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The Clungene Covid-19 Human Antigen Rapid Test is a SARS-COV-2 immunoassay screening device for the qualitative detection of a nucleocapsid protein, an antigen, which forms part of the SARS-CoV-2 virus.

The main benefit of this device is to find out whether a person carries the SARS-CoV-2 virus during the onset of COVID-19. Recommended use is to test persons with COVID-19 symptoms.

Any person who has a positive rapid antigen test result should immediately have a confirmatory PCR test at a COVID-19 testing center.

Intended Use:

The Clungene COVID-19 Antigen Rapid Test is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasopharyngeal swabs or nasal swabs from individuals who are suspected of COVID-19 within the first seven days of symptoms.

Kit Includes:

• Test Cassette, which holds the test strip where detection of the SARS-COV-2 nucleocapsid antigen takes place.
• Extraction Reagent Tube.
• Collection swab
• Waste Bag
• IFU/Product insert

Warnings and Precautions:

• For in vitro diagnostic use only
• Do not use this test as the only guide to managing 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.
• Expiration Date: December 2023
• Only use the test once and only with the provided parts.
• Do not undertake testing in direct sunlight.
• Avoid contact with Extraction reSales Representatives. 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 of all parts of the used test kit into the waste bag, then discard the waste bag in the general waste.

Resources:

• For information on COVID-19 in your state or territory, click here
• To find out more about COVID-19, visit the Commonwealth Department of Health website here.
• Click here for a fact sheet explaining how to use COVID-19 home test kits and what to do when you get a result.
• Download the instructions for using this test kit here.

More Information:

• Box contains five individual tests.
• Usage instructions are included with the packaging.

More Questions:

Still unsure if this product is right for your intended use? Get in contact with one of our Sales Representatives via the contact us page.

Product Description:

The COVID-19/RSV/Influenza A&B Antigen Test Kit is a lateral flow immunoassay for the qualitative detection of SARS-CoV-2, respiratory syncytial, influenza A and influenza B viral nucleoprotein antigens in nasal swabs from subjects. The symptoms of respiratory viral infection due to SARS-CoV-2, respiratory syncytial, influenza can be similar. The test is intended as an aid in diagnosis of symptomatic individual meeting respiratory infection for SARS-CoV-2 (within the first 7 days of the onset of symptoms) and influenza A/B or Respiratory syncytial virus (RSV) (within the first 4 days of the onset of symptoms). This kit is intended for layperson's home use in a non-laboratory environment. Test results of this kit are for clinical reference only. It is recommended that a comprehensive analysis of the disease be conducted based on clinical manifestations of patients and other laboratory tests.

Precautions:

1. For in vitro diagnostic use only.
2. Do not use after the expiration date.
3. Perform the test at room temperature 15 to 30°C.
4. The test cassette should remain in the sealed pouch until use.
5. Please read all information in this leaflet before performing the test.
6. Components from difference lots must not be mixed or used together.
7. Positive result cannot necessarily determine whether a person is infectious.

Storage and Stability:

Store the test kit in the original packaging at 2°C - 30°C. Do not freeze. Test kit contents remain stable until the expiration date printed on the outer packaging.
After opening the pouch, the test should be used within one hour. Prolonged contact with hot and humid environment will cause the product to deteriorate.

Performance Characteristics:

For COVID-19
Using COVID-19/RSV/Influenza A&B Antigen Test Kit by professional was compared to the RT-PCR kit. A
sensitivity of 95.45% (210/220 known confirmed Positives) and a specificity of 99.03% (307/310 known
confirmed Negatives) were determined for the COVID-19/RSV/Influenza A&B Antigen Test Kit.

For influenza A test
UsingCOVID-19/RSV/Influenza A&B Antigen Test Kit by professional was compared to the RT-PCR kit. A
sensitivity of 93.48%(86/92 known confirmed Positives)and a Specificity of 98.29% (288/293 known confirmed
Negatives)were determined for the COVID-19/RSV/Influenza A&B Antigen Test Kit.

