RCPAQAP Biosecurity, St Leonards, NSW, Australia.
RCPAQAP Biosecurity, St Leonards, NSW, Australia.
Pathology. 2022 Jun;54(4):472-478. doi: 10.1016/j.pathol.2022.01.006. Epub 2022 Apr 16.
Diagnostic testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has undergone significant changes over the duration of the pandemic. In early 2020, SARS-CoV-2 specific nucleic acid testing (NAT) protocols were predominantly in-house assays developed based on protocols published in peer reviewed journals. As the pandemic has progressed, there has been an increase in the choice of testing platforms. A proficiency testing program for the detection of SARS-CoV-2 by NAT was provided to assist laboratories in assessing and improving test capabilities in the early stages of the pandemic. This was vital in quality assuring initial in-house assays, later commercially produced assays, and informing the public health response. The Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) offered three rounds of proficiency testing for SARS-CoV-2 to Australian and New Zealand public and private laboratories in March, May, and November 2020. Each round included a panel of five specimens, consisting of positive (low, medium or high viral loads), inconclusive (technical specimen of selected SARS-CoV-2 specific genes) and negative specimens. Results were received for round 1 from 16, round 2 from 97 and round 3 from 101 participating laboratories. Improvement in the accuracy over time was shown, with the concordance of results in round 1 being 75.0%, in round 2 above 95.0% for all samples except one, and for round 3 above 95.0%. Overall, participants demonstrated high capabilities in detecting SARS-CoV-2, even in samples of low viral load, indicating excellent testing accuracy and therefore providing confidence in Australian and New Zealand public and private laboratories test results.
在大流行期间，对严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）的诊断测试经历了重大变化。2020 年初，SARS-CoV-2 特异性核酸检测（NAT）方案主要是基于同行评议期刊上发表的方案开发的内部检测。随着大流行的进展，检测平台的选择有所增加。提供了 SARS-CoV-2 的 NAT 检测能力验证计划，以协助实验室在大流行的早期阶段评估和提高测试能力。这对于保证初始内部检测、后来商业化生产的检测以及为公共卫生应对提供信息至关重要。澳大利亚和新西兰皇家病理学家学院质量保证计划（RCPAQAP）于 2020 年 3 月、5 月和 11 月为澳大利亚和新西兰的公共和私人实验室提供了三轮 SARS-CoV-2 的能力验证。每轮包括五个标本的检测，包括阳性（低、中或高病毒载量）、不确定（选择的 SARS-CoV-2 特异性基因的技术标本）和阴性标本。第一轮收到了 16 个实验室的结果，第二轮收到了 97 个实验室的结果，第三轮收到了 101 个实验室的结果。结果表明，随着时间的推移，准确性有所提高，第一轮的一致性为 75.0%，第二轮除一个样本外，所有样本均超过 95.0%，第三轮超过 95.0%。总体而言，参与者在检测 SARS-CoV-2 方面表现出很高的能力，即使是低病毒载量的样本，这表明检测精度非常高，因此对澳大利亚和新西兰的公共和私人实验室的检测结果充满信心。
