SARS-CoV-2 快速抗原检测试剂盒说明书的准确性：制造商数据与系统评价数据的二次分析。
Accuracy of package inserts of SARS-CoV-2 rapid antigen tests: a secondary analysis of manufacturer versus systematic review data.
机构信息
Research Institute of the McGill University Health Centre, Montreal General Hospital, Montreal, QC, Canada; McGill International TB Centre, Montreal, QC, Canada.
Central Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.
出版信息
Lancet Microbe. 2023 Nov;4(11):e875-e882. doi: 10.1016/S2666-5247(23)00222-7. Epub 2023 Oct 13.
BACKGROUND
Rapid antigen tests (RATs) were crucial during the COVID-19 pandemic. Information provided by the test manufacturer in product package inserts, also known as instructions for use (IFUs), is often the only data available to clinicians, public health professionals, and individuals on the diagnostic accuracy of these tests. We aimed to assess whether manufacturer IFU accuracy data aligned with evidence from independent research.
METHODS
We searched company websites for package inserts for RATs that were included in the July 2022 update of the Cochrane meta-analysis of SARS-CoV-2 RATs, which served as a benchmark for research evidence. We fitted bivariate hierarchical models to obtain absolute differences in sensitivity and specificity between IFU and Cochrane Review estimates for each test, as well as overall combined differences.
FINDINGS
We found 22 (100%) of 22 IFUs of the RATs included in the Cochrane Review. IFUs for 12 (55%) of 22 RATs reported statistically significantly higher sensitivity estimates than the Cochrane Review, and none reported lower estimates. The mean difference between IFU and Cochrane Review sensitivity estimates across tests was 12·0% (95% CI 7·5-16·6). IFUs in three (14%) of 22 diagnostic tests had significantly higher specificity estimates than the Cochrane Review and two (9%) of 22 had lower estimates. The mean difference between IFU and Cochrane Review specificity estimates across tests was 0·3% (95% CI 0·1-0·5). If 100 people with SARS-CoV-2 infection were tested with each of the tests in this study, on average 12 fewer people would be correctly diagnosed than is suggested by the package inserts.
INTERPRETATION
Health professionals and the public should be aware that package inserts for SARS-CoV-2 RATs might provide an overly optimistic picture of the sensitivity of a test. Regulatory bodies should strengthen their requirements for the reporting of diagnostic accuracy data in package inserts and policy makers should demand independent validation data for decision making.
FUNDING
None.
背景
快速抗原检测（RAT）在 COVID-19 大流行期间至关重要。测试制造商在产品包装插页中提供的信息，也称为使用说明（IFU），通常是临床医生、公共卫生专业人员和个人获得这些测试诊断准确性的唯一数据。我们旨在评估制造商 IFU 准确性数据是否与独立研究证据一致。
方法
我们在公司网站上搜索了包含在 2022 年 7 月 Cochrane SARS-CoV-2 RAT 荟萃分析更新中的 RAT 包装插页，该分析为研究证据提供了基准。我们拟合了双变量层次模型，以获得每个测试的 IFU 和 Cochrane 综述估计之间的敏感性和特异性的绝对差异，以及总体综合差异。
结果
我们找到了 Cochrane 综述中包含的 22 种 RAT 中的 22 种（100%）IFU。22 种 RAT 中有 12 种（55%）的 IFU 报告的敏感性估计值比 Cochrane 综述有统计学意义的更高，没有报告更低的估计值。跨测试的 IFU 和 Cochrane 综述敏感性估计值之间的平均差异为 12.0%（95%CI 7.5-16.6）。22 种诊断测试中有 3 种（14%）的 IFU 特异性估计值比 Cochrane 综述高，有 2 种（9%）的 IFU 特异性估计值低。跨测试的 IFU 和 Cochrane 综述特异性估计值之间的平均差异为 0.3%（95%CI 0.1-0.5）。如果对 100 名感染 SARS-CoV-2 的人进行了这项研究中的每种测试，平均会有 12 人被错误诊断，这比包装插页中所建议的要少。
解释
卫生专业人员和公众应该意识到，SARS-CoV-2 RAT 的包装插页可能提供了一种测试敏感性过于乐观的情况。监管机构应加强对包装插页中诊断准确性数据报告的要求，决策者应要求为决策提供独立验证数据。
资助
无。
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