Getein One Step Test for SARS-CoV-2 Antigen Approved by Malaysia MDA
19

/Nov 2021

Getein Biotech, Inc., the leading POCT company in China, is delighted to announce that its One Step Test for SARS-CoV-2 antigen (Colloidal Gold) has recently received full approval from the Medical Device Authority (MDA) of Malaysia. This approval certifies that the Getein SARS-CoV-2 antigen self-test meets the strict standards stipulated by the MDA, enabling the product to be distributed to Malaysian pharmacies and healthcare systems. Getein believes that its One Step Test for SARS-CoV-2 antigen will facilitate COVID-19 screening on a massive scale and catapult Malaysia’s fight against the pandemic.



Certificate of Malaysia MDA


COVID-19 is one of the most prevalent and destructive pandemics in human history with over 255 million people infected and 5 million people dead so far. The disease has dramatic socioeconomic consequences, and it has stretched the global healthcare system to its absolute limit. Given the severity of the disease, it is critical that rapid self-tests be developed to complement the existing RT-PCR tests, which are often time-consuming and labour-demanding for healthcare systems in many countries.



CE Certificate


Getein’s One Step Test for SARS-CoV-2 antigen qualitatively detects SARS-CoV-2 antigens in human nasal swab samples and can be used as an auxiliary diagnostic method for COVID-19. The test is easy to operate at home and does not require any professional medical device. Users can conveniently collect nasal swab samples, and the results will be displayed within 10-15 minutes. Therefore, Getein’s One Step Test for SARS-CoV-2 Antigen provides an optimal solution for ordinary people with flu-like symptoms to conduct self-tests within a 7-day window. Moreover, this test is also applicable to people with no symptoms.


Getein’s One Step Test for SARS-CoV-2 Antigen has also received CE mark clearance and Thai FDA approval. These international certifications demonstrate the company’s ability to develop reliable and effective test solutions that meet rigorous international standards.



Certificate of Thailand FDA


Beyond the One Step Test for SARS-CoV-2 Antigen, Getein has also developed a comprehensive product line for COVID-19 diagnosis, including SARS-CoV-2 RT-PCR Test Kit, One Step Test for SARS-CoV-2 Antigen (for professional use), SARS-CoV-2 IgM/IgG Fast Test Kit, and SARS-CoV-2 Neutralizing Antibody Fast Test Kit, etc. These tests can be applied in a diverse range of clinical and home settings, providing multiple reliable options for customers. It is Getein’s unyielding belief that the company has the responsibility to keep developing high-quality products to help counter this unprecedented pandemic, and Getein is committed to playing its part in the fight against COVID-19.





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