NEW YORK and SYDNEY, Australia, Aug. 31, 2021 (GLOBE NEWSWIRE) -- Beroni Group (OTCQX: BNIGF; NSX: BTG) (“Beroni”), an Australia-based biopharmaceutical enterprise, announced the latest clinical study of its SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method) demonstrated an overall sensitivity of 95% and specificity of 100%.
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 is an Australia-based 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 FDA/CE approved virus diagnostic kits, 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.
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This press release contains forward-looking statements or forward-looking information, within the meaning of applicable United States and Australian securities laws with respect to the Company. By their nature, forward-looking statements are subject to a variety of factors that could cause actual results to differ materially from the results suggested by the forward-looking statements. Accordingly, readers should not place undue reliance on the forward-looking statements. Generally forward-looking statements can be identified by the use of terminology such as “anticipate”, “will”, “expect”, “may”, “continue”, “could”, “estimate”, “forecast”, “plan”, “intend”, “believe”, “potential” and similar expressions.
Forward-looking information contained in this press release is based on Company management’s opinions, estimates and assumptions in light of its experience and perception of historical trends, current conditions and expected future developments, as well as other factors that management currently believes are appropriate and reasonable in the circumstances. Forward-looking statements involve significant risks, uncertainties and assumptions, and there can be no assurance that such statements, or its underlying risks, uncertainties and assumptions will prove to be accurate. Factors that could cause actual results or events to differ materially include, without limitation, risks related to laws, rules and regulation applicable to the Company as well as the industry in which it operates (including in respect of taxes and other levies), economic or market conditions on both a national and global level, currency fluctuations, risks inherent to other entities at a similar stage of development and industry in which the Company currently is, competition from the Company’s competitors, unsatisfactory development or marketing of the Company and/or its products or services, regulatory action or litigation (including product liability claims), and failure to enter into agreements or arrangements with other parties on fair or reasonable terms. Forward-looking information is made only as of the date on which it is provided and, except as may be required by applicable laws, the Company disclaims any intent or obligation to update such forward-looking information whether as a result of new information, future events or otherwise.
For more information, please contact our IR consultants at:
Dragon Gate Investment Partners LLC
Tel: +1(646)-801-2803
Email: BNIGF@dgipl.com
