化学发光法与电化学发光法筛查献血者梅毒抗体的检测性能评价
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摘要
目的:评价化学发光法(CLIA)和电化学发光法(ECLIA)筛查无偿献血者梅毒抗体的性能。方法:利用卫生部临检中心提供的梅毒抗体血清盘,对比分析化学发光法、电化学发光法与酶联免疫吸附试验(ELISA)检测梅毒抗体的性能。结果:CLIA的灵敏度和阴性预期值均为100%,与1种ELISA相同,优于另一种ELISA;特异性为88. 46%,正确率为97. 02%,阳性预期值为96. 13%,均高于2种ELISA。由于血清盘样本为热灭活样本,对ECLIA梅毒抗体检测试剂盒的影响较大,结果未能评估出该试剂盒的真实性能(初步计算结果为4例假阴性,灵敏度为98. 93%,阴性预期值为96. 75%,;正确率为97. 02%,特异性为91. 54%,阳性预期值为97. 10%)。结论:CLIA对梅毒抗体的检测性能优于ELISA,具有更高的灵敏度和特异性,可用于血站筛查梅毒抗体项目;而ECLIA方法在本次实验中未能评估出试剂盒的真实性能,需进一步研究。
Objective: To evaluate the performance of the chemiluminescence immune assay( CLIA) and the electrochemiluminescence immuneoassay( ECLIA) for Treponemapallidum antibody( anti-TP) screening in blood donors.Methods: The sero-panel samples from NCCL w ere tested w ith ELISA,CLIA and ECLIA assays synchronously to evaluate their performances respectively. Results: The sensitivity and the negative predictive value of the CLIA w ere100%,w hich w ere the same as one kind of ELISA,and better than the other ELISA; The specificity of the CLIA w as88. 46%,the accuracy rate w as 97. 02%,the positive predictive value w as 96. 13%,w hich w ere higher than both ELISA. Due to the significant interference of sample heat inactivation in ECLIA detection,the result can not demonstrate the true performance of ECLIA in this study. The preliminary result w as as follow s: the sensitivity w as 98. 93%,the negative predictive value w as 96. 75%,and the accuracy rate,specificity and positive predictive value of ECLIA w ere97. 02%,91. 54% and 97. 10% respectively. Conclusion: Compared w ith ELISA,the CLIA has higher sensitivity and specificity and can be used for Treponemal antibody screening in blood bank. Unfortunately,the data in this study cannot come to a conclusion for ECLIA and needs more testing.
Objective: To evaluate the performance of the chemiluminescence immune assay( CLIA) and the electrochemiluminescence immuneoassay( ECLIA) for Treponemapallidum antibody( anti-TP) screening in blood donors.Methods: The sero-panel samples from NCCL w ere tested w ith ELISA,CLIA and ECLIA assays synchronously to evaluate their performances respectively. Results: The sensitivity and the negative predictive value of the CLIA w ere100%,w hich w ere the same as one kind of ELISA,and better than the other ELISA; The specificity of the CLIA w as88. 46%,the accuracy rate w as 97. 02%,the positive predictive value w as 96. 13%,w hich w ere higher than both ELISA. Due to the significant interference of sample heat inactivation in ECLIA detection,the result can not demonstrate the true performance of ECLIA in this study. The preliminary result w as as follow s: the sensitivity w as 98. 93%,the negative predictive value w as 96. 75%,and the accuracy rate,specificity and positive predictive value of ECLIA w ere97. 02%,91. 54% and 97. 10% respectively. Conclusion: Compared w ith ELISA,the CLIA has higher sensitivity and specificity and can be used for Treponemal antibody screening in blood bank. Unfortunately,the data in this study cannot come to a conclusion for ECLIA and needs more testing.
引文
1中华人民共和国卫生部.中国预防与控制梅毒规划(2010-2020年),2010.
2郑和平,黄进梅,黄澍杰等.化学发光法检测梅毒螺旋体特异性抗体的方法学评价.中国艾滋病性病,2008;81(6):609-610,616.
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5 2018年1月全国艾滋病性病疫情.中国艾滋病性病,2018;174(3):219.
