一种新型恶性疟原虫和间日疟原虫联合快速检测胶体金试剂盒的性能评价  

Performance evaluation of a plasmodium falciparum and plasmodium vivax malaria joint colloidal-gold rapid detection kit

作　　者：何叶莉 赵晓茹[1] 赵利利[1] 申艳[1] 李波[1] 毛远丽[1] 李伯安[1] 王晗[1] HE Yeli ZHAO Xiaoru ZHAO Lili SHEN Yan LI Bo MAO Yuanli LI Bo＇an WANG Hart(Center for Clinical Laboratory, 302 Military Hospital of PLA Clinical Laboratory Diagnosis Center for Infectious Dis- eases of Military, Beijing 100039, China)

机构地区：[1]全军感染病临床实验诊断中心解放军第三〇二医院临床检验医学中心,北京100039

出　　处：《中国医药导报》2016年第34期4-7,共4页China Medical Herald

基　　金：国家重大新药创制课题(2013ZX09J13106-06A);解放军第三〇二医院院长创新课题

摘　　要：目的评价一种新型恶性疟和间日疟联合快速检测胶体金试剂盒的检测性能。方法对2001年1月-2016年4月解放军第三0二医院及协助医院留取的疟原虫感染患者及其他发热患者全血样本345例，分别采用疟原虫免疫胶体金法与显微镜检法进行疟原虫检测，以显微镜检法结果为金标准评价免疫胶体金快速检测试剂的灵敏度、特异度和一致性。结果发热患者中血涂片镜检法检出疟原虫感染204例。快速检测胶体金试剂盒检出疟原虫感染207例。其中恶性疟原虫免疫胶体金法检出111例，显微镜检法检出112例，灵敏度为99.11％，特异度为100.000％，两种方法一致性检验Kappa值为0.993，两种检测结果具有很好的一致性。间日疟原虫免疫胶体金法检测出96例，显微镜检法检出92例，灵敏度为100.000％，特异度为98.42％。两种方法的一致性检验Kappa值0.971，两种检测结果具有很好的一致性。结论新型快速检测试剂盒疟原虫抗体免疫胶体金法与显微镜检法结果具有较好的一致性，且具有操作简便、快速、无需专业仪器和专门技术人员等优点，适合于临床实验室疟疾的辅助诊断和筛查。Objective To evaluate the performance of a plasmodium falciparum and plasmodium vivax joint colloidal- gold rapid detection kit. Methods 345 blood samples from patients with fever which included malaria parasite infection ones, collected from 302 Military hospital of PLA and its cooperative hospital from January 2001 to April 2016, were included in this study. According to microscopy which was used as the gold standard, the sensitivity, specificity and consistency of colloidal-gold rapid detection kit by immune colloidal gold method were calculated. Results Totally, plasmodium were detected in 204 samples by microscopy, while 207 samples were detected by immune colloidal gold method. Plasmodium falciparum were detected in 112 samples by microscopy, and 111 samples were detected by im- mune colloidal gold method. Accordingly, the sensitivity and specificity were 99.11% and 100.00% respectively. The consistency check value of Kappa of the two methods was 0.993, indicating the two methods had good consistency. For plasmodium vivax dectection, 96 samples were positive by immune colloidal gold method, while 92 were positive for that by microscopy. And the sensitivity and specificity were 100.00% and 98.42% respectively. The Kappa value was 0.971, indicating the two methods also had good consistency. Conclusion The two methods of immune colloidal gold method and microscopy method have good consistency. And the new rapid detection method by immune colloidal gold has the advantages of simple operation, rapid, no need of professional instrument and special technical personnel. It is suitable for clinical laboratory diagnosis and screening of malaria.

关 键 词：疟原虫 免疫胶体金法 显微镜检法 性能评价 

分 类 号：R531.3[医药卫生—内科学]