三种快速诊断试剂盒检测疟原虫的效果评价

Evaluation of three rapid diagnostic tests for detection of malaria parasite

目的 比较三种品牌快速诊断试剂盒(rapid diagnostic tests, RDTs)对疟原虫检测效果的差异,为RDTs产品的选择提供依据。方法 采用伊仕、蓝十字、BinaxNOW三种品牌的RDTs产品对170例疟疾确诊病例和30例阴性血样进行检测,计算灵敏度、特异度、总符合率等指标,同时比较三种产品对不同种类疟原虫检测的一致性。结果 以省级镜检和核酸复核确认结果为金标准,伊仕与蓝十字品牌的RDTs产品检测疟原虫的灵敏度分别为93.02%、92.25%,均高于BinaxNOW的84.12%,差异有统计学意义(P<0.05);伊仕、蓝十字和BinaxNOW三种RDTs检测疟原虫的特异度分别为76.67%、76.67%、82.14%,总符合率分别为89.94%、89.31%、83.84%,三种RDTs的特异度、总符合率比较无统计学差异(P>0.05)。三种RDTs对恶性疟与间日疟的检测结果与省级复核结果相比均无统计学差异(P>0.05),但BinaxNOW对其他类型疟疾的检测明显差于省级复核检测。任意两种RDTs对恶性疟和间日疟的检测均无统计学差异(P>0.05),且任意两种RDTs检测的结果一致性较好(Kappa>0.75,P<0.001)。结论 三种RDTs产品在对恶性疟、间日疟的检测中均具有较好的检测水平,伊仕与蓝十字品牌在基层疟疾检测工作中更具优势。

Objective To evaluate the effectiveness of three rapid diagnostic tests(RDTs)for detecting malaria parasite so as to provide evidence for the selection of RDTs products.Methods The blood samples of 170 confirmed cases and 30 negative cases were tested with three different brands of RDTs products(EGENS,Blue CROSS,and BinaxNOW).The sensitivity,specificity,total coincidence rate and other indicators were calculated,and the consistency of the three products for different malaria parasites were compared.Results Taking microscopy results at the provincial lab and nucleic acid recheck results as the gold standard,the sensitivities of the RDTs of EGENS and Blue CROSS tests were 93.02%and 92.25%,respectively,higher than that of BinaxNOW test(84.12%),and the differences were statistically significant(P<0.05).The specificities of the three RDTs,EGENS,Blue CROSS,and BinaxNOW,in detecting malaria parasites were 76.67%,76.67%and 82.14%,and the total coincidence rate were 89.94%,89.31%and 83.84%,respectively.There were no significant differences in the specificity and total coincidence rate among them(P>0.05).There were no significant differences in the detection results of the three RDTs for P.falciparum and P.vivax compared with the recheck results at the provincial lab(P>0.05),but the results of BinaxNOW for other types of malaria were significantly worse than the results of the provincial recheck.There were no significant differences between any two RDTs in the detection of P.falciparum and P.vivax(P>0.05),and the results of any two RDTs were consistent(Kappa>0.75,P<0.001).Conclusions The three RDTs products have good detection levels in the detection of P falciparum and P.vivax,and EGENS and Blue CROSS RDTs have more advantages in the detection of malaria at the grassroots level.