MyEG has announced that its COVID-19 rapid test kits has fulfilled regulatory requirements in the United States. However, they have yet to obtain approval or certification from the Malaysian Ministry of Health (MOH) for sale and use in the country.
The test kits are developed by an unnamed “reputable Chinese biomedical company,” qualified for emergency use with the authorisation granted by the US Food and Drug Administration (FDA) under a policy to accelerate detection and diagnosis during public health emergencies.
MyEG says the FDA authorisation is in addition to the European CE mark which certifies conformity with health, safety, and environmental protection standards, obtained earlier. The kits are also approved and widely used in China and Europe during the COVID-19 pandemic.
The rapid test kit is available for pre-order now on the MyEG website at a price of MYR99 (~USD23) per unit in a set of 10 units, while stocks last.
MyEG is also introducing an upgraded kit with testing for additional antibody, offered at MYR149 (~USD34) per unit and is also available in packs of 10.
Earlier, the rapid test kits sparked controversy as the MOH reported them as “fake news” on its official social media channel. The authority has since retracted the posting without any explanation. MyEG subsequently thanked the MOH for rescinding the statement.
MyEG claims its kit can accurately detect the SARS-CoV-2 virus (the coronavirus that causes COVID-19 disease) within a span of 30 minutes without the need for nose or throat swabs.
Its simplistic one-step use makes it an accessible option to increase testing amongst Malaysians to assist in early detection and further prevent the spread of the virus.