Optimization and application of performance evaluation protocol for syphilis serologic assays

doi:10.3969/j.issn.1673-8640.2014.11.021

Abstract

Abstract:

Objective　To design and optimize performance evaluation protocol for syphilis serologic assays， and to investigate the significance of new protocol for discovering the characteristics of assay performance. Methods　Technical parameters， such as lower limit of detection， interference and stability were introduced firstly into the optimized performance evaluation protocol， and 6 domestic and imported assay reagents for syphilis serology were evaluated according to the protocol by multi-center joint study. Results　The qualitative test for 456 definite specimens showed 100% agreement result between point-of-care testing and clinical diagnostic test， and exhibited various degrees of false positive and false negative results among the other 4 screening assays， although their sensitivity and specificity had no statistical difference. The lower limits of detection of the reagents descended from high to low in the order of screening assays were treponema pallidum particle agglutination assay， point-of-care testing and enzyme-linked immunosorbent assay/chemiluminescence immunoassay. Two brands of procoagulant vacuum blood collection tubes interfered with non-specific antibody detection reagent for syphilis in a 96.88% proportion. Conclusions　The study shows that the performance of domestic syphilis serologic assays is comparable with that of imported ones. The result by point-of-care testing exhibits a high agreement with clinical diagnostic test result， and its sensitivity is better than that of the traditional method， which lays a foundation for spreading in clinical application. The optimized performance evaluation protocol for syphilis serologic assays would reflect assay performance better.

Key words: Syphilis serology, Assay performance, Evaluation protocol, Point-of-care testing, Lower limit of detection

CLC Number:

R446.11

GU Weiming, YANG Yang, WU Lei, GUO Wei, SONG Binbin, DENG Anmei, WANG Qingzhong. Optimization and application of performance evaluation protocol for syphilis serologic assays[J]. , 2014, 29(11): 1169-1174.

References

[1] 王千秋,张国成. 性传播疾病临床诊断指南 [M]. 上海:上海科学技术出版社,2007:2-16.
[2] Galvin SR,Cohen MS. The role of sexually transmitted diseases in HIV transmission [J]. Nat Rev Microbiol,2004,2(1):33-42.
[3] 岳晓丽,蒋宁,龚向东. 2012年全国梅毒与淋病疫情分析报告[EB/OL]. (2014-03-01)[2014-09-30].http: //www.ncstdc.org/shav.asp?id=158.
[4] 尹跃平. 性传播疾病实验室诊断指南[M]. 上海:上海科学技术出版社,2007:7-8.
[5] Herring A, Ballard R, Mabey D, et al. Evaluation of rapid diagnostic tests: syphilis [J]. Nat Rev Microbiol,2006,4(12 Suppl): S33-S40.
[6] 杨阳,顾伟鸣,金月兰,等. 上海市梅毒螺旋体血清学实验室室间质量评价 [J].检验医学,2009,24(12):922-926.
[7] The National Institute for Biological Standards and Control[EB/OL].(2014-03-01)[2014-09-30]. http://www.nibsc.org/about_us.aspx.
[8] Clinical and Laboratory Standards Institute. User protocol for evaluation of qualitative test performance; approved guideline-second edition[S]. EP12-A2, CLSI, 2008.
[9] 王治国. 临床检验方法确认与性能验证[M]. 北京:人民卫生出版社, 2009:340-348
[10] Clinical and Laboratory Standards Institute. Interference testing in clinical chemistry; approved guideline-second edition[S]. EP7-A2, CLSI, 2005.
[11] Clinical and Laboratory Standards Institute. Protocols for determination of limits of detection and limits of quantitation; approved guideline[S]. EP17-A2, CLSI, 2004.
[12] 王春仁,许伟. 医疗器械加速老化实验确定有效期的基本原理和方法[J]. 中国医疗器械信息,2008,14(5):67-70.
[13] Gu WM, Yang Y, Wang QZ,et al. Comparing performance of traditional non-treponemal tests on syphilis and non-syphilis serum samples[J]. Int J STD AIDS,2013,24(12):919-925.
[14] Rigsby P, Ison C, Brierley M, et al. Evaluation of two human plasma pools as candidate international standard preparations for syphilitic antibodies[J]. Biologicals, 2009, 37(4): 245-251.
[15] 侯晓菁,梁艳,陈洁,等. 化学发光法检测梅毒螺旋体特异性抗体的实验评价[J].检验医学,2010,25(5):365-367.