title: Evaluation of FDA licensed HIV assays using plasma from Cameroonian blood donors.
abstract: Several diagnostic assays for the detection of HIV infection have been approved and licensed by the FDA for blood donor screening. However, the performance of these assays is unknown when testing genetically divergent blood specimens. To evaluate the performance of these assays with diverse HIV strains, we chose to study specimens collected from blood donors in Cameroon where genetic diversity and recombinant variants are prevalent. In this study, we tested 240 human plasma specimens collected from two blood centers in Cameroon. These samples were screened initially in Cameroon for antibody to HIV using a rapid assay. We also performed sequencing to determine subtype. Our evaluation has demonstrated that HIV infection in most HIV plasma samples could be detected by most of the US FDA licensed diagnostic assays. With the exception of a few specimens, HIV-1 p24 antigen was not detected in any of the samples. In addition, some nucleic acid tests (NAT) assays were not able to detect a few serologic reactive samples and all new variants including some CRF02_AG variants.
authors.affiliation: Laboratory of Molecular Virology, Division of Emerging and Transfusion Transmitted Diseases, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Bethesda, Maryland 20892, USA.
authors.forename: Sherwin
authors.initials: S
authors.lastname: Lee
authors.forename: Jinjie
authors.initials: J
authors.lastname: Hu
authors.forename: Shixing
authors.initials: S
authors.lastname: Tang
authors.forename: Owen
authors.initials: O
authors.lastname: Wood
authors.forename: Kori
authors.initials: K
authors.lastname: Francis
authors.forename: Ana
authors.initials: A
authors.lastname: Machuca
authors.forename: Maria
authors.initials: M
authors.lastname: Rios
authors.forename: Sylvester
authors.initials: S
authors.lastname: Daniel
authors.forename: Christopher
authors.initials: C
authors.lastname: Vockley
authors.forename: Bih
authors.initials: B
authors.lastname: Awazi
authors.forename: Leopold
authors.initials: L
authors.lastname: Zekeng
authors.forename: Indira
authors.initials: I
authors.lastname: Hewlett
mesh_terms: D001782:Blood Donors; D002163:Cameroon; D005188:False Negative Reactions; D015483:HIV Antibodies / Q000097:blood*; D016655:HIV Core Protein p24 / Q000032:analysis; D015658:HIV Infections / Q000175:diagnosis*; D015497:HIV-1 / Q000235:genetics / Q000276:immunology; D006801:Humans; D008004:Licensure; D012367:RNA, Viral / Q000032:analysis; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D012680:Sensitivity and Specificity; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015483:HIV Antibodies; D016655:HIV Core Protein p24; D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic