The AcroMetrix® BB NAT Triplex Positive Control was developed for use with qualitative assays for the detection of human immunodeficiency virus type 1 (HIV-1) RNA, hepatitis C virus (HCV) RNA and hepatitis B virus (HBV) DNA, respectively. AcroMetrix® BB NAT Triplex Positive Control is intended to provide a means of estimating accuracy and has the potential for detecting systematic deviations of nucleic acid test procedures for the qualitative determination of HIV-1 RNA, HCV RNA and⁄or HBV DNA. For In Vitro Diagnostic Use. The AcroMetrix® BB NAT Triplex Positive Control has been designed to maintain quality assurance and for the purpose of assessing assay performance of nucleic acid based HIV-1 RNA, HCV RNA and⁄or HBV DNA tests. The AcroMetrix® BB NAT Triplex Positive Control contains preserved processed human plasma and is supplied in single-use vials. The reagent has been formulated to ensure stability of the final product.

Each lot of Control is designed to produce a reactive result when used with the appropriate qualitative assays. The AcroMetrix® BB NAT Triplex Positive Control should be analyzed in the same manner as a specimen, according to the appropriate qualitative assay package insert.