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AIDS Res Hum Retroviruses. 2013 Jan;29(1):61-7. doi: 10.1089/aid.2012.0121.

Development of a novel rapid HIV test for simultaneous detection of recent or long-term HIV type 1 infection using a single testing device.

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Division of HIV/AIDS, National Center for HIV, Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA 30329, USA.


Laboratory assays for the detection of recent HIV infection for HIV incidence surveillance are essential to HIV prevention efforts worldwide because they can identify populations with a high incidence and allow targeting of resources and monitoring of incidence trends over time. This study describes the development of a novel rapid HIV-1 incidence-prevalence (I-P) test that can be used for the simultaneous detection and discrimination of prevalent (long-term) or incident (recent) HIV infections using a single device. A lateral flow assay was developed that uses a multisubtype recombinant gp41 protein applied at two concentrations of antigen (high and low). Prevalent and incident HIV-1 infections can be distinguished based on differential antibody binding at the two antigen concentrations. High level/high avidity antibodies present in prevalent infections bind to and are detected at both antigen concentrations while low level/low avidity antibodies present in recent HIV infections are detected only at the higher antigen concentration line. A total of 205 HIV-positive specimens with known status (recent=105, long-term=100), including 57 specimens from seroconversion panels, were tested by the rapid I-P assay and the results were compared to the HIV-1 BED capture enzyme immunoassay (CEIA). There was a 95.1% agreement of final classification (recent or long-term) with the BED assay (kappa=0.910) (mean recency period=162 days) and a high correlation between the intensity score of the low antigen line with the BED OD-n (Pearson correlation=0.89). The new rapid I-P test has great potential to simplify HIV surveillance efforts by simultaneously providing information on both HIV prevalence and incidence using a single, rapid test device.

[Indexed for MEDLINE]

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