Evaluation of FDA licensed HIV assays using plasma from Cameroonian blood donors.
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.
Lee
Sherwin
S
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.
Hu
Jinjie
J
Tang
Shixing
S
Wood
Owen
O
Francis
Kori
K
Machuca
Ana
A
Rios
Maria
M
Daniel
Sylvester
S
Vockley
Christopher
C
Awazi
Bih
B
Zekeng
Leopold
L
Hewlett
Indira
I
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
D015483:HIV Antibodies; D016655:HIV Core Protein p24; D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic