Background

Rapid, accessible, and accurate testing was paramount to an effective US COVID-19 response. Federal partners supported SARS-CoV-2 testing scale-up through an interagency-coordinated approach that focused on expanding supply chains, research and development, validation, and improving patient access. We aimed to provide an overview of the federal efforts to scale up the testing response and study the impact of scale-up.

Methods

In this descriptive analysis, we mapped federal partner activities and milestones using the US Government Testing and Diagnostics Working Group (TDWG) and participating agency and department data from Jan 1, 2020, to Dec 31, 2022. Tests produced (TDWG), reported test positivity (US Centers for Disease Control and Prevention [CDC]'s COVID-19 Electronic Laboratory Reporting system and the Federal Direct Report testing data), reported COVID-19 case counts (CDC), hospitalisations (Department of Health and Human Services Unified Hospital Data Surveillance System and the CDC's National Healthcare Safety Network), and deaths (CDC) were analysed over time. We then developed an agent-based model to evaluate the impact testing had on COVID-19 outcomes using different scenarios. The scenarios were (1) if efforts led to substantially fewer tests produced, (2) if scale-up was delayed, affecting test access, and (3) if efforts led to substantially more tests produced.

Findings

Approximately 6·7 billion SARS-CoV-2 tests, including over 1·5 billion laboratory-based, 1·9 billion point-of-care (POC), and 3·2 billion over-the-counter (OTC) tests, were produced, and approximately 2·7 billion tests were performed between Jan 1, 2020, and Dec 31, 2022. Testing capacity exhibited various expansion phases, with laboratory-based capacity growing from approximately 6 million tests per month in March, 2020 to approximately 34 million tests per month in July, 2020; POC increased to approximately 126 million tests per month by December, 2020, and OTC increased to approximately 986 million tests per month by February, 2022. Comparison between the baseline (actual) and delay-in-testing scenario suggests the increased testing capacity potentially saved upwards of 1·4 million lives and averted 7 million hospitalisations.

Interpretation

Our study suggests that early development, manufacturing, and distribution of tests had a great impact on reducing severe COVID-19 outcomes. These results highlight the importance of robust and rapid test development, production, and distribution when addressing future public health threats.

Funding

US Administration for Strategic Preparedness and Response and US Centers for Disease Control and Prevention.

中文翻译：

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美国 SARS-CoV-2 检测的规模扩大：分析随时间生产和使用的检测数量及其对 COVID-19 大流行的建模影响

 背景

快速、可访问和准确的检测对于有效的美国 COVID-19 应对措施至关重要。联邦合作伙伴通过机构间协调的方法支持扩大 SARS-CoV-2 检测的规模，该方法侧重于扩大供应链、研发、验证和改善患者可及性。我们旨在概述联邦政府为扩大检测响应所做的努力，并研究扩大规模的影响。

 方法

在这项描述性分析中，我们使用美国政府检测和诊断工作组 （TDWG） 以及参与机构和部门的数据，绘制了 2020 年 1 月 1 日至 2022 年 12 月 31 日期间的联邦合作伙伴活动和里程碑。随着时间的推移，分析了产生的检测 （TDWG）、报告的检测阳性率（美国疾病控制和预防中心 [CDC] 的 COVID-19 电子实验室报告系统和联邦直接报告检测数据）、报告的 COVID-19 病例数 （CDC）、住院人数（卫生与公众服务部统一医院数据监测系统和 CDC 的国家医疗保健安全网络）和死亡人数 （CDC）。然后，我们开发了一个基于代理的模型，以使用不同的情景评估测试对 COVID-19 结果的影响。这些情景是 （1） 如果努力导致产生的测试大幅减少，（2） 如果扩大规模被延迟，影响了测试的可及性，以及 （3） 如果努力导致生产的测试大幅增加。

 发现

在 2020 年 1 月 1 日至 2022 年 12 月 31 日期间，生产了大约 67 亿次 SARS-CoV-2 检测，包括超过 15 亿次实验室检测、190 亿次即时护理 （POC） 检测和 320 亿次非处方药 （OTC） 检测，并进行了约 27 亿次检测。检测能力经历了不同的扩展阶段，实验室能力从 2020 年 3 月的每月约 600 万次测试增长到 2020 年 7 月的每月约 3400 万次测试;到 2020 年 12 月，POC 增加到每月约 1.26 亿次测试，到 2022 年 2 月，OTC 增加到每月约 9.86 亿次测试。基线（实际）和延迟检测情景之间的比较表明，增加的检测能力可能挽救了 1·40 多万人的生命，并避免了 700 万人住院。

 解释

我们的研究表明，测试的早期开发、制造和分发对减少严重的 COVID-19 结果有很大影响。这些结果凸显了在应对未来公共卫生威胁时稳健、快速的检测开发、生产和分发的重要性。

 资金

美国战略准备和响应管理局和美国疾病控制和预防中心。