Introduction. Brazil was one of the most affected countries by the COVID-19 pandemic. Instituto Adolfo Lutz (IAL) is the reference laboratory for COVID-19 in São Paulo, the most populous state in Brazil. In April 2020, a secondary diagnostic pole named IAL-2 was created to enhance IAL’s capacity for COVID-19 diagnosis. Hypothesis/Gap Statement. Public health laboratories must be prepared to rapidly respond to emerging epidemics or pandemics. Aim. To describe the design of IAL-2 and correlate the results of RT-qPCR tests for COVID-19 with secondary data on suspected cases of SARS-CoV-2 infection in the São Paulo state. Methodology. This is a retrospective study based on the analysis of secondary data from patients suspected of infection by SARS-CoV-2 whose clinical samples were submitted to real-time PCR after reverse transcription (RT-qPCR) at IAL-2, between 1 April 2020 and 8 March 2022. RT-qPCR Ct results of the different kits used were also analysed. Results. IAL-2 was implemented in April 2020, just over a month after the detection of the first COVID-19 case in Brazil. The laboratory performed 304,250 RT-qPCR tests during the study period, of which 98 319 (32.3 %) were positive, 205827 (67.7 %) negative, and 104 (0.03 %) inconclusive for SARS-CoV-2. RT-qPCR Ct values≤30 for E/N genes of SARS-CoV-2 were presented by 79.7 % of all the samples included in the study. Conclusion. IAL was able to rapidly implement a new laboratory structure to support the processing of an enormous number of samples for diagnosis of COVID-19, outlining strategies to carry out work with quality, using different RT-qPCR protocols.

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公共卫生参考实验室对 COVID-19 大流行的快速反应

介绍。巴西是受 COVID-19 大流行影响最严重的国家之一。阿道夫·卢茨研究所 (IAL) 是位于巴西人口最多的州圣保罗的 COVID-19 参考实验室。2020 年 4 月，创建了名为 IAL-2 的二级诊断极，以增强 IAL 对 COVID-19 的诊断能力。假设/差距陈述。公共卫生实验室必须做好准备，以快速应对新出现的流行病或大流行病。目的。描述 IAL-2 的设计，并将 COVID-19 的 RT-qPCR 检测结果与圣保罗州 SARS-CoV-2 感染疑似病例的二手数据相关联。方法。这是一项回顾性研究，基于对疑似感染 SARS-CoV-2 的患者的二手数据进行分析，这些患者的临床样本于 2020 年 4 月 1 日期间提交给 IAL-2 进行逆转录后实时 PCR (RT-qPCR) 2022 年 3 月 8 日。还分析了所用不同试剂盒的 RT-qPCR Ct 结果。结果。IAL-2 于 2020 年 4 月实施，距巴西发现首例 COVID-19 病例仅一个多月。该实验室在研究期间进行了 304,250 次 RT-qPCR 检测，其中 98 319 次（32.3 %）次检测呈阳性，205 827 次（67.7 %）次检测呈阴性，104 次（0.03 %）次检测对 SARS-CoV-2 不确定。研究中 79.7% 的样本中 SARS-CoV-2 E/N 基因的 RT-qPCR Ct 值≤30。结论。IAL 能够快速实施新的实验室结构，以支持处理用于诊断 COVID-19 的大量样本，并概述使用不同 RT-qPCR 方案高质量开展工作的策略。