成人 COVID19 快速抗原检测与病毒基因检测诊断准确性的比较:系统综述与荟萃分析。

IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES
Ellyn Hirabayashi, Guadalupe Mercado, Brandi Hull, Sabrina Soin, Sherli Koshy-Chenthittayil, Sarina Raman, Timothy Huang, Chathushya Keerthisinghe, Shelby Feliciano, Andrew Dongo, James Kal, Azliyati Azizan, Karen Duus, Terry Else, Megan DeArmond, Amy E L Stone
{"title":"成人 COVID19 快速抗原检测与病毒基因检测诊断准确性的比较:系统综述与荟萃分析。","authors":"Ellyn Hirabayashi, Guadalupe Mercado, Brandi Hull, Sabrina Soin, Sherli Koshy-Chenthittayil, Sarina Raman, Timothy Huang, Chathushya Keerthisinghe, Shelby Feliciano, Andrew Dongo, James Kal, Azliyati Azizan, Karen Duus, Terry Else, Megan DeArmond, Amy E L Stone","doi":"10.11124/JBIES-23-00291","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>The objective of this review was to determine the diagnostic accuracy of the currently available and upcoming point-of-care rapid antigen tests (RATs) used in primary care settings relative to the viral genetic real-time reverse transcriptase polymerase chain reaction (RT-PCR) test as a reference for diagnosing COVID-19/SARS-CoV-2 in adults.</p><p><strong>Introduction: </strong>Accurate COVID-19 point-of-care diagnostic tests are required for real-time identification of SARS-CoV-2 infection in individuals. Real-time RT-PCR is the accepted gold standard for diagnostic testing, requiring technical expertise and expensive equipment that are unavailable in most primary care locations. RATs are immunoassays that detect the presence of a specific viral protein, which implies a current infection with SARS-CoV-2. RATs are qualitative or semi-quantitative diagnostics that lack thresholds that provide a result within a short time frame, typically within the hour following sample collection. In this systematic review, we synthesized the current evidence regarding the accuracy of RATs for detecting SARS-CoV-2 compared with RT-PCR.</p><p><strong>Inclusion criteria: </strong>Studies that included nonpregnant adults (18 years or older) with suspected SARS-CoV-2 infection, regardless of symptomology or disease severity, were included. The index test was any available SARS-CoV-2 point-of-care RAT. The reference test was any commercially distributed RT-PCR-based test that detects the RNA genome of SARS-CoV-2 and has been validated by an independent third party. Custom or in-house RT-PCR tests were also considered, with appropriate validation documentation. The diagnosis of interest was COVID-19 disease and SARS-CoV-2 infection. This review considered cross-sectional and cohort studies that examined the diagnostic accuracy of COVID-19/SARS-CoV-2 infection where the participants had both index and reference tests performed.</p><p><strong>Methods: </strong>The keywords and index terms contained in relevant articles were used to develop a full search strategy for PubMed and adapted for Embase, Scopus, Qinsight, and the WHO COVID-19 databases. Studies published from November 2019 to July 12, 2022, were included, as SARS-CoV-2 emerged in late 2019 and is the cause of a continuing pandemic. Studies that met the inclusion criteria were critically appraised using QUADAS-2. Using a customized tool, data were extracted from included studies and were verified prior to analysis. The pooled sensitivity, specificity, positive predictive, and negative predictive values were calculated and presented with 95% CIs. When heterogeneity was observed, outlier analysis was conducted, and the results were generated by removing outliers.</p><p><strong>Results: </strong>Meta-analysis was performed on 91 studies of 581 full-text articles retrieved that provided true-positive, true-negative, false-positive, and false-negative values. RATs can identify individuals who have COVID-19 with high reliability (positive predictive value 97.7%; negative predictive value 95.2%) when considering overall performance. However, the lower level of sensitivity (67.1%) suggests that negative test results likely need to be retested through an additional method.</p><p><strong>Conclusions: </strong>Most reported RAT brands had only a few studies comparing their performance with RT-PCR. Overall, a positive RAT result is an excellent predictor of a positive diagnosis of COVID-19. We recommend that Roche's SARS-CoV-2 Rapid Antigen Test and Abbott's BinaxNOW tests be used in primary care settings, with the understanding that negative results need to be confirmed through RT-PCR. We recommend adherence to the STARD guidelines when reporting on diagnostic data.</p><p><strong>Review registration: </strong>PROSPERO CRD42020224250.</p>","PeriodicalId":36399,"journal":{"name":"JBI evidence synthesis","volume":null,"pages":null},"PeriodicalIF":1.5000,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11462910/pdf/","citationCount":"0","resultStr":"{\"title\":\"Comparison of diagnostic accuracy of rapid antigen tests for COVID-19 compared to the viral genetic test in adults: a systematic review and meta-analysis.