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Evaluation of the Specificity of a New HCV Antigen/Antibody Combination test

Aims: This study was undertaken to evaluate the specificity of the Murex HCV Ag/Ab Combination assay, to compare to another antigen-antibody combination assay (Monolisa HCV Ag-Ab Ultra, Bio-Rad) or a combination of antibody assays with a separate HCV antigen assay. Methods: Murex HCV Ag/Ab Combination assay was used to test 1.022 presumed negative routine donor specimens. 584 specimens were tested in parallel by Monolisa HCV Ag-Ab Ultra and another 438 by Ortho HCV Core Ag test in combination with Ortho HCV Enhanced SAVe or Abbott PRISM anti-HCV tests. In addition, 357 repeatedly reactive (RR) by other HCV serological assays were analyzed to characterize sensitivity and false-reactivity rate for this new device. Results: 1.022 routine donor samples were tested by Murex assay, resulting in a specificity of 99, 80 % (2/1.022). 582 of these were also tested by Bio-Rad with similar specificity of 99, 82% (1/582). No false-reactive results were seen when separate HCV antigen and HCV antibody assays were used. In a group of 357 a-HCV RR donors, 9 RIBA-3 positive were clearly detected by all three assays (Murex, Bio-Rad and Ortho HCV Enhanced SAVe). Out of 88 RIBA-3 indetermined samples, 11 were found reactive by Murex, 32 by Bio-Rad and 23 by Ortho Enhanced HCV. In the group of 242 RIBA negative samples, 3 were Murex reactive, 47 tested positive by Bio-Rad and 14 were Ortho positive. Conclusion: The Murex HCV Ag/Ab combination assay has demonstrated excellent specificity and may thus be considered as less expensive alternative to the introduction of HCV RNA screening.

HCV Ag/Ab test

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