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目的探讨TP-ELISA试剂在血液筛查的使用情况及灰区限设置的必要性及合理性。方法收集231份TP-ELISA不合格标本,再使用梅毒颗粒凝集试验(TP-PA)进行确证。结果 TP-PA确证结果:阳性158份(68.4%)、可疑15份(6.5%)、阴性58份(25.1%)。在确证为阳性的标本中,有154份是2种TP-ELISA结果均为阳性,有2份是1种TP-ELISA结果阳性,有2份是TP-ELISA结果处于灰区值。结论 TP-ELISA试剂存在一定比例的假阳性,有必要作确证检测,同时设置合理的灰区范围很有必要。
Objective To investigate the use of TP-ELISA reagents in blood screening and the necessity and rationality of setting gray zone limits. Methods 231 TP-ELISA unqualified samples were collected and confirmed by TP-PA. Results TP-PA confirmed the results: positive 158 (68.4%), suspicious 15 (6.5%), negative 58 (25.1%). Of the specimens confirmed positive, 154 were positive for both TP-ELISA results, 2 were positive for one of the TP-ELISA results and 2 were for TP-ELISA results in gray zone values. Conclusion There is a certain proportion of false positive TP-ELISA reagent, it is necessary to confirm the test, while setting a reasonable range of gray areas is necessary.