Uganda National Tuberculosis Reference Laboratory, Kampala, Uganda.
Makerere University College of Health Sciences, Kampala, Uganda.
PLoS One. 2021 May 14;16(5):e0251691. doi: 10.1371/journal.pone.0251691. eCollection 2021.
Following the WHO's endorsement of GeneXpert MTB/RIF assay for tuberculosis diagnosis in 2010, Uganda's ministry of health introduced the assay in its laboratory network in 2012. However, assessing the quality of the result produced from this technique is one of its major implementation challenges. To bridge this gap, the National tuberculosis reference laboratory (NTRL) introduced the GeneXpert MTB/RIF proficiency testing (PT) Scheme in 2015.
A descriptive cross-sectional study on the GeneXpert PT scheme in Uganda was conducted between 2015 and 2018. Sets of panels each comprising four 1ml cryovial liquid samples were sent out to enrolled participants at preset testing periods. The laboratories' testing accuracies were assessed by comparing their reported results to the expected and participants' consensus results. Percentage scores were assigned and feedback reports were sent back to laboratories. Follow up of sites with unsatisfactory results was done through "on and off-site support". Concurrently, standardization of standard operating procedures (SOPs) and practices to the requirements of the International Organization for Standardization (ISO) 17043:2010 was pursued.
Participants gradually increased during the program from 56 in the pilot study to 148 in Round 4 (2018). Continual participation of a particular laboratory yielded an odd of 2.5 [95% confidence interval (CI), 1.22 to 4.34] times greater for achieving a score of above 80% with each new round it participated. The "on and off-site" support supervision documented improved performance of failing laboratories. Records of GeneXpert MTB/RIF PT were used to achieve accreditation to ISO 17043:2010 in 2018.
Continued participation in GeneXpert MTB/RIF PT improves testing accuracy of laboratories. Effective implementation of this scheme requires competent human resources, facility and equipment, functional quality management system, and adherence to ISO 17043:2010.
2010 年世界卫生组织（WHO）认可 GeneXpert MTB/RIF 检测法用于结核病诊断后，乌干达卫生部于 2012 年在其实验室网络中引入了该检测法。然而，评估该技术产生的结果质量是其主要实施挑战之一。为了弥补这一差距，国家结核参考实验室（NTRL）于 2015 年引入了 GeneXpert MTB/RIF 能力验证（PT）计划。
2015 年至 2018 年期间，对乌干达的 GeneXpert PT 计划进行了描述性的横断面研究。在预设的检测期内，将包含四个 1ml 冷冻管液体样本的样本组发送给参与的实验室。通过将实验室的报告结果与预期结果和参与者的共识结果进行比较，评估实验室的检测准确性。分配百分制分数，并将反馈报告发送回实验室。对结果不理想的实验室进行现场和场外支持。同时，根据国际标准化组织（ISO）17043：2010 的要求，对标准操作程序（SOP）和实践进行了标准化。
在该计划中，参与者的数量逐渐增加，从试点研究中的 56 个增加到 2018 年第 4 轮的 148 个。参与的实验室连续参与，每参加一轮新的测试，其获得 80%以上分数的几率增加 2.5 倍[95%置信区间（CI），1.22 至 4.34]。“现场和场外”支持监督记录了失败实验室性能的提高。GeneXpert MTB/RIF PT 的记录用于 2018 年达到 ISO 17043：2010 的认证。
继续参与 GeneXpert MTB/RIF PT 可提高实验室的检测准确性。有效实施该计划需要具备能力的人力资源、设施和设备、功能齐全的质量管理体系，并遵守 ISO 17043：2010。
