梅毒螺旋体抗体筛查反应性献血者归队策略研究

Establishing Blood Donor Reentry Strategy for Syphilis Screening Reactive Donors in China

目的制定梅毒螺旋体抗体(抗-TP)筛查反应性献血者归队策略。方法收集全国12家采供血机构2013年12月-2015年6月抗-TP ELISA筛查反应性献血者标本373例,经ELISA、TPPA确证检测或/和8周后追踪检测,鉴别这些献血者抗-TP是否为真(假)阳性,确定其是归队还是继续屏蔽。结果在373例抗-TP筛查反应性标本中,确证(经确证试验和/或追踪)抗-TP阳性145例(38.9%,145/373)、不确定4例,此149名献血者可作暂时性屏蔽;抗-TP阴性114例(30.6%,114/373),其献血者可以归队;110例(29.5%,110/373)因未成功追踪而被放弃。结论抗-TP筛查反应性献血者的归队策略:确证试验ELISA有反应性、TPPA为阳性者,判为抗-TP阳性,暂时性屏蔽;确证试验ELISA有(或无)反应性而TPPA是阴性,8周后追踪检测。

Objective To establish a blood donor reentry strategy for syphilis screening reactive donors by follow-up.Methods This study was a collaboration between the Institute of Blood Transfusion（ IBT） of Chinese Academy of Medical Sciences and 12 blood centers. All 373 samples that were screened reactive for anti-TP by ELISA were collected and sent to IBT laboratory between December 2013 and June 2015. After retest by ELISA and confirmation by TPPA,and / or tracking after eight weeks,donors were identified either as true positive or false positive,and then were determined to reenter or deferred temporarily.Results There were 373 samples that were collected from twelve blood centers in China. Of these,263 donors could be classified successfully： 145（ 38. 9%,145 /373） anti-TP true positives,4 indeterminates. These 149 donors were deferred temporarily. 114（ 30. 6%,114 /373） were anti-TP false positives and may be reentered. 110（ 29. 5%,110 /373）donors were abandoned due to unsuccessful follow-up. Conclusion According to the experimental results,a blood donor reentry strategy for Syphilis screening reactive donors was formulated： if the results were ELISA reactive and TPPA positive,the donors were identified as syphilis antibody positive and would be deferred temporarily; if the results were ELISA reactive and TPPA negative,or ELISA non-reactive,they would be followed up after eight weeks.