目的:全球献血者中梅毒的复发需要新的诊断和预防方法来鼓励及时干预。因此,本研究计划评估化学发光免疫测定(CLIA)作为梅毒筛查试验的有效性.
方法:这项前瞻性横断面观察研究于2021年10月至2022年9月进行。采用目的抽样法共纳入344名捐献者,包括在研究期间通过快速血浆反应蛋白测试(RPR)反应的另外16名供体。来自三个筛选测试的数据-RPR测试,分析了360名献血者的梅毒螺旋体血凝试验(TPHA)和CLIA。TPHA被认为是黄金标准测试。
结果:在总共360个测试样品中,通过RPR测试,21(5.8%)是反应性的。在这21个RPR反应样品中,19(90.5%)对TPHA和CLIA均有反应,而2例(9.5%)RPR反应样品在TPHA和CLIA中均无反应。在剩余的339个RPR非反应性样本中,1(0.3%)样品被TPHA和CLIA反应,1(0.3%)仅通过CLIA反应。发现CLIA的敏感性和特异性分别为100%和99.7%,阳性预测值(PPV)和阴性预测值(NPV)分别为95.2%和100%。虽然是95%,99.4%,90%,99.7%,分别,RPR测试。
结论:发现CLIA具有更高的灵敏度,特异性,PPV和NPV比RPR试验。因此,CLIA可以是献血者梅毒筛查的可接受的替代方案。
OBJECTIVE: Global re-emergence of syphilis among blood donors necessitates novel diagnostic and prevention approaches that encourage timely intervention. Thus, the present study was planned to evaluate the efficiency of Chemiluminescence immunoassay (CLIA) as a screening test for syphilis.
METHODS: This prospective cross-sectional observational study was conducted from October 2021 to September 2022. A total of 344 donors were enrolled by purposive sampling method, including additional 16 donors who were reactive by the Rapid plasma reagin test (RPR) during the study period. Data from three screening tests - RPR test, Treponema pallidum haemagglutination assay (TPHA) and CLIA for 360 blood donors were analysed. TPHA was considered the gold standard test.
RESULTS: Of the total 360 samples tested, 21 (5.8 %) were reactive by the RPR test. Of these 21 RPR reactive samples, 19 (90.5 %) were reactive by both TPHA and CLIA, while 2 (9.5 %) RPR reactive samples were non-reactive by both TPHA and CLIA. Of the remaining 339 RPR non-reactive samples, 1 (0.3 %) sample was reactive by both TPHA and CLIA, and 1 (0.3 %) was reactive by CLIA alone. CLIA was found to have sensitivity and specificity of 100 % and 99.7 % and positive predictive value (PPV) and negative predictive values (NPV) of 95.2 % and 100 % respectively, while it was 95 %, 99.4 %, 90 %, and 99.7 %, respectively, with the RPR test.
CONCLUSIONS: CLIA was found to have a higher sensitivity, specificity, PPV and NPV than the RPR test. Thus, CLIA can be an acceptable alternative for syphilis screening in blood donors.