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The clinical study was conducted with 70 subjects providing 105 true-positive specimens and 105 true-negative specimens. The results for the different types of swab sampling are as follows:
- Nasal sampling - sensitivity 92%; specificity 100%
- Nasopharyngeal sampling - sensitivity 97%; specificity 100%
- Oropharyngeal sampling - sensitivity 95%; specificity 100%
The report also showed that in the interference experiment, 8 interfering substances such as Tobramycin and Hemoglobin were not found to affect the results of the detection of SARS-CoV-2 in human nasal cavity, nasopharyngeal and oropharyngeal swab specimens. In the cross-reaction experiment, the researchers selectively evaluated the cross-reactivity of 9 pathogens including rhinovirus and adenovirus when using the product to test SARS-CoV-2, and no cross-reactivity with the above-mentioned pathogens was observed. In the hook effect experiment, when using media such as HM contaminated by SARS-CoV-2 "GC2020/1" strain with a high concentration (maximum concentration available), no hook effect was observed and in the repeatability experiment, the product was used to test positive and negative clinical specimens, and the reproducibility (repeatability) is 100%.
Beroni Group's SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method) received CE certification in December 2020 and was granted authorization for export in April 2021. The product can be used for in vitro qualitative auxiliary detection of SARS-CoV-2 antigen specimens and is for professional use only.
"We are encouraged by the latest clinical report. The experimental results show that the SARS-CoV- 2 Antigen Test Kit demonstrated a high level of accuracy. This product is a simple, convenient rapid test kit, and the test results can be obtained within 10 minutes," commented Jacky Zhang, Chairman and CEO of Beroni Group. "Beroni is dedicated to the global fight against the COVID-19 virus. Apart from this product, Beroni's SARS-CoV-2 IgG/IgM Antibody Detection Kit has been exported to Britain, Japan and other countries."
About Beroni Group Limited:
Beroni Group (NSX:BTG) (OTCMKTS:BNIGF) is an international biopharmaceutical enterprise dedicated to the innovation and commercialization of drugs and therapies to combat various global diseases such as cancer and infectious diseases. Its diversified portfolio is comprised of a US FDA approved virus diagnostic kit, an e-commerce platform for the sale of pharmaceutical products and a development pipeline targeting oncology and cell therapies. Beroni has operations in Australia, United States, China and Japan. To learn more about Beroni, please visit www.beronigroup.com.
Source:
Beroni Group Limited
Contact:
Dragon Gate Investment Partners LLC
Tel: +1(646)-801-2803
Email: BNIGF@dgipl.com
