ELISA二步法试剂在献血者抗-TP筛查中的应用

目的了解ELISA二步法试剂在献血者抗-TP筛查中的应用情况并建立预测TPPA结果方案。方法用两个厂家的ELISA方法试剂筛查21 620例无偿献血者血液,有反应性样本用TPPA方法确证,分析同方法不同厂家试剂的检测情况及其与TPPA结果的关系。结果 21 620例样本中抗-TP有反应性的129例,两个厂家试剂的结果和TPPA确证结果均无统计学意义;两厂家试剂有反应性样本和仅一厂家试剂有反应性样本经TPPA确证比较,结果有统计学意义。当S/CO值≥5时,两个厂家的试剂其阳性预测值≥88%;当S/CO值≥10时,两个厂家的试剂其阳性预测值≥98%。结论两个厂家试剂都会出现假阳性反应,应建立预测TPPA结果方案,以减少错误地反馈献血者检测信息的机率。

Application of two-step ELISA kit in screening of anti-TP from blood donors

Objective To investigate the application of 2-step ELISA kit in the anti-TP screening test of samples from blood donors and establish the scheme for prediction TPPA test result. Methods The 21620 samples from voluntary blood donors were screened by ELISA kits from 2 manufacturers respectively and the positive samples were confirmed again with TPPA test, so as to verify the test result of ELISA kits from different manufacturers in the same method and investigate the coincidence with TPPA test result. Results One hundred and nine out of the 21 620 sample were anti-TP positive. No statistically significant differences were observed between the results of ELISA using two reagents and the TPPA results. When S/CO ≥5 and S/CO ≥10,the positive prediction value of these 2 manufactuers＇reagents ≥88% and 98%. CoNclusions False positives might exist in both manufacturers＇reagents and therefore ,a scheme for predicting TPPA test result should be established so as to reduce the err in screening sample from blood donors.