Media Release

23.07.2021

Roche is ready to brings up COVID-19 Antigen Test Kit (Home Use), allowing antigen self-testing at home after approved by the Thai FDA—aiming to reduce the risk of domestic transmission

  • The COVID-19 Antigen Test Kit (Self-test) for home use enables individuals to quickly and conveniently test themselves for SARS-CoV-2 that causes COVID-19 at home using a simple nasal swab.
  • Available as a home-test to individuals through pharmacies and other locations in accordance to local guidelines and testing strategies
     

Bangkok, 23 July 2021—Roche Diagnostics (Thailand) Co., Ltd today announced it has received the Thai Food and Drug Administration approval its COVID-19 Antigen Self-Test for at-home testing since July 15, 2021. The test will be available through licensed pharmacies and other locations in accordance to local guidelines. It will be in packs of five tests.

Roche’s COVID-19 Antigen Test Kit (Self-test) is an early version of the test that has already been available as a home-test in a number of European markets under local special approval pathways since June 2021 while the rapid antigen test (professional use) certified since February 2021. With the CE Mark, the Antigen tests have been widely used in number of European countries, following the traditional registration pathway and in accordance of each country’s regulatory approvals and regulations since February 2021.

By following simple instructions, individuals can perform the test at home using a nasal swab (2 cm.) without special training or the supervision of a healthcare worker. The test provides results in as little as 15 – 30 minutes and can help people to conveniently check if they are likely to be infectious from the comfort of their home. In the case of children under 18 years of age, the test must be performed by an adult or under close adult supervision.

As societies begin to reopen and in line with local health regulations, the convenient test allows individuals planning to attend an event or gathering to use the test as a tool to confirm that they are not likely to be carriers of a substantial amount of the virus thus helping them make informed decisions and reduce the risk of transmission to others.
 

“As the world prepares to reopen, high-quality, home-based testing will play an important role in the battle against the pandemic,” said Thomas Schinecker, CEO, Roche Diagnostics. “Regular self-testing at home can reduce pressure on healthcare systems. It can quickly identify people with the highest potential to be infectious so they can take immediate action to seek medical advice, manage their infection and protect others.”
 

Mr. Pichetpong Srisuwankul, Managing Director of Roche Diagnostics (Thailand) Co., Ltd said that the COVID-19 Antigen Test Kit (self-test) is now approved by the Thai FDA and is expected to be available in the market through pharmacies and hospitals in early of August. Moreover, the Roche’s rapid antigen test (professional use) has also received the FDA’s approval since January 2021 and is allowed for professional and medical personnel use only.

“We hopefully that Roche’s COVID-19 Antigen Test Kit (self-test) and Rapid Antigen Test would help alleviating this outbreak which number of people found infected increasingly and rapidly. Under this serious situation which people infected with COVID-19 should be urgently identified and isolated from others while the RT PCR could take longer time in laboratory, the Antigen Test Kit provides results in as little as 15 – 30 minutes and is convenient to use. It would be very useful for people, medical personnel and the country,” Mr. Pichetpong Srisuwankul added.
 

In addition to diagnostic testing, preventive measures remain key to protecting yourself and others against SARS-CoV-2. It is recommended to continue wearing masks, socially distance and practice good hygiene, especially if you have symptoms or known contact with others who have tested positive for the virus.

Roche continues to expand its comprehensive COVID-19 portfolio to support healthcare systems in diagnosing SARS-CoV-2 infection.
 

Roche's COVID-19 Responses

As a leading healthcare company, Roche is doing all it can to support countries in minimising the impact of COVID-19. Roche has developed a growing number of diagnostic solutions which help detect and diagnose the infection in patients, as well as providing digital support to healthcare systems, and Roche continues to identify, develop and support potential therapies which can play a role in treating the disease.

Roche understands the impact of COVID-19 goes beyond those who contract it, which is why the company is working with healthcare providers, laboratories, authorities and organisations to help make sure that patients continue to receive the tests, treatment and care they need during these challenging times. The pandemic gave Roche an important lesson of partnering with private and public sectors to make healthcare stronger and more sustainable in the future.

As for the third wave, Roche continues to leverage its strengths and expertise to fight the disease and alleviate the severity of the pandemic.

  • Strengths in diagnostics: SARS-CoV-2 Rapid Antigen Test (nasopharyngeal) for hospital settings, and Antigen Test Kit (Nasal Swab) for home use.
  • Strengths in pharmaceuticals: Rheumatoid arthritis drug recommended by the World Health Organization for treating hospitalised patients with severe or critical COVID-19, and the new antibody cocktail. 

 


 

Referance:
[1] Péré H, Podglajen I, Wack M et al. (2020).  J of Clin Microbiol 58, e00721-20
[2] Kevadiya BD, Machhi J, Herskovitz J et al. (2021). Nat Mater. DOI: https://doi.org/10.1038/s41563-020-00906-z
[3] SD Biosensor. (2021). SARS-CoV-2 Antigen Self Test Nasal package insert
[4] Lindner AK, Nikolai O,  Rohardt C et al. (2021). DOI: https://doi.org/10.1101/2021.01.06.20249009
[5] European Centre for Disease Prevention and Control. Diagnostic testing and screening for SARS-CoV-2. 2020.
[6] Cerutti, Krüger, van Beek, Igloi, Krüttgen, Salvagno

 


MC-TH-00604