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Hepatitis C Virus (HCV) Quantitative RNA PCR

Alternate Name: HCV PCR_Roche

SAL Code:

896

CPT:

87522

Loinc:

11011-4

Setup:

Mondays, Wednesdays, and Fridays

Department:

Hepatitis C

Methodology:

Polymerase Chain Reaction (RT-PCR)

Specimen Requirements:

Primary Tube:

SST

Primary Substance:

Serum

Rejection Criteria:

REJECTION CRITERIA:
Samples will be rejected if improperly labeled, grossly hemolyzed, lipemic, clotted or contaminated. Improper or expired collection containers , improper storage and transport, insufficient volume (less than 650 µL), leaking, unsealed, or broken containers will also be rejected.

Clinical Info:

CLINICAL INFO:
The cobas® HCV Quant PCR test is a fully automated, quantitative nucleic acid amplification assay performed on the cobas® 6800/8800 systems to detect and quantify HCV RNA in human EDTA plasma or serum. It serves as a diagnostic tool to confirm active infection in specimens that reflex following a reactive antibody immunoassay, and as a monitoring tool to measure viral load at baseline, during, and after antiviral therapy to assess sustained virologic response (SVR).

Sample Collection:

SPECIMEN COLLECTION:
Collect patient samples using a BD Vacutainer® SST™ Serum Separation Tube, allowing it to clot for 30 minutes before centrifuging for 10 to 15 minutes to isolate the serum. Alternatively, collect whole blood into a BD Vacutainer® PPT™ Plasma Preparation Tube and centrifuge within two hours to create a secure gel barrier that isolates undiluted K2EDTA plasma for molecular PCR diagnostic test.

Test Limitations:

TEST LIMITATIONS:
The Cobas® HCV test has been validated for use only with the reagents and controls specified for this procedure on the cobas® 6800/8800 System. Accurate and reliable results depend on proper specimen collection, storage, and handling. This assay is validated exclusively for EDTA plasma and serum collected from whole blood in SST™ Serum Separation Tubes, BD Vacutainer® PPT™ Plasma Preparation Tubes for Molecular Diagnostic Test Methods, or sterile tubes containing EDTA as the anticoagulant. Quantification of HCV RNA is dependent on the concentration of viral particles present in the specimen and may be influenced by collection techniques, patient-specific factors, and the stage of infection. Additionally, mutations within highly conserved regions of the viral genome may result in under-quantification or failure to detect the presence of HCV RNA.

Specimen Handling Instructions:

SPECIMEN HANDLING & STORAGE:
Whole blood collected in Serum Separation Tubes (SST) and/or BD Vacutainer® Plasma Preparation Tubes (PPT) for Molecular Diagnostic Test Methods may be stored and/or transported for up to 24 hours at 2°C - 25°C prior to plasma/serum preparation. Centrifugation should be performed according to manufacturer instructions. Following preparation, isolated plasma or serum specimens stored in secondary tubes remain stable for a duration of up to 6 days when refrigerated at 2°C to 8°C, or may be maintained for up to 12 weeks when kept at temperatures less than or equal to -18°C. Collect enough whole blood to yield at least 500 µL of plasma or serum (minimum total sample: 650 µL).

Test Information:

Components:

Component Name CPT Loinc
HCV PCR Viral Log 38180-6
HCV Quant 11011-4