COVID-19 Antigen Saliva Test

Intended Use

The COVID-19 Antigen Test Cassette is a rapid test for the qualitative detection of the nucleocapsid antigen from SARS-CoV-2 in the saliva specimen from individuals suspected of COVID-19 within the first 7 days of symptom onset. This COVID-19 Antigen Test Cassette is intended for use by consumers enabling self-testing at home and healthcare professionals at point of care.

The performance of the COVID-19 Antigen Test Cassette is not affected by different variants of SARS-CoV-2, including alpha, beta, gamma, keppa and delta variants. This test is recommended for individuals above 4 years of age.

Principle

COVID-19 Antigen Test Cassette detects nucleocapsid antigen from SARS-CoV-2 in the saliva and is interpreted through development of colour. Anti-SARS-CoV-2-N antibodies are immobilised in the test region of the nitrocellulose membrane, marked with “T”.

Anti-SARS-CoV-2-N antibodies conjugated to coloured particles are placed on the conjugated pad. During testing, SARS-CoV-2 nucleocapsid antigen present in the saliva will bind to anti-SARS-CoV-2-N conjugated with colour. The mixture will migrate chromatographically along the length of the test strip and interact with anti-SARS-CoV-2-N immobilised at the “T” mark.

If the saliva specimen contains SARS-CoV-2 nucleocapsid antigen, a coloured line will appear in this region indicating a positive result. If the specimen does not contain SARS-CoV-2 nucleocapsid protein, a coloured line will not appear in this region.

To serve as a procedural control, a coloured line will always appear at the control line region, marked with “C”, indicating appropriate volume of specimen has been added and membrane wicking has occurred.

Precautions

For in vitro diagnostic use only. Do not use after the expiry date.
Before use, read the instructions provided carefully and only use as directed. Failure to follow directions may produce inaccurate test results.
A negative result may not mean that you are not infectious. If symptoms are present, seek further testing by PCR.
A negative result does not rule out infection with another type of respiratory virus.
Keep out of reach of Children. Children aged 4- 15 must be closely supervised by an adult. Not recommended for children below 4 years of age.
The likelihood of false-negative would increase after 4 days from the onset of symptoms. If you test negative and continue experiencing symptoms or symptoms become more severe, please contact your State or Territory Coronavirus testing services to get a laboratory PCR testing immediately.
Repeat testing within 1-2 days if there is an ongoing suspicion of infection, if you are in a high-risk setting or if it is an occupational or legal requirement
Each cassette is for single use. Do not reuse the cassette for multiple specimens.
Do not use if the foil pouch is opened or damaged. Do not open the pouch until ready for testing and use it within 30 minutes of opening the foil.
Do not eat, drink or smoke in the area where the samples and kits are handled.
Handle all samples as if they contain infectious agents.
Carry out the test at a room temperature of 15 – 30 0C and humidity of no more than 90%.

Storage And Stability

The kit should be stored between 4 – 30 ⁰C
DO NOT FREEZE
Do not use beyond expiration date printed on the foil pouch
The cassette must remain inside the foil pouch until use

Materials

Provided: Test device, instruction leaflet
Required but not provided: Timer

Directions For Use

Do not each, drink, smoke or wash your mouth for 30 minutes prior testing. Do not consume foods that contain or may contain nitrite (such as pickles, cured meat and other preserved products) within 24 hours before the test. Read expiration date printed on the pouch. Do not use if expired.

1. Wash your hands. Open the pouch, using the tear line. Take the cassette from pouch.

Remove the lid. Ensure no contact is made with the wick before placing in mouth.

2. Insert the cotton wick directly under your tongue. The cotton wick must remain in the saliva for 2 minutes or until the liquid appears in the results window of the cassette.

Keep your tongue pressed against the cotton wick, do not roll your tongue up during testing time. (Note: Only insert the cotton wick and wick collar into your mouth, not any other part of the cassette)

3. When test is complete remove the cassette from your mouth, close the lid and place it on a clean and levelled surface.

4. Start the timer. Read result after 15 minutes. Do not read after 20 minutes.

5. When the test is complete, place the cassette in a disposal bag and dispose of it via your general household waste. Wash your hands.

Interpretation Of Results

POSITIVE RESULT

POSITIVE:

Two lines appear. One line should appear in the control region “C” and another in the test region “T”.

NOTE: The intensity of colour in the test line “T” will vary depending on the presence of nucleocapsid antigen in the sample. Appearance of a coloured line of any intensity should be considered positive.

A positive test result means it is likely you currently have COVID-19 disease. Follow your State or Territory COVID-19 requirements for reporting positive test results and if PCR testing is required. Follow the local guidelines for self-isolation.

NEGATIVE RESULT

NEGATIVE:

One coloured line appears in the control region “C”. No coloured line appears in the test
region “T”.

NOTE: A negative result does not rule out the possibility of SARS-CoV-2 infection. Follow your State or Territory guidelines if you present with COVID-19 symptoms or have been in contact with a confirmed case. If you suspect COVID-19 infection, repeat the test within 1-2 days.

