Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based)

*For Australia market

Intended Use

The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Self-testing Kit is a rapid test for the qualitative detection of SARS-CoV-2 antigen in human nasal swab samples directly from individuals suspected of COVID-19 with symptoms, which is designed for self-testing and can be used as an auxiliary tool for the diagnosis of the current COVID-19 infection. It is recommended that this product is used within 7 days of onset of symptoms.

 

Nasal swab samples may be self-collected by individuals over 15 years old. It is suggested that individuals 2 to 15 years of age must have their samples collected and tested by an adult. This product is not suitable for use by children under 2 years of age.

 

Specification

 

 1 test/kit       5 tests/kit        20 tests/kit

Product Parameter

Preparation 

• Check the components

• Preparation

Sample Collection

Nasal swab samples can be collected by an individual over 15 years old. Individual aged 2 to 15 years must be tested by an adult.

Test Procedure

After opening the inner package, the test contents should be used within 1 hour to ensure the reliability of the result.

Result Interpretation

Download the Instructions for use

Operation Video

CONTACT INFORMATION

If there are poor performance or usability issues, please contact the TGA to report an issue via the Users Medical Device Incident Report, 

email iris@tga.gov.au or call 1800 809 361.

Customer Support Helpline
+1300 846 928
https: www.agicol.com.au
The service is available between 9 am and 7 pm (AEST) or 9 am and 8pm (AEDT) 7 Days a week.

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

Australian Capital Territory Department of Health
General Enquiries: 02 5124 9213
Coronavirus helpline (8am to 8pm daily) :02 6207 7244
Website: https://health.act.gov.au/

New South Wales Department of Health
General enquiries: 1300 066 055
Coronavirus hotline (Service NSW, 24/7): 137 788
Website: https://www.health.nsw.gov.au/

Northern Territory Department of Health
General enquiries: 08 8922 8044
Coronavirus hotline (National helpline): 1800 020 080
Website: https://health.nt.gov.au/

Queensland Department of Health
General enquiries: 13HEALTH or 13 432 584
Coronavirus hotline: 134COVID or 134 268
Website: https://www.health.qld.gov.au/

 

South Australian Department of Health
General enquiries: 1300 232 272
Coronavirus hotline (9am to 5pm daily): 1800 253 787
Website: https://www.sahealth.sa.gov.au/

 

Tasmanian Department of Health
General enquiries: 1300 135 513
Public Health Hotline (coronavirus): 1800 671 738
Website: https://www.health.tas.gov.au/

Victorian Department of Health
Department of Health and Human Services: 1300 650 172
Victorian coronavirus hotline (24/7) : 1800 675 398
Website: https://www.dhhs.vic.gov.au/

Western Australian Department of Health
General enquiries 08 9222 4222
Coronavirus hotline: 13COVID (8am to 6pm, Mon‒Fri)
Website : https://www.healthywa.wa.gov.au/
 

 

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