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Two brands of Covid-19 self-test kits have their conditional approval revoked for failing to comply with the approval conditions given by the Medical Device Authority (MDA).
MDA informed that the cancellation was effective immediately and advised consumers not to buy or use the COVID-19 self-test kit.
The affected test kits are Deepblue by Innovac Technology Sdn. Bhd and Wiz Biotech by Conan Medical Technology Berhad.
Accordingly, the establishments failed to comply with the conditions of approval given by MDA.
MDA advises consumers not to purchase or use Covid-19 self-test kits that do not comply with its requirements for fear of being unsafe.
Health Ministry Evaluating Self-Test Kits
Meanwhile, Health Minister Khairy Jamaluddin said his ministry had received several complaints regarding Covid-19 self-test kits sold in the market.
Following that, he said, MDA tested 22 brands of self-test kits, with the results of 12 of them already obtained.
He said through a Twitter post that approval for the two self-test kits was suspended upon findings that they did not reach the set performance level.
Saya telah menerima beberapa aduan berkenaan kit ujian kendiri COVID-19 yang ada di pasaran. MDA telah menguji 22 jenama. Setakat ini, 12 keputusan telah diperolehi dan mendapati 2 kit tidak mencapai tahap prestasi yang ditetapkan. Kelulusan 2 kit ini digantung serta-merta. pic.twitter.com/svwbHNRcKv
— Khairy Jamaluddin 🇲🇾🌺 (@Khairykj) April 11, 2022
Types Of Covid-19 Self-Test Kits
A Covid-19 self-test kit is based on an antigen test designed to detect viral proteins related to the Covid-19 virus.
There are currently two main types of Covid-19 RTK-Ag self-test kits.
One requires a nasal specimen (either through an anterior nasal swab or a nasal mid-turbinate swab), while the other requires a saliva specimen.
Self-tests for COVID-19 give rapid results and can be taken anywhere, regardless of your vaccination status or whether or not you have symptoms.
These test kits can produce a negative or positive result in as little as 15 minutes.
Should I Trust The Results Of A Self-Test?
Positive results from self-tests are highly reliable, although negative results from self-tests do not rule out SARS-CoV-2 infection.
A negative self-test result may not be reliable, especially if you have symptoms associated with Covid-19.
Invalid results from self-tests mean the test did not work properly, and a new test is needed to get an accurate result.
It must also be noted that testing too long after symptom onset or possible exposure would produce false negatives due to decreased viral loads.
Self-test kits are meant to help individuals perform self-screenings rapidly and reduce the burden on healthcare workers.
It does not replace the reverse-transcription polymerase chain reaction (RT-PCR) tests, which is needed for a confirmed diagnosis of Covid-19.