\",\"authors\":\"Ellyn Hirabayashi, Guadalupe Mercado, Brandi Hull, Sabrina Soin, Sherli Koshy-Chenthittayil, Sarina Raman, Timothy Huang, Chathushya Keerthisinghe, Shelby Feliciano, Andrew Dongo, James Kal, Azliyati Azizan, Karen Duus, Terry Else, Megan DeArmond, Amy E L Stone\",\"doi\":\"10.11124/JBIES-23-00291\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>The objective of this review was to determine the diagnostic accuracy of the currently available and upcoming point-of-care rapid antigen tests (RATs) used in primary care settings relative to the viral genetic real-time reverse transcriptase polymerase chain reaction (RT-PCR) test as a reference for diagnosing COVID-19/SARS-CoV-2 in adults.</p><p><strong>Introduction: </strong>Accurate COVID-19 point-of-care diagnostic tests are required for real-time identification of SARS-CoV-2 infection in individuals. Real-time RT-PCR is the accepted gold standard for diagnostic testing, requiring technical expertise and expensive equipment that are unavailable in most primary care locations. RATs are immunoassays that detect the presence of a specific viral protein, which implies a current infection with SARS-CoV-2. RATs are qualitative or semi-quantitative diagnostics that lack thresholds that provide a result within a short time frame, typically within the hour following sample collection. In this systematic review, we synthesized the current evidence regarding the accuracy of RATs for detecting SARS-CoV-2 compared with RT-PCR.</p><p><strong>Inclusion criteria: </strong>Studies that included nonpregnant adults (18 years or older) with suspected SARS-CoV-2 infection, regardless of symptomology or disease severity, were included. The index test was any available SARS-CoV-2 point-of-care RAT. The reference test was any commercially distributed RT-PCR-based test that detects the RNA genome of SARS-CoV-2 and has been validated by an independent third party. Custom or in-house RT-PCR tests were also considered, with appropriate validation documentation. The diagnosis of interest was COVID-19 disease and SARS-CoV-2 infection. This review considered cross-sectional and cohort studies that examined the diagnostic accuracy of COVID-19/SARS-CoV-2 infection where the participants had both index and reference tests performed.</p><p><strong>Methods: </strong>The keywords and index terms contained in relevant articles were used to develop a full search strategy for PubMed and adapted for Embase, Scopus, Qinsight, and the WHO COVID-19 databases. Studies published from November 2019 to July 12, 2022, were included, as SARS-CoV-2 emerged in late 2019 and is the cause of a continuing pandemic. Studies that met the inclusion criteria were critically appraised using QUADAS-2. Using a customized tool, data were extracted from included studies and were verified prior to analysis. The pooled sensitivity, specificity, positive predictive, and negative predictive values were calculated and presented with 95% CIs. When heterogeneity was observed, outlier analysis was conducted, and the results were generated by removing outliers.</p><p><strong>Results: </strong>Meta-analysis was performed on 91 studies of 581 full-text articles retrieved that provided true-positive, true-negative, false-positive, and false-negative values. RATs can identify individuals who have COVID-19 with high reliability (positive predictive value 97.7%; negative predictive value 95.2%) when considering overall performance. However, the lower level of sensitivity (67.1%) suggests that negative test results likely need to be retested through an additional method.</p><p><strong>Conclusions: </strong>Most reported RAT brands had only a few studies comparing their performance with RT-PCR. Overall, a positive RAT result is an excellent predictor of a positive diagnosis of COVID-19. We recommend that Roche's SARS-CoV-2 Rapid Antigen Test and Abbott's BinaxNOW tests be used in primary care settings, with the understanding that negative results need to be confirmed through RT-PCR. We recommend adherence to the STARD guidelines when reporting on diagnostic data.</p><p><strong>Review registration: </strong>PROSPERO CRD42020224250.</p>\",\"PeriodicalId\":36399,\"journal\":{\"name\":\"JBI evidence synthesis\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.5000,\"publicationDate\":\"2024-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11462910/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"JBI evidence synthesis\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.11124/JBIES-23-00291\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"HEALTH CARE SCIENCES & SERVICES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"JBI evidence synthesis","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.11124/JBIES-23-00291","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}
引用次数: 0

