Evaluation of six commercial SARS-CoV-2 rapid antigen tests in nasopharyngeal swabs: Better knowledge for better patient management?

Andréani, Julien; Lupo, Julien; Germi, Raphaële; Laugier, Christel; Roccon, Marie; Larrat, Sylvie; Morand, Patrice; Némoz, Benjamin

doi:10.1016/j.jcv.2021.104947

Cited by 11 publications

(14 citation statements)

References 28 publications

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“…Several studies have also evaluated the Panbio COVID-19 antigen (Ag) rapid test obtaining sensitivities ranging between 80% to 90% which increased above 95% when the C T value was lower than 25 ( 7 , 10 , 11 ). Although we observed a slightly low overall sensitivity (70%) like that obtained by Andreani et al ( 12 ), this finding was in line with our results. Despite that high sensitivities of the Roche SARS-CoV-2 rapid antigen test were first described in samples with a C T of <30 ( 13 ), the results obtained in our comparison were more similar with those observed recently (i.e., 95% to 100% only for C T values of <25) ( 5 , 14 ).…”

Section: Discussionsupporting

confidence: 93%

Diagnostic Performance of Six Rapid Antigen Tests for SARS-CoV-2

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Section: Discussionsupporting

confidence: 93%

Diagnostic Performance of Six Rapid Antigen Tests for SARS-CoV-2

et al. 2022

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“…However, the rapid antigen test provides less sensitivity and specificity than the RT-PCR technique. The lower sensitivity of rapid antigen kit tests is of paramount concern, and the sensitivity varies widely among different kit types and company brands ( 19 ). Despite these challenges, the specificity is higher in those patients with a higher viral load ( 19 ).…”

Section: Discussionmentioning

confidence: 99%

Utilization of rapid antigen tests for screening SARS-CoV-2 prior to dental treatment

Pittayapat

Trachoo

Jirachoksopon

et al. 2022

Front. Oral. Health

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Potential aerosols containing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral particles can be generated during dental treatment. Hence, patient triage is essential to prevent the spread of SARS-CoV-2 in dental clinical settings. The present study described the use of rapid antigen tests for SARS-CoV-2 screening prior to dental treatment in an academic dental clinical setting in Thailand during the pandemic. The opinions of dental personnel toward the use of rapid antigen test screening prior to dental treatment were also assessed. From August 25 to October 3, 2021, dental patients who were expected to receive aerosols generating dental procedures were requested to screen for SARS-CoV-2 using a rapid antigen test before their treatment. A total of 7,618 cases completed the screening process. The average was 212 cases per day. Only five patients (0.07%) were positive for SARS-CoV-2 in the rapid antigen screening tests. All positive cases exhibited mild symptoms. For the questionnaire study, experienced dental personnel frequently and consistently agreed with the use of the rapid antigen test for SARS-CoV-2 screening, which made them feel safer during their patient treatment. However, implementing rapid antigen tests for SARS-CoV-2 may increase the total time spent on a dental appointment. In conclusion, a rapid antigen test could detect the infected individual prior to dental treatment. However, the specificity of rapid antigen tests for SARS-CoV-2 must be taken into account for consideration as a screening process before dental treatment. The enhanced infection control protocols in dental treatment must be consistently implemented.

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“…Additionally, under a scenario like the COVID-19 pandemic, a reduction in sensitivity is acceptable as long as it comes with an increase in testing capacities, so the final output is a higher number of SARS-CoV-2 positive individuals detected ( Mina et al., 2020 ). RDAgTs would fulfill these requirements as they are fast, cheap, and accurate enough to allow massive and rapid detection and isolation of new cases to stop transmission chains and reduce the impact of COVID-19 ( World Health Organization (WHO), 2020 ; Andreani et al., 2021 ; Corman et al., 2021 ; Cubas-Atienzar et al., 2021 ; Lee et al., 2021 ; Pekosz et al., 2021 ; Weiss and Bellmann-Weiler, 2021 ).…”

Section: Introductionmentioning

confidence: 99%

“…Moreover, as vaccination programs have been progressing slowly in middle- and low-income countries, SARS-CoV-2 circulation is still happening very actively in those settings, threatening COVID-19 pandemic control and eradication through new SARS-CoV-2 variant appearances ( Dhawan et al., 2022 ). RDAgTs have the necessary features to improve effective SARS-CoV-2 surveillance programs in developing countries ( World Health Organization (WHO), 2020 ; Andreani et al., 2021 ; Corman et al., 2021 ; Lee et al., 2021 ; Pekosz et al., 2021 ; Weiss and Bellmann-Weiler, 2021 ). However, the clinical performance evaluation studies for RDAgTs have been done in high-income countries ( Albert et al., 2021 ; Andreani et al., 2021 ; Baro et al., 2021 ; Cerutti et al., 2020 ; Corman et al., 2021 ; Cubas-Atienzar et al., 2021 ; Iglὁi et al., 2021 ; Lee et al., 2021 ; Pérez-García et al., 2021 ; Pollock et al., 2021 ; Pray et al., 2021 ; Tinker et al., 2021 ; Weitzel et al., 2021 ).…”

