Liao Wan-Ting, Hsu Min-Yen, Shen Ching-Fen, Hung Kai-Feng, Cheng Chao-Min
Institute of Biomedical Engineering and Frontier Research Center on Fundamental and Applied Sciences of Matters, National Tsing Hua University, Hsinchu, 30013, Taiwan.
School of Medicine, Chung Shan Medical University, Taichung, 40201, Taiwan.
Adv Biosyst. 2020 Nov;4(11):e2000150. doi: 10.1002/adbi.202000150. Epub 2020 Oct 1.
Real-time reverse transcription-polymerase chain reaction (qRT-PCR) using specimens collected from nasopharyngeal and/or oropharyngeal swabs is the standard screening approach for coronavirus disease 2019 (COVID-19). While PCR is rapid and highly accurate, it requires costly laboratory equipment and healthcare professionals that limit its use for large-scale screening of mild or asymptomatic patients. Self-collection kits for use in the home could remedy this and have consequently received great attention. In April, 2020, a self-collection kit from LapCorp was the first such kit to be approved by the FDA. In the following month, May 2020, another kit developed by Everlywell received FDA approval, and more kits are evidently on their way to the market in the United Kingdom and elsewhere. Because these home-based, self-collection kits are easy to use and may be more acceptable for patients, they provide a superior screening option for mild or asymptomatic patients under self-quarantine. These kits conserve personal protective equipment and healthcare manpower already in short supply. The primary issues affecting the efficacy of this approach are the potential for inappropriate sampling and insufficient clinical examination. A detailed review of the commercially available kits currently available is provided and their prospective impact is noted during the current pandemic.
使用从鼻咽拭子和/或口咽拭子采集的样本进行实时逆转录聚合酶链反应（qRT-PCR）是2019冠状病毒病（COVID-19）的标准筛查方法。虽然PCR快速且高度准确，但它需要昂贵的实验室设备和医疗专业人员，这限制了其用于对轻症或无症状患者的大规模筛查。家用自采试剂盒可以解决这一问题，因此受到了极大关注。2020年4月，LapCorp公司的一款自采试剂盒成为首个获得美国食品药品监督管理局（FDA）批准的此类试剂盒。在接下来的2020年5月，Everlywell公司研发的另一款试剂盒也获得了FDA批准，显然还有更多试剂盒正在进入英国及其他地区的市场。由于这些家用自采试剂盒使用方便，患者可能更容易接受，它们为处于自我隔离中的轻症或无症状患者提供了更好的筛查选择。这些试剂盒节省了本就短缺的个人防护装备和医疗人力。影响这种方法有效性的主要问题是采样不当的可能性和临床检查不足。本文对目前市面上可用的试剂盒进行了详细综述，并指出了它们在当前疫情期间的潜在影响。
