Robust processes to ensure Covid-19 test kits are effective

There have been several reports on Covid-19 test kits.

The Health Sciences Authority (HSA) regulates Covid-19 test kits for domestic use, whether in licensed laboratories, healthcare institutions or for commercial sale.

These same test kits may be used for other purposes which do not require the Ministry of Health's approval, such as pre-departure tests for travel out of Singapore, requirements of which are determined by the destination country. It is in this context that alternative specimen collection methods using saliva are being used.

Hence, licensed laboratories and travellers need to ascertain the suitability and validity of the test method of the pre-departure test, that it will be accepted by the destination countries.

For self-test antigen rapid test (ART) kits for domestic use, all suppliers are free to apply for registration by HSA.

However, as we are in a pandemic crisis, registration under the Pandemic Special Access Route is by invitation only after MOH preliminarily evaluates the test's usability and performance to meet specific pandemic needs.

These will then be further evaluated on appropriate standards of safety, quality and efficacy by HSA.

To date, nine self-test ART kits have been registered under the Pandemic Special Access Route.

Raymond Chua (Associate Professor)
Deputy Director of Medical Services
Health Regulation Group
Ministry of Health