KUALA LUMPUR: MY EG Services Bhd claims that the Covid-19 rapid test kits it is offering in Malaysia, subject to government approval, has fulfilled regulatory requirements in the United States, clearing the way for the sale of the devices there.
The company said the test kits, developed by a reputable Chinese biomedical company, has qualified for emergency use authorisation granted by the US Food and Drug Administration (FDA) under a policy to accelerate detection and diagnosis during public health emergencies.
The authorisation by the FDA for the test kits is in addition to the European CE mark, which certifies conformity with health, safety, and environmental protection standards, obtained earlier.
Presently available for pre-order on MYEG’s website at a price of RM99 per unit in a set of 10 units while stocks last.
MYEG said an upgraded kit with testing for additional antibody has been introduced at RM149 per unit and also available in sets of 10 units per pack.
The rapid test kits in Malaysia is pending approval and certification by the Ministry of Health.
The acceptance of the test kits worldwide, including in major regions like the US and Europe, is timely amid growing acknowledgement worldwide of the need for faster and more widespread detection capacities in the fight to contain the spread of the virus.
The test kit enables the early detection of the Covid-19 virus through the use of blood samples obtained from finger-pricking, specifically by detecting the presence of antibodies.
Test results are generated on-site within minutes, with no requirement for the time-consuming process of sending samples to external diagnostic laboratories.
MYEG said due to the simplicity of use of the rapid test kits, the company believes that it is an accessible and affordable option to increase testing and early detection amongst Malaysians, thus boosting testing capacity in the country and helping reduce the strain on existing public health facilities.