Test directory: HCV Quant w/ Reflex to Genotype

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: 6 Days
Frozen: 30 Days
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 February 21, 2026.
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...
The linear range for the cobas (R) HCV quantitation for a 500 uL sample processing volume is from 15 IU/mL (lower limit) to 1.00E+08 IU/mL (upper limit). Accuracy is within +/-0.24 log10

EDTA plasma mirrors the lower limit of quantification (LLoQ) at 15 IU/mL for a 500 uL sample processing volume; however, the test will detect HCV below this LoD/LLoQ at a frequency lower than required by the FDA for labeling (<95%)

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 maybe affected by sample collection methods and other patient factors (i.e. age, symptoms, immune status, stage of infection, etc.)
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 quantitation for a 500 uL sample processing volume is from 15 IU/mL (lower limit) to 1.00E+08 IU/mL (upper limit). Accuracy is within +/-0.24 log10

EDTA plasma mirrors the lower limit of quantification (LLoQ) at 15 IU/mL for a 500 uL sample processing volume; however, the test will detect HCV below this LoD/LLoQ at a frequency lower than required by the FDA for labeling (<95%)

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 maybe affected by sample collection methods and other patient factors (i.e. age, symptoms, immune status, stage of infection, etc.)
.