TGA Reference: ARTG342512
CareStart COVID-19 Antigen Home Test is intended to aid the diagnosis of COVID-19 in symptomatic patients and for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens. 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 covid like symptoms within the last 5 days
The test must be used with the nasal swab provided in the kit.
Each test can only be used once
Test results must be read at 10 minutes and no later than 15 minutes
Interpretation of any result after 15 minutes may yield inaccurate test results
If you receive a positive result, you must immediately seek a laboratory PCR test and follow-up care
A positive result cannot determine whether you are infectious
False-negative results are more likely to occur if the test is performed after 5 days of symptom onset
False negatives are more likely to occur in the later phase of infection and in asymptomatic individuals
A negative result does not rule out infection with another type of respiratory virus.
Negative results should be treated as presumptive only and may not mean you are not infectious. If you are experiencing any COVID symptoms you must
seek immediate further laboratory PCR testing and follow up clinical care.
Repeat testing is recommended (between 24-48 hours after your first test) if there is an ongoing suspicion of infection, being in a high-risk setting or where
there is an occupational risk or other requirements.
Do not re-use any contents in the kit as they are single-use only.
Do not interpret the test result before 10 minutes or after 15 minutes of
starting the test
Do not use on anyone under 2 years of age
Do not operate your test outside of the storage conditions
Do not touch the tip (specimen collection area) of the swab
Do not use on anyone who is prone to nosebleeds or has had facial or
head injury/surgery in the last 6 months.
Do not use if the test device packaging is damaged or shows signs of
being tampered with
Do not interchange kit contents from different packs
Do not use the kit contents beyond the expiration date
Do not eat or drink in the area where the specimens and kit contents are
Avoid eye and skin contact with the extraction solution
Do not ingest the extraction solution