INSTAND E.V., Society for Promoting Quality Assurance in Medical Laboratories, Ubierstr. 20, 40223, Düsseldorf, Germany.
GBD Gesellschaft für Biotechnologische Diagnostik mbH, Berlin, Potsdamer Chaussee 80, 14129, Berlin, Germany.
Sci Rep. 2023 Aug 14;13(1):13206. doi: 10.1038/s41598-023-40330-2.
The COVID-19 pandemic illustrated the important role of diagnostic tests, including lateral flow tests (LFTs), in identifying patients and their contacts to slow the spread of infections. INSTAND performed external quality assessments (EQA) for SARS-CoV-2 antigen detection with lyophilized and chemically inactivated cell culture supernatant of SARS-CoV-2 infected Vero cells. A pre-study demonstrated the suitability of the material. Participants reported qualitative and/or quantitative antigen results using either LFTs or automated immunoassays for five EQA samples per survey. 711 data sets were reported for LFT detection in three surveys in 2021. This evaluation focused on the analytical sensitivity of different LFTs and automated immunoassays. The inter-laboratory results showed at least 94% correct results for non-variant of concern (VOC) SARS-CoV-2 antigen detection for viral loads of ≥ 4.75 × 10 copies/mL and SARS-CoV-2 negative samples. Up to 85% had success for a non-VOC viral load of ~ 1.60 × 10 copies/mL. A viral load of ~ 1.42 × 10 copies/mL of the Delta VOC was reported positive in > 96% of results. A high specificity was found with almost 100% negative SARS-CoV-2 antigen results for HCoV 229E and HCoV NL63 positive samples. Quantitative results correlated with increasing SARS-CoV-2 viral load but showed a broad scatter. This study shows promising SARS-CoV-2 antigen test performance of the participating laboratories, but further investigations with the now predominant Omicron VOC are needed.
COVID-19 大流行说明了诊断检测的重要作用，包括侧向流动检测（LFT），以识别患者及其接触者，从而减缓感染的传播。INSTAND 对 SARS-CoV-2 感染的 Vero 细胞的冻干和化学灭活细胞培养上清液进行了侧向流动检测的外部质量评估（EQA）。一项预研究证明了该材料的适用性。参与者使用 LFT 或自动化免疫分析报告了五个 EQA 样本中的定性和/或定量抗原结果。在 2021 年的三次调查中，报告了 711 个用于 LFT 检测的数据组。这项评估侧重于不同 LFT 和自动化免疫分析的分析灵敏度。实验室间的结果表明，对于非关注变异株（VOC）SARS-CoV-2 抗原检测，对于病毒载量≥4.75×10 拷贝/mL 和 SARS-CoV-2 阴性样本，至少有 94%的结果是正确的。对于非 VOC 的病毒载量1.60×10 拷贝/mL，有 85%的结果是成功的。Delta VOC 的病毒载量1.42×10 拷贝/mL，在超过 96%的结果中被报告为阳性。对于 HCoV 229E 和 HCoV NL63 阳性样本，几乎 100%的 SARS-CoV-2 抗原结果为阴性，具有很高的特异性。定量结果与 SARS-CoV-2 病毒载量的增加相关，但显示出广泛的分散。这项研究表明，参与实验室的 SARS-CoV-2 抗原检测性能有了很大的提高，但需要对现在占主导地位的奥密克戎 VOC 进行进一步的研究。
