Clungene (Nasal) – COVID-19 Antigen Rapid Self Test – 55 Tests

All our products are included in the Australian Register of Therapeutic Goods (TGA) register.

ARTG No: 333341

The COVID-19 Antigen Test Cassette is a rapid test for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in anterior nasal swabs. It is used to aid in the diagnosis of SARS-CoV-2 infection that may lead to COVID-19 disease.

The test is suitable for people with symptoms. Minors must be tested with the assistance of an adult.

The test is single use only and intended for self-testing，it is recommended to use this test within 7 days of symptom onset.

EASY – Easy Sample
– 2 Step Process

FAST – Test takes 2 mins
– Results in 15 mins

Easy to use

1. Sampling – The entire tip of the swab, app 2.5 cm, is inserted into the left nostril, where it is firmly brushed against the inside of the nostril in a circular motion 5 times or more. With the same swab, carry out the same procedure in the right nostril.
2. Extraction – After sampling the swab is inserted into a tube containing an extraction solution, where it is left for a minute.
3. Analysis – Three droplets of the extraction solution, now containing the sample, is added to a sample well on the test cassette. Results are read after 15 minutes.

ACCURATE

• Sensitivity up to 95.1%
• Specificity up to 95%

 Shelf life & Storage conditions

The Clungene Covid-19 Antigen Rapid  Self Test offers two years shelf life from date of manufacturing.
Storage temperature 4ºC – 30ºC.

The Clungene COVID-19 Antigen Test Cassette is a chromatographic immunoassay for the qualitative detection of SARS-CoV-2(COVID-19) nucleocapsid antigen in nasopharyngeal, oropharyngeal and nasal swabs to aid in the diagnosis of SARS-CoV-2 virus infection.

To do this, a smear is taken from the front of the nose and applied to a test cassette. This works according to the lateral flow principle and shows within 10 to 15 minutes whether COVID-19 antigens could be detected in the sample. All the necessary materials are included in the test kit.

Materials provided
Test device

Extraction buffer

Package insert

Sterile swab

Workstation

It detects the COVID-19 pathogen and its antigens directly and can thus recognise symptomatic and asymptomatic infections.

• Approved for Self Testing from 12th Jan, 2022 for Home Use
• Easily performed as an anterior nasal swab
• The test is developed as a Self-Test. No equipment is required, all consumables are included
• Use also with minors under the supervision

Warnings and Precautions

• For in vitro diagnostic use only.
• Do not use this test as the only guide to manage your illness. Please contact your State or Territory
• Coronavirus testing services to get a laboratory PCR test if your symptoms are persisting or
• worsening, or if you are concerned at any time.
• The test is less reliable in the later phase of infection and in asymptomatic individuals.
• Negative results may occur if testing is not performed within the first 7 days of symptom onset.
• If the test is to be used on a person under 15 years of age, the test must be undertaken by an adult.
• Keep out of reach of children to reduce the risk of accidentally drinking the extraction reagent or
• swallowing small parts.
• Do not use this product after the expiration date.
• Only use the test once and only with the provided parts.
• Do not undertake testing in direct sunlight.
• Avoid contact with Extraction Reagent. If the extraction reagent is accidentally exposed to a person’s
• skin or eye, rinse with plenty of running water immediately. If irritation persists, seek medical assistance.
• This test involves taking a sample from deep inside your nose. When doing the test, pay particular attention to the instructions on how to swab your nose. Incorrect swabbing may lead to an inaccurate
• test result.
• The test cassette should remain in the sealed pouch until use.
• Wash hands thoroughly before and after testing.
• Dispose all parts of the used test kit into the waste bag, then discard the waste bag in the general waste.

Frequently Asked Questions

How does the Covid-19 Antigen Rapid test ( Self Test ) work?
Covid-19 Antigen Rapid test ( Self Test ) is a screening tool to help detect COVID-19 in people without any symptoms of COVID-19. Rapid antigen testing involves a nasal swab (using a small cotton bud) that is placed into a chemical solution The result displays within 15 minutes.

Is this kit TGA approved?
Yes all of our tests are Covid-19 Antigen Rapid test ( Self Test ) TGA approved.

What age group can be tested on Covid-19 Antigen Rapid Self testing device? Anyone above the age 2 can be tested. For children younger than 14 years, an adult caretaker should help collect the nasal samples and conduct the test procedures.

What does positive test result means for me?
If you get a positive rapid antigen test result, you must review the states rules at that time.

What does negative test result means for me?
Individuals must continue to follow the latest health advice and restrictions in their area.

What does an invalid result mean?
Sometimes the results are inconclusive or not clear, and the test cannot tell you if your results are positive or negative. If the display on the self-test shows an invalid result or a test error, the test did not work properly. If this happens, refer to the instructions for use in the package insert and contact the manufacturer for assistance. Invalid results can occur for many reasons. Your specimen may not have been collected correctly, or the testing instrument may have malfunctioned. Invalid test results are rare but can occur. Regardless of what your test results are, you should always review the results with a healthcare provider. The healthcare provider will consider the test result together with your symptoms and possible exposure in deciding how to care for you.

What are the advantages of performing self testing?
Rapid antigen tests have been used internationally and in some Australian industries for some time to screen employees for COVID-19 with no symptoms. Rapid antigen tests can be performed easily with results available within minutes. However, these tests have some limitations compared to the standard COVID-19 tests (PCR) used at testing clinics.

How does the nasal swab work? The nasal swab head has a brush which trap the virus in its bristles when the swab is rotated in the nostrils brushing it against the walls of the nasal passage. When the swab is inserted in the buffer and squeezed, the virus breaks down and is released in the buffer.

Why do I need to swab both nostrils?
Swabbing both nostrils ensures that quality sample is collected for testing. How deep should I insert the swab? The swab needs to be inserted only 1 to 2 cms in the nostril.

How do I collect sample of a child?
This test is not suitable for children below the age of 2 years. 3 to 14 years children can be tested with these devices and an adult is required to collect their sample and perform the test. Ask the child to blow the nose gently and clean with tissue. Then while sitting upright, get them to slightly tilt their head so the nasal passage is clearly visible to the collector. Insert the swab around 1 cms in one nostril and rotate it 5 times while brushing the swab head against the nasal passage. Repeat with the same swab in the other nostril.

If I have a runny or blocked nose can I use the swab to do the test?
Yes, you can. Clean the nose with tissue and get rid of excess mucus, then collect sample.