Weekly update – 9 new studies
During the last week, the BfArM approved the usage of certain Ag-RDTs for self-testing with nasal sampling at home. For one of these Ag-RDTs, the Standard Q by SD Biosensor / Roche (nasal sampling), manufacturer independent evaluations have already been published by our group (Nikolai, O., et al., 2021; Lindner, A.K., et al., 2020). For the Panbio by Abbott (nasal sampling), data also already exits also generated from our group (FINDdx, 2021a), but this test is not yet approved by the BfArM.
In addition, two head-to-head studies have been published, comparing Ag-RDTs that have not been evaluated before (Exdia COVID-19 Ag by Precision Biosensors, COVID-19 Rapid Antigen Test Cassette by SureScreen and SARS-CoV-2 Antigen Rapid Test Kit by Lepu Medical) with well-known Ag-RDTs such as the Panbio by Abbott (Baro, B., et al., 2021; Caruana, G., et al., 2021). Both studies underestimated the performance as samples were not collected according to manufacturer’s guidance and prediluted. Furthermore, there are three new studies from the Foundation of Innovative New Diagnsotics (FINDdx), evaluating the COVID-19 Antigen Rapid Test Kit by JOYSBIO Biotechnology (FINDdx, 2021e), the iChroma COVID-19 AG by Boditech Medical (FINDdx, 2021b) and the 2019-nCoV Antigen Test by Guangzhou Wondfo Biotech (FINDdx, 2021d). Finally, we also found one new study providing further data for the Standard Q test (Pena, M., et al., 2021).
Weekly update – 3 new studies
During the last week a study was published evaluating the accuracy of the Panbio by Abbott in a setting with considerable prevalence of the SARS-CoV-2 501Y.v2 (lineage B.1.351) mutation (Akingba, O.L., et al., 2021). Herein, the Panbio showed a sensitivity of 69.2% (95% CI 61.4-75.8).
In addition, two head-to-head studies were published. Within one, the Rapid COVID-19 Ag Test by Healgen and the VITROS® SARS-CoV-2 Ag Test by Ortho Clinical Diagnostics showed a better performance than both the Standard Q by SD Biosensor/Roche and the Panbio (Favresse, J., et al., 2021). The other study showed the COVID-19 SARS-CoV-2 Ag Test by LumiraDx to have a higher sensitivity than the Standard Q (Kohmer, N., et al.). It is of note that both studies reported a comparably low sensitivity across all tests.
Weekly update – Data from the Swiss Public Health Authority + 6 new studies
Within the course of the last week, the Federal Public Health authority in Switzerland released a list of Ag-RDTs they find to be appropriate for use at the point of care based on manufacturer independent evaluations (Schweizer Bundesamt für Gesundheit, 2021). The list can be found following this link at the end of the paragraph. It is of note that all tests mentioned on this list recommend the use of nasopharyngeal swabs only.
In addition, we found 6 new studies published. Herein, three studies provided new data for Ag-RDTs that had only been evaluated to a limited extent before: the CLINITEST by Siemens Healthineers (Torres, I., et al. 2021), the INNOVA by Innova Medical Group (Houston, H., et al. 2021) and the Lumipulse by Fujirebio (Menchinelli, G., et al. 2021). Finally, further data was added with regards to the Panbio by Abbott (Ngo Nsoga, M.T., et al. 2021), Standard Q by SD Biosensor/Roche (Kannian, P., et al. 2021) and the COVID-19 Ag respi strip by Coris (Ciotti, M., et al. 2021).
Weekly update – 1 new study
The only study that was published during the last week evaluates the Abbott BinaxNOW [James, A.E., et al. 2021] and was performed on symptomatic and asymptomatic health care workers in the US. The interesting aspect about this study is also that the results were compared to viral culture, the better comparison for virus viability and thus transmissibility. In symptomatic patients with positive virus culture the study detected 92.6% to be Ag-RDT positive, while only in 64.2% when compared against PCR. This shows the problem with PCR as a reference standard for Ag-RDT. The results can be found in the main table on our home page.
Weekly update – 5 new studies
During the last week we found 5 new studies (Halfon, P., et al. 2021; Möckel, M., et al. 2021; Osterman, A., et al. 2021; Peto, T., et al. 2021; Prince-Guerra, J.L., et al. 2021). One study was the first to report on a new test called Innova, which is widely used in the UK (Peto, T., et al. 2021). Another study assessed the accuracy of the BinaxNOW by Abbott (Prince-Guerra, J.L., et al. 2021). The remaining studies added further data to evaluations of the Standard F, Standard Q and Panbio (Halfon, P., et al. 2021; Möckel, M., et al. 2021; Osterman, A., et al. 2021)
Weekly update – 4 new studies
Since the last post, we have updated the website with 4 new studies [55, 62, 63, 64]. Two studies provided data on tests that had not been evaluated before: the COVID-19 Ag test by EcoDiagnostica  and the Salocor SARS-CoV-2 Antigen by Salofa Ltd . Another evaluation adds further data for the Roche / SD Biosensor, Standard Q test  and compares the test’s performance to a test by the same manufacturer specifically designed for anterior nasal samples. In addition, the already announced study evaluating the BinaxNOW test by Abbott is now available .