For influenza B test
Using COVID-19/RSV/Influenza A&B Antigen Test Kit by professional was compared to the RT-PCR kit. A
sensitivity of 91.11% (82/90 known confirmed Positives) and a Specificity of 97.89% (278/284 known confirmed
Negatives)were determined for the COVID-19/RSV/Influenza A&B Antigen Test Kit.

For RSV test
Using COVID-19/RSV/Influenza A&B Antigen Test Kit by professional was compared to the RT-PCR kit. A
sensitivity of 94.81% (201/212 known confirmed Positives) and a Specificity of 98.87% (175/177 known
confirmed Negatives)were determined for the COVID-19/RSV/Influenza A&B Antigen Test Kit.

Usability Study
Lay users in different age distribution, different education level and different gender participated in usability
study conducted in the self-testing environment. Compared to RT-PCR, the clinical performance of COVID19/RSV/Influenza A&B Antigen Test Kit in hands of lay persons showed a sensitivity of 94.87% (N=39) and a
specificity of 98.57% (N=70) for COVID-19 antigen, a sensitivity of 94.29% (N=35) and a specificity of 98.57%
(N=70) for RSV antigen, a sensitivity of 90.00% (N=30) and a specificity of 98.57% (N=70) for influenza A
antigen and a sensitivity of 93.33% (N=30) and a specificity of 98.57% (N=70) for influenza B antigen

More Questions:

Still unsure if this product is right for your intended use? Get in contact with one of our Sales Representatives via the contact us page.

Information:

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.

More Questions:

Still unsure if this product is right for your intended use? Get in contact with one of our Sales Representatives via the contact us page.

General Description:

The LYHER COVID-19 Antigen Swab Test is a rapid, reliable & simple test to use.

Use the test in the comfort of your own home or workplace.
This product is TGA certified (ARTG374507).

• Comfortable and easy Swab sample-based test
• Simple 2-Step Process. The test takes 2 minutes
• Results are available in 15 minutes
• 12-month shelf life, compared to 12 months for other similar products
• Safe to use, all testing fluids are contained and retained in the sealed pen
• Clear and easy instructions for use, packaging shows simple to use instructions
• Pack includes detailed instructions sheet and other important information
• Each 2 Pack contains: 1 x Nasal Swab Antigen Tests, 2 x Disposal Bags, 1 x Set of Instructions for Use

The LYHER® antigen test is a single use, in vitro (outside the body) test to aid in the diagnosis of SARS-CoV-2 infection in individuals with symptoms of COVID-19. The test uses specimens collected from your nasal cavity using a nasal swab to detect the presence of the nucleocapsid protein SARS-CoV-2 antigen (Ag). An immunoassay technique is used to detect antigens of COVID-19. The sample pad is coated with colloidal gold bound antibodies. The quality control area is coated with goat anti-mouse Immunoglobulin G (IgG), and test area with anti-SARS-CoV-2 antibodies. If SARS-CoV-2 antigen is detected in specimen, the T line will become visibly colored. The C line should always be colored, or the test is not valid.

Intended Use:

• The test kit is intended for self-testing purposes by untrained individuals outside of laboratory or clinical settings such as in your home.
• You can use this test if you have symptoms of COVID-19. It is recommended to use the test within the first 7 days following the start of symptoms; the test is less reliable in the later phase of infection and in asymptomatic individuals.

If you have severe symptoms of COVID-19 including severe difficulty of breathing, call triple zero (000) immediately and tell the call handler and the paramedics on arrival about your recent travel history and any close contact with an infected person.

Warnings and Precautions for Use:

• Do not use the test kit after the expiry date on the carton or if any components appear to be damaged or tampered with.
• You must ask an adult to do the test, or you must do it under adult supervision if you are under the age of 16.
• You should not use this test in children aged 2 years and under.
• Keep the test kit including all components, out of reach of children – ingestion of the diluent can be dangerous.
• If the diluent solution comes into contact with your skin or eyes, immediately wash with large amount of water.
• You should not use this test if you are likely to experience difficulties taking the sample specimen or interpreting the results unless you have someone to help you.
• You should not use this test if you are prone to nosebleeds.          

More Questions:

Still unsure if this product is right for your intended use? Get in contact with one of our Sales Representatives via the contact us page.