Performance of 22 Rapid Lateral Flow Tests for SARS-CoV-2 Antigen Detection and Influence of “Variants of Concern”: Implications for Clinical Use

Gourgeon, Aurélie; Soulier, Alexandre; Audureau, Étienne; Khouider, Souraya; Galbin, Arnaud; Langlois, Camille; Bouvier‐Alias, Magali; Rodriguez, Christophe; Chevaliez, Stéphane; Pawlotsky, Jean‐Michel; Fourati, Slim

doi:10.1128/spectrum.01157-22

Cited by 9 publications

(13 citation statements)

References 16 publications

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“…Thirdly, the correlation between RAT results and cell culture/subgenomic RNA results may differ for other commercial SARS-CoV-2 RAT kits. In two independent evaluation studies, the RAT from the same manufacturer (Humasis Co., South Korea), although not the at-home kit used in this study, showed similar sensitivities compared to RATs from other manufacturers, but with lower specificity, from 72.8 to 79.0% (34,35). Such low specificity may raise concerns about an increased risk for false positives.…”

Section: Discussionmentioning

confidence: 67%

Daily, self-test rapid antigen test to assess SARS-CoV-2 viability in de-isolation of patients with COVID-19

et al. 2022

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BackgroundIsolation of COVID-19 patients is a crucial infection control measure to prevent further SARS-CoV-2 transmission, but determining an appropriate timing to end the COVID-19 isolation is a challenging. We evaluated the performance of the self-test rapid antigen test (RAT) as a potential proxy to terminate the isolation of COVID-19 patients.Materials and methodsSymptomatic COVID-19 patients were enrolled who were admitted to a regional community treatment center (CTC) in Seoul (South Korea). Self-test RAT and the collection of saliva samples were performed by the patients, on a daily basis, until patient discharge. Cell culture and subgenomic RNA detection were performed on saliva samples.ResultsA total of 138 pairs of saliva samples and corresponding RAT results were collected from 34 COVID-19 patients. Positivity of RAT and cell culture was 27% (37/138) and 12% (16/138), respectively. Of the 16 culture-positive saliva samples, seven (43.8%) corresponding RAT results were positive. Using cell culture as the reference standard, the overall percent agreement, percent positive agreement, and percent negative agreement of RAT were 71% (95% CI, 63–78), 26% (95% CI, 12–42), and 82% (95% CI, 76–87), respectively. The sensitivity, specificity, positive predictive value, and negative predictive value of the RAT for predicting culture results were 44% (95% CI, 20–70), 75% (95% CI, 66–82), 18% (95% CI, 8–34), and 91% (95% CI, 84–96), respectively.ConclusionAbout half of the patients who were SARS-CoV-2 positive based upon cell culture results gave negative RAT results. However, the remaining positive culture cases were detected by RAT, and RAT showed relatively high negative predictive value for viable viral shedding.

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Section: Discussionmentioning

confidence: 67%

Daily, self-test rapid antigen test to assess SARS-CoV-2 viability in de-isolation of patients with COVID-19

et al. 2022

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“…The RAT kits are simple and reliable on-site testing tools used for the rapid (less than 30 min) detection of SARS-CoV-2 infection from self-collected nasal swabs [ 11 ]. A previous study reported a similar performance between self-collected and healthcare-worker-collected samples [ 9 ].…”

Section: Discussionmentioning

confidence: 99%

“…Unlike rRT-PCR, the rapid lateral flow test employs direct detection methods, is easy to perform (and does not need to be performed by healthcare workers), and yields results within 30 min [ 11 ]. However, rapid lateral flow tests for the detection of antigens are considered less sensitive and less specific than rRT-PCR [ 12 ].…”

Section: Introductionmentioning

confidence: 99%

“…To overcome these limitations, various signal-amplified methods have been used for the sensitive detection of antigens in rapid lateral flow tests, including chemical enhancement, surface-enhanced Raman scattering, and fluorescence, as well as photothermal, electrochemical, and magnetic reactions [ 13 ]. Numerous studies have evaluated the sensitivity and reliability of the commercially available rapid antigen test (RAT) kits for SARS-CoV-2 detection [ 11 , 14 , 15 ]. However, only a few studies have analyzed the specificity of RATs for other respiratory viruses and SARS-CoV-2 variants or compared the results with the cycle threshold (Ct) values obtained from rRT-PCR assays [ 12 , 16 ].…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of Four Rapid Antigen Tests for the Detection of SARS-CoV-2 Infection with Nasopharyngeal Swabs

