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MoH approves sale of two Covid-19 self-test kits

KUALA LUMPUR: The Health Ministry (MoH) has just conditionally approved two Covid-19 self-test kits for import and distribution. This was done through the Medical Devices Authority (MDA), an organisation in the Ministry of Health in charge of enforcing medical device regulations and medical device registration.

These Rapid Antigen Kits allow individuals to self-screen for Covid-19 for less than RM40 and get results immediately. The two kits are:

1. Salixium Covid-19 Rapid Antigen Rapid Test (Saliva/Nasal Swab Samples) by Reszon Diagnostic International Sdn Bhd Malaysia; and
2.Gmate Covid-19 Ag Saliva For Home Use by Philosys Co Ltd, South Korea.

MoH said the list will be updated occasionally and can be checked on the MDA portal, as reported by The Malay Mail.

Salixium is the first Malaysian-made Covid-19 rapid antigen testing kit. MyMedKad claims that it is currently the only self-test kit available to the public that will have integration with MySejahtera.

RT-PCR vs RTK-Ag tests

Take note that Rapid Antigen Kit (RTK-Ag) can produce a false-negative result if the concentration of antigen is too low, or if the sample was simply not taken properly. Because of this, these tests should only be used for instant screening.

To get a confirmatory test, one must do an RT-PCR test at clinics and health labs. An RT-PCR test usually costs around RM190-240 and the results may take about 24 hours.

According to the MoH’s guidelines, RTK-Ag testing is considered as a screening test and RT-PCR shall be used as a confirmatory test to define a Covid-19 case. However, RTK-Ag can be used as a confirmatory test in certain circumstances where there are confirmed Covid-19 clusters or outbreaks or areas that are identified by the National Crisis Preparedness Response Centre (CPRC).

How does Salixium work?

Salixium is an RTK Antigen test that uses saliva and a nasal sample to detect the presence or absence of the SARS-CoV-2 antigen. Don’t be alarmed, as the nasal sample doesn’t require you to go as deep as a PCR test. You only need to swab gently 2cm up your nostrils.

Salixium has a sensitivity of 91.23 per cent and a specificity of 100 per cent. What does this mean? Sensitivity measures how often a test correctly generates a positive result, while specificity measures how often a test correctly generates a negative result.

How do I use Salixium?

Here is a 12-step image guide on how to use the Salixium test:

First, peel off the seal on the extraction buffer tube and place the tube on the rack. Then, remove one disposable swab from the sterile packaging and swab the fabric tip on the inside of your left cheek by rubbing up and down at least five times. Do the same with your right cheek with the same swab and swab the top of your mouth five times as well. Place that swab in the tube.

Remove another disposable swab from the packaging and avoid touching any surface or object with the swab tip, including your own hand. Insert only the fabric tip of the swab gently into one nostril until you feel a slight resistance (approx. 2cm up). Roll the swab around the inside of your nostril, making 5 complete circles.

Repeat the same step with the other nostril using the same swab. It can feel a little uncomfortable, but it shouldn’t be painful. After this, place the second swab in the tube.

Immerse and mix the swab heads in the extraction buffer completely and vigorously. Squeeze liquid from both swabs to keep as much solution in the tube as possible and then discard the swabs in the waste bag provided. Then, cover the tube with the dripper head and mix it thoroughly.

Gently tear open the pouch and remove the test cassette. Lay it on a clean, flat work surface and label it with a sample name. Then, add two drops of the sample solution to the sample well and make sure there is no air bubble. The sample will start wicking up the membrane.

Read the results within 10-15 minutes. They will be shown with lines next to the letters C and T. Do not read the result after 15 minutes, as it may lead to inaccurate results

If you only see a red line next to ‘C’, you have a negative result.

If you see a red line next to ‘C’ and you see a line next to ‘T’ (even if it’s faded), you have a positive result.

If you do not see a red line next to ‘C’, the results are invalid, even if you see something next to ‘T’. If this occurs, you have to take another test to get a proper result.

Where can I get Salixium?

Salixium is priced at RM39.90 and you can purchase it at registered community pharmacies and health facilities. It is now available for pre-order at MeDKAD for RM39.90 and the kits will be shipped out by 21st July. It’s also available on DoctorOnCall.

How does Gmate work?

The Gmate test is also an RTK Antigen test, but it only uses a saliva sample to detect the presence or absence of the SARS-CoV-2 antigen.

Gmate has a sensitivity of 90.9 per cent and a specificity of 100 per cent, meaning it is 90.9 per cent accurate at generating a positive result, and 100 per cent accurate at generating a negative result.

How do I use Gmate?

The Gmate test takes just five steps but you must first rinse your mouth with water. 30 minutes before conducting the test, you should not eat, drink or smoke.

Tear off the seal and connect the funnel to the reagent container. Spit your saliva until it reaches at least ¼ of the reagent container. Remove the funnel and put the cap on the reagent container.

Squeeze the container 20 times and shake 20 times to mix it. Attach the reagent container to the box and leave it for five minutes.Open the test kit and drop four drops of mixed reagent onto the test kit.

The results will also show up with red lines after 15 minutes.

The results read the same as with Salixium. If you only see a red line next to ‘C’, you have a negative result.

If you see a red line next to ‘C’ and you see a line next to ‘T’ (even if it’s faded), you have a positive result.

If you do not see a red line next to ‘C’, the results are invalid, even if you see something next to ‘T’. If this occurs, you have to take another test to get a proper result.

Where can I get Gmate?

Gmate is officially priced at RM39.90 and it is also available at registered community pharmacies and health facilities. The test kit can be purchased online via AlPro Pharmacy and DoctorOnCall.

What should you do if you’re tested positive?

If you’re positive, you must report to the Ministry of Health via MySejahtera. Just open the app, go to the home screen and tap on HelpDesk. Select “F. I am Covid-19 positive and would like to report my results”.

After filling up your personal details, you can choose which test was conducted (RTK Antigen Naso-oropharyngeal or RTK Antigen Saliva). You are also required to attach a photo of the test result.

If your results return negative, you must still continue to adhere to the SOP including wearing a face mask and to social distance.

Written by Ezri

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