Humasis Obtains Canadian Certification for COVID-19 Self-Test Kit

[Asia Economy Reporter Lee Gwan-joo] Humasis announced on the 25th that it has obtained Canadian personal use certification (CE-Self testing) for its self-test kit.

The self-test kit certified this time is the ‘Humasis COVID-19 Ag Home Test,’ which has been officially approved in Korea. As Omicron subvariants spread globally, demand for personal test kits is increasing again.

Humasis conducted a clinical evaluation in collaboration with the National University of South Africa using positive specimens from patients infected with Omicron subvariants BA.4 and BA.5 to verify detection capability. The results confirmed positive detection in all cases, proving that the product’s detection performance for subvariants is reliable. Although testing for the Centaurus (BA.2.75) variant was not included, additional evaluations are planned to be conducted soon.

A Humasis official stated, “Humasis continuously monitors variants in accordance with recommendations from the Ministry of Food and Drug Safety and the World Health Organization (WHO) as COVID-19 variants continue to emerge. After obtaining Canadian certification, we plan to promptly supply the product locally in Canada.”