Orawell Covid-19 Antigen Rapid Saliva Test Device Single (Self-Test)

The Orawell Ag Rapid Saliva Self-Test Device is a rapid chromatographic immunoassay for the qualitative detection of the nucleocapsid antigen from SARS-CoV-2 present in human saliva within the first 7 days of symptom onset. This test is for self-testing purposes, as an aid to the diagnosis of SARS-CoV-2 infection in an individual.

FEATURES:

Simple All-In-One Test Kit
Non-invasive - no nose or throat swab required
Simply rub the kit on the sides of the mouth & place on tongue
No mixing, spitting, saliva collection or messy procedure required to get result
Intuitive and easy to use with written and illustrated instructions
Contents:
- 1x Test device (individually packed in a foil pouch with desiccant)
- 1x Instruction for use
- 1x Biohazard bag

SPECIFICATIONS:

Format: Test Cassette
Quantity: 1 Test/Kit
Time to result: 10-15 Minutes
Storage Condition: 2-30oC
Shelf Life: 24 Months
Sample: Ag Rapid Saliva
Simple All-In-One Test Kit

NOTES:

For self-testing in the home or other environments.
Negative test results do not exclude infection with SARS-CoV-2 ( ) so face masks, social distancing and good hygiene practice must be maintained.
Positive test results or any symptomatic persons require immediate confirmatory testing using a polymerase chain reaction (PCR) test.
Follow current government health messaging regarding polymerase chain reaction (PCR) testing requirements.
If symptoms persist, consult your healthcare professional.
Test kits are singular use and for self-testing purposes only.
Testing must be performed by adults or under adult supervision.
All products must be used in accordance with the dedicated package insert and only for its intended purpose as stated.

DISCLAIMER: Negative test results do not exclude infection with SARS-CoV-2 ( ). Follow current government health messaging regarding polymerase chain reaction (PCR) testing requirements.

SUGGESTED APPLICATIONS**:**

This test is authorised for home use in individuals:

Aged 12 years or older
Aged 2 - 11 who will have their test supervised by a parent or legal guardian
Who have experienced like symptoms within the last 7 days

Please refer to attached pdf for instruction on how to use test.

CERTIFICATIONS:

Listed on ARTG (ARTG: 377136)
WARNINGS

Negative test results do not exclude infection with (so face masks, social distancing and good hygiene practice must be maintained

Follow current government health messaging regarding polymerase chain reaction (PCR) testing requirements (replaces Positive test results or symptomatic persons require immediate confirmatory testing using a polymerase chain reaction (PCR) test)
Always read the label
Use only as directed
Use test only one time
Test within 7 days of symptoms
Testing by adult only or under adult supervision
If symptoms persist, talk to your healthcare professional.

Information Regarding Available Support Services Can Also Be Obtained By Contacting Your Local State & Territory Health Department at:

Australian Capital Territory Department of Health 02 62077244

New South Wales Department of Health 137788

Northern Territory Department of Health 1800 020080

Queensland Department of Health 134268

South Australian Department of Health 1800 253787

Tasmanian Department of Health 1800 671738

Victorian Department of Health 1800 675398

Western Australian Department of Health 1800 595206

If there are poor performance or usability issues Use Medical Device Incident Report Call 1800 809361 or E-mail iris@tga.gov.au