Validation of rapid HIV antibody tests in 5 African countries.
The sensitivity and specificity of 3 rapid HIV antibody tests were assessed at 5 clinical trial sites in Africa and 1 site in the United States using a minimum of 100 HIV antibody positive samples and 100 HIV antibody negative samples at each site. The overall sensitivity and specificity for the OraSure OraQuick, Abbott Determine, and Trinity Unigold tests were 99.3%, 99.8%, and 98.5%, respectively, and 99.3%, 99.4%, and 99.5%, respectively. There were no instances at any site in which false-negative or false-positive results were obtained for the same sample on more than 1 rapid test kit. The results of this study provide assurance that for these diverse sites in Africa, the accuracy of these kits is quite good. Given the excellent accuracy, relatively fast turnaround time, and minimal infrastructure required, these rapid tests for HIV antibody provide a very attractive and accurate testing format.
Johns Hopkins University, Department of Pathology, Baltimore, MD, USA. epiwowa@jhmi.edu
Estelle M
EM
Piwowar-Manning
Nancy B
NB
Tustin
Physiwell
P
Sikateyo
Debbie
D
Kamwendo
Chifundo
C
Chipungu
Rashika
R
Maharaj
Jabulani
J
Mushanyu
Barbra A
BA
Richardson
Sharon
S
Hillier
J
J
Brooks Jackson
D000349:Africa; D015483:HIV Antibodies / Q000097:blood*; D015658:HIV Infections / Q000175:diagnosis*; D006801:Humans; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity
D015483:HIV Antibodies; D011933:Reagent Kits, Diagnostic