Lucira CHECK IT Covid-19 self-test is said to be the first self-test authorised by Health Canada for individuals with or without Covid-19 symptoms
US-based medical technology company Lucira Health has received the Health Canada conditional authorisation for its CHECK IT Covid-19 test kit.
The regulatory authorisation was issued under the Interim Order (IO) respecting the import and sale of medical devices for use in relation to Covid-19.
Lucira CHECK IT Covid-19 test kit was designed and tested widely for self-use by individuals and does not require a physician’s prescription or supervised assistance.
The single-use test kit delivers PCR quality molecular accuracy, to detect a positive result within 11 minutes or confirm a negative result within 30 minutes.
The company is planning to commercialise the test in Canada by June 2021, at a price of about C$75 ($60.5), excluding taxes and delivery charges.
Lucira CEO Erik Engelson said: “Canada has a global reputation for world-class health care. We are proud our self-test was the first one authorized for use within this vast country.
“Numerous Covid-19 studies have demonstrated that testing improves safety and health, and no other self-test has Lucira’s PCR quality accuracy in such an easy-to-use form.”
Lucira claimed that its CHECK IT Covid-19 test kit is the first self-test authorised by Health Canada for people with or without symptoms.
The test kit fits in the palm of a hand and works by extracting genetic material from the virus and amplifying it similar to PCR lab tests.
It includes a test device, two AA batteries, sample vial, swab and instructions.
After the batteries are inserted and the sample vial is placed in the test unit, the user has to stir the swab which collected the sample in the vial, to start the test.
In clinical trials, the test showed that 100% of users successfully performed the test in less than two minutes, while current laboratory tests take two to 14 days.
The test was previously authorised in the US for prescription use at-home and point of care.
It is the first and only over-the-counter, single-use, PCR quality molecular test with US FDA Emergency Use Authorisation (EUA) for at-home self-administration, said the company.