43 coronavirus tests approved for use in Singapore: HSA
Expediting approval has expanded number and variety of diagnostic tests: HSA
A total of 43 different Covid-19 tests have been authorised for use in Singapore over the past three months by the Health Sciences Authority (HSA).
The tests, which include local ones such as the Fortitude test by the Agency for Science, Technology and Research (A*Star) and those made by major companies like Abbott Laboratories, have provisional authorisation.
This means the companies must formally register their tests if they want to supply them in the long term.
HSA said that it has been working with research institutions and companies since Jan 29, and expediting the approval process has helped expand the number and variety of diagnostic tests available here.
In a statement on its website, HSA added that it approves tests based on a "risk-calibrated review process" by considering such factors as how the test is designed and supporting validation data.
The companies must also submit periodic reports on the safety and performance of the tests.
"If any safety or performance issues are observed, HSA will require relevant follow-up actions at the manufacturer's end," it added.
Meanwhile, the Ministry of Health (MOH) said that 13 laboratories are used here to test for Covid-19.
Responding to The New Paper's queries, MOH said most of the tests are done by the National Public Health Laboratory and public acute hospitals. These labs are supported by various private labs.
MOH said on Sunday that a review had uncovered 33 false positives from a lab, which had wrongly labelled the 33 people as infected.
MOH did not name of the lab in its reply but said the error was caused by an apparatus calibration issue for one of the test kits deployed at the lab between May 5 and 9.
The test results of the affected batches have been reviewed and no false-negative results have been found.
The ministry said none of the other labs are using the same test kit and analytical instrument combination, and that the lab has since switched to a different test kit to resolve the issue.
The 33 affected cases were also isolated, and MOH said they would be further tested as necessary.
NEW ADVISORIES
New advisories and guidelines have since been issued to all the labs, which are now required to perform the necessary confirmatory tests before the results are released.
Infectious diseases expert Leong Hoe Nam said that if any of the false positive cases were sent to facilities with infected cases, it is possible they may now be infected.
"But MOH has always done a fail-safe method. A single positive result from an external lab is not good enough. A second positive result from an MOH lab is needed too," said Dr Leong
Only after two positive results is a case sent to an infection ward, he added.
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