Clinical Evaluation of Roche SD Biosensor Rapid Antigen Test for SARS-CoV-2 in Municipal Health Service Testing Site, the Netherlands

Igloi, Zsá1⁄2fia; Velzing, Jans; Beek, Janko van; Vijver, David van de; Aron, Georgina I.; Ensing, Roel; Benschop, Kimberley; Han, Wanda G. H.; Boelsums, Timo; Koopmans, Marion; GeurtsvanKessel, Corine; Molenkamp, Richard

doi:10.3201/eid2705.204688

Cited by 86 publications

(100 citation statements)

References 7 publications

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“…Furthermore, when we compared qRT-PCR results from nasopharyngeal swabs of patients in which viral culture was performed (from corresponding lung tissue swabs of an additional cohort), cultivability was restricted to cases with C t values < 23.7, which is below the threshold of false-negative RAT cases (C t values > 25.8; Figure , panels B, C). These results are in line with most clinical RAT studies that also used virus culture ( 2 – 4 , 6 ), in which cultivability is exceedingly rare in cases with low viral loads determined with qRT-PCR. We used cultivation from lung tissue swab specimens for this analysis because the lung often shows increased SARS-CoV-2 loads in deceased patients ( 7 ; Appendix Table 2) and therefore represents a major infection source during autopsy.…”

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confidence: 86%

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Rapid Antigen Test for Postmortem Evaluation of SARS-CoV-2 Carriage

Zacharias¹,

Stangl²,

Thüringer³

et al. 2021

Emerg. Infect. Dis.

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supporting

confidence: 86%

“…Rapid antigen tests (RATs) have recently been approved and are now widely used in the current coronavirus disease (CO-VID-19) pandemic (1). Although the performance of RATs has been evaluated extensively in clinics (2)(3)(4), data on postmortem testing are still lacking (5).…”

mentioning

confidence: 99%

Rapid Antigen Test for Postmortem Evaluation of SARS-CoV-2 Carriage

Zacharias¹,

Stangl²,

Thüringer³

et al. 2021

Emerg. Infect. Dis.

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“…The copyright holder for this this version posted August 1, 2021. ; https://doi.org/10.1101/2021.07.29.21261314 doi: medRxiv preprint Jegerlehner et al, 2021;Iglòi et al, 2021;Bekliz et al, 2021;Cubas-Atienzar et al, 2021, Haage et al, and more). Corman and colleagues determined 95% limits of detection for each AgPOCT using 138 SARS-CoV-2 positive clinical samples with viral loads ranging from 1.9*10⁴ to 1.8*10⁹ genome copies per ml.…”

Section: Discussionmentioning

confidence: 99%

Rapid comparative evaluation of SARS-CoV-2 rapid point-of-care antigen tests

Denzler

Jacobs

Witte

et al. 2021

Preprint

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Background: Currently, more than 500 different AgPOCTs for SARS-CoV-2 diagnostics are on sale, for many of which no data about sensitivity other than self-acclaimed values by the manufacturers are available. In many cases these do not reflect real-life diagnostic sensitivities. Therefore, manufacturer-independent quality checks of available AgPOCTs are needed, given the potential implications of false-negative results. Objective: The objective of this study was to develop a scalable approach for direct comparison of the analytical sensitivities of commercially available SARS-CoV-2 antigen point-of-care tests (AgPOCTs) in order to rapidly identify poor performing products. Methods: We present a methodology for quick assessment of the sensitivity of SARS-CoV-2 lateral flow test stripes suitable for quality evaluation of many different products. We established reference samples with high, medium and low SARS-CoV-2 viral loads along with a SARS-CoV-2 negative control sample. Test samples were used to semi-quantitatively assess the analytical sensitivities of 32 different commercial AgPOCTs in a head-to-head comparison. Results: Among 32 SARS-CoV-2 AgPOCTs tested, we observe sensitivity differences across a broad range of viral loads (~7.0*10⁸ to ~1.7*10⁵ SARS-CoV-2 genome copies per ml). 23 AgPOCTs detected the Ct25 test sample (~1.4*10⁶ copies/ ml), while only five tests detected the Ct28 test sample (~1.7*10⁵ copies/ ml). In the low range of analytical sensitivity we found three saliva spit tests only delivering positive results for the Ct21 sample (~2.2*10⁷ copies/ ml). Comparison with published data support our AgPOCT ranking. Importantly, we identified an AgPOCT offered in many local drugstores and supermarkets, which did not reliably recognize the sample with highest viral load (Ct16 test sample with ~7.0*10⁸ copies/ ml) leading to serious doubts in its usefulness in SARS-CoV-2 diagnostics. Conclusion: The rapid sensitivity assessment procedure presented here provides useful estimations on the analytical sensitivities of 32 AgPOCTs and identified a widely-spread AgPOCT with concerningly low sensitivity.

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“…Previous performance studies of rapid antigen tests in people with covid-19 symptoms found sensitivities of around 85% 11152122. We based our sample size calculation on an expected sensitivity of 80%, with a margin of error of 7%, type I error of 5%, and power of 90%.…”

Section: Methodsmentioning

confidence: 99%

Diagnostic accuracy of rapid antigen tests in asymptomatic and presymptomatic close contacts of individuals with confirmed SARS-CoV-2 infection: cross sectional study

Schuit

Veldhuijzen

Venekamp

et al. 2021

BMJ

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Objective To assess the diagnostic test accuracy of two rapid antigen tests in asymptomatic and presymptomatic close contacts of people with SARS-CoV-2 infection on day 5 after exposure. Design Prospective cross sectional study. Setting Four public health service covid-19 test sites in the Netherlands. Participants 4274 consecutively included close contacts (identified through test-and-trace programme or contact tracing app) aged 16 years or older and asymptomatic for covid-19 when requesting a test. Main outcome measures Sensitivity, specificity, and positive and negative predictive values of Veritor System (Beckton Dickinson) and Biosensor (Roche Diagnostics) rapid antigen tests, with reverse-transcriptase polymerase chain reaction (RT-PCR) testing as reference standard. The viral load cut-off above which 95% of people with a positive RT-PCR test result were virus culture positive was used as a proxy of infectiousness. Results Of 2678 participants tested with Veritor, 233 (8.7%) had a RT-PCR confirmed SARS-CoV-2 infection of whom 149 were also detected by the rapid antigen test (sensitivity 63.9%, 95% confidence interval 57.4% to 70.1%). Of 1596 participants tested with Biosensor, 132 (8.3%) had a RT-PCR confirmed SARS-CoV-2 infection of whom 83 were detected by the rapid antigen test (sensitivity 62.9%, 54.0% to 71.1%). In those who were still asymptomatic at the time of sampling, sensitivity was 58.7% (51.1% to 66.0%) for Veritor (n=2317) and 59.4% (49.2% to 69.1%) for Biosensor (n=1414), and in those who developed symptoms were 84.2% (68.7% to 94.0%; n=219) for Veritor and 73.3% (54.1% to 87.7%; n=158) for Biosensor. When a viral load cut-off was applied for infectiouness (≥5.2 log10 SARS-CoV-2 E gene copies/mL), the overall sensitivity was 90.1% (84.2% to 94.4%) for Veritor and 86.8% (78.1% to 93.0%) for Biosensor, and 88.1% (80.5% to 93.5%) for Veritor and 85.1% (74.3% to 92.6%) for Biosensor, among those who remained asymptomatic throughout. Specificities were >99%, and positive and negative predictive values were >90% and >95%, for both rapid antigen tests in all analyses. Conclusions The sensitivities of both rapid antigen tests in asymptomatic and presymptomatic close contacts tested on day 5 onwards after close contact with an index case were more than 60%, increasing to more than 85% after a viral load cut-off was applied as a proxy for infectiousness.

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Clinical Evaluation of Roche SD Biosensor Rapid Antigen Test for SARS-CoV-2 in Municipal Health Service Testing Site, the Netherlands

Cited by 86 publications

References 7 publications

Rapid Antigen Test for Postmortem Evaluation of SARS-CoV-2 Carriage

Rapid Antigen Test for Postmortem Evaluation of SARS-CoV-2 Carriage

Rapid comparative evaluation of SARS-CoV-2 rapid point-of-care antigen tests

Diagnostic accuracy of rapid antigen tests in asymptomatic and presymptomatic close contacts of individuals with confirmed SARS-CoV-2 infection: cross sectional study

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