Evaluation of a new assay for simultaneous detection of HCV core antigen and anti-HCV antibodies
Abstract number: p650
Carlos S., Fornieles C., Chueca N., Alvarez M., Bernal C.
The serological HCV diagnosis may present false negative results in the window period, which can be reduced by doing HCV RNA or HCV core Ag. A new ELISA technique for simultaneous detection of HCV core Ag and anti-HCV antibodies has been studied and evaluated for laboratory routine use.
Materials and methods:
1491 sera with anti-HCV antibodies request received in our laboratory and 3 seroconversion panels with 24 serum samples were analysed. All these samples were tested by a routine assay which detects anti-HCV antibodies (Assay 1, Ortho HCV 3.0 ELISA), and by the new one that detects both HCV core Ag and anti-HCV antibodies simultaneously (Assay 2, Monolisa HCV Ag/Ab Ultra, Bio-Rad). All positive sera were confirmed by recombinant immunoblot (INNO-LIA de Innogenetics).
The number of positive (303) and negative (1188) sera was the same for both techniques; however, 6 sera had divergent results. They are shown in the following table: Considering routine technique 1 as reference, the Ag/Ab assay had a sensitivity of 99.01% and a specificity of 99.75%. 99.07% of the negative sera and 93.72% of the positive ones presented an index far from the cut off. Considering the seroconversion panels, in all cases the combination assay reduce the window period.
The new assay for simultaneous detection of HCV core Ag and anti-HCV antibodies presents very good sensitivity and specificity values and it can differentiate very well positive and negative results. This makes it a valuable assay for routine diagnosis which allows early detection of HCV infection.
|Session name:||XXIst ISTH Congress|
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