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目的将国产试剂疟疾快速诊断试验(RDT)检测结果与镜检结果及进口试剂RDT和PCR结果进行比较,评价国产试剂RDT诊断疟疾的效果。方法收集160例疟疾病人或疑似疟疾病人血样,分别采用两种RDT、镜检和PCR进行检测,对检测结果进行比较。结果 160份血样采用国产、进口试剂RDT及镜检和PCR检测疟疾感染,阳性率分别为45.00%、47.50%、41.25%和42.50%,经配对资料的χ2检验,差异无统计学意义(P>0.05);镜检和PCR法均检出2例卵形疟,而国产和进口试剂RDT均为阴性。以镜检为标准,国产试剂RDT检测间日疟和恶性疟的敏感度为94%,特异度87%,假阳性率13%,假阴性率6%,阳性预测值83%,阴性预测值95%;以PCR为标准,国产试剂RDT检测间日疟和恶性疟的敏感度为94%,特异度89%,假阳性率11%,假阴性率6%,阳性预测值83%,阴性预测值95%。国产试剂RDT与进口试剂RDT检测结果比较差异无统计学意义(Kappa=0.95,P>0.05)。结论国产试剂RDT与进口试剂RDT检测结果高度一致,在基层可取代进口试剂RDT进行疟疾病例主动监测。
OBJECTIVE To compare the results of RDT test with the results of microscopic examination and the RDT and PCR results of imported reagents to evaluate the effect of domestic reagent RDT in diagnosis of malaria. Methods Blood samples of 160 malaria patients or suspected malaria patients were collected and tested by two kinds of RDT, microscopic examination and PCR, respectively. The results of the tests were compared. Results 160 blood samples were detected by RDT, microscopic examination and PCR. The positive rates were 45.00%, 47.50%, 41.25% and 42.50% respectively. There was no significant difference between the two groups (χ2 test, P> 0.05). Two cases of oviparous malaria were detected by microscopy and PCR, while both RDT of domestic and imported reagents were negative. According to the microscopic examination, the RDT test of domestic reagents showed 94% sensitivity, 87% specificity, 13% false positive rate, 6% false positive rate, 83% positive predictive value and 95% negative predictive value. %; PCR-based, the domestic reagent RDT detection of Plasmodium vivax and Plasmodium falciparum sensitivity was 94%, specificity of 89%, false positive rate of 11%, false negative rate of 6%, positive predictive value of 83%, negative predictive value 95%. There was no significant difference in RDT test results between RDT and imported reagent (Kappa = 0.95, P> 0.05). Conclusion RDT of domestic reagents is highly consistent with RDT of imported reagents. Active detection of malaria cases can be replaced at the grassroots level by imported reagent RDT.