Author(s): De Cock L, Hutse V, Verhaegen E, Quoilin S, Vandenberghe H,
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Abstract Although conventionally the detection of HCV antibodies is carried out on serum, the collection of oral fluid is non-invasive, safe and cost effective. In this study, the efficacy of the detection of HCV antibodies in oral fluid was assessed. 73 anti-HCV positive and 73 anti-HCV negative paired serum/oral fluid samples, drawn from patients visiting a Belgian academic hospital, were tested using the modified Ortho HCV 3.0 and LIA confirmation assay. Performing the test on oral fluid with the modified protocol, 61/73 anti-HCV positive samples were tested positive, while 73/73 anti-HCV negative samples were tested negative, giving a sensitivity and specificity of 83.6\% (95\% CI: 72.7-90.9\%) and 100.0\% (95\% CI: 93.8-100.0\%), respectively. Comparing S/CO of concordantly positive and negative samples, the cut-off point was lowered by 30\% resulting in a sensitivity of 89.0\% (95\% CI: 79.0-94.8\%) while the specificity remained 100.0\% (95\% CI: 93.8-100.0\%). The confirmation assay was carried out as described by the manufacturer, diluting the oral fluid 1:10. Testing paired samples gave a concordance of 85.6\% (125/146), yielding no more accurate results. These findings suggested that the modified ELISA method for anti-HCV detection in oral fluid can be used for epidemiological surveys.
This article was published in J Virol Methods
and referenced in Journal of Nanomedicine & Nanotechnology