免疫比浊法与ELISA法检测梅毒抗体的一致性比较

Consistency of immune turbidimetry and ELISA in detection of syphilis antibody:a comparative study

目的评价免疫比浊法与酶联免疫吸附试验(ELISA)法检测梅毒抗体的一致性。方法以ELISA检测门诊和住院患者标本共10 985例,ELISA阳性者再做苍白密螺旋体明胶颗粒凝集试验(TPPA)及免疫比浊法(3TP)。结果共检出ELISA阳性200例,ELISA法与3TP和TPPA检测结果阳性符合率均为92.50%,ELISA法无漏检,出现假阳性15例,假阳性率1.70%;3TP与TPPA检测阳性符合率为98.40%,3TP漏检3例,漏检率1.60%,出现假阳性3例,假阳性率为0.03%,3种方法的阳性检出率差异无统计学意义;按ELISA的原始吸光度值,将200例标本分为高、中和低吸光度组,把每组中的3种方法进行统计学比较,高吸光度组和中吸光度组中3种方法的阳性符合率均>95.0%,检测结果差异无统计学意义;在低吸光度组中,ELISA法与3TP和TPPA的符合率均为70.70%,3TP与TPPA的符合率为87.80%,检测结果差异均有统计学意义(P<0.05)。结论 ELISA、3TP两种检测方法均有较高的灵敏度和特异性,尤其是在中、高吸光度值时,3TP特异性比ELISA强,且与TPPA的一致性很好,可用做梅毒的大批量初筛和确认试验。

OBJECTIVE To evaluate the consistency of immune turbidimetry（3TP） and ELISA for detecting syphilis specific antibody.METHODS A total of 10985 samples of outpatients and inpatients were detected by using ELISA for syphilis antibody,and those positive samples were examined by 3TP and TPPA.RESULTS Of 10985 samples,ELISA positive samples were 200,and the positive coincidence rate of ELISA and 3TP,TPPA was 92.5%.No sample missed the detection,and 15 samples were false positive by TP-ELISA.The false negative rate and false positive rate of ELISA method were 0%,1.7% respectively.Of 200 samples,the positive coincidence rate of 3TP and TPPA was 98.4%.3 samples were undetected and 3 samples were false positive by 3TP,and the false negative rate and false positive rate were 1.6% and 0.03% respectively;the difference in the positive detection rate among the three methods was not statistically significant;the 200 positive samples were divided into the high,medium and low absorption group according to the original value of ELISA,and the three methods were statistically compared;the results showed that the positive coincidence rates of ELISA,3TP and TPPA were above 95%,there was no statistical significance in the result;however,in the low absorption group,the positive coincidence rates of ELISA and 3TP,ELISA and TPPA,3TP and TPPA were 70.7%,70.7%,and 87.8% respectively,the difference in the detection result was statistically significant（P0.05）.CONCLUSION Both ELISA and 3TP have high sensitivity and specificity,especially as it is the middle and high absorbance values,3TP has higher specificity than does ELISA,and has good consistency with TPPA so that it is available for the screening of large quantities of syphilis and confirmatory test.