摘要

目的:本综述旨在确定目前在初级医疗机构中使用的和即将使用的床旁快速抗原检测(RAT)与病毒基因实时逆转录酶聚合酶链反应(RT-PCR)检测的诊断准确性,后者是诊断成人 COVID-19/SARS-CoV-2 的参考依据:导言:要实时确定个人是否感染了 SARS-CoV-2,需要准确的 COVID-19 床旁诊断测试。实时 RT-PCR 是公认的诊断检测黄金标准,但需要专业技术和昂贵的设备,而大多数基层医疗机构都不具备这些条件。RAT 是一种免疫测定方法,可检测出特定病毒蛋白的存在,这意味着当前感染了 SARS-CoV-2。RAT 是一种定性或半定量诊断方法,缺乏阈值,可在短时间内(通常在样本采集后一小时内)提供结果。在本系统综述中,我们综合了目前有关 RAT 与 RT-PCR 相比检测 SARS-CoV-2 的准确性的证据:纳入标准:纳入疑似感染 SARS-CoV-2 的非怀孕成人(18 岁或以上)的研究,无论其症状或疾病严重程度如何。指标检验是任何可用的 SARS-CoV-2 床旁 RAT。参考检验是指任何商业销售的基于 RT-PCR 的检验,该检验可检测 SARS-CoV-2 的 RNA 基因组,并已通过独立第三方的验证。定制或内部 RT-PCR 检测也可考虑,但需提供适当的验证文件。相关诊断为 COVID-19 疾病和 SARS-CoV-2 感染。本综述考虑了对COVID-19/SARS-CoV-2感染的诊断准确性进行研究的横断面研究和队列研究,这些研究的参与者都进行了指标检验和参考检验:相关文章中包含的关键词和索引词被用于制定PubMed的完整检索策略,并在Embase、Scopus、Qinsight和WHO COVID-19数据库中进行了调整。由于SARS-CoV-2是在2019年末出现的,并且是持续大流行的原因,因此纳入了2019年11月至2022年7月12日期间发表的研究。我们使用 QUADAS-2 对符合纳入标准的研究进行了严格评估。使用定制工具从纳入的研究中提取数据,并在分析前进行核实。计算汇总的灵敏度、特异性、阳性预测值和阴性预测值,并给出 95% CI。当观察到异质性时,进行离群值分析,去除离群值后得出结果:对检索到的 581 篇全文文章中的 91 项研究进行了元分析,这些研究提供了真阳性、真阴性、假阳性和假阴性值。考虑到整体性能,RATs 能以较高的可靠性(阳性预测值 97.7%;阴性预测值 95.2%)识别出 COVID-19 患者。然而,较低的灵敏度(67.1%)表明,阴性检测结果可能需要通过其他方法重新检测:结论:大多数报告的 RAT 品牌仅有少数研究将其性能与 RT-PCR 进行了比较。总体而言,RAT 阳性结果是 COVID-19 阳性诊断的绝佳预测指标。我们建议在基层医疗机构使用罗氏的 SARS-CoV-2 快速抗原检测试剂盒和雅培的 BinaxNOW 检测试剂盒,但阴性结果需要通过 RT-PCR 进行确认。我们建议在报告诊断数据时遵守 STARD 指南:审查注册:prospero crd42020224250。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comparison of diagnostic accuracy of rapid antigen tests for COVID-19 compared to the viral genetic test in adults: a systematic review and meta-analysis.

