Multiple blood-borne pathogen antibody/antigen IVD, control
Definition
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antibodies to, and antigens from multiple blood-borne pathogens in a clinical specimen. Pathogens detected may include (but are not limited to) human immunodeficiency virus 1 and 2 (HIV1 and HIV2), Hepatitis B virus, Hepatitis C virus, human T-cell lymphotrophic virus 1 and/or 2 (HTLV1 and/or HTLV2), and Treponema pallidum.