Lim

Park²,

Baek³

et al. 2023

Biomedicines

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Owing to the high transmissibility of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants, the capacity of testing systems based on the gold standard real-time reverse transcription–polymerase chain reaction (rRT-PCR) is limited. Rapid antigen tests (RATs) can substantially contribute to the prevention of community transmission, but their further assessment is required. Here, using 1503 nasopharyngeal swabs, we compared the diagnostic performance of four RAT kits (Abbott Panbio™ COVID-19 Ag Rapid Test, SD Biosensor Standard™ Q COVID-19 Ag Test, Humasis COVID-19 Ag Test, and SG Medical Acrosis COVID-19 Ag Test) to the cycle threshold (Ct) values obtained from rRT-PCR. The precision values, area under the curve values, SARS-CoV-2 variant detection ability, and non-SARS-CoV-2 specificity of all four kits were similar. An assay using the Acrosis kit had a significantly better positive detection rate with a higher recall value and cut-off value than that using the other three RAT kits. During the current COVID-19 pandemic, the Acrosis kit is an effective tool to prevent the spread of SARS-CoV-2 in communities.

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“…Rapid antigen tests identify particular viral proteins (as antigens) during the viral life cycle using anti‐SARS‐COV‐2 monoclonal antibodies within 15–30 minutes 22 Many RAT kits have shown a successful performance owing to the conserved structure of the N protein of SARS‐COV‐2 as the target 23 . Different types of chromatography‐based SARS‐COV‐2 antigen tests are available such as enzyme immunoassays (EIAs), 24 fluorescent immunoassays (FIAs), 25 and chemiluminescence enzyme immunoassays (CLEIAs), which are laboratory‐based methods, 26 and rapid lateral‐flow immunoassays (LFIAs) 26 . Lateral flow device (LFD) immunoassays are routinely used for healthcare applications during epidemic waves 27 .…”

Section: Introductionmentioning

confidence: 99%

Clinical performance of rapid antigen tests in comparison to RT‐PCR for SARS‐COV‐2 diagnosis in Omicron variant: A systematic review and meta‐analysis

Mohammadie

Akhlaghi

Samaeinasab

et al. 2023

Reviews in Medical Virology

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The Omicron variant of concern has a high level of mutations in different genes that has raised awareness about the performance of immunological products such as vaccines and antigen detection kits. In this systematic review and meta-analysis, we investigated whether Omicron had a significant influence on rapid antigen test (RAT) performance in comparison to PCR. We registered this systematic review and meta-analysis in PROSPERO with the registration number CRD42022355510. We searched PubMed, Scopus, Embase, and Web of Science databases systematically to 1 August 2022. After article screening, we assessed the quality of the included studies based on the JBI checklist. Following data extraction, we performed a metaanalysis using R software. We included 18 qualified articles presenting sufficient data about RATs performance in comparison to RT-PCR in Omicron infections. The pooled specificity and sensitivity of RATs were 1.000 (0.997-1.000) and 0.671 (0.595-0.721), respectively. The FDA-approved kits showed a better performance than WHO-approved ones with a sensitivity of 0.728 (0.620-0.815). The use of RATs with nasal swabs showed a higher sensitivity compared with nasopharyngeal swabs. The sensitivity for samples with a CT-value >25 was 0.108 (0.048-0.227). Rapid antigen tests show impaired performance for COVID-19 diagnosis when theOmicron variant is circulating, particularly in samples with low viral loads.

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Performance of 22 Rapid Lateral Flow Tests for SARS-CoV-2 Antigen Detection and Influence of “Variants of Concern”: Implications for Clinical Use

Abstract: The use of lateral-flow tests (LFTs) to detect SARS-CoV-2 has expanded worldwide. LFTs detect SARS-CoV-2 viral antigen and are less sensitive than nucleic acid amplification testing (NAAT).

Cited by 9 publications

References 16 publications

Daily, self-test rapid antigen test to assess SARS-CoV-2 viability in de-isolation of patients with COVID-19

Daily, self-test rapid antigen test to assess SARS-CoV-2 viability in de-isolation of patients with COVID-19

Evaluation of Four Rapid Antigen Tests for the Detection of SARS-CoV-2 Infection with Nasopharyngeal Swabs

Clinical performance of rapid antigen tests in comparison to RT‐PCR for SARS‐COV‐2 diagnosis in Omicron variant: A systematic review and meta‐analysis

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