Aptima HCV RNA qualitative assay
The Aptima HCV RNA qualitative assay is FDA approved for the diagnosis of active hepatitis C virus (HCV) infection:
Amongst highest sensitivity of detection compared to other FDA approved qualitative HCV RNA assays.
Identify active HCV infections in individuals with antibody evidence and link to care using highly effective antiviral regimens to eradicate virus.
The Aptima HCV RNA Qualitative Assay is an in vitro nucleic acid amplification assay offering proven performance for the detection of HCV RNA in fresh or frozen human plasma (EDTA, sodium citrate and ACD) and serum:
Specific and sensitive detection across HCV genotypes 1 to 6 (and major subtypes).
Fully validated, transcription-mediated amplification (TMA) system with simple and controlled workflow without thermocycling.
The Aptima HCV RNA Qualitative Assay supports CDC testing algorithms for HCV diagnosis with the use of an FDA-approved nucleic acid amplification test (NAAT) intended for detection of HCV RNA in serum or plasma from blood of at-risk patients who test reactive for HCV antibody.1