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Published on: March 13, 2015
[Quality evaluation of locally-prepared kits for HIV antibody detection in clinical applications]
1Institute for Microbiology and Epidemiology, Academy of Military Medical Sciences, Beijing.
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%.
Conclusion:
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.

