title: A field test for the detection of antibodies to human immunodeficiency virus types 1 and 2 in serum or plasma.
abstract: In response to the need for simple and rapid tests for infectious diseases, we have devised a test for antibodies to human immunodeficiency virus type 1 (HIV-1) and HIV-2 which resembles many contemporary strip-style pregnancy tests in format and ease of use. The test was evaluated with 2,928 serum specimens (1,541 reactive and 1,387 nonreactive) collected and tested at a Mexico City hospital clinic and was compared with a laboratory assay (Abbott) performed simultaneously. The sensitivity and specificity of the test using these serum specimens were 99.68 and 99.71%, respectively (before the code of the blinded study was broken). This compares with 100% sensitivity and 97.55% specificity with the laboratory assay (specificity upon reassay after the code was broken, 99.21%). In a survey of HIV-2 specimens, reactive (positive) specimens were detected in 51 of 51 cases. The test was examined with 21 commercially available (HIV-1) seroconversion panels. The performance of the test was comparable to that of a group of Food and Drug Administration-approved (antibody-based) HIV tests.
authors.affiliation: Saliva Diagnostic Systems, Inc., Vancouver, Washington 98682-2444, USA.
authors.forename: A
authors.initials: A
authors.lastname: Burgess-Cassler
authors.forename: G
authors.initials: G
authors.lastname: Barriga Angulo
authors.forename: S E
authors.initials: SE
authors.lastname: Wade
authors.forename: P
authors.initials: P
authors.lastname: Castillo Torres
authors.forename: W
authors.initials: W
authors.lastname: Schramm
mesh_terms: D004311:Double-Blind Method; D015483:HIV Antibodies / Q000097:blood*; D015658:HIV Infections / Q000097:blood / Q000175:diagnosis* / Q000276:immunology; D015497:HIV-1 / Q000276:immunology*; D015498:HIV-2 / Q000276:immunology*; D006801:Humans; D011934:Reagent Strips; D012680:Sensitivity and Specificity
chemical_list: D015483:HIV Antibodies; D011934:Reagent Strips