Roche ready to release its COVID-19 Antigen Test Kit

webfact · July 27, 2021

By Tarin Angskul

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

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

Roche’s COVID-19 Antigen Test Kit (Self-test) is a version of the test that has been available as a home-test in a number of European markets under special approval arrangements since June 2021, while the rapid antigen test (professional use) was certified in February 2021. As for the CE Mark, the Antigen tests have been widely used in a number of European countries, following the traditional registration process and in accordance with 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 conveniently check if they are likely to be infectious, in 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 today 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 August. Moreover, the Roche rapid antigen test (professional use) also received the FDA’s approval in January 2021 and is allowed for professional and medical personnel use only.

“We hope that Roche’s COVID-19 Antigen Test Kit (self-test) and Rapid Antigen Test will help in alleviating this outbreak, in which the number of people found infected increased rapidly. In this serious situation, people infected with COVID-19 should be urgently identified and isolated from others while the RT PCR takes a longer time in the laboratory, the Antigen Test Kit provides results in as little as 15 – 30 minutes and is convenient to use. It should 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 people continue wearing masks, socially distance and practice good hygiene, especially if you have symptoms or have nown contact with others who have tested positive to the virus.

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

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