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急性SARS-CoV-2感染过程中诊断测试性能的纵向评估。

Longitudinal assessment of diagnostic test performance over the course of acute SARS-CoV-2 infection.

作者信息

Smith Rebecca L, Gibson Laura L, Martinez Pamela P, Ke Ruian, Mirza Agha, Conte Madison, Gallagher Nicholas, Conte Abigail, Wang Leyi, Fredrickson Rick, Edmonson Darci C, Baughman Melinda E, Chiu Karen K, Choi Hannah, Jensen Tor W, Scardina Kevin R, Bradley Shannon, Gloss Stacy L, Reinhart Crystal, Yedetore Jagadeesh, Owens Alyssa N, Broach John, Barton Bruce, Lazar Peter, Henness Darcy, Young Todd, Dunnett Alastair, Robinson Matthew L, Mostafa Heba H, Pekosz Andrew, Manabe Yukari C, Heetderks William J, McManus David D, Brooke Christopher B

出版信息

medRxiv. 2021 Mar 22:2021.03.19.21253964. doi: 10.1101/2021.03.19.21253964.

DOI:10.1101/2021.03.19.21253964
PMID:33791719
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8010751/
Abstract

WHAT IS ALREADY KNOWN ABOUT THIS TOPIC?: Diagnostic tests and sample types for SARS-CoV-2 vary in sensitivity across the infection period.

WHAT IS ADDED BY THIS REPORT?: We show that both RTqPCR (from nasal swab and saliva) and the Quidel SARS Sofia FIA rapid antigen tests peak in sensitivity during the period in which live virus can be detected in nasal swabs, but that the sensitivity of RTqPCR tests rises more rapidly in the pre-infectious period. We also use empirical data to estimate the sensitivities of RTqPCR and antigen tests as a function of testing frequency.

WHAT ARE THE IMPLICATIONS FOR PUBLIC HEALTH PRACTICE?: RTqPCR tests will be more effective than rapid antigen tests at identifying infected individuals prior to or early during the infectious period and thus for minimizing forward transmission (provided results reporting is timely). All modalities, including rapid antigen tests, showed >94% sensitivity to detect infection if used at least twice per week. Regular surveillance/screening using rapid antigen tests 2-3 times per week can be an effective strategy to achieve high sensitivity (>95%) for identifying infected individuals.

摘要

关于该主题已知的信息有哪些?:针对严重急性呼吸综合征冠状病毒2(SARS-CoV-2)的诊断检测和样本类型在整个感染期的敏感性各不相同。

本报告补充了哪些内容?:我们发现,逆转录定量聚合酶链反应(RTqPCR,来自鼻拭子和唾液样本)以及Quidel SARS Sofia荧光免疫分析快速抗原检测在鼻拭子中可检测到活病毒的期间敏感性达到峰值,但RTqPCR检测在感染前期敏感性上升得更快。我们还利用经验数据估算了RTqPCR和抗原检测的敏感性与检测频率的函数关系。

对公共卫生实践有何启示?:在感染期之前或早期识别感染者方面,RTqPCR检测将比快速抗原检测更有效,从而可最大程度减少病毒的进一步传播(前提是检测结果报告及时)。如果每周至少使用两次,包括快速抗原检测在内的所有检测方式对检测感染的敏感性均超过94%。每周进行2至3次快速抗原检测的定期监测/筛查可以成为一种有效的策略,以实现识别感染者的高敏感性(>95%)。