We are happy to announce that BÜHLMANN Laboratories AG has two new, attractive SARS-CoV-2 Antigen (Ag) rapid tests in its portfolio.
On the one hand the very fast FREND ™ COVID-19 Ag test from NanoEntek, which delivers an electronic result after just three minutes, thanks to microfluidics. On the other hand, the Coronavirus Ag Rapid Test from Zhejiang Orient Gene Biotech Co., Ltd, which is a classic and attractively priced antigen test, without a device. Both assays were submitted to SGM for validation a few weeks ago and the Coronavirus Ag Rapid Test from Zhejiang Orient Gene Biotech Co., Ltd has already been successfully validated. With a Ct value of 23, the sensitivity was 100%, with Ct values of 26 and 29 it was 95.5% and 93.5% and the specificity was 100%. The test has just been added as No. 29 to the BAG list of the validated SARS-CoV-2 rapid tests. We also expect approval for the FREND ™ COVID-19 Ag test in the near future.
The FREND ™ COVID-19 Ag Test is a fluorescence immunoassay for use with the FREND ™ POCT System. It is intended for the qualitative detection of the nucleocapsid protein of SARS-CoV-2 directly from nasopharyngeal swab samples from people who are suspected of having a SARS-CoV2 infection. With the help of the FREND ™ system, the qualitative result is available within 3 minutes, faster than any other test on the Swiss market. This saves valuable time in treating / isolating patients and for health care workers. The simple handling with just a few steps is also convincing with this test system (see flyer). Another added value is the new FREND ™ POCT system, which includes a laboratory information system / data management (up to 1,000 patient results can be saved). The data can also be collected and transferred automatically (using a LIS connection). With the help of this technology, the result can be traced back to a patient ID. In addition, the respective results can also be printed out and documented directly for convenient data management. This guarantees simple data processing and transmission of the results (see flyer). In the clinical evaluation, the test shows 94.12% PPA (Positive Percent Agreement) and 100.00% NPA (Negative Percent Agreement). 109 clinical samples (34 positive and 75 negative) were confirmed by RT-PCR.
The Coronavirus-Ag Rapid Test from Zhejiang Orient Gene Biotech Co., Ltd is an in vitro immunochromatographic assay for the qualitative detection of the nucleocapsid protein antigen of SARS-CoV-2 in direct swab specimens from suspected individuals insists on COVID-19. It is intended to support the rapid diagnosis of SARS-CoV-2 infections. The test delivers a test result within 15 minutes and at an attractive price. The clinical performance of this Ag test was evaluated by a multicenter study at 7 locations in the USA. The tests were carried out by healthcare workers who were unfamiliar with the testing procedure. A total of 865 fresh nasopharyngeal swab specimens were collected and tested, including 119 positive specimens and 746 negative specimens. The results were compared to an FDA-approved RT-PCR assay for SARS-CoV-2. The relative sensitivity is 98.32% (95% CI * 94.06% to 99.80%) and the relative specificity is 99.60% (95% CI * 98.83% to 99.92%). The accuracy is 99.42% (95% CI * 98.66% to 99.81%) With these excellent performance data, the Ag test from Zhejiang Orient Gene Biotech Co., Ltd is probably one of the best classical immunochromatographic tests on the market.
For further information please click on the flyers below.