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r;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。
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. The K values 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.
作者
陈明军
张燕
吕永磊
CHEN Mingjun;ZHANG Yan;LV Yonglei(Henan Red Cross Blood Center,Zhengzhou,450012,China)
出处
《临床血液学杂志》
CAS
2022年第2期126-129,共4页
Journal of Clinical Hematology
关键词
梅毒
化学发光免疫分析
酶联免疫吸附试验
检测性能
血液筛查
syphilis
chemiluminescence immunoassay
enzyme linked immunosorbent assay
detection performance
blood screening