In response to the COVID – 19 pandemic, the HSA wants to make sure that authorization for testing kits for the detection and diagnosis will be expedited. They have been working closely with research institutions as well as local and multinational companies to ensure the availability of test kits with good quality during this critical period.
HSA has set up a provisional authorization process for the tests, which has helped in the expansion of the number and variation of the diagnostic tests in Singapore. This authorization is based on a risk – calibrated review process that focuses on the design aspect of the test. This may include primers and probe design, and target sequence in the viral RNA, as well as validation data (e.g. Limit of detection, cross reactivity, inclusivity). However, periodic reports must be provided regarding safety and performance of the tests after the authorization has been given. If issues regarding these arise, follow – up actions will be required at the manufacturer’s end. Finally, provisional authorization is just a temporary measure in place for the timely detection of COVID – 19. Registration of the test will be required should the applicant wishes to supply it in the long run.
Submission of application for provisional authorization can be done by sending an email to [email protected] with the subject “Provisional Authorization” with the information below:
- Brief description of the test (test design, target biomarker, device technology, description of key functional elements, specifications, composition, accessories)
- Intended purpose of the test
- Information for users (IFU) of the test
- Summary of analytical validation (e.g. Limit of Detection, inclusivity, cross-reactivity, precision, interfering substances, Hook effect) and clinical data collected for your test where available
- Summary of any planned or ongoing validation including clinical studies
HSA will then contact the applicant within three (3) working days.
The article also lists several COVID – 19 test kits that have received provisional authorization. The list will be updated as more kits gets approved. For updated list, proceed to the original article found on the HSA website.