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《International Journal of Laboratory Medicine》 2015-02
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Evaluation of human papillomavirus nucleic acid detection Kit

Qu Shoufang;Yu Ting;Sun Nan;Gao Shangxian;Huang Jie;1st Division of in Vitro Diagnostic Reagents,National Institutes for Food and Drug Control;  
Objective To evaluate the performance of sampling diagnostic kit for detecting human papillomavirus(HPV)nucleic acid.Methods HPV genotyping reference materials was selected as the standard.According to the sampling plan,evaluated the accuracy,specificity and detection limits of HPV nucleic acid detection kit(polymerase chain reaction-fluorescent probing method).Results The results of accuracy and detection limit were accord with the demands of enterprise product registration standard.But there was cross-reactivity phenomenon for HPV genotype in the specificity.Conclusion The sample testing work of medical devices should fully incorporate the domestic and imported medical devices into the system and continue to monitor the performance of these products.
【CateGory Index】: R446.5
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