National Serology Reference Laboratory , Fitzroy, Victoria, Australia.
Microbiol Spectr. 2024 Jan 11;12(1):e0322823. doi: 10.1128/spectrum.03228-23. Epub 2023 Nov 29.
We have previously highlighted the fact that hundreds of SARS-CoV-2 serology tests were released months after the onset of the COVID-19 pandemic. Of the hundreds of studies investigating the test kits' performance, few were comparative reports, using the same comprehensive sample set across multiple tests. Recently, we reported a comparative assessment of 35 rapid diagnostic tests (RDTs) or microtiter plate enzyme immunoassays (EIA) for use in low- and middle-income countries, using a large sample set from individuals with a history of COVID-19. Only a few tests meet WHO Target Product Profile performance requirements. This study reports on the performance of a further 25 automated SARS-CoV-2 immunoassays using the same panel of samples. The results highlight the better analytical and clinical performance of automated serology test kits compared with RDTs, and the importance of independent comparative assessments to inform the use and procurement of these tests for both diagnostic and epidemiological investigations.
我们之前已经强调了这样一个事实,即在 COVID-19 大流行开始数月后,就已经有数百种 SARS-CoV-2 血清学检测试剂盒问世。在数百项研究检测试剂盒性能的研究中,很少有使用相同的综合样本集进行比较的报告。最近,我们报道了对 35 种快速诊断检测试剂盒(RDT)或微量滴定板酶免疫分析(EIA)的比较评估,这些试剂盒用于中低收入国家,使用了来自有 COVID-19 病史的个体的大样本集。只有少数检测符合世卫组织目标产品特性性能要求。本研究报告了使用相同样本组对另外 25 种自动化 SARS-CoV-2 免疫分析试剂盒的性能。结果突出表明,与 RDT 相比,自动化血清学检测试剂盒具有更好的分析和临床性能,以及进行独立比较评估以告知这些检测用于诊断和流行病学调查的使用和采购的重要性。