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Weekly update – 3 new studies

26.07.21

We added three new studies to our website this week. All publications evaluated rapid antigen tests, which were already well known: BinaxNOW by Abbott (Shah et al., 2021), the COVID-19 RAT by Mologic (Cubas-Atienzar et al., 2021) and the Standard Q by SD Biosensor/Roche (Lee et al., 2021). Interestingly, the Standard Q performed quite poorly with an overall clinical sensitivity of only 28.7%. However, a significant difference in sensitivity was observed between specimens with Ct values ≤23.37 (81.4%) and >23.37 (10.6%), which corresponds to the manufacturer-claimed limit of detection.

In the coming week, we will take a short summer break and the next update will follow on the 9th of August 2021.

Weekly update – 3 new studies

19.07.21

Last week we included an evaluation of the COVID-19 Antigen Kit (Colloidal Gold) from Lituo Biotechnology (Terpos et al., 2021). This test had not been assessed before. Further, García-Fiñana et al., 2021 added new data to the Innova lateral flow antigen test. Finally, Fiedler et al., 2021 assessed the performance of the LIAISON SARS-CoV-2 Antigen assay using different Tissue Culture Infectious Dose (TCID50/ml) cut-off values.

Weekly update – 7 new studies

12.07.21

Over the course of last week, we found a new study performing a head-to-head evaluation of the Vitros and the Lumipulse SARS-CoV-2 Ag Tests (Matsuzaki et al., 2021). Here, the Lumipulse Ag Test showed a higher sensitivity of 87.8% in comparison to the Vitros Antigen Test with a sensitivity of 75.5%. The remaining studies added new data to the already known Antigen Tests Standard Q (Abdul-Mumin et al., 2021 and Amer et al.,2021), Panbio (Ferté et al., 2021), LumiraDx (Fernández et al., 2021), AMP (Leixner et al., 2021) and the Roche SARS-CoV-2 RAT (Fernandez-Montero et al., 2021).

Weekly update – 4 new studies

05.07.21

During the last days we included three new studies on our website, which provided data for the well-known Antigen Tests Nadal by NAL von minden (Dierks et al., 2021), LumiraDx (Dierks et al., 2021), Panbio by Abbott (Eleftheriou et al., 2021) and Sofia by Quidel (Smith et al., 2021). Further, Kontogianni et al., 2021 assessed the analytical limit of detection for 17 different Ag-RDTs (results can be found in the analytical studies section).

Weekly update - 3 new studies

28.06.21

Last week we found a head-to-head study comparing the performance of the Quick Navi Ag test by Denka and the Quick Chaser Auto SARS CoV-2 Antigen Kit from Mizuho Medy, which had not been evaluated before (Akashi et al., 2021). The sensitivity for both was found to be 87.5%.  A second study assessed the accuracy of the well-known Panbio Ag test by Abbott and added new data to the so far only scarcely evaluated Ag Rapid Test from Orient Gene (Nordgren et al., 2021). Finally, Lindner et al., 2021 evaluated Antigen tests by Mologic and Fujirebio (Espline), as well as the Sure Status Antigen Card Test by Premier Medical Corporation with the B.1.1.7 variant. The latter test had not been evaluated before.

Weekly update - 2 new studies

21.06.21

Over the course of last week, we uploaded two new studies onto our website. Blairon et al., 2021 performed a head-to-head evaluation of SARS-CoV-2 Antigen Rapid Tests by LumiraDx, GSD NovaGen and Bio-Rad, out of which the LumiraDx performed best. Both the GSD NovaGen, as well as the Bio-Rad Ag tests had not been assessed before. Further, Harris et al., 2021 added data to the well known Sofia SARS Antigen FIA by QUIDEL.

Weekly update – 7 new studies

14.06.21

This week we found seven new studies. Four of those added data to well-known Ag Rapid Tests by QUIDEL (Bornemann et al., 2021), Abbott (Panbio) and SD Biosensor (Standard F) (Caramello et al., 2021 and Pérez‐García et al., 2021), BD Veritor (Christensen et al., 2021) and LumiraDx (Caramello et al., 2021). In addition, Chiu et al., 2021 assessed the INDICAID COVID-19 RAT by Phase Scientific International, which had not been evaluated previously. Further, the study by Abusrewil et al., 2021 evaluated Ag Tests by Microprofit Biotech (fluorecare), Fujirebio (Espline), RapiGEN (Biocredit), Assut, Orient Gene, AMP, ACON (Flowflex), Abbott (Panbio), CerTest Biotech and Bioperfectus Technologies. All tests showed variable performance. Finally, Beklitz et al., 2021 compared the analytic limit of detection of Antigen Tests by GCMS (Genedia W), Premier Medical Corporation (Sure Status), Joysbio, Edinburgh Genetics (ActivXpress), Guangzhou Wondfo Biotech, SD Biosensor (Standard Q), Abbott (Panbio), Bionote (NowCheck) and iChroma with the B.1.1.7,  B.1.351 , B.1.610, P.2 and the P.1 variants.

