CLUNGENE COVID-19 Antigen Rapid 25 Test box
Shallow Nasal, Low Intrusion, Self Test
Box of 25
Features
- Rapid testing for COVID-19
- Results in 15 minutes
- 98% effective
- High sensitivity and specificity
- Dual band results for simple interpretation
- All necessary reagents and equipment provided
- Includes full instructions for use
- No instrumentation required
- Simple, time-saving procedure
Pack Contents
- 25 x Test cassettes
- 25 x Sterile swabs
- 25 x Extraction reagent tubes
- 25 x Waste bags
- 1 x Instructions for use
- 1 x Workstation
FAQs
Can I collect the specimen and test at a later time?
The specimen should be tested immediately after collection. The specimen can be retained up to 1 hour following collection if immediate testing of specimens is not possible. Dispose of the specimen and recollect if retained for more than 1 hour.
Can I freeze the device for long-term storage?
The device should never be frozen. If refrigerated, allow the test kit components to reach room temperature before use.
Can the test be used with alternative specimen types such as nasal swabs or any specimen contained in viral transport media?
The Rapid COVID-19 Antigen Test is for direct nasopharyngeal swab specimen only. The test can only be used with the swab provided in the kit.
Does the test kit include transport media?
The test kit includes an extraction buffer that is used to prepare the specimen for testing purposes. The extraction buffer IS NOT transport media and should not be used to preserve or transport specimens.
How do I dispose of used tests?
It's recommended that used tests are disposed of in medical waste bins.
What is antigen testing
Antigen tests detect proteins specific to a virus that appears in infected individuals, which indicates active infection. Rapid antigen testing is beneficial because of their portability, ease-of-use, and swift time to result.
Description
The COVID-19 Antigen Rapid Test is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swab from individuals with symptoms or other epidemiological reasons to suspect COVID-19 infection. This test is intended for self-use by individuals aged 15 years or older and, as applicable for an adult lay user testing another person under 15 years of age. Individuals over 65 years of age should seek assistance in performing test.
The test provides only a preliminary screening test result for the SARS-CoV-2 virus. Confirmation of positive results is required using a laboratory PCR test. Persons who test negative and continue to experience COVID-19 like symptoms should seek follow up care with a doctor.
Rapid COVID-19 Antigen Self-Test
TEST PROCEDURE
IMPORTANT This test can be used within the first ten days that symptoms appear for COVID-19.
The test will take approximately 5 minutes to setup and the test results must be read at 15 minutes. It is important that you carefully follow the instructions to achieve the correct result.
The test device and the buffer solution must be at room temperature (15-30°C) before starting the test.
Step 1.
Insert the tube into the workstation. Remove the lid from the top of the tube.
Step 2.
Open the swab package where indicated. Pull the swab out by grasping the plastic end. Do not touch the absorbent swab tip.
Step 3.
Carefully insert the absorbent tip of the swab into your left nostril. Ensure that the entire swab tip is inside your nostril (2-4 cm deep). Do not insert the swab further after you feel resistance.
Step 4.
Roll the swab at least 5 times against the insides of your nostril. Ensure good contact between the swab and the insides of your nostril.
Step 5.
Remove the swab and insert into your right nostril. Repeat Steps 3 and 4.
Step 6.
Remove the swab from your nostril and insert the swab into the prepared tube in the workstation.
Step 7.
Mix well by rolling the swab at least 6 times while pressing the head of the swab against the bottom and sides of the tube.
Step 8.
Start timer. Leave the swab in the tube for 1 minute.
Step 9.
Squeeze the tube several times from the outside. Try to dissolve as much solution from the swab as possible.
Step 10.
Remove the swab and discard in a plastic bag.
Step 11.
Push the tip provided in the kit into the tube and ensure it fits tightly.
Step 12.
Remove the test device from the pouch and lay it on a fiat clean surface.
Step 13.
Add 4 drops of the solution into the sample well of the test device by gently squeezing the tube.
Step 14.
Start timer and read results at 15 minutes. It is important to read the results at 15 minutes.
Step 15.
Read your results. There are three possible types of results.
Positive Test Result
If the test device looks like either of the positive result above, you have a current Covid-19 infection. Please call your doctor or your local health department and make sure you adhere to local guidelines for self-isolation. Re-testing with other test methods such as a PCR test may be required.
Negative Test Result
If the test device looks like the negative result above, no Covid-19 infection could be detected. In a suspected case, repeat the test after 1-2 days since the virus cannot be accurately detected in all phases of an infection. Despite a negative test result, you still have to comply with all applicable rules regarding contact with others and protective measures.
Invalid Test Result
If your test result looks different, meaning there is no line visible or only one line at T, the result is invalid. This may be a result of the test execution, and the test should be repeated. If invalid test results continue, please contact your doctor or a COVID test center.