Klein Katherine, DeGruy Kyle, Rey Zilma, Hall Patricia, Kim Andrea, Gutreuter Steve, Alexander Heather
Centers for Disease Control and Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Division of TB Elimination, Atlanta, Georgia, United States.
Centers for Disease Control and Prevention, Division of Global HIV and TB, International Laboratory Branch, Atlanta, Georgia, United States.
Afr J Lab Med. 2020 Nov 27;9(1):1167. doi: 10.4102/ajlm.v9i1.1167. eCollection 2020.
Proficiency testing (PT) is an important quality assurance measure toward ensuring accurate and reliable diagnostic test results from clinical and public health laboratories. Despite the rapid expansion of the Xpert® MTB/RIF assay for the detection of tuberculosis in resource-limited settings (RLS), low-cost PT materials for Xpert MTB/RIF external quality assessment (EQA) are not widely available.
We sought to determine whether a dried tube specimen (DTS)-based PT programme would be a feasible option to support Xpert MTB/RIF EQA in RLS.
Between 2013 and 2015, the United States Centers for Disease Control and Prevention developed and conducted a voluntary EQA programme using DTS-based PT material. Eight rounds of PT, each comprising five DTS samples, were provided to enrolled testing sites. After each round, participant results were compared to expected results, scored as satisfactory or unsatisfactory, and sites were provided with performance reports.
Programme enrolment increased from 102 testing sites in seven countries to 441 testing sites in 14 countries over the course of three years. In each PT round, approximately 90% of participating sites demonstrated satisfactory performance. In seven of the 14 enrolled countries, the proportion of sites with a satisfactory score increased between the first round of participation and the most recent round of participation.
This programme demonstrated that it is possible to implement an Xpert MTB/RIF PT programme for RLS using DTS, that substantial demand for Xpert MTB/RIF PT material exists in RLS, and that country performance can improve in a DTS-based PT programme.
能力验证（PT）是一项重要的质量保证措施，有助于确保临床和公共卫生实验室的诊断检测结果准确可靠。尽管用于在资源有限环境（RLS）中检测结核病的Xpert® MTB/RIF检测方法迅速推广，但用于Xpert MTB/RIF外部质量评估（EQA）的低成本PT材料却并不广泛可得。
我们试图确定基于干管标本（DTS）的PT计划是否是支持RLS中Xpert MTB/RIF EQA的可行选择。
2013年至2015年期间，美国疾病控制与预防中心开发并实施了一项使用基于DTS的PT材料的自愿性EQA计划。向登记的检测点提供了八轮PT，每轮包括五个DTS样本。每轮之后，将参与者的结果与预期结果进行比较，评定为满意或不满意，并向各检测点提供性能报告。
在三年时间里，参与计划的检测点从七个国家的102个增加到14个国家的441个。在每一轮PT中，约90%的参与检测点表现令人满意。在14个登记国家中的7个国家，从第一轮参与到最近一轮参与，得分满意的检测点比例有所增加。
该计划表明，使用DTS为RLS实施Xpert MTB/RIF PT计划是可行的，RLS对Xpert MTB/RIF PT材料有大量需求，并且基于DTS的PT计划可以提高国家的检测表现。
