Huggett Jim F, Moran-Gilad Jacob, Lee J Eugene
National Measurement Laboratory (NML) at LGC, Queens Rd, Teddington.
School of Biosciences & Medicine, Faculty of Health & Medical Science, University of Surrey, Guildford, UK.
Curr Opin Pulm Med. 2021 May 1;27(3):155-162. doi: 10.1097/MCP.0000000000000768.
COVID-19 has put the in-vitro-diagnostic community under an unprecedented spotlight, with a global requirement for accurate SARS-CoV-2 tests. This review will outline technological responses to this need and the analytical considerations required for their translation to routine use.
SARS-CoV-2 diagnostic solutions directly detect the virus or measure host-derived surrogate markers of infection. With pressure upon supply chains for the 'traditional' molecular approaches, a wide variety of analytical tools spanning the molecular, serology, imaging and chemistry space are being developed, including high throughput solutions and simplified near-patient formats.
The unique genetic nature of SARS-CoV-2 means high analytical specificity is achievable by most diagnostic formats. However, clinical sensitivity assessment is complicated by wide discrepancies in analytical range and challenges associated with standardising these differences. When coupled with the acute nature of SARS-CoV-2 infection, reported precise metrics of test performance must be questioned. The response to SARS-CoV-2 has delivered considerable diagnostic innovation, but for a technology to be maximised, it must be demonstrably reproducible and fit for purpose. If novel diagnostic solutions for SARS-CoV-2 are to succeed, equally innovative mechanisms are needed to ensure widespread clinical and surveillance application, enabling agreed standards and metrics to ensure comparability.
新型冠状病毒肺炎（COVID-19）使体外诊断领域受到前所未有的关注，全球都需要准确的严重急性呼吸综合征冠状病毒2（SARS-CoV-2）检测方法。本综述将概述针对这一需求的技术应对措施以及将其转化为常规应用所需的分析考量。
SARS-CoV-2诊断解决方案可直接检测病毒或测量宿主衍生的感染替代标志物。由于“传统”分子方法的供应链面临压力，正在开发包括高通量解决方案和简化的床旁检测形式在内的跨越分子、血清学、成像和化学领域的多种分析工具。
SARS-CoV-2独特的基因性质意味着大多数诊断形式都能实现高分析特异性。然而，分析范围的巨大差异以及标准化这些差异所面临的挑战使临床敏感性评估变得复杂。再加上SARS-CoV-2感染的急性性质，所报道的检测性能精确指标必须受到质疑。对SARS-CoV-2的应对带来了可观的诊断创新，但要使一项技术得到最大化利用，它必须具有可证明的可重复性且符合目的。如果针对SARS-CoV-2的新型诊断解决方案要取得成功，就需要同样具有创新性的机制来确保广泛的临床和监测应用，制定统一的标准和指标以确保可比性。
