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目的分析时间分辨荧光免疫法用于低危人群梅毒螺旋体抗体筛查的结果,研究其适用性和流程。方法采用时间分辨免疫荧光法(TRFIA)检测住院患者血清中梅毒螺旋体抗体含量,TRFIA阳性标本用梅毒螺旋体明胶颗粒凝集试验(TPPA)确认。二者不符者用荧光密螺旋体抗体吸收试验(FTAABS)验证。结果 15 786例住院患者血清标本中,TRFIA法筛查阳性317例(2.01%),其S/CO值中位数为20.61(9.48,33.55)。筛查阳性标本经TPPA确认,阳性284例,保留2例。33例结果不一致标本经FTA-ABS验证,1例TP-Ig M阳性(TPPA为保留),2例TP-Ig G阳性。随机抽取TRFIA筛查阴性标本253例,TPPA验证皆阴性。TRFIA法对梅毒螺旋体抗体检测的敏感性和特异性分别为100%和89.08%。结论 TRFIA法适合作为低危人群梅毒螺旋体抗体的筛查方法,可结合TPPA等确诊方法进行结果判断,不一致标本可用蛋白印迹技术或FTA-ABS法第三方验证,或者随访后再次检测。
Objective To analyze the results of time-resolved fluorescence immunoassay for the screening of antibodies against Treponema pallidum in low-risk population and to investigate its applicability and procedure. Methods The serum levels of syphilis were detected by time-resolved immunofluorescence assay (TRFIA). TRFIA positive samples were confirmed by TPPA. Fluorescent Treponema pallidum antibody Absorption Assay (FTAABS) was used to verify the difference between the two. Results Among the 15 786 hospitalized patients, 317 (2.01%) were TRFIA positive and the median S / CO was 20.61 (9.48, 33.55). Screening positive specimens confirmed by TPPA, positive 284 cases, retained in 2 cases. 33 cases of inconsistent results of the specimen by FTA-ABS verification, 1 cases of TP-Ig M positive (TPPA reserved), 2 cases of TP-Ig G positive. A total of 253 cases of negative TRFIA screening samples were randomly selected and TPPA tests were negative. The sensitivity and specificity of TRFIA for the detection of Treponema pallidum antibodies were 100% and 89.08%, respectively. Conclusion The TRFIA method is suitable as a screening method for Treponema pallidum antibody in low-risk population. It can be combined with the diagnosis of TPPA and other methods to determine the results. Inconsistent specimens can be verified by Western blot or FTA-ABS third-party method or re-tested after follow-up.