[Clinical evaluation of HIV-1/2 antibody rapid tests.].
BACKGROUND
To evaluate the sensitivity and specificity of HIV-1/2 antibody rapid tests prior to licensing.


METHODS
Four hundred forty, 264 and 300 blood samples were collected from normal blood donors, drug addicted individuals and HIV infected patients, respectively. All the samples were tested with 17 kinds of HIV-1/2 antibody rapid tests prior to licensing. The sensitivity and specificity of each test were calculated.


RESULTS
The sensitivity for all evaluated rapid tests was 100% for detecting 300 strong positive samples for HIV antibody; the specificity for all evaluated rapid tests was within the range of 97.7%-100% for detecting 440 samples from normal blood donors; the sensitivity and specificity of all tests were within the range of 70.3%-95.1% and 59.1%-100% respectively for detecting 264 samples from HIV high risk population.


CONCLUSIONS
The sensitivity and specificity of different tests were different and the samples from HIV high risk population may be very useful for evaluation of the quality of HIV-1/2 antibody rapid tests.
Li
X H
XH
Department of Cell Biology, National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China. Corresponding author: WANG You-chun, E-mail: wangyc@nicpbp.org.cn.
Song
A J
AJ
Wang
Y C
YC
D001782:Blood Donors; D015483:HIV Antibodies / Q000097:blood; D015658:HIV Infections / Q000175:diagnosis; D015497:HIV-1 / Q000276:immunology; D006801:Humans; D008403:Mass Screening; D012680:Sensitivity and Specificity
D015483:HIV Antibodies