title: Comparison of a conventional HIV 1/2 line immunoassay with a rapid confirmatory HIV 1/2 assay.
abstract: The performance of the rapid confirmatory HIV 1/2 assay Geenius was compared with the conventional HIV 1/2 line immunoblot (INNO-LIA HIV I/II Score). One hundred HIV 1/2 confirmed positive samples from donors and patients and 136 negative screening samples from blood donors were evaluated with both assays. A 20 member performance panel consisting of different HIV 1 and 2 subtypes was also analysed. Ninety-nine of the confirmed HIV positive samples were positive with both assays. One sample was positive with the INNO-LIA HIV I/II Score but indeterminate with the Geenius HIV 1/2. From 136 negative blood donor samples (negative with a combo HIV assay and a highly sensitive ID-NAT), 125 were concordant negative. Six and five samples were incorrectly indeterminate with the INNO-LIA HIV I/II Score and the Geenius HIV 1/2, respectively. One sample was weak positive with the INNO-LIA HIV I/II Score but negative with the Geenius HIV 1/2. The 20 member performance showed equivalent results with both assays. The rapid assay showed a comparable sensitivity and specificity for confirmation for positive and negative HIV donor and patient samples as well for a 20 member performance panel.
authors.affiliation: Blood Transfusion Service SRC Berne, Murtenstrasse 133, 3008 Berne, Switzerland.
authors.forename: Caroline
authors.initials: C
authors.lastname: Tinguely
authors.affiliation: Blood Transfusion Service SRC Berne, Murtenstrasse 133, 3008 Berne, Switzerland.
authors.forename: Therese
authors.initials: T
authors.lastname: Schild-Spycher
authors.affiliation: Blood Transfusion Service SRC Berne, Murtenstrasse 133, 3008 Berne, Switzerland.
authors.forename: Zahra
authors.initials: Z
authors.lastname: Bahador
authors.affiliation: Blood Transfusion Service SRC Berne, Murtenstrasse 133, 3008 Berne, Switzerland.
authors.forename: Peter
authors.initials: P
authors.lastname: Gowland
authors.affiliation: Blood Transfusion Service SRC Berne, Murtenstrasse 133, 3008 Berne, Switzerland.
authors.forename: Martin
authors.initials: M
authors.lastname: Stolz
authors.affiliation: Blood Transfusion Service SRC Berne, Murtenstrasse 133, 3008 Berne, Switzerland. Electronic address: christoph.niederhauser@bsd-be.ch.
authors.forename: Christoph
authors.initials: C
authors.lastname: Niederhauser
mesh_terms: D003951:Diagnostic Errors; D015658:HIV Infections / Q000175:diagnosis* / Q000821:virology*; D015497:HIV-1 / Q000276:immunology*; D015498:HIV-2 / Q000276:immunology*; D006801:Humans; D007118:Immunoassay / Q000379:methods; D012680:Sensitivity and Specificity
keywords: Confirmation assays; HIV; Sensitivity; Specificity