Evaluation of two HIV antibody confirmatory assays: Geenius™ HIV1/2 Confirmatory Assay and the recomLine HIV-1 & HIV-2 IgG Line Immunoassay.

Abstract The laboratory diagnosis of an HIV infection mainly depends on the detection of HIV-specific antibodies/HIV p24 antigen whereby different algorithms for the confirmation of reactive screening assays exist. The objective of the present study was to compare the performance of two supplemental HIV antibody confirmatory assays: the Geenius™ HIV1/2 Confirmatory Assay and the recomLine HIV-1 & HIV-2 IgG Line Immunoassay. Therefore 279 serum samples previously analyzed for HIV during routine diagnostics at the Institute for Medical Virology, National Reference Center for Retroviruses, University Hospital Frankfurt, were analyzed retrospectively. 96.8% samples had concordant results in both HIV confirmatory assays, whereby the Geenius Assay showed a discrimination rate of 100% while two HIV-1 samples were not typeable with the recomLine Assay. Overall assay sensitivity was 100% in both assays and specificity was 99.0% (recomLine Assay) and 93.4% (Geenius Assay), respectively. The κ-values for both assays indicated high agreement. Overall nine samples had discordant results from which four were from acutely EBV/CMV-infected patients and one from a patient with primary HIV-1 infection during seroconversion. In conclusion, both assays are well suited for the detection, confirmation and discrimination of HIV-1- and -2-specific antibodies.