无偿献血者梅毒抗体筛检方法与试剂的价值评价

目的：评价无偿献血者梅毒抗体筛检方法与试剂的筛检价值。方法：以卫生部临床检验中心梅毒抗体临床科研血清盘标本40份及随机抽取西安市无偿献血者梅毒抗体阴性血清100份为评价标本。用梅毒甲苯胺红不加热血清试验(TRUST)法，厦门新创梅毒抗体ELISA1诊断试剂盒(ELISA1)及北京金豪梅毒抗体ELISA诊断试剂盒(ELISA2)对评价标本作盲法筛检，以卫生部临床检验中心梅毒抗体已知阳性和阴性作为金标准。用四格表法评价真实性与可靠性指标，并对二种ELISA试剂盒的Cut-off值的合理性进行评价。结果：TRUST法、ELISA1及ELISA2试剂盒的灵敏度分别为68．2％，95．5％，100．0％，特异度分别为77．8％，94．4％，94．4％，约登指数分别为0．46，0．900．94，重复试验符合率分别为90．0％，100．0％，100．0％，二种ELISA试剂盒的Cut-off值较合理。结论：ELISA试剂盒的灵敏度、特异度及重复试验符合率要远高于TRUST法。尽管TRUST法的灵敏度与特异度较低，在无偿献血者的粗筛快检中可降低血液报废率，因而在无偿献血中的仍有很高价值，如果将ELISA试剂盒的灵敏度与特异度加以提高，将会具有更大的临床应用价值。

Evaluation of treponema pallidum antibody screening method and reagents on blood donors

Objective:To evaluate treponema pallidum (TP) antibody screening method and reagents on blood donors. Methods: Samples for evaluation included 40 TP serum plates for clinical scientific reseach from Clinical Testing Center of the Ministry of Health and 100 sets of TP antibody negative serum from blood donors in Xi'an city. The samples underwent blind screening with TRUST method, TP antibody ELISA diagnostic kit of Xiamen INTEC (ELISA 1) and TP antibody ELISA diagnostic kit of Shanghai Rongsheng (ELISA 2). With the serum plate from Clinical Testing Center of the Ministry of Health as the golden criteria, the authenticity and reliability indexes were tested with four-fold table and the cut-off value of two ELISA kits was reasonably evaluated. Results: The sensitivities of TRUST, ELISA 1 and ELISA 2 were 68.2%, 95.5%, 100.0% respectively. Their specificities and repetition coincidence rates were 77.8%, 94.4%, 94.4% and 90.0%, 100.0%,100.0% respectively. The due cut-off values of two ELISA kits were reasonable. Conclusion: The sensitivity, specificity and repetition coincidence rate of two ELISA kits were much higher than that of TRUST method. Though TRUST method have poor sensitivity and specificity, when used among blood donors for rough screening and quick testing, the TP antibody positive rate in blood will be reduced; so it still has high value in gratuitous blood donation. If the sensitivities of two ELISA kits are increased, they will have more valuable clinical applications.