Coronavirus Singapore

Test kit that detects Covid-19 and flu receives HSA's provisional approval

Dr Zhou Lihan, co-founder and chief executive officer of MiRXES, a local molecular diagnostic company that developed the new test kit together with A*Star and Tan Tock Seng Hospital.
Dr Zhou Lihan, co-founder and chief executive officer of MiRXES, a local molecular diagnostic company that developed the new test kit together with A*Star and Tan Tock Seng Hospital.

A new multi-virus test kit that is able to detect both Covid-19 and the seasonal flu has obtained provisional authorisation from Singapore's Health Sciences Authority (HSA).

The Fortitude Sars-CoV-2 and Flu A/B test kit was jointly developed by the Agency for Science, Technology and Research (A*Star), Tan Tock Seng Hospital (TTSH) and local molecular diagnostic company MiRXES.

Building on the existing Fortitude Kit which tests only for Covid-19, this new kit has additional polymerase chain reaction (PCR) primers - short genetic sequences - designed to detect influenza A and B. The test uses PCR to look for the viruses that cause Covid-19 or the flu and will give two readouts, showing if the patient has either.

Since February last year, more than five million Fortitude Kit tests have been sold locally and globally. The kits have been deployed in 13 local hospitals and labs and exported to more than 40 countries worldwide, including the United States.

Sales of the new kit have just been launched, after it obtained the regulatory approval on Jan 8.

Patients with Covid-19 or flu exhibit a set of similar symptoms, making it difficult for healthcare professionals to differentiate between the two. This new kit will allow for a more accurate and timely diagnosis.

MiRXES has also obtained the Conformite Europeenne mark approval, a European certification, for the new kit.

The company is applying for emergency use authorisation from the US Food and Drug Administration, and for approval from Japan's Pharmaceuticals and Medical Devices Agency.

Dr Zhou Lihan, co-founder and chief executive officer of MiRXES, said: "Following the deployment of the MiRXES Fortitude Kit worldwide, we continue to monitor and identify global needs in infectious disease testing."

He added: "We are working in close collaboration with key partners such as A*Star and TTSH to meet these needs by expanding our Fortitude Covid-19 test range. Hospitals and labs in US, Europe and Japan have already expressed interest in deploying the Fortitude Sars-CoV-2 and Flu A/B test kit."

A version of this article appeared in the print edition of The Straits Times on January 19, 2021, with the headline 'Test kit that detects Covid-19 and flu receives HSA's provisional approval'. Subscribe