Diagnosis of human immunodeficiency virus (HIV) infection is importantInfection with human immunodeficiency virus (HIV) has become pandemic since its first documentation in 1981 and is a major public health concern (11). HIV antibody testing is critical for the diagnosis and counseling of HIV-infected persons, the monitoring of trends in HIV prevalence, and the evaluation of the effectiveness of HIV prevention programs (5,12). An unprecedented number of tests for the detection of HIV antibodies are available. In some kits, improved sensitivity is frequently accompanied by a decreased specificity. This has been of particular concern with the introduction of test kits that detect all isotypes of antibodies, such as those based on antibody capture by antigens on a solid phase with labeled antigens as the detecting reagents (4,8).In resource-poor developing countries, the surveillance and diagnosis of HIV infection are major challenges (15). The conventional algorithm for HIV diagnostic testing consists of screening with enzyme immunoassays followed by confirmation with a Western blot test. Moreover, a double enzymelinked immunosorbent assay (ELISA) without Western blotting has been accepted as the customary screening assay for HIV infection (18). Because of the high cost of the Western blot test, it has not been affordable in a number of laboratories in developing countries (1). Rapid screening for HIV infection performed on-site with tests that do not require expensive laboratory infrastructure or highly skilled personnel helps with the diagnoses of patients in emergencies (13). The present study has been designed to evaluate five different commercially available diagnostic ELISA kits, and also a rapid test kit, for their performance in diagnosing HIV infection.
MATERIALS AND METHODSThis study was carried out at the Y. R. Gaitonde Centre for AIDS Research and Education (YRG CARE) in Chennai, India; it is a referral center for voluntary counseling and testing (VCT) in South India. A total of 264 specimens (plasma and serum) collected from VCT clients were tested using various commercial HIV ELISA kits, and the positive specimens were confirmed by Western blot analysis (Genetic Systems HIV-1 Western blot; Bio-Rad Laboratories, Redmond, WA). The following commercially available ELISA kits were employed in this study: Enzaids HIV 1ϩ2 (Span Diagnostics Ltd., Surat, India), HIV-CheX (Xcyton Diagnostics Ltd., Bangalore, India), Murex HIV-1.2.0 (Murex Biotech Limited, Dartford, United Kingdom), Genscreen HIV 1/2 version 2 (Bio-Rad Laboratories, France), and Vironostika HIV Uni-Form II Ag/Ab (BioMérieux, The Netherlands). Along with these, a rapid test kit, CombAids RS Advantage (Span Diagnostics Ltd., Surat, India), was also evaluated. A double-blind format was adopted in order to conceal patient information from the testing personnel. One staff member generated duplicate numbers for specimens at the specimen processing section; a second staff member generated plate maps and performed the tests. Finally, the results were ...