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目的评价三种梅毒血清学检测方法的临床应用价值。方法同时应用梅毒螺旋体明胶颗粒凝集试验(TPPA)、梅毒螺旋体抗体酶联免疫吸附试验(TP-ELISA)、梅毒甲苯胺红不加热血清反应素试验(TRUST)对2 561例患者血清标本进行检测(术前患者、输血前患者、产前检查孕妇、性病门诊患者)。用灵敏度、特异性、准确性、阳性预测值、阴性预测值以及Youden指数对三种方法进行评价。以TPPA为对照标准,用χ~2检验分析三种方法对同一标本检验结果的一致性。结果 TPPA,ELISA以及TRUST的阳性率分别为20.30%,20.23%和13.71%。以TPPA为标准,ELISA阳性符合率为98.26%(509/518),敏感度、特异性、准确性分别为97.88%,99.56%和99.22%,差异无统计学意义(P>0.05);以TPPA为标准,TRUST阳性符合率为99.15%(348/351),灵敏度、特异性、准确性分别为66.92%,99.85%和93.17%,差异也有统计学意义(P<0.05)。结论三种梅毒血清学检测方法单独使用均不能快速、准确并且经济的检出梅毒抗体,需联合检测以提高梅毒检测的临床符合率。
Objective To evaluate the clinical value of three serological tests for syphilis. Methods Serum samples from 2 561 patients were also tested by TPPA, TP-ELISA and TRUST. Preoperative patients, patients before transfusion, prenatal examination of pregnant women, STD clinic patients). Three methods were evaluated using sensitivity, specificity, accuracy, positive predictive value, negative predictive value, and Youden index. Using TPPA as the control standard, the consistency of the three methods on the same specimen test results was analyzed by χ ~ 2 test. Results The positive rates of TPPA, ELISA and TRUST were 20.30%, 20.23% and 13.71% respectively. The positive rate of ELISA was 98.26% (509/518). The sensitivity, specificity and accuracy of TPPA were 97.88%, 99.56% and 99.22%, respectively, with no significant difference (P> 0.05) As the standard, the positive coincidence rate of TRUST was 99.15% (348/351). The sensitivity, specificity and accuracy were 66.92%, 99.85% and 93.17%, respectively. The difference was also statistically significant (P <0.05). Conclusions The three methods of serology detection of syphilis alone can not detect syphilis antibody quickly, accurately and economically. Therefore, syphilis antibody should be combined to improve the clinical coincidence rate of syphilis detection.