False positive rapid antigen tests for SARS-CoV-2 in the real-world and their economic burden

Kretschmer, A.; Kossow, Annelene; Grüne, Barbara; Schildgen, Oliver; Mathes, Tim; Schildgen, Verena

doi:10.1016/j.jinf.2021.08.020

Cited by 22 publications

(14 citation statements)

References 10 publications

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“…Rapid tests for COVID-19 based on antigen detection have been initially acclaimed as fast assays able to provide results in less than one hour, and in some cases, in less than 30 minutes. However, many concerns have been raised in the field due to collected data showing a continuous increase in false positivity rate and inaccuracies of these tests in some challenging circumstances [ 11 , 12 ]. Consequently, the FDA has issued an alert to healthcare providers regarding the potential for false-positive antigen results and steps to mitigate this risk ( https://www.fda.gov/medical-devices/letters-health-care-providers/potential-false-positiveresults-antigen-tests-rapid-detection-sars-cov-2-letter-clinical-laboratory ).…”

Section: Discussionmentioning

confidence: 99%

“…Rapid tests for SARS-CoV-2 were implemented as fast assays to control transmission and provide results in less than one hour. However, increasing evidence suggests significant risks associated with the false positivity and negativity rate of these tests, especially if the screening strategy is based on lateral flow antigen tests (rapid tests) [ 11 , 12 ]. Thus, alternative testing methods based on fast and reliable approaches without compromising the rigor of the testing pipeline are critically needed.…”

Section: Introductionmentioning

confidence: 99%

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A rapid, specific, extraction-less, and cost-effective RT-LAMP test for the detection of SARS-CoV-2 in clinical specimens

et al. 2022

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In 2019 a newly identified coronavirus, designated as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has spread rapidly from the epicenter in Wuhan (China) to more than 150 countries around the world, causing the Coronavirus disease 2019 (COVID-19) pandemic. In this study, we describe an extraction-less method based on reverse transcriptase loop-mediated isothermal amplification (RT-LAMP) intended for the rapid qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens, including oropharyngeal and nasopharyngeal swabs, anterior nasal and mid-turbinate nasal swabs, nasopharyngeal washes/aspirates or nasal aspirates as well as bronchoalveolar lavage (BAL) from individuals suspected of COVID-19 by their healthcare provider. The assay’s performance was evaluated and compared to an RT quantitative PCR-based assay (FDA-approved). With high sensitivity, specificity, and bypassing the need for RNA extraction, the RT-LAMP Rapid Detection assay is a valuable and fast test for an accurate and rapid RNA detection of the SARS-CoV-2 virus and potentially other pathogens. Additionally, the versatility of this test allows its application in virtually every laboratory setting and remote location where access to expensive laboratory equipment is a limiting factor for testing during pandemic crises.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A rapid, specific, extraction-less, and cost-effective RT-LAMP test for the detection of SARS-CoV-2 in clinical specimens

et al. 2022

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“…These results inform the discussion of whether rapid antigen tests will result in too many false-positives that could overwhelm PCR testing capacity in other settings. 1,2 Also, the results demonstrate the importance of having a comprehensive data system to quickly identify potential issues. With the ability to identify batch issues within 24 hours, workers could return to work, problematic test batches could be discarded, and the public health authorities and manufacturer could be informed.…”

mentioning

confidence: 90%

False-Positive Results in Rapid Antigen Tests for SARS-CoV-2

Gans

Goldfarb

Agrawal

et al. 2022

JAMA

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Concerns have been raised whether rapid antigen tests for SARS-CoV-2 can result in false-positive test results 1,2 and undermine pandemic management for COVID-19. This study investigated the incidence of false-positive results in a large sample of rapid antigen tests used to serially screen asymptomatic workers throughout Canada.Methods | Rapid antigen tests for SARS-CoV-2 were implemented as an extra layer of protection to control transmission in workplaces throughout Canada by the Creative Destruction Lab Rapid Screening Consortium (CDL RSC). Asymptomatic employees were screened twice weekly. Workplace participation was voluntary. From January 11 to October 13, 2021, tests were conducted by employees, with some workplaces providing at-home screening and others on-site screening programs. Over this period, Canada experienced 2 significant Delta variant-driven waves from March to June and August to October. Screening results were recorded, including a deidentified record identifier, the place of employment, the test, and (optionally) the lot number. If a test result was positive, the patient was immediately referred for a confirmatory polymerase chain reaction (PCR) test to be completed within 24 hours. Initial data validation was completed at the point of collection. All data collected before June 26 and presumptive positive screen results and PCR test results reported before September 15 were externally verified through an audit process by participant organizations. False-positive results were matched to lot number and test manufacturer. A falsepositive result was defined as a positive screen on a rapid antigen test and a subsequent negative confirmatory PCR.The data from the CDL RSC were collected to inform the operational requirements of deploying rapid antigen screens in workplaces. All participants provided written consent to participate in the screening program and to share their deidentified data with the CDL RSC, including for publication, and with public health authorities. This study was approved by the

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“…False positive LFAT remain a concern in daily routine testing. First of all there is a number of false positive samples, that can reach up 50% of positive results altogether [3] . Second, false positive patients might be sent to a COVID-19 ward and get infected there [9] .…”

Section: Discussionmentioning

confidence: 99%

“…However, these tests are criticized to be inaccurate. LFAT can produce false positive results in some cases even close to 50% [3] , and due to their lower sensitivity in comparison to many PCR assays, there is a possibility for false negative results [4] , [5] , [6] .…”

Section: Introductionmentioning

confidence: 99%

Verification of lateral flow antigen tests for SARS-CoV-2 by qPCR directly from the test device

et al. 2022

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False positive rapid antigen tests for SARS-CoV-2 in the real-world and their economic burden

Cited by 22 publications

References 10 publications

A rapid, specific, extraction-less, and cost-effective RT-LAMP test for the detection of SARS-CoV-2 in clinical specimens

A rapid, specific, extraction-less, and cost-effective RT-LAMP test for the detection of SARS-CoV-2 in clinical specimens

False-Positive Results in Rapid Antigen Tests for SARS-CoV-2

Verification of lateral flow antigen tests for SARS-CoV-2 by qPCR directly from the test device

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