title: Rapid HIV testing using Determine™ HIV 1/2 antibody tests: is there a difference between the visual appearance of true- and false-positive tests?
abstract: HIV point-of-care tests (POCTs) give occasional false positive results, causing unnecessary patient anxiety. We aimed to elicit whether false- and true-positive POCTs differed visually. Seventeen false- and 17 true-positive serum samples were randomized into pairs, comprising one false- and one true-positive sample. Two independent readers identified each POCT as negative or positive and compared line strength between pairs. Six further readers graded line strength, 0-5, from POCT photographs. All true-positive samples were identified positive and 8/17 false-positive samples negative, on repeat testing of stored sera. Eight out of the 9 remaining false-positive tests were described as having weaker pigment uptake than their paired true-positive POCT. Mean grade of line strength was 4.2 in true- and 0.9 in false-positive samples, on photographic evaluation. These results suggest false-positive POCTs may differ visually from true-positive POCTs. If larger studies confirm these findings, we may be able to alleviate anxiety in low risk patients with faintly positive POCTs awaiting their confirmatory laboratory result, where the possibility of a false-positive result could be emphasized.
authors.affiliation: rachel.sacks@imperial.nhs.uk
authors.forename: R
authors.initials: R
authors.lastname: Sacks
authors.forename: A
authors.initials: A
authors.lastname: Omodele-Lucien
authors.forename: N
authors.initials: N
authors.lastname: Whitbread
authors.forename: D
authors.initials: D
authors.lastname: Muir
authors.forename: A
authors.initials: A
authors.lastname: Smith
mesh_terms: D002846:Chromatography, Affinity / Q000295:instrumentation / Q000379:methods / Q000592:standards*; D005189:False Positive Reactions; D015483:HIV Antibodies / Q000097:blood*; D015658:HIV Infections / Q000097:blood* / Q000821:virology*; D015497:HIV-1 / Q000276:immunology*; D015498:HIV-2 / Q000276:immunology*; D006801:Humans; D019095:Point-of-Care Systems; D011933:Reagent Kits, Diagnostic / Q000821:virology*; D013997:Time Factors
chemical_list: D015483:HIV Antibodies; D011933:Reagent Kits, Diagnostic