Over the weekend, the Medical Device Authority (MDA) has revealed the list of two saliva-based COVID-19 self-test kits that have received conditional approval for import and distribution in Malaysia. The announcement has formalised what the regulator and its parent organisation, the Ministry of Health have mentioned several times earlier this month.
While the formal announcement took place yesterday, both of the kits have appeared inside MDA’s recommended test kit list on 9 July. One of them is Salixium which is manufactured by a local company, Reszon Diagnostic International that is based in Shah Alam while another is made by Philosys of South Korea under the brand Gmate.
Senarai dua kit ujian kendiri COVID-19 yang telah mendapat Kelulusan Bersyarat untuk diimport dan diedarkan di Malaysia.
Kit ujian ini boleh dijual di farmasi komuniti berdaftar atau fasiliti kesihatan.
Senarai ini akan dikemas kini dari semasa ke semasa. pic.twitter.com/1nrv9UeM5d
— KKMalaysia🇲🇾 (@KKMPutrajaya) July 18, 2021
In terms of usage, the Salixium test kit requires saliva and nasal swab. Specifically, the saliva sample is taken within the cheek and palate area of your mouth while the nasal swab is performed approximately 2cm up your nose, which is less intrusive than the RT-PCT test that goes much deeper to collect samples from your nasopharynx.
As for Gmate, it utilises just a saliva sample alone in which you have to spit into the provided container up to the required level. In terms of sensitivity, Salixium and Gmate are rated at 91.23% and 91.0%, respectively while they also have a similar specificity rating of 100%.
Both of these test kits are apparently able to provide results within 15 minutes although it has been noted you should not interpret the results on the test cassette after the said time. Additionally, if you receive a positive result from the test or show COVID-19 symptoms despite having a negative result, you have to follow up with an RT-PCR test to fully confirm whether you have been infected with COVID-19 or otherwise.
Meanwhile, the distributor of Salixium, MeDKAD has noted on its website that users can upload their test results directly to MySejahtera although the actual upload method has not yet been revealed there. Nevertheless, you can always self-report a positive result using the Helpdesk function within MySejahtera regardless of your test method.
In terms of pricing, Salixium can be obtained directly from MeDKAD’s online store, Medcart as well as DoctorOnCall (DoC) for RM 39.90. DoC together with several well-known pharmacies such as Caring, BIG, and Alpro have also begun taking orders for Gmate at the same price tag.
Ikmal Roslan contributed to this story.