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|40738:HEPATITIS C VIRUS (HCV) RNA, QUANTITATIVE BY PCR, ULTRA-SENSITIVE|
|Alias Names:||HCV ultra-sensitive / Viral Load / Viral burden|
|Methodology:||Real-Time Polymerase Chain Reaction (RT-PCR)|
|Performed:||Tuesday, Thursday, Saturday|
|Specimen Collection Details|
|Collection:||Two 7.5 serum separator tubes (SST), or three 5 mL red top tubes, or three 4 mL lavender top tubes (EDTA).|
|Handling:||Centrifuge and separate plasma or serum from cells within 6 hours. Freeze serum or plasma in a sterile polypropylene vial ≤ -20° C. May be stored refrigerated for 72 hours. Plasma or serum samples may be frozen and thawed up to 5 times without being detrimental to HCV RNA.|
|Standard Volume:||3 mL plasma or serum.|
|Minimum Volume:||2 mL plasma or serum.|
|Transport:||Frozen ≤ -20° C.|
|Rejection Criteria:||Heparinized specimen; specimen left ambient beyond 6 hours; specimen frozen and thawed more than 5 times.|
|43 IU/mL to 69,000,000 IU/mL.
Interpretive Data: The expected reference range for an individual not infected with HCV RNA virus is HCV RNA Not Detected. A positive HCV RNA PCR result (HCV RNA Detected) is consistent with a HCV infection. A negative HCV RNA PCR result (HCV RNA Not Detected) is consistent with the absence of a HCV infection. A negative HCV RNA PCR result does not rule out the presence of PCR inhibitors in the patient specimen or HCV RNA concentrations below the level of detection of the assay.
Assay methodology is Real-Time Polymerase Chain Reaction (RTPCR) as performed using the FDA approved Roche COBAS AmpliPrep/COBAS TaqMan HCV Test. This assay is an ultrasensitive quantitative HCV RNA test with an analytical measurement range of 43-69,000,000 IU/mL (1.63-7.84 logIU/mL).