Sensitivity and specificity of a new automated system for the detection of hepatitis B virus, hepatitis C virus, and human immunodeficiency virus nucleic acid in blood and plasma donations. Issue 3 (17th December 2017) - Galel, Susan A.
Abstract : BACKGROUND: Use of nucleic acid testing (NAT) in donor infectious disease screening improves transfusion safety. Advances in NAT technology include improvements in assay sensitivity and system automation, and real‐time viral target discrimination in multiplex assays. This article describes the sensitivity and specificity of cobas MPX, a multiplex assay for detection of human immunodeficiency virus (HIV)‐1 Group M, HIV‐2 and HIV‐1 Group O RNA, HCV RNA, and HBV DNA, for use on the cobas 6800/8800 Systems. STUDY DESIGN AND METHODS: The specificity of cobas MPX was evaluated in samples from donors of blood and source plasma in the United States. Analytic sensitivity was determined with reference standards. Infectious window periods (WPs) before NAT detectability were calculated for current donor screening assays. RESULTS: The specificity of cobas MPX was 99.946% (99.883%‐99.980%) in 11, 203 blood donor samples tested individually (IDT), 100% (99.994%‐100%) in 63, 012 donor samples tested in pools of 6, and 99.994% (99.988%‐99.998%) in 108, 306 source plasma donations tested in pools of 96. Seven HCV NAT‐yield donations and one seronegative occult HBV infection were detected. Ninety‐five percent and 50% detection limits in plasma (IU/mL) were 25.7 and 3.8 for HIV‐1M, 7.0 and 1.3 for HCV, and 1.4 and 0.3 for HBV. The HBV WP was 1 to 4 days shorter than other donor screening assays by IDT. CONCLUSION: cobas MPX demonstrated high specificity in blood and source plasma donations tested individually and in pools. High sensitivity, in particular for HBV, shortens the WP and may enhance detection of occult HBV.