6王静,周春,蒋昵真.2010-2014年中国南京地区自愿无偿献血者梅毒流行趋势分析.中国实验血液学杂志,2016;24(4):1206-1210.
7李军,王林娜,郑和义,等.1125例梅毒分析.中国医学科学院学报,2010;32(2):185-189.
8李玲,郭晓婕,牛丽彬,等.梅毒螺旋体抗体筛查反应性献血者归队策略研究.中国输血杂志,2016;29(1):21-24.
9钱立琼,蹇志伟,廖秀云.献血者梅毒检测不合格样本TP-PA确证分析.中国输血杂志,2014;27(8):845-846.
10庞栋,申卫东,张翙,等.ELISA筛查单试剂反应献血者追踪检测.中国输血杂志,2014;27(4):381-383.
11郑佳,阿祥仁.33412例临床样本梅毒血清学试验结果分析.青海医药杂志,2015;45(11):69-71.
12上官志敏,唐亮,钱新瑜,等.72例住院患者HBsAg合并梅毒抗体定量检测双阳性结果分析.国际检验医学杂志,2012;33(24):3052-3054.
13胡志,曾嫚妮,秦丽容,等.梅毒螺旋体抗体检测的分析和应用.医学信息,2015;28(35):218-218.
14 Tao CM,Hao XK,Xu W,et al.Evaluation of the Elecsys?syphilis assay for screening routine samples obtained from Chinese patients.SCIENTIFIC REPORT,25 Aug 2017;7(1):9559
15 Tong ML,Lin LR,Liu LL,et al.Analysis of 3 algorithms for syphilis serodiagnosis and implications for clinical management.Clin Infect Dis.2014 Apr;58(8):1116-24.
16 Janier M,Hegyi V,Dupin N,et al.2014 European guideline on the management of syphilis.J Eur Acad Dermatol Venereol.2014 Dec;28(12):1581-93.
2郑和平,黄进梅,黄澍杰等.化学发光法检测梅毒螺旋体特异性抗体的方法学评价.中国艾滋病性病,2008;81(6):609-610,616.
3血站技术操作规程(2015版).卫医政发[2015]95号.
4黄家萍.浅谈我国梅毒防治的挑战和策略.求医问药,2012;10(6):545.
5 2018年1月全国艾滋病性病疫情.中国艾滋病性病,2018;174(3):219.
6王静,周春,蒋昵真.2010-2014年中国南京地区自愿无偿献血者梅毒流行趋势分析.中国实验血液学杂志,2016;24(4):1206-1210.
7李军,王林娜,郑和义,等.1125例梅毒分析.中国医学科学院学报,2010;32(2):185-189.
8李玲,郭晓婕,牛丽彬,等.梅毒螺旋体抗体筛查反应性献血者归队策略研究.中国输血杂志,2016;29(1):21-24.
9钱立琼,蹇志伟,廖秀云.献血者梅毒检测不合格样本TP-PA确证分析.中国输血杂志,2014;27(8):845-846.
10庞栋,申卫东,张翙,等.ELISA筛查单试剂反应献血者追踪检测.中国输血杂志,2014;27(4):381-383.
11郑佳,阿祥仁.33412例临床样本梅毒血清学试验结果分析.青海医药杂志,2015;45(11):69-71.
12上官志敏,唐亮,钱新瑜,等.72例住院患者HBsAg合并梅毒抗体定量检测双阳性结果分析.国际检验医学杂志,2012;33(24):3052-3054.
13胡志,曾嫚妮,秦丽容,等.梅毒螺旋体抗体检测的分析和应用.医学信息,2015;28(35):218-218.
14 Tao CM,Hao XK,Xu W,et al.Evaluation of the Elecsys?syphilis assay for screening routine samples obtained from Chinese patients.SCIENTIFIC REPORT,25 Aug 2017;7(1):9559
15 Tong ML,Lin LR,Liu LL,et al.Analysis of 3 algorithms for syphilis serodiagnosis and implications for clinical management.Clin Infect Dis.2014 Apr;58(8):1116-24.
16 Janier M,Hegyi V,Dupin N,et al.2014 European guideline on the management of syphilis.J Eur Acad Dermatol Venereol.2014 Dec;28(12):1581-93.