Finally, as you might have noticed, we did not share a weekly update last week. This was due to an alignment of our schedule for updating the website with the rhythm in which we provide the same data to the Foundation for Innovative New Diagnostics (FIND). As this has been solved, we will now resume with the weekly updates.
Weekly update – 4 new studies
Since Christmas, 4 new studies evaluating the accuracy of Ag-RDTs have been published [58, 59, 60, 61]. The first provides new data on the sensitivity of the NADAL test by Nal van minden . The second evaluated the Lumipulse G. This Ag-RDT can be used for both saliva and nasopharyngeal samples, but not at the point of care . In addition, there is also data on QuickNavi, a new test from Japan . Finally, a new analytical study has come out providing further details on the LOD of multiple Ag-RDTs and also assessing their performance in a high-temperature environment .
Weekly update – 1 new study and end of year planning
During the past week, one new study has been published. This analytical study is the first to evaluate the Abbott, BinaxNOW test and determined its limit of detection in a laboratory environment . Note that the BinaxNOW is the US Version of the Abbott Panbio (with slight changes in design and operation). We are also expecting the first clinical study evaluating the Abbott, BinaxNOW to come out soon .
For the final weeks of this year, we will update our website once more on the December 22nd. We will also post a new blog entry summarizing what has happened during the Christmas breaks in the first week of January 2021. Until then, we wish you all a merry Christmas and a good start into the new year. Stay safe and healthy!
Weekly update – 6 new studies
Out of the 6 new studies published on Ag-RDTs during the last week, 4 were clinical evaluations [49, 51, 53, 54]. One of these included the first clinical evaluation of the Siemens CLINITEST . However, this study shows methodological shortcomings that have very likely affected the reported sensitivity. In addition to the 4 clinical evaluations, another study evaluated the use of the Abbott, Panbio as a monitoring tool . Furthermore, new data was published comparing the accuracy of professional-collected anterior nasal versus nasopharyngeal swab using the Roche / SD Biosensor, Standard Q .
New evaluation from the Paul-Ehrlich-Institute
The Paul-Ehrlich-Institute (PEI, Federal Institute for Vaccines and Biomedicines) has conducted a large scale-study with contrived samples to assess the sensitivity of more than 20 Ag-RDTs. Based on this study, they have published a list of Ag-RDTs that they consider to perform to the current state of the art. This list does not contain any concrete values nor are the tests’ specificity taken into account, but it will be updated as the study continues. It can be found following this link.
Weekly update – 3 new studies and English language
During the past week, 3 new studies have been published [45, 46, 47]. These studies provide further evaluations of the Abbott, Panbio and the Roche / SD Biosensor, Standard Q test. In one of these studies, it is interesting to observe the assays sensitivity early in the disease . As expected, the antigen test was missing infections early on in infection, when viral loads are rising rapidly. In addition to the new studies, we have also upgraded the website – as you might have already noticed reading this post, going forward everything will be in English ;-) We have done this upon request from the federal ministry of health (BMG), in order to allow others to benefits from the work.
Wöchentliches Update – 7 neue Studien
Innerhalb der letzten Woche wurden 6 neue Evaluationen veröffentlicht [39, 40, 41, 42, 43, 44]. Hierbei gibt es unter anderem neue Daten zu den sonst eher selten evaluierten Tests AAZ, COVID-VIRO und Quidel, Sofia SARS Antigen FIA. Des Weiteren wurden schon früher veröffentlichte Rohdaten einer Evaluation von Abbott, Panbio und SD Biosensor / Roche, Standard Q als komplettes Paper auf medRxiv hochgeladen . Die Ergebnisse aller 7 Studien sind auf unserer Homepage bei den jeweils evaluierten Tests zusammengefasst.
Wir haben die Webseite aktualisiert und um analytische Studien erweitert
Wir aktualisieren die Webseite mindestens einmal wöchentlich mit neuen Artikeln, die in der systematischen Suche der preprint und peer-reviewed Datenbanken auftauchen. Wir haben jetzt zusätzlich eine Seite für analytische Studien erstellt. Analytische Studien untersuchen Tests an vordefinierte Proben mit bekannter Viruslast und in Verdünnungsreihen, um die geringste Menge an Virus, die ein Test erkennt, zu definieren (das Limit der Detektion – LOD). Dies ist wie die klinische Sensitivität eine Kenngröße, nach der Tests verglichen werden können. Corman, V.M., et al. an der Charite in Berlin haben kürzlich in einer Publikation das LOD von 7 Tests untersucht.
Ab heute ist unsere Website ‘diagnosticsglobalhealth.org’ offiziell online. Mit der Website möchten wir einen Überblick über aktuelle Studienergebnisse zu Antigen Schnelltests auf den Coronavirus SARS-CoV-2 geben. Wir freuen uns auf neue wissenschaftliche Erkenntnisse und spannende Diskussionen mit den Besuchern unserer Website.