Test directory: Hepatitis C RNA, Quant.

Ordering Code 5442
Test Name Hepatitis C RNA, Quant.
Alias HCV RNA Quantitative
HCV Viral Load
Preferred Specimen Serum
Preferred Container SST (Gold)
Other Specimen/Container Plasma in EDTA, K2 (Lavender), Serum in Plain (Red)
Optimum Volume 2 mL
Collection Instructions Cannot share with any other test!
Handling Instructions Separate serum/plasma 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 Oahu: Refrigerated
Airline: Frozen
Specimen Stability Refrigerated: 6 Days
Frozen: 12 Weeks
Rejection Criteria Specimen older than stability limits, Unspun & unseparated specimen >6 hours, Plasma other than EDTA, Frozen specimen thawed, Non-polypropylene aliquot tube
Avail. Stat NO
Analytic Time Up to 7 Days
Methodology Real time PCR

Reference range(s)

The reference ranges listed below are valid on this date of May 27, 2025.
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 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
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
.