Description:
BiolineHCV is an in vitro immunochromatographic, rapid assay designed for the qualitative detection of antibodies specific to HCV, in human serum, plasma (heparin, EDTA and sodium citrate) or whole blood. Bioline HCV is intended only for professional use as the initial test, as an aid to diagnosis. Reactive specimens should be reflexed for additional testing, either by nucleic acid testing (NAT) technologies for the detection of HCV RNA or HCV core antigen testing, to identify current HCV infection.
This product is intended for use in a population with high HCV prevalence or who have a history of HCV risk exposure/behaviour including pregnant women. This test may not be suitable for diagnosis of early infection or blood donation screening. The performance of the assay has not been established for populations of infants or children.