[Quality evaluation of locally-prepared kits for HIV antibody detection in clinical applications].
OBJECTIVE
To evaluate the quality of eight kinds of locally prepared enzyme-linked immunosorbent assay (ELISA) kits for HIV antibody (anti-HIV) detection and study their current status in clinical applications.


METHODS
Two hundred serum specimens were tested with eight kinds of locally prepared ELISA kits for anti-HIV screening, with an imported kit as reference, including 100 specimens with confirmed positive, negative or undetermined anti-HIV and 100 specimens collected from the drug abusers in Xinjiang Region.


RESULTS
Anti-HIV could be detected in all the 74 confirmed positive specimens with the imported reference kit, with sensitivity of 100%. But, six to eighteen specimens were false negative detected with local prepared kits, with sensitivities of 81.1%-91.9%, mainly in those collected from the drug abusers with weak positive for anti-HIV. Two of the 107 confirmed negative specimens were false positive by the imported reference kit, with a specificity of 98.2%, and 0-8 specimens were false positive by locally prepared kits, with specificities of 92.5%-100%.


CONCLUSIONS
The sensitivity of locally prepared ELISA kits for anti-HIV screening should be improved further to ensure the safety of blood transfusion and the control of AIDS/HIV.
Li
J
J
Institute for Microbiology and Epidemiology, Academy of Military Medical Sciences, Beijing.
Bao
Z
Z
Lu
F
F
D002681:China; D004797:Enzyme-Linked Immunosorbent Assay; D005069:Evaluation Studies as Topic; D006678:HIV / Q000276:immunology*; D015483:HIV Antibodies / Q000097:blood*; D006801:Humans; D011933:Reagent Kits, Diagnostic / Q000592:standards; D012680:Sensitivity and Specificity
D015483:HIV Antibodies; D011933:Reagent Kits, Diagnostic