Novel Coronavirus (2019-ncov) Antigen testing kit (colloidal gold)

Summary

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

How accurate is the NORMAN Antigen Rapid Self test kit?

The test has been approved by the Ministry of Health(MOH) and Medical Device Authority of Malaysia and evaluation by Makmal Kesihatan Awam Kebangsaan (MKAK) shows that it is highly accurate with:

- Sensitivity 96.7%
- Specificity 100.0%

Product Details

Brand	NORMAN
Model	Novel Coronavirus (2019-nCoV) Antigen Testing Kit (Colloidal Gold)
Conditional Approval reference number	(36) MDA. 600-1/6/27
Lot No	S2052621- 21032308/21042608/22020808/22030808
Dimensions	14.2 × 7 × 1.6 cm
Disclaimer	Home testing carried out by Norman Rapid Antigen Test Kit (RTK) is advised in symptomatic individuals and immediate contacts of confirmed positive cases.
Principle	The COVID-19 Antigen Rapid Test (Oral Fluid) is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 Antigens in human oral fluid specimen.
What is in the box?	Test Cassette x 1 Reagent Tube x 1 Collection Device x 1 Treatment Reagant x 1 Dropper Collection x 1 Instruction for use x 1 Biological Hazard Bag x1

What does the test results mean?

Give the result within 20 minutes with high accuracy

⊕ Positive Result
If you see two red lines by C and T regions, you have been tested positive for Covid-19. The lines can be distinct or faint.

RT-PCR test is still required for a confirmation of a Covid-19 case. You are advised to seek medical attention immediately even though you might have no symptom
Do follow the current SOP given

Θ Negative Result
If you see one red line by C, and no line by T, it is a negative result.

You probably do not have Covid-19. If you suspect you have been exposed to the virus, we advise you to continue monitoring for symptoms
There is a chance for a false-negative result. If you develop symptoms later on, you are advised to do a RT-PCR test as confirmation

⊗ Invalid Result
If you do not see any lines, or one line by T, it is an invalid result. There is an error in the test.

You will need to do another test with a new test kit.

Certified

Step-By-Step Processes

Those who received a positive result should report themselves through MySejahtera’s Helpdesk.

Bulk & Corporate Order

FAQ

Is this accurate?

Yes, this test is registered and approved by the Medical Devices Authority (MDA) which is the medical devices division under the Ministry of Health.
NORMAN Saliva Antigen Test Kit is certified by the Institute of Medical Research (IMR) that is has 96.7% accuracy based on 96.7% sensitivity and 100% specificity.

Should I store the test kit in the fridges?

No, just store it in a cool place at home where it is around 20°C to 30°C.

Could other throat infection cause a false positive?

No, a throat infection that is not due to Covid-19 infection will not cause a false positive.

Would the bubbles formed affect the result?

No. However, the bubbles might hinder the tidal flow of the test kit due to insufficient sample. Hence, we recommend that you wait for 5 minutes before dropping the mixed samples.

if I am recently vaccinated, will my results show as positive?

Vaccination does not provide complete immunity against the virus. It reduces the complication risks if infected. However, if you are infected even if you are vaccinated, you will be tested as positive.