Evaluation of Double Antigen Sandwich Time-resolved Fluoroimmunoassay for Specific Total Antibodies to Treponema Pallidum
10.3969/j.issn.1671-7414.2018.02.027
- VernacularTitle:双抗原夹心时间分辨荧光免疫法检测梅毒螺旋体特异性总抗体的性能研究
- Author:
Yu-Hua TAN
1
;
Ze-Hong LEI
;
Dan ZHENG
;
Can LIU
;
Fan-Yi ZHAO
Author Information
1. 广州市丰华生物工程有限公司体外诊断试剂研发中心
- Keywords:
Treponema pallidum;
multi-epitope chimeric antigen;
double antigen sandwich method;
time-resolved fluoroimmunoassay;
performance evaluation
- From:
Journal of Modern Laboratory Medicine
2018;33(2):97-100
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluation the performance of double antigen sandwich time-resolved fluoroimmunoassay(TRFIA)for specific total antibody to Treponema pallidum (TP).Methods Specific total antibody to TP was detected by a double antigen TRFIA based on recombinant multi epitope chimeric antigen.The methodological precision,low limit of detection,accuracy,linearity,reference standard coincidence rate and other analytical performance indicators were evaluated,and clinical comparison research trials were completed.The x2 test was used for the difference between two methods results,the P ＜0.05 which represents the difference was statistically significant.Results The intra-assay and inter-assay coefficients of var iation (CV) were both less than 10％ respectively.The low limit of detection was 0.05 mIU/ml.The relative deviation of de tecting the national standard was not exceed 10％.The linear range was 1.50～ 155.00 mIU/ml and the linear correlation co efficient could be reached 0.999 9.The performance of detection national reference could meet the national accreditation requirements.The consistent rate was 100 ％ when the TRFIA methodology detected the standardized serum plate.The parallel test of TRFIA and treponema pallidum gelatin agglutination test (TPPA) were completed,the total coincidence rate was 99.56％,and the Kappa index was 0.990 6.Conclusion Their result showed that the TRFIA methodology is high sensitivity,accuracy,wide linear range,and highly clinical coincidence rate,which is valuable for clinical application.
