ELISA方法检测梅毒抗体灰区设置的探讨
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摘要
目的探讨ELISA方法检测无偿献血者抗-TP灰区设置的合理性。方法本站采用2种ELISA试剂对2016.1.1—2017.12.31无偿献血者标本分别进行抗-TP检测,检测结果s/co≥0.5的标本进行同种试剂双孔复试,双孔中至少有1孔结果仍为s/co≥0.5的标本做梅毒螺旋体颗粒凝集试验(TPPA),以TPPA的结果作为金标准,绘制ROC曲线,比较不同s/co情况下灵敏度和特异性的变化。对225份双试剂检测阴性(s/co<0.5)标本做TPPA确认,确定是否有阳性标本漏检。结果新创试剂对21 874份无偿献血者标本检测抗-TP阳性116份,灰区标本6份;丽珠试剂对21 874份无偿献血者标本检测抗-TP阳性125份,灰区标本11份;用TPPA试剂对ELISA检测阳性标本进行确认,确认出105例阳性结果且2种厂家ELISA检测结果均阳性,无漏检;17例灰区标本经TPPA确认均阴性;225例阴性标本确认均阴性。结论试剂厂商提供的CO值具有较高灵敏度,满足血液筛查要求,对抗-TP应不设灰区不会造成漏检。
Objective To explore the rationality of gray zone setup in anti-TP ELISA tests of blood screening.Methods Blood samples recorded during January 1 2016 to December 31 2017 were retrospectively studied. Those reactive samples with S/CO value≥0.5 in dual-reagent(from Xinchuang and Lizhu Company, respectively) ELISA tests were further retested by the same reagent in double holes. TPPA was performed once at least single hole remaining S/CO≥0.5. And operating characteristic curve(ROC curve) was established based on TPPA results to analyze sensitivity and specificity under different S/CO values.And 225 non-reactive(S/CO<0.5) samples in dual-reagent ELISA tests were confirmed by TPPA to verify no positive samples undetected.Results Among the 21 874 blood samples, 116 anti-TP reactive samples and 6 gray zone samples were detected by Xinchuang ELISA reagent; 125 anti-TP reactive samples and 11 gray zone samples by Lizhu ELISA reagent. In dual-reactive samples, 105 were confirmed positive by TPPA and none was omitted by two ELISA reagents. No positive sample was confirmed by TPPA in 17 gray zone samples and 225 non-reactive samples in dual-reagent ELISA tests remained negative.Conclusion The CO values recommended by the reagent manufacturers has high sensitivity to meet the requirements of blood screening, and gray zone in the anti-TP screening test by ELISA serves little significance.
Objective To explore the rationality of gray zone setup in anti-TP ELISA tests of blood screening.Methods Blood samples recorded during January 1 2016 to December 31 2017 were retrospectively studied. Those reactive samples with S/CO value≥0.5 in dual-reagent(from Xinchuang and Lizhu Company, respectively) ELISA tests were further retested by the same reagent in double holes. TPPA was performed once at least single hole remaining S/CO≥0.5. And operating characteristic curve(ROC curve) was established based on TPPA results to analyze sensitivity and specificity under different S/CO values.And 225 non-reactive(S/CO<0.5) samples in dual-reagent ELISA tests were confirmed by TPPA to verify no positive samples undetected.Results Among the 21 874 blood samples, 116 anti-TP reactive samples and 6 gray zone samples were detected by Xinchuang ELISA reagent; 125 anti-TP reactive samples and 11 gray zone samples by Lizhu ELISA reagent. In dual-reactive samples, 105 were confirmed positive by TPPA and none was omitted by two ELISA reagents. No positive sample was confirmed by TPPA in 17 gray zone samples and 225 non-reactive samples in dual-reagent ELISA tests remained negative.Conclusion The CO values recommended by the reagent manufacturers has high sensitivity to meet the requirements of blood screening, and gray zone in the anti-TP screening test by ELISA serves little significance.
引文
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[2] 陈显,胡文佳,黄成垠,等.献血者ELISA 检测为灰区标本的确证试验与核酸检测情况分析.中国输血杂志,2015,28(2) :198-199.
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[4] 高楠,王瑞,常乐,等.11家血站实验室抗-TP酶联免疫吸附试验临界值的评价.中国输血杂志,2017,30(10) :1201-1205.
[5] 王庆敏,冯陈晨,将昵真,等.常用抗-HIV、抗-TPELISA血液筛查试剂盒阳性判断值得验证.中国输血杂志,2017,30(8) :904-906.