快速抗原检测与逆转录-聚合酶链反应检测 SARS-CoV-2 的准确性和成本描述。

Accuracy and cost description of rapid antigen test compared with reverse transcriptase-polymerase chain reaction for SARS-CoV-2 detection.

出版信息

Dan Med J. 2021 Jun 14;68(7):A03210217.

Abstract

INTRODUCTION

Fast and accurate detection of SARS-CoV-2 is essential in limiting the COVID-19 pandemic. Rapid antigen (AG) tests provide results within minutes; however, their accuracy has been questioned. The study aims to determine the accuracy and cost of the STANDARD Q COVID-19 AG test compared with RT-PCR.

METHODS

Individuals 18 years or older with an appointment for a RT-PCR test on 26-31 December 2020 at a public test centre in Copenhagen, Denmark were invited to participate. An oropharyngeal swab was collected for RT-PCR analysis, followed by a nasopharyngeal swab examined by the AG test (SD Biosensor). The diagnostic accuracy of the AG test was calculated with RT-PCR as reference. Costs were evaluated for both tests.

RESULTS

A total of 4,811 paired conclusive test results were collected (median age: 45 years, female: 53%). The RT-PCR test revealed 221 (4.6%) positive tests. The overall sensitivity and specificity of the AG test were 69.7% and 99.5%, respectively. Viral cycle threshold values were significantly higher in individuals with false negative AG tests than in individuals who were true positives. The RT-PCR test and AG test costs were 67.0 DKK (10.8 USD) and 35.0 DKK (5.7 USD), respectively, per positive case detected at 100,000 daily tests.

CONCLUSIONS

The AG test enables mass testing and provides immediate results, which is important in SARS-CoV-2 screening. The AG test is a good and relevant supplement to RT-PCR testing in public SARS-CoV-2 screenings.

FUNDING

This project received no external funding. Copenhagen Medical A/S delivering the rapid AG tests and provided test personnel but were not otherwise involved.

TRIAL REGISTRATION

Clinicaltrials.org: NCT04716088.

摘要

简介

快速准确地检测 SARS-CoV-2 对于限制 COVID-19 大流行至关重要。快速抗原（AG）检测可在数分钟内提供结果；然而，其准确性受到了质疑。本研究旨在比较 STANDARD Q COVID-19 AG 检测与 RT-PCR 的准确性和成本。

方法

邀请 2020 年 12 月 26 日至 31 日在丹麦哥本哈根的一个公共检测中心预约进行 RT-PCR 检测的 18 岁或以上的个体参加。采集口咽拭子进行 RT-PCR 分析，然后用 AG 检测（SD Biosensor）检测鼻咽拭子。AG 检测的诊断准确性以 RT-PCR 为参考进行计算。评估了两种检测的成本。

结果

共收集了 4811 对明确的检测结果（中位年龄：45 岁，女性：53%）。RT-PCR 检测显示 221 例（4.6%）阳性检测。AG 检测的总体敏感性和特异性分别为 69.7%和 99.5%。假阴性 AG 检测个体的病毒循环阈值明显高于真阳性个体。每检测 10 万例阳性病例，RT-PCR 检测和 AG 检测的成本分别为 67.0 DKK（10.8 美元）和 35.0 DKK（5.7 美元）。