Section: Introductionmentioning

confidence: 99%

“…RDAgTs have the necessary features to improve effective SARS-CoV-2 surveillance programs in developing countries ( World Health Organization (WHO), 2020 ; Andreani et al., 2021 ; Corman et al., 2021 ; Lee et al., 2021 ; Pekosz et al., 2021 ; Weiss and Bellmann-Weiler, 2021 ). However, the clinical performance evaluation studies for RDAgTs have been done in high-income countries ( Albert et al., 2021 ; Andreani et al., 2021 ; Baro et al., 2021 ; Cerutti et al., 2020 ; Corman et al., 2021 ; Cubas-Atienzar et al., 2021 ; Iglὁi et al., 2021 ; Lee et al., 2021 ; Pérez-García et al., 2021 ; Pollock et al., 2021 ; Pray et al., 2021 ; Tinker et al., 2021 ; Weitzel et al., 2021 ). It has been already reported that low-quality COVID-19 diagnosis products are commercialized in developing countries and genomic surveillance in those settings is limited, so the tracking of new mutations or variants of SARS-CoV-2 potentially compromises the sensitivity of RDAgTs for COVID-19 diagnosis ( Cota et al., 2020 ; Freire-Paspuel and Garcia-Bereguiain, 2020 ; Freire-Paspuel and Garcia-Bereguiain, 2021 ; Freire-Paspuel and Garcia-Bereguiain, 2021 ; Freire-Paspuel et al., 2021 ).…”

Section: Introductionmentioning

confidence: 99%

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Clinical Performance of Three Commercial SARS‐CoV‐2 Rapid Antigen Tests for Community-Dwelling Individuals in a Tropical Setting

Morales-Jadán

Viteri-Dávila

Castro-Rodriguez

et al. 2022

Front. Cell. Infect. Microbiol.

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During the second year of the COVID-19 pandemic, the use of Rapid Diagnosis Antigen Tests (RDAgTs) for SARS-CoV-2 detection has substantially increased as some of the brands available in the market were certified for clinical use by international regulatory agencies. RDAgTs are a fast and cheap tool for SARS-CoV-2 surveillance with great potential to improve testing capacities in middle- and low-income countries compared to the gold standard RT-qPCR. However, as the clinical performance of RDAgTs has been shown to vary greatly between the commercial brands available, evaluation studies are necessary. Moreover, the available evaluation has been done in high-income countries while SARS-CoV-2 transmission is also actively happening in developing countries, many of which are located in tropical latitudes where cross-reactivity with other infectious agents is highly prevalent, which could compromise RDAgT specificity. Moreover, unreported mutations and/or new SARS-CoV-2 variants may compromise RDAgT sensitivity as genomic surveillance is limited in these settings. Here we describe a multicenter and manufacturer‐independent evaluation of the clinical performance and analytical sensitivity of three different RDAgTs brands available in South America from three companies, Rapigen (South Korea), SD-Biosensor (South Korea), and Certest (Spain), compared to the gold standard RT-qPCR. A total number of 1,646 nasopharyngeal swabs from community-dwelling individuals were included in the study, and 379 of them were SARS-CoV-2 positive by RT-qPCR. The overall sensitivity for each RDAgT was 79% (IC95%: 72 - 86.2), 64.2% (IC95%: 56.7 - 71.6), and 45.8% (IC95%: 35.8 - 55.8) for SD-Biosensor, Certest, and Rapigen, respectively. The overall specificity for each RDAgT was 100%, 97.7% (IC95%: 96.8 - 98.6), and 100% for SD-Biosensor, Certest, and Rapigen, respectively. However, the limit of detection (LoD) to achieve a sensitivity over 90% was substantially lower for Certest RDAgT (102 copies/uL) compared to SD-Biosensor (103 copies/uL) or Rapigen (106 copies/uL) RDAgTs, considering that the gold standard RT-qPCR method used in this study has a high sensitivity of 97.7% and low LoD of 5 copies/uL. Additionally, the Certest RDAgT also showed an improved sensitivity up to 79.7% (IC95%: 70.2 – 89.2) for symptomatic individuals. Finally, the slight reduction in specificity for Certest RDAgTs was only associated with one of the laboratories performing this study, pointing out the need for locally assessed evaluation for RDAgTs like this one carried out in Ecuador. In conclusion, two of the three the RDAgTs tested in this study are a fast, cheap, and point of care tool for SARS-CoV-2 surveillance and reliable enough to detect SARS-CoV-2 infectious individuals.

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Evaluation of six commercial SARS-CoV-2 rapid antigen tests in nasopharyngeal swabs: Better knowledge for better patient management?

Cited by 11 publications

References 28 publications

Diagnostic Performance of Six Rapid Antigen Tests for SARS-CoV-2

Diagnostic Performance of Six Rapid Antigen Tests for SARS-CoV-2

Utilization of rapid antigen tests for screening SARS-CoV-2 prior to dental treatment

Clinical Performance of Three Commercial SARS‐CoV‐2 Rapid Antigen Tests for Community-Dwelling Individuals in a Tropical Setting

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