presence of symptoms), and/or stage of infection
.