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Hepatitis C Virus (HCV) Quantitative RNA PCR

Alternate Name: HCV PCR_Roche

SAL Code:

223

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

Sample Collection:

Sample Collection and Handling

- Collect whole blood in one of the following:
SST™ Serum Separation Tube
Sterile EDTA tube
Follow the manufacturer’s collection instructions.

- Storage before processing:
Store or transport whole blood at 2–25°C for up to 24 hours before plasma or serum separation.
Centrifuge according to the tube manufacturer’s guidelines.

- After separation:
Store EDTA plasma or serum:
Up to 6 days at 2–8°C, or
Up to 12 weeks at ? –18°C.
Samples are stable for up to 4 freeze/thaw cycles when stored at ? –18°C.

- Sample volume:
Collect enough blood to yield at least 500 µL plasma or serum (minimum total 650 µL).

Test Limitations:

Procedural Limitations

- The cobas® HCV test is only validated for use with:
cobas® HBV/HCV/HIV-1 Control Kit
cobas® NHP Negative Control Kit
cobas omni reagents (MGP, Lysis, Specimen Diluent, and Wash)
On the cobas® 6800/8800 Systems

- Reliable results require proper sample collection, handling, and storage.

- The test is validated only for EDTA plasma and serum. Other sample types may give inaccurate results.

- Quantitation accuracy can be affected by:
Virus concentration
Collection methods
Patient factors (age, symptoms, infection stage)

- The cobas® HCV test is not approved for:
Blood donor screening
Confirming HCV infection diagnosis

Test Information:

Components:

Component Name CPT Loinc
HCV PCR Viral Log 38180-6
HCV Qual 11259-9
HCV Quant 11011-4