Evaluation of chemiluminescent and ELISA reagents for syphilis detection
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摘要: 目的 通过与酶联免疫吸附试验(ELISA)试剂对比，探讨梅毒化学发光免疫分析(CLIA)试剂的检测性能及其在血液筛查中的应用价值。方法 分别采用2种ELISA试剂和2种CLIA试剂对血清盘和无偿献血标本进行梅毒抗体(抗-TP)检测, 并对检测结果进行对比。结果 4种试剂的C1和C2浓度的批内CV均小于15%，所有试剂批间CV均小于20%。4种试剂中除了1个1︰800的稀释标本未被ELISA2试剂检出，其他稀释标本全部检测阳性。各试剂间的相关系数rs均大于0.8，有极强的相关性。各试剂间的K值均大于0.8，具有极好的一致性。4种试剂ROC曲线下面积在0.980~0.998，表明这几种试剂的准确性均较好，其中CLIA1试剂的准确性最好，4种试剂的最佳临界值均大于说明书推荐的临界值。3050份普通无偿献血者标本中初筛反应性标本11份，其中1份确认阳性，其余均阴性。ELISA1假阳性2例，ELISA2和CLIA1试剂假阳性均3例，CLIA2试剂假阳性6例。结论 CLIA试剂有较好的诊断性能，可以用于血液筛查。Abstract: Objective To explore the detection performance and application value of syphilis chemiluminescence in blood screening by comparing with ELISA.Methods Serum panel and blood donor samples were tested using 2 ELISA reagents and 2 CLIA reagents simultaneously. The results were compared and analyzed.Results The intra-assay coefficient variations(CV) of C1 and C2 concentrations of 4 reagents were less than 15%, and the inter-assay CV of all reagents were less than 20%. Except one 1︰800 diluted sample was not detected by ELSIA2, all the other diluted samples were positive. The correlation coefficient of each reagent was greater than 0.8, which showed a strong correlation. TheKvalues of all reagents were greater than 0.8, which showed excellent consistency. The area under the ROC curv of the 4 reagents ranged from 0.980 to 0.998, indicating that the accuracy of the 4 reagents was good, among which CLIA1 reagent had the best accuracy. Of the 3050 blood donors, 11 were positive, and the rest were negative. The false positive numbers of ELISA1, ELISA2, CLIA1 and CLIA2 were 2, 3, 3 and 6, respectively.Conclusion CLIA reagents show good detection performance and are suitable for blood screening.
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表 1 4种试剂的精密度评价
% 试剂 批内CV 批间CV C1
(n=20)C2
(n=20)C1
(n=20)C2
(n=20)ELISA1 3.99 2.61 14.13 16.88 ELISA2 14.49 8.76 12.50 15.79 CLIA1 6.34 2.49 19.70 15.16 CLIA2 14.79 13.24 14.36 19.26 
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表 2 梯度稀释标本各试剂的检测结果
稀释比例 编号 ELISA1 ELISA2 CLIA1 CLIA2 1︰50 TPS B 38 20.46 10.85 27.23 24.07 TPS B 39 20.48 11.21 28.89 23.27 1︰100 TPS B 41 18.91 7.00 17.99 13.54 TPS B 79 19.17 7.64 17.83 11.45 1︰200 TPS B 42 13.90 3.92 10.79 6.56 TPS B 43 13.71 4.09 9.89 7.01 1︰400 TPS B 44 7.36 2.21 5.71 3.78 TPS B 47 7.07 2.12 5.64 3.87 1︰800 TPS B 48 3.49 1.12 2.71 2.75 TPS B 49 3.40 1.20 2.74 2.23 TPS B 58 1.95 0.67 1.484 1.56
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表 3 4种试剂间的相关性和一致性分析结果
试剂 CLIA2 CLIA1 ELISA2 rs K rs K rs K ELISA1 0.810 0.868 0.824 0.926 0.882 0.926 ELISA2 0.880 0.865 0.867 0.933 / / CLIA1 0.846 0.888 / / / /
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表 4 4种试剂在不同临界值时的性能指标
% 试剂 最佳临界值 说明书临界值 临界值 灵敏度 特异性 Youden 临界值 灵敏度 特异性 Youden ELISA1 2.85 98.66 93.08 91.74 1.00 99.73 83.08 82.81 ELISA2 1.44 98.39 93.08 91.47 1.00 99.73 88.46 88.19 CLIA1 3.37 98.39 98.46 96.85 1.00 100.00 89.23 89.23 CLIA2 1.59 93.82 93.08 86.90 1.00 98.66 85.38 84.04
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表 5 11份初筛反应性献血者标本确认结果
序号 ELISA1 ELISA2 CLIA1 CLIA2 确认结果 1 0.00 0.03 0.02 1.03 - 2 0.92 0.03 0.02 0.60 - 3 0.67 0.97 0.95 0.73 - 4 2.16 1.43 2.41 0.85 - 5 15.90 20.22 58.19 40.56 + 6 0.17 1.19 0.22 0.55 - 7 0.01 0.01 0.04 8.18 - 8 0.02 0 0 18.00 - 9 0.22 0.42 0.47 4.19 - 10 0.01 0.02 0.01 2.93 - 11 0.01 0.07 0.17 6.06 -
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