GMATE COVID-19 AG SALIVA ANTIGEN RAPID TEST KIT (RTK)

Interpretation of test results, what to do if:

(a) Positive result

Symptomatic or non-symptomatic person that got a positive result has to undergo RT-PCR test for the true confirmation of a COVID-19 case.

(b) Negative result

Only symptomatic people with negative RTK-Ag results shall be tested with RT-PCR.

(c) Invalid result

A re-test shall be done with a new sample (saliva) and a new test kit.

The RTK-Antigen Test is a screening tool, not a diagnostic tool!

1. This test can only detect SARS-CoV-2 antigen in human saliva only, not other specimen.
2. If the procedure is done incorrectly, it may cause inaccurate results. 
3. False negative results happen if:
1. the concentration of antigen in a specimen is below the detection limit of the test.
2. the specimen was not collected or transported properly.
4. Positive results do not rule out co-infections with other pathogens.

Therefore, due to its limitation in detection range and sensitivity, RTK-Antigen test is used as a screening test and RT-PCR is used as confirmatory test to define a COVID-19 case.

Box contains
Test Kit x 1
Funnel x 1
Reagant Container x 1
Cap x 1

Frequently Asked Questions:

1. Is this test approved by the Malaysia Ministry of Health (KKM)?
Yes, this test is registered and approved by the Medical Devices Authority (MDA) which is the medical devices division under the Ministry of Health.

2. I accidentally spit too much saliva into the saliva collection kit, does it affect the accuracy?
No, it doesn’t. However do not spit lesser than the recommended amount into the saliva collection kit.

3. Should I put all the reagent into the saliva collection kit?
Yes, please drop all the reagent into the saliva collection kit.

4. I have accidentally exposed the test kit to high heat in my car, will the kit still be accurate?
The storage condition of the kit needs to be at 2ºc to 30 ºc and heat will affect the accuracy of the test. In that case, please purchase a new kit.

5. Should I store the test kit in the fridge?
No, just store it in a cool place at home where it is around 2ºc to 30 ºc.

6. I accidentally spilled the saliva and reagent mixture, what should I do?
Clean the surface with a disinfectant solution and leave to dry. Purchase a new test kit.

7. If I did not shake 20 times and press 20 times, or I have lost count, what should I do?
Shake another 20 times and press another 20 times and proceed with the rest of the steps.