Information given by websites selling home self-sampling COVID-19 tests: an analysis of accuracy and completeness.
Information given by websites selling home self-sampling COVID-19 tests: an analysis of accuracy and completeness.
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DOI：
10.1136/bmjopen-2020-042453
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发表时间：
2020-11-06
期刊：
影响因子：
2.9
通讯作者：
Deeks JJ
中科院分区：
文献类型：
--
作者：
Taylor-Phillips S;Berhane S;Sitch AJ;Freeman K;Price MJ;Davenport C;Geppert J;Harris IM;Osokogu O;Skrybant M;Deeks JJ
评估销售COVID-19家庭自采样和检测试剂盒的网站提供信息的准确性和完整性。横断面观察研究。2020年5月23日通过网站搜索确定的在英国（39项检测）和美国（2项检测）直接向用户家庭销售COVID-19自采样和检测试剂盒（41项检测）的所有网站（n=27）。13个预先定义的基本信息项目与用户沟通，包括谁应该被测试，何时以及如何进行测试，测试的准确性，以及对结果的解释。许多网站没有提供测试的名称或制造商（32/41;78%），何时使用测试（10/41;24%），测试准确性（12/41;29%）以及如何解释结果（21/41;51%）。敏感性和特异性是最常报道的检测准确性度量（27/41[66%]的检测报告）：我们只能将这些数据与四种（10%）检测的制造商文件或出版物联系起来。与用户最相关的预测值很少报告（5个[12%]试验报告阳性预测值）。对于分子病毒检测，9/23（39%）的网站解释说检测阳性应该自我隔离，8/23（35%）的网站解释说检测阴性可能仍然有疾病。对于抗体检测，12/18（67%）的网站解释说，检测呈阳性并不一定意味着对未来感染具有免疫力。7家（39%）销售抗体测试的网站声称该测试具有CE标志，但它们用于不同的预期用途（静脉血而不是手指刺破样本）。在英国，用户在线购买家用自采样COVID-19检测产品时，会获得不完整的，在某些情况下，关于检测准确性、预期用途和检测解释的误导性信息。针对在线销售COVID-19检测产品，应制定并执行向公众传播检测产品的最佳实践指南。
To assess the accuracy and completeness of information provided by websites selling home self-sampling and testing kits for COVID-19. Cross-sectional observational study. All websites (n=27) selling direct to user home self-sampling and testing kits for COVID-19 (41 tests) in the UK (39 tests) and USA (two tests) identified by a website search on 23 May 2020. Thirteen predefined basic information items to communicate to a user, including who should be tested, when and how testing should be done, test accuracy, and interpretation of results. Many websites did not provide the name or manufacturer of the test (32/41; 78%), when to use the test (10/41; 24%), test accuracy (12/41; 29%), and how to interpret results (21/41; 51%). Sensitivity and specificity were the most commonly reported test accuracy measures (either reported for 27/41 [66%] tests): we could only link these figures to manufacturers’ documents or publications for four (10%) tests. Predictive values, most relevant to users, were rarely reported (five [12%] tests reported positive predictive values). For molecular virus tests, 9/23 (39%) websites explained that test positives should self-isolate, and 8/23 (35%) explained that test negatives may still have the disease. For antibody tests, 12/18 (67%) websites explained that testing positive does not necessarily infer immunity from future infection. Seven (39%) websites selling antibody tests claimed the test had a CE mark, when they were for a different intended use (venous blood rather than finger-prick samples). At the point of online purchase of home self-sampling COVID-19 tests, users in the UK are provided with incomplete, and, in some cases, misleading information on test accuracy, intended use, and test interpretation. Best practice guidance for communication about tests to the public should be developed and enforced for online sales of COVID-19 tests.
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