Weekly update - 4 new studies

07.06.21

Last week we included a study by Koeleman et al., which performed a head-to-head assessment of five Antigen tests. Among those tests, the BD Veritor Antigen test from Becton, Dickinson and Company, as well as the Romed Holland Coronavirus Ag Rapid Test performed best. The latter had not been assessed before. The three remaining publications evaluated already known tests: BinaxNOW by Abbott (Shaikh et al., 2021), COVID-19 SARS-CoV-2 Antigen Test by LumiraDx (Bianco et al., 2021) and the Roche SARS-CoV-2 RAT (Šterbenc et al., 2021).

Weekly update – 4 new studies

31.05.21

Over the course of last week, we found one study assessing the performance of both the Panbio Ag Test by Abbott and the BioSpeedia Covid 19 Antigen Test. The latter test had not been evaluated before. In this head-to-head comparison, the BioSpeedia Test showed lower accuracy than the Antigen Test by Abbott (Reza, S., et al., 2021). Further, Homza, M., et al., 2021 published their second study evaluating the Ecotest COVID-19 Antigen Rapid Test by Assure Tech, this time also comparing the test performance to viral culture. Finally, further data was added to the well-known Standard Q by SD Biosensor / Roche and the Sofia SARS Antigen FIA by QUIDEL (Kumar, K. K., et al., 2021; Brihn, A., et al., 2021).

weekly update - 1 new study

24.05.21

Last week we uploaded one new study onto our website. Holzner, C., et al., 2021 evaluated the Standard Q AgPOCT by SD Biosensor/Roche in symptomatic and asymptomatic patients presenting to an emergency department. The sensitivity for both symptomatic (69.49%, 95% CI 67.16-71.76) and asymptomatic (62%, 95% CI 61.78-62.32) patients fell within the lower third of all other previous assessments of the same tests.

Weekly update - 13 new studies

17.05.21

This week we included five more studies from the Foundation of Innovative New Diagnsotics (FINDdx) which evaluated known Antigen tests but also the Mologic COVID-19 Rapid Antigen Test that had not been assessed before. Several other publications also provided data for tests that had not been evaluated previously: PathoCatch/Accucare SARS-CoV-2 Antigen Test by Lab Care Diagnostics (Thakur, P., et al., 2021), FREND COVID-19 Ag by NanoEmtek and Prima COVID-19 Antigen Rapid Test (Bruzzone, B., et al,.2021), ND COVID-19 Ag Test by NDFOS, as well as Ecotest COVID-19 Antigen Rapid Test by Assure Tech and VivaDiag SARS-CoV-2 Ag Rapid Test by VivaCheck (Homza, M., et al., 2021). All tests showed variable performance. In addition, more data was added to already known tests: NADAL by NAL von minden, Panbio by Abbott and the SARS-CoV-2 Antigen Rapid Test by MEDsan (Wagenhäuser, I., et al., 2021); COVID-19 Antigen Rapid Test Kit by JOYSBIO Biotechnology and the Standard Q test by SD Biosensor/Roche (Homza, M., et al., 2021); Biocredit Covid-19 Antigen Detection Kit by RapiGEN, COVID-19 SARS-CoV-2 Antigen Test by LumiraDx, as well as the Standard Q and Standard F Antigen tests by SD Biosensor (Bruzzone, B., et al,.2021). Finally, Rodgers M.A., et al., 2021 and Jungnick, S., et al., 2021 performed head-to-head studies comparing the analytic limit of detection of Antigen tests by Abbott (Panbio and BinaxNOW), Roche, Siemens Healthineers (CLINITEST), NAL von minden (NADAL) and RapiGEN (Biocredit) with the B.1.1.7,  B.1.351 and the P.1 variants.

Weekly update – 10 new studies

09.05.21

Over the course of the last week, we found evaluations of two tests that had not been assessed before: the Antigen SARS-CoV-2 test by Dräger (Osmanodja, B., et al., 2021) and the Elecsys SARS-CoV-2 Antigen Test by Roche (Nörz, D., et al., 2021). In addition, the study assessing the Ag-RDT by Dräger included the B.1.1.7 variant into their evaluation. The remaining 8 studies added further data to already well-known tests (Asai, N., et al., 2021; Caruana, G., et al., 2021; Micocci, M., et al., 2021; Thell, R., et al., 2021; Yin, N., et al., 2021; Sberna, G., et al., 2021; Kenyeres, B., et al., 2021; Ferguson, J., et al., 2021).

Weekly update – 3 new studies

02.05.21

During the last days we found one study performing a head-to-head assessment of six Ag-RDTs. Herein, the INNOVA SARS-CoV-2 Antigen Rapid Qualitative Test by Innova Medical Group performed best, followed by Green Spring® SARS-CoV-2-Antigen-Schnelltest-Set by Shenzhen Lvshiyuan Biotechnology. In addition, the same study compared the initial SARS-CoV-2 to the B.1.1.1.7 variant, and found no significant difference in Ag-RDT performance (Pickering, S., et al., 2021). Furthermore, to other studies added further data to the BD Veritor by Becton, Dickinson and Company (Kilic, A., et al., 2021) and the Panbio by Abbott (L’Huillier, A.G., et al., 2021).

