恶性疟原虫/间日疟原虫抗原检测试剂盒的临床研究

Clinical Study on Plasmodium Falciparum/Plasmodium Vivax Antigen Detection Kit

按照《体外诊断试剂注册与备案管理办法》,对英科新创(厦门)科技股份有限公司研发生产的恶性疟原虫/间日疟原虫抗原检测试剂盒(胶体金法)进行临床考核,共考核临床静脉全血样本1 100份,结果表明,试验产品能够达到与已上市同类对照检测方法的检测效能,考核试剂50例样本的静脉全血与指尖血对比检测结果一致,符合临床人体静脉全血或指尖血样本的中恶性疟原虫抗原或间日疟原虫抗原的检测。

According to the Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents, a clinical assessment was conducted on the Plasmodium falciparum/Plasmodium vivax antigen detection kit(colloidal gold method) developed and produced by Yingke Xinchuang(Xiamen) Technology Co., Ltd. A total of 1100 clinical venous whole blood samples were assessed. The results showed that the test product could achieve the detection efficiency of the same control detection methods that have been marketed, The contrast test results of venous whole blood and fingertip blood of 50 samples of the test reagent were consistent, which was consistent with the detection of falciparum malaria antigen or vivax malaria antigen in clinical human venous whole blood or fingertip blood samples.