|Last Updated: May 25, 2019 @ 9:13 am|
Hepatitis C RNA Quant by PCR w/Reflex
|Stability:||Ambient: 24 Hour(s); Refrigerated: 5 Day(s); Frozen: 2 Month(s); Incubated: Unacceptable|
|Performed:||Monday, Wednesday, Friday|
|Interpretive Data:||Please see report for interpretive data.|
NOT DETECTED - The result is less than the limit of detection. This does not rule out the presence of PCR inhibitors in the patient sample or hepatitis C virus concentrations below the level of detection of the assay. Care should be taken when interpreting any single viral load determination.
NOT QUANTIFIED - The assay detected the presence of the virus but was unable to accurately quantify the number of copies. This would indicate a result less than 1.0 log IU/mL (10 IU/mL).
HCV PCR Quantitation is a real-time transcription mediated amplification (TMA) test used for both the detection and quantitation of Hepatitis C (HCV) RNA genotypes 1 to 6 in human EDTA plasma or serum of HCV-infected individuals using Hologic Panther (Aptima) System.
The test 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. Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active infection.
NOTICE: Guidance for hepatitis C treatment is changing constantly with the advent of new therapies and other developments. We urge you to review this guidance on this website (www.hcvguidelines.org) for the latest recommendations.
Analytical Measurement Range for HCV RNA QUANT by PCR is 1.0 log IU/mL (10 IU/mL) to 8.0 log IU/mL (100,000,000 IU/mL).
A minimum viral load of 1000 IU/mL is required for the reflex to HCV Genotype testing. Insufficient viral loads may not be able to provide a Genotype.