International collaborative study to compare assays for antibodies that neutralize human immunodeficiency virus.
A variety of techniques are currently in use to measure antibodies that neutralize human immunodeficiency virus (HIV), and standardization of these assays is needed. Eleven laboratories participated in this comparison study of 14 methods for detection of HIV neutralizing antibodies (NA). A panel of 10 coded sera and a positive and a negative control serum were tested in each assay. The 10 coded samples included aliquots of the same sera that were distributed as positive and negative control sera, an aliquot of the WHO reference human anti-HIV-1 serum, and seven other sera from people with HIV-1 infection. Each laboratory reported features of its test methods and results. The results demonstrated excellent within laboratory and between laboratory consistency. The most important variable appeared to be the virus strain used. Cell line, conditions of neutralization or culture, method of endpoint determination, or use of VSV pseudotypes did not appear to be important variables. The results indicate that standardization of HIV-1 NA assays should be readily achievable.
Vujcic
L
L
Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, MD.
Katzenstein
D
D
Martin
M
M
Quinnan
G
G
D015153:Blotting, Western; D004797:Enzyme-Linked Immunosorbent Assay; D015483:HIV Antibodies / Q000097:blood* / Q000276:immunology; D015658:HIV Infections / Q000276:immunology*; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D009500:Neutralization Tests; D012016:Reference Values
D015483:HIV Antibodies