Performance of a Fourth-Generation HIV Screening Assay and an Alternative HIV Diagnostic Testing Algorithm
Published Date:Mar 13 2013
Pubmed Central ID:PMC4582659
Funding:HIJ9/Intramural CDC HHS/United States
We evaluated the performance of the GS fourth-generation antigen/antibody assay and compared CDC’s proposed alternative algorithm (repeatedly reactive [RR] fourth-generation immunoassay [IA] followed by an HIV-1/HIV-2 differentiation IA and, if needed, nucleic acid testing [NAT]) with the current algorithm (RR third-generation IA followed by HIV-1 Western blot [WB]).
A convenience sample of the following four specimen sets was acquired: 10,014 from insurance applicants, 493 known WB-positive, 20 known WB-indeterminate specimens, and 230 specimens from 26 HIV-1 seroconverters.
Specimens were tested with the GS third- and fourth-generation IAs, the Multispot HIV-1/HIV-2 differentiation IA, NAT, and WB. We applied the two algorithms using these results.
Among insurance specimens, 13 (0.13%) specimens were IA RR: 2 were HIV-positive (RR by third- and fourth-generation IAs, and WB and Multispot positive); 2 third-generation RR and 9 fourth-generation RR specimens were false-positive. Third- and fourth-generation specificities were 99.98% (95%CI: 99.93%–100%) and 99.91% (95%CI: 99.84%–99.96%) respectively.
The alternative testing algorithm improved early infection sensitivity and identified HIV-2 infections. Two potential false-positive algorithm results occurred with WB-indeterminate specimens.
text/plain image/gif image/jpeg
You May Also Like: