Urgent need of rapid tests for SARS CoV-2 antigen detection: Evaluation of the SD-Biosensor antigen test for SARS-CoV-2

Cerutti, Francesco; Burdino, Elisa; Milia, Maria Grazia; Allice, Tiziano; Gregori, Gabriella; Bruzzone, Bianca; Ghisetti, Valeria

doi:10.1016/j.jcv.2020.104654

Cited by 190 publications

(225 citation statements)

References 11 publications

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“…The main advantages of RAD tests are their rapidity, and their ease of interpretation, and the limited technical skill/infrastructure requirements. Moreover, the use of RAD tests in mass screening programs could decrease the burden on laboratories that have been overwhelmed during the last COVID-19 pandemics [ 9 ]. Nevertheless, it is important to keep in mind that even with a high viral load (i.e., Ct values <25), a RAD test can result in false-negative estimates in both symptomatic patients and asymptomatic subjects [ 12 , 13 , 17 , 20 , 21 , 22 , 23 ].…”

Section: Discussionmentioning

confidence: 99%

“…Head-to-head comparisons of AD test performance for SARS-CoV-2 detection are scarce. The majority of the studies only included few patients, precluding a wide characterization of the “real-life” performance of these devices [ 3 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 ]. Recently, a Cochrane study found an average sensitivity of only 56.2% (95% confidence interval (CI): 29.5–79.8%) for rapid AD (RAD) tests [ 11 ].…”

Section: Introductionmentioning

confidence: 99%

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Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection

Favresse

Gillot

Oliveira

et al. 2021

JCM

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(1) Background: The detection of SARS-CoV-2 RNA in nasopharyngeal samples through real-time reverse transcription-polymerase chain reaction (RT-PCR) is considered the standard gold method for the diagnosis of SARS-CoV-2 infection. Antigen detection (AD) tests are more rapid, less laborious, and less expensive alternatives but still require clinical validation. (2) Methods: This study compared the clinical performance of five AD tests, including four rapid AD (RAD) tests (biotical, Panbio, Healgen, and Roche) and one automated AD test (VITROS). For that purpose, 118 (62.8%) symptomatic patients and 70 (37.2%) asymptomatic subjects were tested, and results were compared to RT-PCR. (3) Results: The performance of the RAD tests was modest and allowed us to identify RT-PCR positive patients with higher viral loads. For Ct values ≤25, the sensitivity ranged from 93.1% (95% CI: 83.3–98.1%) to 96.6% (95% CI: 88.1–99.6%), meaning that some samples with high viral loads were missed. Considering the Ct value proposed by the CDC for contagiousness (i.e., Ct values ≤33) sensitivities ranged from 76.2% (95% CI: 65.4–85.1%) to 88.8% (95% CI: 79.7–94.7%) while the specificity ranged from 96.3% (95% CI: 90.8–99.0%) to 99.1% (95% CI: 95.0–100%). The VITROS automated assay showed a 100% (95% CI: 95.5–100%) sensitivity for Ct values ≤33, and had a specificity of 100% (95% CI: 96.6–100%); (4) Conclusions: Compared to RAD tests, the VITROS assay fully aligned with RT-PCR for Ct values up to 33, which might allow a faster, easier and cheaper identification of SARS-CoV-2 contagious patients.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection

Favresse

Gillot

Oliveira

et al. 2021

JCM

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“…Numerous commercial assays are now available [ 5 ], but there are limited data on their clinical performance. Based on previous studies, the sensitivity of SARS-CoV-2 Ag-RDTs range between 22.9% and 93.9% when compared to rRT-PCR [ 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 ]. Apart from sensitivity, it is important that such tests identify potentially contagious individuals to reduce SARS-CoV-2 transmission.…”

Section: Introductionmentioning

confidence: 99%

The Comparative Clinical Performance of Four SARS-CoV-2 Rapid Antigen Tests and Their Correlation to Infectivity In Vitro

Kohmer

Toptan

Pallas

et al. 2021

JCM

150

140

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Due to globally rising numbers of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections, resources for real-time reverse-transcription polymerase chain reaction (rRT-PCR)-based testing have been exhausted. In order to meet the demands of testing and reduce transmission, SARS-CoV-2 antigen-detecting rapid diagnostic tests (Ag-RDTs) are being considered. These tests are fast, inexpensive, and simple to use, but whether they detect potentially infectious cases has not been well studied. We evaluated three lateral flow assays (RIDA®QUICK SARS-CoV-2 Antigen (R-Biopharm), SARS-CoV-2 Rapid Antigen Test (Roche)), and NADAL® COVID-19 Ag Test (Nal von Minden GmbH, Regensburg, Germany) and one microfluidic immunofluorescence assay (SARS-CoV-2 Ag Test (LumiraDx GmbH, Cologne, Germany)) using 100 clinical samples. Diagnostic rRT-PCR and cell culture testing as a marker for infectivity were performed in parallel. The overall Ag-RDT sensitivity for rRT-PCR-positive samples ranged from 24.3% to 50%. However, for samples with a viral load of more than 6 log10 RNA copies/mL (22/100), typically seen in infectious individuals, Ag-RDT positivity was between 81.8% and 100%. Only 51.6% (33/64) of the rRT-PCR-positive samples were infectious in cell culture. In contrast, three Ag-RDTs demonstrated a more significant correlation with cell culture infectivity (61.8–82.4%). Our findings suggest that large-scale SARS-CoV-2 Ag-RDT-based testing can be considered for detecting potentially infective individuals and reducing the virus spread.

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“…In this note we consider the specificity of the SD Biosensor Standard Q Ag-Test based on data of mass tests in Slovakia and infer Ag-Test specificity from a large sample of the general population. This is in contrast to other studies which use a PCR-test as a reference to estimate sensitivity and specificity of an Ag-test [4][5][6][7].…”

Section: Aimmentioning

confidence: 63%

Analysis of the specificity of the SD Biosensor Standard Q Ag-Test based on Slovak mass testing data

Hledík

Polechová²,

Beiglboeck³

et al. 2020

Preprint

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From 31.10. - 1.11.2020 Slovakia has used the SD Biosensor Standard Q Ag-Test for nationwide tests for SARS-CoV-2, in which 3,625,332 persons from 79 counties were tested. Based on this data, we calculate that the specificity of the test is at least 99.6% (with a 97.5% one-sided lower confidence bound). Our analysis is based on a worst case approach in which all positives are assumed to be false positives. Therefore, the actual specificity is expected to exceed 99.6%.

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Urgent need of rapid tests for SARS CoV-2 antigen detection: Evaluation of the SD-Biosensor antigen test for SARS-CoV-2

Cited by 190 publications

References 11 publications

Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection

Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection

The Comparative Clinical Performance of Four SARS-CoV-2 Rapid Antigen Tests and Their Correlation to Infectivity In Vitro

Analysis of the specificity of the SD Biosensor Standard Q Ag-Test based on Slovak mass testing data

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