Conditional Approval For Third China Made Covid 19 Test Kit Revoked

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Self-test kits must show 100% for specificity and at least 90% sensitivity before the Medical Device Authority gives conditional approval.PETALING JAYA: The Medical Device Authority (MDA) has revoked the conditional approval for another China-made Covid-19 self-test kit, its CEO, Ahmad Shariff, has revealed.
The Eagle Bio SARS-CoV-2 Antigen IVD Kit Lollipop is the third Covid-19 self-test kit to be taken off the shelves.
The other two are Covid-19 Antigen Test Kit (Colloidal Gold) and Wiz Biotech SARS-CoV-2 Antigen Rapid Test. The approvals for these two test kits were revoked in April.
Ahmad said MDA would also be sending letters to four other companies this week demanding they carried out further investigations and corrective measures after their kits were found to be defective.

He said MDA had been collecting samples on the ground and testing them for sensitivity and specificity.
Self-test kits must show 100% for specificity and at least 90% sensitivity before MDA gives conditional approval.
Sensitivity measures the proportion of positive test results out of all truly positive samples. A test’s sensitivity is its ability to correctly identify those with the disease (the true positives) while minimising the number of false negative results.
Specificity measures the proportion of negative test results out of all truly negative samples. A test’s specificity is its ability to correctly identify those without the disease (the true negatives) while minimising false positive results.
“If a certain test kit is not satisfactory, we will ask the company to carry out further investigations and take corrective measures.
“If the company has done as instructed and if the result is still unsatisfactory, we will revoke the approval for that product,” he said.
As of July 19, there were 142 RTK antigen self-test kits that had been given conditional approval by MDA. - FMT

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