Salixium– COVID-19 Antigen Rapid Self Test (Saliva / Nasal) - Single Test

Frequently Asked Questions

How does the Salixium Covid-19 Antigen Rapid test (Self Test) work?

Salixium 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 Saliva and Nasal swab that is placed into a buffer solution. The result is displayed within 15 minutes.

Is This Kit TGA Approved?

Yes, all of our tests are TGA Approved for Self Test ARTG No. 418208.

What age group can be tested on the COVID-19 Antigen Rapid Self-testing device?

Anyone above the age of 2 can be tested. For children younger than 14 years, an adult caretaker should assist in collecting the Saliva & Nasal samples to conduct the test procedures.

What Does Positive Test Result Mean For Me?

If you get a positive rapid antigen test result, you must review the state 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 Saliva and Nasal Swabs work?

The swab's head has a brush that traps the virus in its bristles when the swab is rotated in the Cheek and Nostrils brushing it against the walls of the Cheek and Nasal passage. When both swabs are inserted in the buffer and squeezed, the virus breaks down and is released in the buffer.

Why Do I Need To Swab The Inner Cheeks / Palate & Both Nostrils?

Swabbing The Inner Cheeks / Palate & Both Nostrils ensures that a quality sample is collected for testing.

How Do I Collect A Sample From a child?

This test is not suitable for children below the age of 2 years. Children 3 to 14 years 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 that all passages are clearly visible to the collector. Insert the swab as directed on the Video.

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.

Resources:

• INSTRUCTION FOR USE (IFU), Attach link to IFU Attached
• For state and territory COVID information visit the relevant local state and territory health departments – here.
• For other relevant information about COVID-19 visit the Commonwealth Department of Health website – here.

Easy to use

1. Remove one disposable swab from the sterile packaging.
2. Swab the fabric tip on inside of your left cheek (between the cheek and the gum) by rubbing up and down for at least 5 times.
3. Repeat step on the right cheek using the same swab.
4. Using the same swab, swab the palate for 5 times.
5. Extraction – After sampling the swab is inserted into a tube containing an extraction solution, where it is left for a minute.

Sensitivity and Specificity

• Sensitivity up to 97.1%
• Specificity up to 100%

Shelf Life & Storage Conditions

The Saixium Covid-19 Antigen Rapid Self Test Nasal & Saliva offers 27 Months Shelf Life from the date of manufacturing. Storage temperature: 2ºC – 30ºC.

Contents

1 Pack

• Test device (Cassette)
• Extraction buffer & Dropper
• Sterile swabs
• Bio Hazard Waste Bag
• Instruction For Use (IFU)

5 Pack

• 5. Test device’s (Cassette)
• 5. Extraction buffer & Dropper
• 10. Sterile swabs
• 5. Bio Hazard Waste Bag
• 1. Workstation
• 2. Instruction For Use (IFU)

20 Pack

• 20. Test device’s (Cassette)
• 20. Extraction buffer & Droppers
• 40. Sterile swabs
• 20. Bio Hazard Waste Bag
• 1. Workstation
• 3. Instruction For Use (IFU)

Product Features

• Approved for Self Testing from 15 August 2023 for Home Use
• Easily performed as an anterior nasal and salival swab
• The test is developed as a Self-Test.
• Use also with minors under Adult Supervision

Warnings and Precautions

• For in Vitro Diagnostic use only.
• 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.