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Multicenter performance evaluation of a transcription‐mediated amplification assay for screening of human immunodeficiency virus‐1 RNA, hepatitis C virus RNA, and hepatitis B virus DNA in blood donations
Author(s) -
Koppelman Marco H.G.M.,
Assal Azzedine,
Chudy Michael,
Torres Pilar,
De Villaescusa R. Garcia,
Reesink Henk W.,
Lelie P. Nico,
Cuypers H. Theo M.
Publication year - 2005
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1111/j.1537-2995.2005.00197.x
Subject(s) - hbsag , seroconversion , medicine , virology , hepatitis b virus , hepatitis c virus , window period , hepatitis b , hbeag , virus , immunology , antibody , serology
BACKGROUND: The performance of the recently launched Procleix Ultrio (Chiron/Gen‐Probe) human immunodeficiency virus‐1 (HIV‐1), hepatitis C virus (HCV), and hepatitis B virus (HBV) blood screening assay was evaluated in a European multicenter study. STUDY DESIGN AND METHODS: Serial dilutions of reference materials were tested to determine the detection limits. Robustness and specificity were assessed by testing alternating high‐load HCV RNA–positive and –negative samples, and 2912 test pools of eight donations. The added value of minipool and single‐donation HBV nucleic acid testing protocols was compared to the currently used Prism (Abbott GmbH & Co. KG) hepatitis B surface antigen (HBsAg) and Auszyme (Abbott GmbH & Co. KG) dynamic HBsAg tests in 15 HBV seroconversion panels. RESULTS: The 95 percent detection limits (and 95% confidence interval [CI]) on the WHO International Standards was 26 (16‐58) IU per mL for HIV‐1 RNA, 4.6 (3.7‐6.5) IU per mL for HCV RNA, and 11 (7.3‐22) IU per mL for HBV DNA. No cross‐contamination was observed. Testing 2912 pools of eight donations revealed 16 initial reactive samples; 11 were confirmed. The specificity after initial testing and percentage of invalid results were 99.83 and 0.48 percent, respectively. The HBV window‐period (WP) reductions relative to HBsAg seroconversion in Prism and Auszyme dynamic HBsAg were, respectively, 6 days (95% CI, 3‐8) and 9 days (95% CI, 7‐12) in 1:8 minipool (MP) testing. CONCLUSION: The performance characteristics of Procleix Ultrio assay and the Procleix HIV‐1 and HCV assay are comparable. The sensitivity for HIV‐1 and HCV met the directives of the Paul‐Ehrlich Institute and the FDA. The assay can reduce the WP for HBV by 6 days to 2 weeks when used in small MP (<1:8) or single‐donation screening protocols.