Specimen Collection Manual and Test Catalog

3-4 mL of plasma in one (1) aliquot tube; minimum 2.0 mL of plasma in aliquot. NO SHARED SPECIMENS.

Separate plasma from whole blood within 24 hours of collection. Centrifuge for 10 minutes at 3000 rpm, room temperature. Using a sterile pipet, transfer 3-4 mL of plasma to one (1) labeled, sterile, aliquot tube. Each molecular test ordered requires its own aliquot tube (e.g., HEPCR requires one 3-4 mL aliquot tube and HIVRNA requires one 3-4 mL aliquot tube).

Plasma frozen, -20 to -80°C (preferred). Plasma may also be transported at 2-8°C. Transport EDTA whole blood at 2-8°C.

Plasma specimens may be stored at 2-8°C for up to 6 days, or frozen at -20 to -80°C up to 12 weeks (preferred). EDTA whole blood specimens can be stored at 2-8°C up to 24 hours prior to centrifugation.

Whole blood specimens must be collected in EDTA tubes. Specimens must be separated within 24 hours, or they will be rejected. Plasma must be stored at 2-8°C for up to 6 days and at -20 to -80°C up to 12 weeks. Stability limits exceeded. Shared or comingled specimens.

Negative IU/mL.

Linear range of the assay is 15 IU/mL to 100 million IU/mL. Positive results less than 15 IU/mL will be reported as: HCV RNA detected but not quantified. The calculated titer is below the lower limit of quantification (LLoQ) of the assay.

Quantitative HCV RNA.

HCV RNA Quant Viral Load, HCV Viral Load, Quantitative, Hepatitis C Viral Load, HCV PCR, Hepatits C virus PCR, HCV RNA Quant, HEPCR, HCV RNA Quantitative, Hepatitis C virus RNA Quantitative

The hepatitis C quantitative test offers a measure of active viremia in antibody-positive chronic HCV-infected individuals undergoing antiviral therapy. The current FDA guidelines support the importance of measuring HCV RNA levels at baseline prior to treatment, at intervals during treatment to assess viral response, and after treatment is completed to assess the efficacy of treatment. Also, this assay is intended for use as an aid in the diagnosis of HCV infection in the following populations: individuals with antibody evidence of HCV infection with evidence of liver disease, individuals suspected to be actively infected with HCV antibody evidence, and individuals at risk for HCV infection with antibodies to HCV.