Evaluation of the accuracy, ease of use and limit of detection of novel, rapid, antigen-detecting point-of-care diagnostics for <i>SARS-CoV-2</i>

Krüger, Lisa J.; Gaeddert, Mary; Koeppel, Lisa; Brümmer, Lukas E.; Gottschalk, Claudius; Miranda, Isabel Barreto; Schnitzler, Paul; Kräusslich, Hans Georg; Lindner, Andreas; Nikolai, Olga; Mockenhaupt, Frank P.; Seybold, Joachim; Corman, Victor M.; Drosten, Christian; Pollock, Nira R.; Cubas-Atienzar, Ana I; Kontogianni, Konstantina; Collins, Andrea; Wright, A.; Knorr, Britta; Welker, Andreas; Vos, Margaretha de; Sacks, Jilian A.; Adams, Emily; Denkinger, Claudia M.

doi:10.1101/2020.10.01.20203836

Cited by 96 publications

(131 citation statements)

References 16 publications

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“…We found that test sensitivity was higher in samples that had high viral loads (Ct < 25), even in patients who were asymptomatic at the moment of testing (86.2%, 95% CI: 68.3%, 96.1%). This is an important finding because some asymptomatic individuals with SARS-CoV-2 infections (i.e., "super spreaders") might have a substantial impact on the spreading of this virus 19 (9). The Ag-RDT provides fast results, thus facilitating early identification, rapid isolation of the patient, and early contact tracing of highly contagious cases (10,11).…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the Panbio™ rapid antigen test for SARS-CoV-2 in primary health care centers and test sites

Bulilete

Lorente

Leiva

et al. 2020

Preprint

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BackgroundRapid antigen tests (Ag-RDT) are emerging as new diagnostic tools for COVID-19 and real-world evaluations are needed to establish their performance characteristics.Main objectiveTo evaluate the accuracy of the Panbio™ Ag-RDT at primary health care (PHC) centers and test sites in symptomatic patients and close contacts, using the Reverse-Transcription Polymerase Chain Reaction (RT-PCR) test as the gold standard.MethodsThis was a prospective diagnostic study conducted in four PHC centers and two test sites in Mallorca, Spain. Consecutive patients older than 18 years, attending the sites for RT-PCR testing either for suggestive symptoms of infection or a close contact, were included. Two nasopharyngeal samples were collected, one for RT-PCR and the other was processed on-site using the Panbio™ rapid antigen test kit for SARS-CoV-2. The sensitivity and specificity were calculated using RT-PCR as the reference, and the predictive values using the pretest probability results for each analyzed group.ResultsA total of 1369 participants were included; mean age 42.5 ± 14.9 years and 54.3% women. The overall prevalence was 10.2%. Most participants (70.6%) presented within 5 days of the onset of symptoms or close contact, and more than 70% had high viral loads. The overall sensitivity was of 71.4% (95% CI: 63.1%, 78.7%), the specificity of 99.8% (95% CI: 99.4%, 99.9%), the positive predictive value of 98.0% (95% CI: 93.0%, 99.7%) and a negative predictive value of 96.8% (95% CI: 95.7%, 97.7%). The sensitivity was higher in symptomatic patients, in those arriving within 5 days since symptom onset and in those with high viral load.ConclusionAg-RDT had relatively good performance characteristics in suspected symptomatic patients within five days since the onset of symptoms. However, our results concludes that a negative Ag-RDT in these settings must be considered as presumptive.

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Section: Discussionmentioning

confidence: 99%

Evaluation of the Panbio™ rapid antigen test for SARS-CoV-2 in primary health care centers and test sites

Bulilete

Lorente

Leiva

et al. 2020

Preprint

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“…The above estimate is consistent with the information provided by the manufacturer [13], stating 0.32% (0.01, 1.78) as a false positive rate -a very broad CI. The derived upper bound from the mass testing is more informative and appears relevant in that it constitutes the first (to the best of our knowledge) bound obtained from large scale practical use of Standard Q and also suggests (slightly) better performance of Standard Q compared to previous studies: [4] It is well understood in the epidemiology literature that imperfect reference criteria lead to a systematic bias of the true incidence [14]. Specifically, the sensitivity and specificity of tests are systematically underestimated if the criterium (SARS-CoV-2 infection) cannot be assessed directly and tests are compared to a surrogate criterion as gold standard which is subject to errors.…”

Section: Resultsmentioning

confidence: 74%

“…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: 62%

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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“…age-or risk groups. For antigen-based rapid diagnostic tests, we assumed that sensitivity kinetics resemble those of PCR, albeit with lower analytical sensitivity 41,74,75 . This approach was chosen because clinical data on the kinetics of RDT sensitivity is currently limited 76 .…”

Section: Discussionmentioning

confidence: 99%

COVIDStrategyCalculator: A software to assess testing- and quarantine strategies for incoming travelers, contact person management and de-isolation

Toorn

Bourquain

et al. 2020

Preprint

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In early 2020 COVID-19 turned into a global pandemic. Non-pharmaceutical interventions (NPIs), including the isolation of infected individuals, tracing and quarantine of exposed individuals are decisive tools to prevent onwards transmission and curb fatalities. Strategies that combine NPIs with SARS-CoV-2 testing may help to shorten quarantine durations while being non-inferior with respect to infection prevention. Thus, combined strategies can help reducing the socio-economic burden of SARS-CoV-2 and increase public acceptance.We developed a software that enables policy makers to calculate the reduction in transmissibility through quarantine or isolation in combination with arbitrary testing strategies. The user chooses between three different modi [(i) isolation of infected individuals, (ii) management of potentially infected contacts and (iii) quarantine of incoming travelers], while having flexibility in customizing testing strategies and model parameters. The software enables decision makers to tailor calculations specifically to their questions and perform an assessment ‘on the fly’, based on current evidence on infection dynamics.Underneath, we analytically solve a stochastic transit compartment model of the infection time course, which captures temporal changes in test sensitivities, incubation- and infectious periods, as well as times to symptom onset using its default parameters.Using default parameters, we estimated that testing travelers at the point of entry reduces the risk about 4.69 (4.19,4.83) fold for PCR vs. 3.59 (3.22, 3.69) fold for rapid diagnostic tests (RDT, 87% relative sensitivity) when combined with symptom screening. In comparison to 14 days of pure quarantine, 8 (PCR) vs. 10 (RDT) days of pre-test quarantine would be noninferior for incoming travelers as well as for contact person management. De-isolation of infected individuals 11 days after symptom onset reduces the risk by >99fold (7.68,>1012). This tool is freely available from: https://github.com/CovidStrategyCalculator/CovidStrategyCalculator

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Evaluation of the accuracy, ease of use and limit of detection of novel, rapid, antigen-detecting point-of-care diagnostics for SARS-CoV-2

Cited by 96 publications

References 16 publications

Evaluation of the Panbio™ rapid antigen test for SARS-CoV-2 in primary health care centers and test sites

Evaluation of the Panbio™ rapid antigen test for SARS-CoV-2 in primary health care centers and test sites

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

COVIDStrategyCalculator: A software to assess testing- and quarantine strategies for incoming travelers, contact person management and de-isolation

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