INVALID RESULT

INVALID:

If a line fails to appear at the control region, “C”, the test is deemed invalid. Repeat the test and call Aero Healthcare at 1800 628 881 (9 AM – 7 PM (AEST), 7 days per week) for further assistance.

QUALITYCONTROL:

The COVID-19 Antigen Test Cassette has built-in procedural controls. A coloured line appearing in the control region, “C”, serves as a procedural control which indicates sufficient specimen volume and correct procedure was carried out.

Limitations

This test detects both replicable and nonreplicable SARS-CoV-2 viruses. Test performance depends on amount of nucleocapsid antigen present in the saliva sample. The intensity of the test line does not necessarily relate to the SARS-CoV-2 viral load in the specimen.
The test may produce a false-negative result if the antigen level in the sample is below the test detection level or if the sample was collected incorrectly.
Detection limit = 100 pg/mL.
Test results should be interpreted together with other clinical data available to the doctor
This rapid antigen test is recommended for presumptive screening only. Please consult the relevant State or Territory COVID-19 resources for how and when to report test results and if any additional testing is required.
A positive result cannot necessarily determine if a person is infectious.
A positive test result does not rule out co-infection with other pathogens.
A positive test results do not differentiate between SARS-CoV and SARS-CoV-2.
A negative test result does not rule out other viral or bacterial infections.
A negative result after 7 days of symptoms onset should be treated as likely negative and confirmed with a PCR test if required.
The test is less reliable after 7 days of symptoms onset and in asymptomatic individuals.

Performance Characteristics

1.Clinical Sensitivity and Specificity

Clinical-Sensitivity-and-Specificity-Rat-Test

The performance of the COVID-19 Antigen Test Cassette was established with 460 specimens from symptomatic patients who were suspected of COVID-19. The test kits were compared to a commercially available PCR and the results show that the sensitivity is 95.6% (153/160) and specificity is 99.7% (299/300).

2. Interfering Substances

The following substances which may be found in the specimen were tested using the COVID-19 Antigen Test Cassette and no interference was observed.

Whole Blood	Mucin
Budesonide Nasal Spray	Dexamethasone
Flunisolide	Mupirocin
Oxymetazolineent	Phenylephrine
Rebetol	Relenza
Tamifluent

3. Cross-reactivity

The COVID-19 Antigen Test Cassette has been tested for cross-reaction with other strains, viruses and bacteria, and the results showed no cross-reactivity.

Candida albicans	Staphylococcus epidermidis	Corynebacterium
Streptococcus pneumoniae	Escherichia coli	Streptococcus pygenes
Moraxella catarrhalis	Streptococcus salivarius	Neisseria lactamica
Streptococcus sp group F	Respiratory syncytial virus	Nesseria subflava
Pseudomonas aeruginosa	Arcanobacterium	Influenza A H1N1
Influenza A H3N2	Influenza B	Human Rhinovirus 2
Human Rhinovirus 14	Human Rhinovirus 16	Measles
Mumps	Parainfluenza virus 2	Parainfluenza virus 3
Respiratory syncytial virus	Human coronavirus 229E	MERS
Human coronavirus OC 43	Human Coronavirus NL63

Symbols

Symbol	Meaning
	Medical in vitro diagnosis
	Manufacturer
	Batch code
	Follow the Package insert
	Expiry date
	Date of manufacture

Symbol	Meaning
	Storage temperature Limits (4-30°C)
	Tests per set
	Do not reuse
	Authorised Representative in the European Community
	Catalogue number
	For Home test/self-testing

Contact Information and Online Support

State Government COVID Support Lines

Australian Capital Territory Department of Health
Phone: 02 6207 7244	Website: https://health.act.gov.au/
New South Wales Department of Health
Phone: 137 788	Website: https://www.health.nsw.gov.au/
Northern Territory Department of Health
Phone: 1800 020 080	Website: https://health.nt.gov.au/
Queensland Department of Health
Phone: 134 268	Website: https://www.health.qld.gov.au/
South Australian Department of Health
Phone: 02 6207 7244	Website: https://www.sahealth.sa.gov.au/
Tasmanian Department of Health
Phone: 1800 671 738	Website: https://www.health.tas.gov.au/
Victorian Department of Health and Human Services
Phone: 1800 675 398	Website: https://www.dhhs.vic.gov.au/
Western Australian Department of Health
Phone: 1800 595 206	Website: https://www.healthywa.wa.gov.au/

Contact Aero Healthcare for test related inquiries:

Phone: 1800 628 881 Hours: 9 AM – 7 PM (AEST), 7 days per week

Email: sales@aerohealthcare.com

Website: https://aerohealthcare.com/

Contact the TGA to report poor performance or usability issues in the
self-test environment:

Report an issue via the Users Medical Device Incident Report, email iris@tga.gov.au or call 1800 809 361

Manufactured for AERO HEALTHCAREAUS
63 Seaton St. Armidale 2350
www.aerohealthcare.com

Hangzhou Testsea biotechnology Co., Ltd.

3rd Floor, Building 6, No. 8-2 Keji Road,
Yuhang District, Hangzhou, China, 311100

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