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Intended Use
The CalypteŽ HIV-1
BED Incidence EIA is an in vitro quantitative
enzyme immunoassay for the determination of the
proportion of HIV-1 specific IgG in a given serum
or plasma specimen with respect to total IgG as an
aid in determining the elapsed time since HIV-1
infection occurred. The Calypte HIV-1 BED
Incidence EIA is to be used for public health
purposes only, such as for population incidence
estimates to assist in prevention programs,
targeting resources, monitoring and evaluation,
and identifying high risk cohorts for prevention
research, including vaccine trials. The assay is
not for diagnosis of HIV infection. |
