Scientific Publications by FDA Staff

AIDS Res Hum Retroviruses 2007 Oct;23(10):1262-7

Detection of Emerging HIV Variants in Blood Donors from Urban Areas of Cameroon.

Lee S, Wood O, Tang S, Hu J, Machuca A, Kerby S, Awazi B, Vockley C, Hewlett I

Hewlett I (reprint author), US FDA, Mol Virol Lab, CBER, HFM-315,1401 Rockville Pike, Rockville, MD 20852 USA US FDA, Mol Virol Lab, CBER, Rockville, MD 20852 USA US FDA, Div Emerging & Transfus Transmitted Dis, CBER, Product Testing Sect, Rockville, MD 20852 USA

The U.S. Food and Drug Administration has licensed several assays for use in donor testing and management of persons with human immunodeficiency virus (HIV) infection. However, the performance of these assays for detection and quantitation of emerging HIV genetic variants has not been studied extensively. We tested 240 human plasma specimens collected from two urban blood centers in Cameroon where HIV genetic diversity and recombinant HIV strains are highly prevalent, using several FDA licensed assays. The testing record in Cameroon indicated that 149 specimens were HIV antibody positive and 91 specimens were negative using a rapid HIV-1/2 antibody assay in routine use in Cameroon blood centers. Both sets of samples were evaluated in the FDA laboratory using four ELISA tests for HIV-1 group M, HIV-1 group O, and HIV-2 antibodies, one IFA for HIV-1 antibody, one Western blot for HIV-1, one HIV-1 p-24 antigen assay, and three nucleic acid tests (NAT). Our results indicate that the assays had high sensitivity for detection of emerging genetic variants, although a small number of samples harboring circulating recombinant forms (CRFs) found in Cameroon were not always consistently detected by a few assays. These findings may be due to the evolving genetic diversity of HIV strains in Cameroon.