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Clungene COVID-19 Rapid Antigen Test for Home, Set of 5 Applications, Nasal Sampling

The COVID-19 Antigen Rapid Test is a lateral flow immunoassay based on the principle of double antibody sandwich technology. The SARS-CoV-2 nucleocapsid protein monoclonal antibody conjugated with colored microparticles is used as a detector and sprayed onto the conjugation pad. During the test, the SARS-CoV-2 antigen in the sample interacts with the SARS-CoV-2 antibody, which is conjugated with colored microparticles, creating an antigen-antibody-labeled complex. This complex migrates via capillary action on the membrane to the
test line, where it is captured by the pre-coated monoclonal SARS-CoV-2 nucleocapsid protein antibody. A colored test line (T) would be visible in the result window if SARS-CoV-2 antigens are present in the sample. The absence of the T-line indicates a negative result. The control line (C) is used as a procedural control and should always be displayed when the test procedure is being carried out properly. Until lay approval from the BfArM is available, the test is only approved for medical or trained personnel.

File number of the special approval of the BfArM 5640S 168/21

• Sensitivity: 91.4% - 97.5%
• Specificity: 95.0% - 99.4%

• 1 test cassette
• 1 swabs
• 1 extraction tubes
• 1 buffer ampoules
• 1 instruction manual

• Individually packed

INTENDED USE

The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is a lateral flow chromatographic immunoassay single-use test kit intended to qualitative detect the SARS-CoV-2 that causes COVID-19 with self-collected nasal swab specimen. The test is intended for use in symptomatic individuals meeting the case definition for COVID-19 within the first 7 days of symptom onset.

Results are for the detection of SARS-CoV-2 Nucleocapsid protein Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status.

Positive results are indicative of the presence of SARS-CoV-2. Individuals who test positive should self-isolate and contact your State or Territory Coronavirus testing services to get a laboratory PCR test. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not preclude SARS-CoV-2 infection. Individuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their COVID testing centre.

he SARS-CoV-2 Antigen Rapid Test (Nasal Swab) obtain a preliminary result only, an aid diagnosis of COVID-19, for the final confirmation should be based on clinical diagnostic results.
The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is intended to be used by laypersons as a self-test for home and workplace (in offices, for sporting events, airports, schools, etc.).

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 diarrhoea are found in a few cases1.

PRINCIPLE

The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 nucleocapsid protein antigens in human swab specimen

PRECAUTIONS

Please read all the information in this package insert before performing the test.

• For self-testing in vitro diagnostic use only.Do not use after expiration date.
• Do not eat, drink or smoke in the area where the specimens or kits are handled.
• Do not drink the buffer in the kit. Carefully handle the buffer and avoid it contacting skin or eyes, rinse with plenty of running water immediately if contacting,
• Store in a dry place at 2-30 °C (36-86 °F), avoiding areas of excess moisture. If the foil packaging is
damaged or has been opened, please do not use.

• This test kit is intended to be used as a preliminary test only and repeatedly abnormal results should be
discussed with doctor or medical professional.
• Follow the indicated time strictly.
• Use the test only once. Do not dismantle and touch the test window of the test cassette.
• The kit must not be frozen or used after the expiration date printed on the package.
• Keep out of the reach of children.
• Test for children and young people should be used with an adult.
• Small children under the age of 16 should be swabbed with the help of a second adult.
• Wash hands thoroughly before and after handling.
• Please ensure that an appropriate amount of samples are used for testing. Too much or too little sample
size may lead to deviation of results.

STORAGE AND STABILITY

Store as packaged in the sealed pouch at room temperature or refrigerated (2-30 °C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

VIDEO:https://youtu.be/hCejITR8_zY

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. 

Information regarding available support services can also be obtained by contacting your local state and territory health department at:

Australian Capital Territory Department of Health

02 62077244 https://www.health.act.gov.au/

New South Wales Department of Health

137788 https://www.health.nsw.gov.au/

Northern Territory Department of health

1800020080 https://www.health.nt.gov.au/

Queensland Department of health

134268 https://www.health.qld.gov.au/

South Australian Department of Health

1800253787 https://www.sahealth.sa.gov.au/

Tasmanian Department of Health

1800671738 https://www.health.tas.gov.au/

Victorian Department of Health

1800675398 https://www.dhhs.vic.gov.au/

Western Australian Department of Health

1800595206 https://www.healthywa.wa.gov.au/

If there are poor performance or usability issues：

Use Medical Device incident Report

Call 1800809361 or E-mail [email protected]