Objective: The objective of this review was to determine the diagnostic accuracy of the currently available and upcoming point-of-care rapid antigen tests (RATs) used in primary care settings relative to the viral genetic real-time reverse transcriptase polymerase chain reaction (RT-PCR) test as a reference for diagnosing COVID-19/SARS-CoV-2 in adults.

Introduction: Accurate COVID-19 point-of-care diagnostic tests are required for real-time identification of SARS-CoV-2 infection in individuals. Real-time RT-PCR is the accepted gold standard for diagnostic testing, requiring technical expertise and expensive equipment that are unavailable in most primary care locations. RATs are immunoassays that detect the presence of a specific viral protein, which implies a current infection with SARS-CoV-2. RATs are qualitative or semi-quantitative diagnostics that lack thresholds that provide a result within a short time frame, typically within the hour following sample collection. In this systematic review, we synthesized the current evidence regarding the accuracy of RATs for detecting SARS-CoV-2 compared with RT-PCR.

Inclusion criteria: Studies that included nonpregnant adults (18 years or older) with suspected SARS-CoV-2 infection, regardless of symptomology or disease severity, were included. The index test was any available SARS-CoV-2 point-of-care RAT. The reference test was any commercially distributed RT-PCR-based test that detects the RNA genome of SARS-CoV-2 and has been validated by an independent third party. Custom or in-house RT-PCR tests were also considered, with appropriate validation documentation. The diagnosis of interest was COVID-19 disease and SARS-CoV-2 infection. This review considered cross-sectional and cohort studies that examined the diagnostic accuracy of COVID-19/SARS-CoV-2 infection where the participants had both index and reference tests performed.

Methods: The keywords and index terms contained in relevant articles were used to develop a full search strategy for PubMed and adapted for Embase, Scopus, Qinsight, and the WHO COVID-19 databases. Studies published from November 2019 to July 12, 2022, were included, as SARS-CoV-2 emerged in late 2019 and is the cause of a continuing pandemic. Studies that met the inclusion criteria were critically appraised using QUADAS-2. Using a customized tool, data were extracted from included studies and were verified prior to analysis. The pooled sensitivity, specificity, positive predictive, and negative predictive values were calculated and presented with 95% CIs. When heterogeneity was observed, outlier analysis was conducted, and the results were generated by removing outliers.

Results: Meta-analysis was performed on 91 studies of 581 full-text articles retrieved that provided true-positive, true-negative, false-positive, and false-negative values. RATs can identify individuals who have COVID-19 with high reliability (positive predictive value 97.7%; negative predictive value 95.2%) when considering overall performance. However, the lower level of sensitivity (67.1%) suggests that negative test results likely need to be retested through an additional method.

Conclusions: Most reported RAT brands had only a few studies comparing their performance with RT-PCR. Overall, a positive RAT result is an excellent predictor of a positive diagnosis of COVID-19. We recommend that Roche's SARS-CoV-2 Rapid Antigen Test and Abbott's BinaxNOW tests be used in primary care settings, with the understanding that negative results need to be confirmed through RT-PCR. We recommend adherence to the STARD guidelines when reporting on diagnostic data.

Review registration: PROSPERO CRD42020224250.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
JBI evidence synthesis
JBI evidence synthesis Nursing-Nursing (all)
CiteScore
4.50
自引率
3.70%
发文量
218
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信