Ministry of Health wants you to stop using these two COVID-19 self-test kits

The Medical Device Authority (MDA), under the Ministry of Health, has withdrawn the conditional approval for two COVID-19 self-test kits. The revocation takes into effect immediately due to the failure to comply with the conditional approval terms granted by the MDA.

The two revoked COVID-19 self-test kits are COVID-19 (SARS-COV-2) Antigen Test Kit (Colloidal Gold)-Saliva manufactured by Anhui Deepblue Medical Technology, Co, and Wiz Biotech SARS-CoV-2 Antigen Rapid Test (Nasal swab) by Xiamen Wiz Biotech Co. Ltd. Both are manufactured in the People’s Republic of China and are distributed by Innovac Technology Sdn Bhd and Conan Medical Technology Berhad respectively.

Consumers are warned not to buy or use the above test kits as they are deemed unsafe to be used. As of 8th April 2022, the Medical Device Authority has given conditional approval to 128 COVID-19 self-test kits. You can view the current approved list here.

Back in February, Health Minister Khairy Jamaluddin called upon the MDA to address accuracy concerns of COVID-19 self-test kits in the country. He said checks on the quality assurance process by suppliers from manufacturers must be made for each self-test kit from time to time. He shared concerns that when the kits were approved, the accuracy might be 99% but the rate may decline over a period of time.

According to Khairy this evening, MDA has recently tested 22 brands following complaints made by the public. Out of 12 test results received so far, two have failed to achieve acceptable performance levels. As a result, the conditional approvals granted previously were revoked immediately.

The folks at Cilisos have evaluated a bunch of COVID-19 test kits with a COVID-19 positive person and discovered that 2 out of 10 kits had failed. They have conducted another round of tests again with one of their writers who got COVID-19. This time, only two out of 10 kits were showing positive, while the rest had a negative result during Day 5 of showing symptoms.

It is worth highlighting that Rapid Test Kits (RTK-Antigen) are only effective during your most infectious period. The RT-PCR (Real-Time Reverse Transcription Polymerase Chain Reaction) is still the gold standard in COVID-19 detection. However, RT-PCR is more expensive and must be conducted at a healthcare facility or lab.

[ SOURCE ]

Recent Posts

Prime Minister’s Department: Over 1,500 cyberattacks launched at ministries’ infrastructure systems

There have been over 1,500 cases of cyberattacks launched against Malaysian ministries' infrastructure systems in…

3 hours ago

Malaysia’s largest DC charging hub is opening soon at Iskandar Puteri, Johor

DC Handal is expected to unveil what appears to be Malaysia's largest EV charging hub…

19 hours ago

Realme GT 7 Pro coming to Malaysia as first smartphone with Snapdragon 8 Elite chip, launching 18th November

Realme has debuted its latest flagship smartphone, the Realme GT 7 Pro in China, featuring…

19 hours ago

Malaysia to kill off NGVs in 2025 due to safety concerns

Malaysia will ban natural gas vehicles (NGVs) on 30 June 2025. Subsequently, no new natural…

21 hours ago

Is your iPhone 14 Plus having camera issues? Apple has a solution for you

Apple has launched a service program for the iPhone 14 Plus where certain units fail…

23 hours ago

U Family 128: U Mobile offers 1000GB shared data with 4 lines and free roaming for RM128/month

U Mobile has introduced its new U Family 128 offering, a new family plan which…

1 day ago

This website uses cookies.