用于双重 HIV/梅毒快速诊断检测的干管标本（DTS）能力验证检测试剂盒的研制和试用。

Development and trial of a dried tube specimen (DTS) proficiency testing panel for dual HIV/syphilis rapid diagnostic tests.

机构信息

Centre for HIV and STI, National Institute for Communicable Diseases, Johannesburg, South Africa.

Centre for HIV and STI, National Institute for Communicable Diseases, Johannesburg, South Africa; Department of Clinical Microbiology and Infectious Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.

出版信息

Diagn Microbiol Infect Dis. 2022 Mar;102(3):115607. doi: 10.1016/j.diagmicrobio.2021.115607. Epub 2021 Nov 26.

DOI:10.1016/j.diagmicrobio.2021.115607

PMID:34953370

Abstract

PURPOSE

To develop and trial a dried tube specimen (DTS) panel for proficiency testing of dual HIV/syphilis rapid diagnostic tests (RDTs) at clinical sites.

RESULTS

DTS panels were prepared using plasma samples with known HIV and syphilis results, to give varying reactivity for syphilis and HIV test lines on RDTs. Laboratory DTS panels were stable for a minimum 4-week period at ambient temperatures with no inter-reader variability of results. Field testing of panels with Standard Diagnostics Bioline HIV/Syphilis duo showed 100% correlation with laboratory results, and excellent mean pair agreement between the two clinical sites (k = 1.0). With Chembio Dual Path Platform HIV-Syphilis, there were two false negative results for HIV and syphilis, respectively, at one site; and good mean pair agreement between the two sites (k = 0.9).

CONCLUSION

It is feasible and practicable to incorporate DTS panels into a field proficiency testing scheme for dual HIV/syphilis RDTs.

摘要

目的

开发并试用一种干试管标本（DTS）检测板，以对临床现场的双 HIV/梅毒快速诊断检测（RDT）进行能力验证。

结果

使用已知 HIV 和梅毒结果的血浆样本制备 DTS 检测板，使 RDT 的梅毒和 HIV 检测线呈现不同的反应性。实验室 DTS 检测板在环境温度下至少稳定 4 周，结果无读者间差异。与 Standard Diagnostics Bioline HIV/Syphilis duo 检测板的现场测试显示，与实验室结果具有 100%的相关性，两个临床地点之间具有极好的平均配对一致性（k=1.0）。使用 Chembio Dual Path Platform HIV-Syphilis，一个地点的 HIV 和梅毒分别有两个假阴性结果；两个地点之间具有良好的平均配对一致性（k=0.9）。