"新吉尔"疟原虫快速检测试剂盒检测效果评价

Study on the effectiveness of the "Xin Jier" rapid detection kit at detecting Plasmodium

目的采用疟疾厚薄血片镜检法(金标准)和"新吉尔"疟原虫抗原检测试剂盒(胶体金法)进行平行检测,评价该疟疾快速检测试剂盒的检测效果。方法收集948份血样,采用镜检作为金标准与新吉尔快速诊断试剂盒进行盲法平行检测,计算试剂盒检测结果的灵敏度、特异性和诊断准确性,分析两种检测方法检测结果的一致性。结果共检测948份血样,其中镜检疟原虫阳性416份。以镜检法结果为标准,"新吉尔"疟原虫检测试剂盒检测灵敏度为96.88%,特异性为100%,诊断准确性为98.63%,一致性系数kappa为0.9721。其中检测间日疟的灵敏度为94.76%,特异度为100%,诊断准确性为98.62%,一致性系数kappa为0.9638;检测恶性疟灵敏度达98.41%,特异度为100%,诊断准确性为99.58%,一致性系数kappa达0.9892。间日疟原虫的检出下限介于105.19-157.94个/?l之间,恶性疟原虫的检测下限介于77.76-103.68个/?l之间。结论与镜检法相比,新吉尔疟原虫检测试剂盒具有较高的灵敏度、特异度和一致性,其中对恶性疟检测的灵敏度和一致性略高于间日疟,但是在原虫密度较低情况下漏检较多。该试剂盒可用于不具备开展镜检的基层医疗机构进行疟疾的快速检测和初筛,但不建议用于健康人群或无症状人群的筛查和检测。

Objective To perform parallel detection using the gold standard microscopy of thick and thin blood smears for Plasmodium)and colloidal gold(the"Xin Jier"Plasmodium antigen detection kit)in order to evaluate the effectiveness of a rapid malaria detection kit.Methods Nine hundred and forty-eight blood samples were collected,and blind parallel detection was performed using microscopy and the Xin Jier rapid diagnostic kit.The sensitivity,specificity,and diagnostic accuracy of the test results of the two methods were calculated,and the consistency of the test results of the two methods was analyzed.Results Nine hundred and forty-eight samples were tested,416 of which were positive for Plasmodium and 532 of which were negative according to microscopy.The"Xin Jier"kit had a detection sensitivity of 96.88%,a specificity of 100%,a diagnostic accuracy of 98.63%,and a kappa coefficient of consistency of 0.9721.The"Xin Jier"kit had a sensitivity of 94.76%when detecting P.vivax,a specificity of 100%,a diagnostic accuracy of 98.62%,and a kappa coefficient of consistency of 0.9638.The"Xin Jier"kit had a sensitivity of 98.41%when detecting P.falciparum,a specificity of 100%,a diagnostic accuracy of 99.58%,and a kappa coefficient of consistency of 0.9892.The lower limit of Plasmodium vivax detection was between 105.19 and 157.94 protozoa/ml,and the lower limit of Plasmodium falciparum detection was between 77.76 and 103.68 protozoa/ml.Conclusion The rapid diagnostic kit had good sensitivity,specificity,and consistency.It had a slightly higher sensitivity and consistency at detecting P.falciparum than at detecting P.vivax,but it often failed to identify the parasite in low-density samples.Thus,the kit can be used in primary medical facilities that can not perform microscopy for the rapid detection and early screening of malaria,but it is not recommended forto screening and detection in healthy people or asymptomatic patients.