Weekly update – 2 new studies

25.04.21

Over the course of the last week, we found one study evaluating the LIAISON® SARS-CoV-2 Antigen assay by DiaSorin, which is a chemiluminescence sandwich-immunoassay and had not been evaluated before (Lefever, S., et al., 2021). In addition, another study added further data to the already well-known Standard Q test by SD Biosensor / Roche (Kernéis, S., et al., 2021).

Weekly update – 1 new study

18.04.21

During the last week we found one new study to be uploaded onto our website. This study assessed the COVID-19 Antigen Test Cassette by Biotime authorized for saliva samples, which had not been evaluated before. However, the population sampled is biased as it was preselected with an antigen-test result on nasopharyngeal sample (Seitz, T., et al., 2021).

Weekly update – 6 new studies

11.04.21

Over the course of the easter holidays we found 6 new studies. One study assessed the analytical limit of detection for 19 different Ag-RDTs (Cubas Atienzar, A., et al., 2021; results can be found in the analytical studies section). Another study evaluated the COVID-19 Antigen Rapid Test by Sienna that had not been evaluated previously (Bouassa, M.R.S., et al., 2021). Furthermore, three studies added further data on the Panbio by Abbott (Faíco-Filho, K., et al., 2021; Stokes, W., et al., 2021; Del Vecchio, C., et al., 2021) and one other study on the BD Veritor by Becton, Dickinson and Company and the Standard Q by SD Biosensor / Roche (Schuit, E., et al., 2021).

Weekly update – 1 new study

28.03.21

The one study we found over the course of the last week evaluated the SGTI flex COVID 19 Ag by Sugentech and the Biocredit Covid-19 Antigen Detection Kit by RapiGEN (Shidlovskaya, E.V., et al., 2021). Interestingly, the Ag-RDTs were not only compared against a RT-PCR but also against viral culture, the better comparison for virus viability and thus transmissibility. In alignment with the results of a study we had already reported on in February (James, A.E., et al., 2021), the Ag-RDTs showed a higher sensitivity when compared with viral culture (76.8% to 100%) than when compared with RT-PCR (around 55%).

Weekly update – 3 new studies

21.03.21

During the last week we found one study being the first to evaluate the CareStart™ COVID-19 Antigen Test by Access Bio (Pollock, N.R., et al., 2021). In addition, two studies provided further data for tests that had only been evaluated scarcely before: the SARS-CoV-2 Ag Test by LumiraDx (Krüger, L.J., et al., 2021) and the RIDA®QUICK SARS-CoV-2 Antigen by R-Biopharm (Takeuchi, Y., et al., 2021).

Weekly update – 9 new studies

14.03.21

Over the course of the last week, one study was published evaluating the SARS-CoV-2 one step test card by CerTest Biotec for the first time. In this head-to-head comparison it showed lower accuracy than the Panbio test by Abbott (Pérez-García, F., et al., 2021). Furthermore, new data was published on the NowCheck by Bionote that had only been evaluated once before (Rottenstreich, A., et al., 2021). In addition, we found 7 studies providing further data on tests that have already been evaluated frequently (Domínguez Fernández, M., et al., 2021; Gili, A., et al., 2021; Jääskeläinen, A.E., et al., 2021; Okoye, N.C., et al., 2021; Salvagno, G.L., et al., 2021; Villaverde, S., et al., 2021; Young, B.C., et al., 2021)

Weekly update – 6 new studies

07.03.21

Within the last week, we found one study that was the first to compare the accuracy of two Ag-RDTs performed by patients themselves (Tests were from SD Biosensor / Roche and Becton, Dickinson & Company; Stohr, J.J.J.M.). Another study provided new data for the COVID-19 SARS-CoV-2 Antigen Test by LumiraDX that had only been evaluated by one other study before (Darin, P.K., et al.). Furthermore, three studies performed evaluations of already well-known tests such as the Standard Q by Roche / SD Biosensor or Lumipulse by Fujirebio (Hirotsu, Y., et al.; Marti, J.L.G.; Ristic, M., et al.). Finally, one new study was published assessing the limit of detection of Panbio by Abbott (Mak, G.C.K., et al.).

Weekly update – 9 new studies

28.02.21

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

21.02.21

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

13.02.21

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

06.02.21

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

30.01.21

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

23.01.21

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 [62] and the Salocor SARS-CoV-2 Antigen by Salofa Ltd [64]. Another evaluation adds further data for the Roche / SD Biosensor, Standard Q test [63] 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 [55].

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

10.01.21

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 [58]. 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 [59]. In addition, there is also data on QuickNavi, a new test from Japan [60]. 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 [61].

Weekly update – 1 new study and end of year planning

20.12.20

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 [56]. 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 [55].

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

13.12.20

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 [53]. 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 [50]. Furthermore, new data was published comparing the accuracy of professional-collected anterior nasal versus nasopharyngeal swab using the Roche / SD Biosensor, Standard Q [52].

New evaluation from the Paul-Ehrlich-Institute

08.12.2020

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

07.12.2020

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 [47]. 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

29.11.20

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 [10]. 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

22.11.20

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. 

Los gehts!

05.11.2020

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.