Quality Evaluation of Six kinds of Commercial HIV Antibodies Screening Kits
Ping Yan, Aids Surveillance
Abstract
Ping Yan, Aids Surveillance
Abstract
To evaluate the quality of commercial kits for HIV antibodies screening 200 serum (or plasma) samples were tested with 6 kinds of commercial HIV antibodies screening kits The positives were confirmed with Western blot According to the results, the test power, sensitivity, specificity and so on were calculated for evaluating The test power of the evaluated 5 ELISA kits equaled to or was higher than 96 5% And some indicators of the evaluated domestic made kits were closed to imported kits However, It was worth to notice that one domestic made kit still had a high false negative rate (9 09%) [Conclusion] This study showed that the test power of ELISA kits was higher than the fast screening kit Among those 5 evaluated ELISA HIV screening kits,the imported one still occupied the first place Although there were improvement in quality of domestic made HIV screening kits,there still is necessary to establish a quality monitoring system, and evaluate them regularly so that problems would be identified and proper measures could be taken to minimize the possible risks
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To evaluate the quality of commercial kits for HIV antibodies screening 200 serum (or plasma) samples were tested with 6 kinds of commercial HIV antibodies screening kits The positives were confirmed with Western blot According to the results, the test power, sensitivity, specificity and so on were calculated for evaluating The test power of the evaluated 5 ELISA kits equaled to or was higher than 96 5% And some indicators of the evaluated domestic made kits were closed to imported kits However, It was worth to notice that one domestic made kit still had a high false negative rate (9 09%) [Conclusion] This study showed that the test power of ELISA kits was higher than the fast screening kit Among those 5 evaluated ELISA HIV screening kits,the imported one still occupied the first place Although there were improvement in quality of domestic made HIV screening kits,there still is necessary to establish a quality monitoring system, and evaluate them regularly so that problems would be identified and proper measures could be taken to minimize the possible risks
Key concepts: Medicine, HIV screening, Human immunodeficiency virus (HIV), False positive paradox, Antibody, Screening test, Notice, External quality assessment