摘要
目的比较酶联免疫吸附试验(ELISA)和甲苯胺红不加热血清试验(TRUST)诊断梅毒的可靠性. 方法分别平行使用TP-ELISA和TRUST(或TP-ELISA)筛查无偿献血者,任何一种试剂检测出阳性标本,均用TP明胶凝集试验(TPPA)确诊,比较ELISA和TRUST及TPPA之间敏感性的差异,计算不同方法假阳性和阴性比率. 结果总共检测94 770例无偿献血者,其中第一批47803名献血者分别用TP-ELISA和TRUST检测,第二批46967名献血者分别用两个厂家TP-ELISA检测,结果第一批标本检出阳性242份,其中TRUST和TP-ELISA阳性率分别为0.18%(87/47 803)、0.49%(233/47 803),第二批标本检出阳性284份,两个厂家TP-ELISA阳性率分别为0.57%(269/46 967)、0.55%(260/46 967),TP-ELISA敏感性明显超过TPPA和TRUST(P＜0.01),国内两个厂家TP-ELISA无显著性差异(P＞0.05),若以TPPA为确认试验,TP-ELISA敏感性明显超过TRUST,TRUST假阴性高达59.5%,TP-ELISA假阴性仅有0%～2.7%,假阳性率0.06%～0.1%,灵敏度97.3%～100%. 结论 TRUST敏感性低,为提高TP筛查的敏感性,对献血者梅毒初检和复检,或者临床梅毒的筛查时,应应用TP-ELISA.
Objective To observe the reliability of ELISA and TRUST in diagnosis of Treponema pallidum by screening syphilis from large batches of blood donors. Methods Blood donors were screened by using TP - ELISA and TRUST （or TP - ELISA）. The positive samples detected with any kind of reagents would be confirmed by TPPA. The differences of sensitivity among ELISA, TRUST and TPPA would be compared and the false positive rate and negative rate would be calculated. Results Totally 94 770 blood donors altogether were determined including the first batch of 47 803 blood donors detected with TP - ELISA and TRUST separately, second 46 967 blood donor were detected with TP - ELISA. 242 positives were detected from the first batch of blood donors with the positive rate of 0.18% （87/47 803 ） by TRUST and 0.49% （233/47 803） by TP- ELISA, respectively. 284 positives were detected from the second batch of blood donors by TP - ELISA made by two manufacturer with the positive rates of 0.57 % （269/46 967） and 0.55% （260/46 967）, respectively. TP- ELISA was obviously more sensitive than TPPA and TRUST （P 〈 0.01）. If the results of test is confirmed with TPPA, TP- ELIS was obviously more sensitive than TRUST, the false negative rate of TRUST was as high as 59.5 % and the false negative and positive rates of TP- ELISA were only 0% - 2.7% and 0.06% - 0.1%, respectively, and a sensitivity of as high as 97.3 - 100%. Conclusion The sensitiveness of TRUST is very low and it can＇ t be used in the screening of syphilis from blood donor. For increasing sensitiveness in screening Treponema paUidum, TP - ELISA should be used in first screening of syphilis from blood donors or rescreening or clinical screening of syphilis.
出处
《中国热带医学》
CAS
2005年第9期1800-1802,1797,共4页
China Tropical Medicine
