Rapid antigen testing and non-infectious shedding of SARS-Cov2

Weiss, Günter; Bellmann‐Weiler, Rosa

doi:10.1007/s15010-020-01570-w

Cited by 8 publications

(8 citation statements)

References 5 publications

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“…There is a growing number of studies suggesting that although antigen detection is less analytically sensitive than nucleic acid amplification techniques, it may strongly correlate with culturable virus, which may be a proxy for transmissibility. Hence Ag-RDTs could be informative for test, trace, isolate processes for the most infectious individuals [10][11][12][13][14][15] . Viral loads have been estimated to range from 10 8 to 10 11 gcn/ml in the most infectious patients [34][35][36] .…”

Section: Discussionmentioning

confidence: 99%

Limit of detection in different matrices of 19 commercially available rapid antigen tests for the detection of SARS-CoV-2

Cubas-Atienzar

Kontogianni

Edwards

et al. 2021

Sci Rep

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In the context of the coronavirus disease 2019 (COVID-19) pandemic there has been an increase of the use of antigen-detection rapid diagnostic tests (Ag-RDT). The performance of Ag-RDT vary greatly between manufacturers and evaluating their analytical limit of detection (LOD) has become high priority. Here we describe a manufacturer-independent evaluation of the LOD of 19 marketed Ag-RDT using live SARS-CoV-2 spiked in different matrices: direct culture supernatant, a dry swab, and a swab in Amies. Additionally, the LOD using dry swab was investigated after 7 days’ storage at − 80 °C of the SARS-CoV-2 serial dilutions. An LOD of ≈ 5.0 × 102 pfu/ml (1.0 × 106 genome copies/ml) in culture media is defined as acceptable by the World Health Organization. Fourteen of 19 Ag-RDTs (ActiveXpress, Espline, Excalibur, Innova, Joysbio, Mologic, NowCheck, Orient, PanBio, RespiStrip, Roche, Standard-F, Standard-Q and Sure-Status) exceeded this performance criteria using direct culture supernatant applied to the Ag-RDT. Six Ag-RDT were not compatible with Amies media and a decreased sensitivity of 2 to 20-fold was observed for eleven tests on the stored dilutions at − 80 °C for 7 days. Here, we provide analytical sensitivity data to guide appropriate test and sample type selection for use and for future Ag-RDT evaluations.

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Section: Discussionmentioning

confidence: 99%

Limit of detection in different matrices of 19 commercially available rapid antigen tests for the detection of SARS-CoV-2

Cubas-Atienzar

Kontogianni

Edwards

et al. 2021

Sci Rep

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“…As an approximate LoD of 10 6 copies/ml has been proposed as the minimal analytical sensitivity by the WHO or the Department of Health and Social Care from the United Kingdom (Department of Health and Social Care, 2020; WHO & R&D Blue Print, 2020), only SD-Biosensor and Certest RDAgTs evaluated in this study accomplished that requirement. Moreover, as the viral load is a dynamic parameter that may grow exponentially during the incubation period, our results would support the use of either Certest or SD-Biosensor over Rapigen RDAgTs (Avanzato et al, 2020;Kawasuji et al, 2020;Kleiboeker et al, 2020;Lavezzo et al, 2020;Pekosz et al, 2021;Singanayagam et al, 2020;Walsh et al, 2020;Weiss and Bellmann-Weiler, 2021). Additionally, we call attention to the variability of sensitivity and specificity among the two labs involved in this evaluation study.…”

Section: Discussionmentioning

confidence: 52%

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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“…There is a growing number of studies suggesting that although antigen detection is less analytically sensitive than nucleic acid ampli cation techniques, it may strongly correlate with culturable virus, which may be a proxy for transmissibility. Hence Ag-RDTs could be informative for test, trace, isolate processes for the most infectious individuals [10][11][12][13][14][15] . Viral loads have been estimated to range from 10 8 to 10 11 gcn/ml in the most infectious patients [34][35][36] .…”

Section: Discussionmentioning

confidence: 99%

“…Ag-RDTs are less sensitive than RT-PCR, but clinical evaluation data is emerging that demonstrates Ag-RDTs are accurate at detecting the vast majority of individuals with a high-viral load (cycle threshold (Ct) on RT-PCR ≤ 25.0 or >10 6 genomic virus copies/ml) 7,[10][11][12][13][14][15][16] . In addition, in outbreak scenarios, a diagnostic test with lower sensitivity but a fast result enables quick interventions such as self-isolation and isolating contacts of cases 17 .…”

Section: Introductionmentioning

confidence: 99%

Limit of detection in different matrices of nineteen commercially available rapid antigen tests for the detection of SARS-CoV-2

Kontogianni

Edwards

Wooding

et al. 2021

Preprint

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In the context of the coronavirus disease 2019 (COVID-19) pandemic there has been an increase of the use of antigen-detection rapid diagnostic tests (Ag-RDT). The performance of Ag-RDT vary greatly between manufacturers and evaluating their analytical limit of detection (LOD) has become high priority. Here we describe a manufacturer-independent evaluation of the LOD of 19 marketed Ag-RDT using live SARS-CoV-2 spiked in different matrices: direct culture supernatant, a dry swab, and a swab in Amies. Additionally, the LOD using dry swab was investigated after 7 days’ storage at -80°C of the SARS-CoV-2 serial dilutions. An LOD of ≈ 5.0 x 102 pfu/ml (1.0 x 106 genome copies/ml) in culture media is defined as acceptable by the World Health Organization. Fourteen of nineteen Ag-RDTs (ActiveXpress, Espline, Excalibur, Innova, Joysbio, Mologic, NowCheck, Orient, PanBio, RespiStrip, Roche, Standard-F, Standard-Q and Sure-Status) exceeded this performance criteria using direct culture supernatant applied to the Ag-RDT. Six Ag-RDT were not compatible with Amies media and a decreased sensitivity of 2 to 20-fold was observed for eleven tests on the stored dilutions at -80°C for 7 days. Here, we provide analytical sensitivity data to guide appropriate test and sample type selection for use and for future Ag-RDT evaluations. 201/200

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Rapid antigen testing and non-infectious shedding of SARS-Cov2

Cited by 8 publications

References 5 publications

Limit of detection in different matrices of 19 commercially available rapid antigen tests for the detection of SARS-CoV-2

Limit of detection in different matrices of 19 commercially available rapid antigen tests for the detection of SARS-CoV-2

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

Limit of detection in different matrices of nineteen commercially available rapid antigen tests for the detection of SARS-CoV-2

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