快速抗原检测是否应作为 COVID-19 检测的一线手段？一项前瞻性城市队列研究的结果。

Should rapid antigen tests be first-line for COVID-19 testing? Results of a prospective urban cohort study.

机构信息

Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.

A.T. Still University School of Osteopathic Medicine in Arizona, Mesa, AZ, USA.

出版信息

BMC Infect Dis. 2023 Apr 18;23(1):243. doi: 10.1186/s12879-023-08171-6.

DOI:10.1186/s12879-023-08171-6

PMID:37072695

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10111331/

Abstract

BACKGROUND

A highly accurate, rapid, and low-cost COVID-19 test is essential for guiding isolation measures. To date, the most widely used tests are either nucleic acid amplification tests or antigen tests. The objective of this study is to further assess the diagnostic performance of the Binax-CoV2 rapid antigen test in comparison to the current gold standard reverse transcription quantitative polymerase chain reaction (RT-qPCR), with additional analysis of symptomatology and cycle threshold utility.

METHODS

This is a prospective cohort study performed between November and December 2020. Individuals who presented to COVID-19 testing events and received both RT-qPCR and a rapid antigent test were included. Testing occurred at the emergency department of an urban hospital and at a community mobile unit. No fees or appointments were required. Individuals self-reported the presence or absence of symptoms and history of positive COVID-19 test within the previous two weeks. Trained staff collected two subsequent nasopharyngeal swabs of both nares. One set of swabs underwent RT-qPCR and the other underwent Binax-CoV2 assay per manufacturer guidelines.

RESULTS

A total of 390 patients were included, of which 302 were from the community site. Of these 302, 42 (14%) were RT-qPCR positive. Of the 42 RT-qPCR positive, 30 (71.4%) were also positive by Binax-CoV2. The Binax-CoV2 test had a sensitivity of 71.4% (95% CI: 55%-84%) and a specificity of 99.6% (95% CI: 98%-100%) in this population. Performance of the Binax-CoV2 test performed better in individuals with higher viral load. For symptomatic patients with cycle threshold < 20, sensitivity reached 100%.

CONCLUSIONS

The Binax-CoV2 assay's specificity and sensitivity in individuals with high viral load makes it a suitable first-line test for detecting COVID-19. However, given the assay's measured sensitivity, a negative result on the Binax-CoV2 assay may warrant additional testing with more sensitive tests, such as the RT-qPCR. This is particularly the case with high clinical suspicion for an active SARS-CoV-2 infection even after a negative Binax-CoV2 result.

摘要

背景

一种高度准确、快速且低成本的 COVID-19 检测对于指导隔离措施至关重要。迄今为止，应用最广泛的检测方法是核酸扩增检测或抗原检测。本研究的目的是进一步评估 Binax-CoV2 快速抗原检测与当前金标准逆转录定量聚合酶链反应（RT-qPCR）相比的诊断性能，并对症状和循环阈值的应用进行额外分析。

方法

这是一项于 2020 年 11 月至 12 月期间进行的前瞻性队列研究。研究纳入了在 COVID-19 检测事件中同时接受 RT-qPCR 和快速抗原检测的个体。检测在城市医院的急诊科和社区移动单位进行。无需支付费用或预约。个体自行报告过去两周内是否存在症状和 COVID-19 检测阳性史。经过培训的工作人员采集了双侧鼻腔拭子各两份。一组拭子根据制造商的指南进行 RT-qPCR 检测，另一组进行 Binax-CoV2 检测。

结果

共纳入 390 例患者，其中 302 例来自社区。在这 302 例患者中，有 42 例（14%）为 RT-qPCR 阳性。在 42 例 RT-qPCR 阳性患者中，30 例（71.4%）也通过 Binax-CoV2 检测阳性。在该人群中，Binax-CoV2 检测的敏感性为 71.4%（95%CI：55%-84%），特异性为 99.6%（95%CI：98%-100%）。在病毒载量较高的个体中，Binax-CoV2 检测的性能更好。对于病毒载量<20 的有症状患者，敏感性达到 100%。

结论

Binax-CoV2 检测在病毒载量较高的个体中具有较高的特异性和敏感性，使其成为检测 COVID-19 的合适一线检测方法。然而，鉴于该检测的敏感性，Binax-CoV2 检测的阴性结果可能需要进一步使用更敏感的检测方法（如 RT-qPCR）进行检测。在高度怀疑 SARS-CoV-2 感染活跃的情况下，即使 Binax-CoV2 检测结果为阴性，也是如此。