Multicenter Postimplementation Assessment of the Positive Predictive Value of SARS-CoV-2 Antigen-Based Point-of-Care Tests Used for Screening of Asymptomatic Continuing Care Staff

Kanji, Jamil N.; Proctor, Dustin T; Stokes, William; Berenger, Byron M.; Silvius, James; Tipples, Graham; Joffe, Ari; Venner, Allison A.

doi:10.1128/jcm.01411-21

Cited by 20 publications

(20 citation statements)

References 20 publications

(23 reference statements)

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“…The NP swab-containing Panbio assay has been an important component of Nova Scotia’s community testing strategies since November 2020 ( https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/guidance-documents/use-rapid-antigen-detection-tests.html ). In spite of the recent manufacturer transition from NP to NA swabs in the Panbio Ag-RDT kit, to our knowledge, there are no published data comparing the two collection methods using this kit, and Ag-RDT performance data in asymptomatic populations are limited ( 6 , 8 , 12 – 15 ). The primary goal of this evaluation was to directly compare the performance of NP and NA swab collections for use with the Panbio Ag-RDT in community-based testing of asymptomatic individuals.…”

Section: Introductionmentioning

confidence: 99%

Comparison between Nasal and Nasopharyngeal Swabs for SARS-CoV-2 Rapid Antigen Detection in an Asymptomatic Population, and Direct Confirmation by RT-PCR from the Residual Buffer

et al. 2022

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Section: Introductionmentioning

confidence: 99%

Comparison between Nasal and Nasopharyngeal Swabs for SARS-CoV-2 Rapid Antigen Detection in an Asymptomatic Population, and Direct Confirmation by RT-PCR from the Residual Buffer

et al. 2022

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“…Discussion | The overall rate of false-positive results among the total rapid antigen test screens for SARS-CoV-2 was very low, consistent with other, smaller studies. 3 The cluster of falsepositive results from 1 batch was likely the result of manufacturing issues rather than implementation. 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.…”

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confidence: 99%

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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“…In a healthcare setting, a high false positive rate may put undue pressure on health systems through the number of staff having to isolate. 48 In contrast, false negative results may enable a SARS-CoV-2-infected person to get on an airplane or attend a mass event.…”

Section: Discussionmentioning

confidence: 99%

Use cases for COVID-19 screening and surveillance with rapid antigen-detecting tests: a systematic review

Anand

Bigio

MacLean

et al. 2021

Preprint

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IntroductionTesting is critical to controlling the COVID-19 pandemic. Antigen-detecting rapid diagnostic tests (Ag-RDTs) that can be used at the point of care have the potential to increase access to COVID-19 testing, particularly in settings with limited laboratory capacity. This systematic review synthesized literature on specific use cases and performance of Ag-RDTs for detecting SARS-CoV-2, for the first comprehensive assessment of Ag-RDT use in real-world settings.MethodsWe searched three databases (PubMed, EMBASE and medRxiv) up to 12 April 2021 for publications on Ag-RDT use for large-scale screening, irrespective of symptoms, and surveillance of COVID-19, excluding studies of only presumptive COVID-19 patients. We tabulated data on the study setting, populations, type of test, diagnostic performance and operational findings. We assessed risk of bias using QUADAS-2 and an adapted tool for prevalence studies.ResultsFrom 4313 citations, 39 studies conducted in asymptomatic and symptomatic adults were included. Study sample sizes varied from 40 to >5 million. Of 39 studies, 37 (94.9%) investigated lateral flow Ag-RDTs and two (5.1%) investigated multiplex sandwich chemiluminescent enzyme immunoassay Ag-RDTs. Six categories of testing (screening/surveillance) initiatives were identified: mass screening (n=13), targeted screening (n=11), healthcare entry testing (n=6), at-home testing (n=4), surveillance (n=4) and prevalence survey (n=1). Across studies, Ag-RDT sensitivity varied from 40% to 100%. Ag-RDTs were noted as convenient, easy-to-use and low cost, with a rapid turnaround time and high user acceptability. Risk of bias was generally low or unclear across the studies.ConclusionThis systematic review demonstrates the use of Ag-RDTs across a wide range of real-world settings for screening and surveillance of COVID-19 in both symptomatic and asymptomatic individuals. Ag-RDTs were overall found to be easy-to-use, low cost and rapid tools, when consideration is given to their implementation and interpretation. The review was funded by FIND, the global alliance for diagnostics.SUMMARYWhat is already known?Antigen-detecting rapid diagnostic tests (Ag-RDTs) have the potential to substantially improve access to timely testing for COVID-19 and are being deployed in a variety of settings around the worldWhile studies have investigated the diagnostic accuracy of Ag-RDTs, less is known about how and in what settings Ag-RDTs are being used around the world and their performance in these different settingsWhat are the new findings?Ag-RDTs are being used in a diverse range of real-world settings for mass screening and surveillance of COVID-19 among symptomatic and asymptomatic individualsThe sensitivity of Ag-RDTs is variable - ranging from 40% to 100% - and in some cases low compared with RT-PCR, meaning that the value of testing with Ag-RDTs needs to be carefully evaluated for each use case taking into account factors such as the prevalence of COVID-19 in the population, the consequences of false positive or false negative results, and whether confirmatory testing of positive or negative Ag-RDT results with RT-PCR is requiredNevertheless, Ag-RDTs are generally reported as being easy to use and low cost, with a rapid turnaround time that enables timely identification of cases and subsequent interventions to prevent onward transmission of COVID-19What do the new findings imply?The evidence indicates that Ag-RDTs can be effectively deployed across a broad range of settings when consideration is given to how they are implemented and interpretedThe development of more detailed, evidence-based testing policies for Ag-RDTs will be important to help countries implement effective testing programmes and make the best use of Ag-RDTs as part of the COVID-19 testing toolkit

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Multicenter Postimplementation Assessment of the Positive Predictive Value of SARS-CoV-2 Antigen-Based Point-of-Care Tests Used for Screening of Asymptomatic Continuing Care Staff

Cited by 20 publications

References 20 publications

Comparison between Nasal and Nasopharyngeal Swabs for SARS-CoV-2 Rapid Antigen Detection in an Asymptomatic Population, and Direct Confirmation by RT-PCR from the Residual Buffer

Comparison between Nasal and Nasopharyngeal Swabs for SARS-CoV-2 Rapid Antigen Detection in an Asymptomatic Population, and Direct Confirmation by RT-PCR from the Residual Buffer

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

Use cases for COVID-19 screening and surveillance with rapid antigen-detecting tests: a systematic review

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