背景:当COVID-19在2019年席卷全球时,加强对SARS-CoV-2诊断测试的关注对于成功应对大流行至关重要。测试实验室通过采用不同的测试方法来扩展他们对新型冠状病毒的能力。由于这种快速扩展,拥有外部质量保证(EQA)机制的必要性甚至更为重要。然而,在提供必要的SARS-CoV-2EQA材料方面缺乏经验,特别是在资源有限的地方。
目标:我们的目标是创建一个PT(能力测试)计划,基于干燥的管标本(DTS)方法,这将是一个实用的选择,基于分子的SARS-CoV-2EQA在低收入和中等收入国家。
方法:基于以前的ISO/IEC17043:2010认证经验,并在美国疾病控制和预防中心的协助下,乌干达国家参考实验室(采用了DTS样品制备方法,并在2020年至2021年之间完成了EQA试点计划。在运送给六个非洲国家的试点参与者之前,对设计的材料进行了稳定性和小组验证测试。参与者收到了一个包含五个SARS-CoV-2DTS样本的小组,在环境条件下运输。将参与者提交的结果与验证结果进行比较。参与者被评为满意(≥80%)或不满意(<80%),并发布绩效报告。
结果:我们的SARS-CoV-2稳定性实验表明,SARS-CoV-2RNA是稳定的(-15至-25°C,4至8°C,(18至28°C)室温和35至38°C)以及DTS面板(4至8°C,18至28°C,35至38°C和45°C)持续4周。SARS-CoV-2DTS面板在赞比亚的35个试验地点成功试验,马拉维,莫桑比克,尼日利亚,还有塞舌尔.参与者的试验结果显示出良好的准确性,与最初的SARSCoV-2预期的平均一致性为86%(30/35)。
结论:SARS-CoV-2DTSPT面板是可靠的,在环境温度下稳定,准备简单,需要最少的资源。
BACKGROUND: When COVID-19 hit the world in 2019, an enhanced focus on diagnostic testing for SARS-CoV-2 was essential for a successful pandemic response. Testing laboratories stretched their capabilities for the new coronavirus by adopting different test methods. The necessity of having external quality assurance (EQA) mechanisms was even more critical due to this rapid expansion. However, there was a lack of experience in providing the necessary SARS-CoV-2 EQA materials, especially in locations with constrained resources.
OBJECTIVE: We aimed to create a PT (Proficiency testing) programme based on the Dried Tube Specimens (DTS) method that would be a practical option for molecular based SARS-CoV-2 EQA in Low- and Middle-Income Countries.
METHODS: Based on previous ISO/IEC 17043:2010 accreditation experiences and with assistance from the US Centers for Disease Control and Prevention, The Supranational Reference Laboratory of Uganda (adapted the DTS sample preparation method and completed a pilot EQA program between 2020 and 2021. Stability and panel validation testing was conducted on the designed materials before shipping to pilot participants in six African countries. Participants received a panel containing five SARS-CoV-2 DTS samples, transported at ambient conditions. Results submitted by participants were compared to validation results. Participants were graded as satisfactory (≥ 80%) or unsatisfactory (< 80%) and performance reports disseminated.
RESULTS: Our SARS-CoV-2 stability experiments showed that SARS-CoV-2 RNA was stable (-15 to -25 °C, 4 to 8 °C, (18 to 28 °C) room temperature and 35 to 38 °C) as well as DTS panels (4 to 8 °C, 18 to 28 °C, 35 to 38 °C and 45 °C) for a period of 4 weeks. The SARS-CoV-2 DTS panels were successfully piloted in 35 test sites from Zambia, Malawi, Mozambique, Nigeria, and Seychelles. The pilot results of the participants showed good accuracy, with an average of 86% (30/35) concordance with the original SARS CoV-2 expectations.
CONCLUSIONS: The SARS-CoV-2 DTS PT panel is reliable, stable at ambient temperature, simple to prepare and requires minimal resources.