The safety of the blood supply and the accurate diagnosis of Hepatitis C infection depend on the sensitivity and overall quality of tests for markers of HCV. Test developers, regulators, and clinical laboratories require highly characterized panels and control materials to challenge sensitivity accuracy and reproducibility of their assays.

SeraCare Life Sciences, a leading expert in human biologicals and the manufacturer of ACCURUN® controls, introduces two new, highly characterized HCV seroconversion panels designed to help diagnostic manufacturers and clinical laboratories effectively evaluate their HCV test systems. The specimens in each panel are collected from a single individual during the evolution of the immune response to HCV. Accurate detection of early HCV infection is especially important for tests used to screen the blood supply, as HCV is not initially symptomatic upon infection.

The two new seroconversion panels, designated PHV922 and PHV923, each consist of a set of undiluted plasma samples collected from a single individual during seroconversion, the period of time during development of infection and early immune response. PHV922 and PHV923 were collected from deferred plasma donors in different regions of the US over 17 and 23 days respectively, in 2008. PHV922 is HCV genotype 3a; PHV923 is HCV genotype 1a. Both series demonstrate the early evolution of the human immune response to HCV, and contain naturally occurring samples to challenge the sensitivity of tests for HCV antibody.

Source: SeraCare Life Sciences