Abstract
The Recombigen HIV-1 Latex Agglutination (LA) Test was recently licensed by the U.S. Food and Drug Administration for use as a rapid screening assay for human immunodeficiency virus type 1 (HIV-1) antibodies. However, its performance in various settings and in different populations has not been firmly established. Consequently, we evaluated the test in the Cleveland Clinic Retrovirus Laboratory, a regional reference laboratory for HIV diagnostic testing and a testing laboratory for the Ohio Department of Health Anonymous HIV Testing and Counseling Program. Serum samples from 93 individuals presumed to be at high risk for HIV infection were evaluated. The sera were initially tested for HIV antibodies by enzyme-linked immunosorbent assay (ELISA). All repeatedly reactive sera were subjected to confirmatory Western blot (WB; immunoblot) testing. Of 97 serum specimens tested (5 were from one seroconverter), 44 were repeatedly reactive by ELISA and 53 were nonreactive. Of the reactive serum specimens, 31 were confirmed positive and 12 were indeterminate by WB. All of the sera were coded and then retested by the LA test. Of 53 serum specimens nonreactive by ELISA, 51 were also nonreactive in the LA test. Of the 44 serum specimens reactive by ELISA, 16 were nonreactive by LA; however, 3 of the latter were WB positive. No serum specimen with an ELISA ratio (specimen optical density/cutoff optical density) of less than 2.1 scored reactive in the LA test. The LA test was positive for only two of five consecutive serum specimens from a seroconverter despite the fact that all but the earliest of these were ELISA reactive and WB positive. Although the LA test appears to be an adequate first-line screening test when appropriately used according to the directions of the manufacturer, our data suggest that occasional sera with low levels of reactivity by ELISA may not be readily detected as reactive by the LA test.
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- Francis H. L., Kabeya M., Kafuama N., Riggins C., Colebunders R., Ryder R., Curran J., Izaley L., Quinn T. C. Comparison of sensitivities and specificities of latex agglutination and an enzyme-linked immunosorbent assay for detection of antibodies to the human immunodeficiency virus in African sera. J Clin Microbiol. 1988 Nov;26(11):2462–2464. doi: 10.1128/jcm.26.11.2462-2464.1988. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Hausler W. J., Jr, Getchell J. P. Report of the Fourth Consensus Conference on HIV Testing sponsored by the Association of State and Territorial Public Health Laboratory Directors (ASTPHLD). Infect Control Hosp Epidemiol. 1989 Aug;10(8):354–367. doi: 10.1086/646045. [DOI] [PubMed] [Google Scholar]
- Heyward W. L., Curran J. W. Rapid screening tests for HIV infection. JAMA. 1988 Jul 22;260(4):542–542. doi: 10.1001/jama.260.4.542. [DOI] [PubMed] [Google Scholar]
- Quinn T. C., Mann J. M., Curran J. W., Piot P. AIDS in Africa: an epidemiologic paradigm. Science. 1986 Nov 21;234(4779):955–963. doi: 10.1126/science.3022379. [DOI] [PubMed] [Google Scholar]
- Quinn T. C., Riggin C. H., Kline R. L., Francis H., Mulanga K., Sension M. G., Fauci A. S. Rapid latex agglutination assay using recombinant envelope polypeptide for the detection of antibody to the HIV. JAMA. 1988 Jul 22;260(4):510–513. [PubMed] [Google Scholar]
- Riggin C. H., Beltz G. A., Hung C. H., Thorn R. M., Marciani D. J. Detection of antibodies to human immunodeficiency virus by latex agglutination with recombinant antigen. J Clin Microbiol. 1987 Sep;25(9):1772–1773. doi: 10.1128/jcm.25.9.1772-1773.1987. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Spielberg F., Kabeya C. M., Ryder R. W., Kifuani N. K., Harris J., Bender T. R., Heyward W. L., Quinn T. C. Field testing and comparative evaluation of rapid, visually read screening assays for antibody to human immunodeficiency virus. Lancet. 1989 Mar 18;1(8638):580–584. doi: 10.1016/s0140-6736(89)91610-3. [DOI] [PubMed] [Google Scholar]
- Thorn R. M., Beltz G. A., Hung C. H., Fallis B. F., Winkle S., Cheng K. L., Marciani D. J. Enzyme immunoassay using a novel recombinant polypeptide to detect human immunodeficiency virus env antibody. J Clin Microbiol. 1987 Jul;25(7):1207–1212. doi: 10.1128/jcm.25.7.1207-1212.1987. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Van de Perre P., Nzaramba D., Allen S., Riggin C. H., Sprecher-Goldberger S., Butzler J. P. Comparison of six serological assays for human immunodeficiency virus antibody detection in developing countries. J Clin Microbiol. 1988 Mar;26(3):552–556. doi: 10.1128/jcm.26.3.552-556.1988. [DOI] [PMC free article] [PubMed] [Google Scholar]