Evaluation of supplemental testing with the Multispot HIV-1/HIV-2 Rapid Test and APTIMA HIV-1 RNA Qualitative Assay to resolve specimens with indeterminate or negative HIV-1 Western blots

Evaluation of the Bio-Rad Geenius HIV 1/2 Assay as an Alternative to the INNO-LIA HIV 1/2 Assay for Confirmation of HIV Infection

“…HIV RNA testing is highly recommended for resolving discordant screening and confirmatory results in cases of suspected acute infection (13). Another limitation of this study is that, since infection with HIV-2 is rare in Israel, only two HIV-2 cases were evaluated; thus, our ability to evaluate the impact of HIV-2 diagnosis is limited.…”

HIV Testing Updates and Challenges: When Regulatory Caution and Public Health Imperatives Collide

“…New developments also occur faster than evidence-based recommendations can be written. Ample evidence demonstrated that the FDA-approved Multispot HIV-1/HIV-2 differentiation assay provided results superior to those of the HIV-1 Western blot when used as a supplemental test [45,52,[79][80][81][82][83]. However, because it was approved only for HIV antibody screening, it could not be recommended as a supplemental test in diagnostic algorithms until the manufacturer obtained FDA approval for this intended use [84].…”

Laboratory testing for the diagnosis of HIV infection : updated recommendations

“…18,62,71,72 Two studies of previously tested specimens with negative or indeterminate Western blot results conducted retrospective testing with the HIV-1/HIV-2 differentiation assay and HIV-1 NAT, but had no information about whether specimens were stored and handled consistent with requirements for the HIV-1 NAT assays. 148,149 CDC writing group members did not conduct pooled data analyses because the studies were conducted with different assays of the same or different classes (that is, three 3rd generation and two 4th generation immunoassays) using specimen collections from different populations with different pre-test probabilities of infection, or enriched with pedigreed specimens with known laboratory diagnosis of HIV-1 or HIV-2 infection. The number of significant digits reported for values in the evidence summary and tables are those as published in the original studies.…”

“…18 88 Five studies documented reactive HIV-1/HIV-2 antibody differentiation assay results in specimens repeatedly reactive by 3rd or 4th generation IA, reactive by HIV-1 NAT, but negative or indeterminate by HIV-1 Western blot. 47,76,107,148,149 2. What is the specificity of individual assays in specimens from uninfected persons?…”

“…148 In the second study, among 570 specimens obtained from public health laboratories, application of the two supplemental tests identified HIV-1 infection in 55 (9.6%); 19 (3.3%) were acute HIV-1 infections. 149 In a prospective analysis of 51,000 specimens during the first 5 months using the recommended testing algorithm in the Florida Bureau of Public Health Laboratories, the recommended algorithm detected 922 HIV-1 infections, of which 4 (0.4%) were acute. 123 In prospective analysis after implementation of the recommended algorithm with 7,984 specimens from Massachusetts, 8 (3.1%) of 258 HIV-1 infections were acute.…”