Rapid Antigen Tests

CareStart™ COVID-19 Antigen Home Test is available in pack sizes of 1, 2 and 20 tests. Each pack size includes a test cassette,
extraction vial tube, extraction vial cap, nasal swab and user instructions. The 1 and 2 tests pack size also include a tray.

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 requirement.

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 dierent 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
being handled
Avoid eye and skin contact with the extraction solution
Do not ingest the extraction solution

For assistance regarding the use of the product and interpretation of test
results call 1800 195 055. This service is available between 9 am and 7 pm
(AEST), or 9 am and 8 pm (AEDT), 7 days per week.

Materials Provided

• Test cassette

• Package insert

• Sterile swab
• Extraction buffer

• Biosafety bag

Materials required but not provided
• Timing device

Please read all the information in this package insert before performing the test.
• For self-testing in vitro diagnostic use only. Do not use after expiration date.
• Do not eat, drink or smoke in the area where the specimens or kits are handled.
• Do not drink the buffer in the kit. Carefully handle the buffer and avoid it contacting
skin or eyes, rinse with plenty of running water immediately if contacting.
• Store in a dry place at 2-30 °C (36-86 °F), avoiding areas of excess moisture. If the foil
packaging is damaged or has been opened, please do not use.
• This test kit is intended to be used as a preliminary test only and repeatedly abnormal
results should be discussed with doctor or medical professional.
• Follow the indicated time strictly.
• Use the test only once. Do not dismantle and touch the test window of the test cassette.
• The kit must not be frozen or used after the expiration date printed on the package.
• Keep out of the reach of children.
• Test for children and young people should be used with an adult.
• Do not use the test on children under 2 years old.
• Small children should be swabbed with the help of a second adult.
• Wash hands thoroughly before and after handling.
• Please ensure that an appropriate amount of samples are used for testing. Too much or
too little sample size may lead to deviation of results.

LIMITATIONS

1. Performance was evaluated with nasal swab specimens only, using the procedures
provided in this package insert.
2. The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) will only indicate the presence of
SARS-CoV-2 antigens in the specimen.
3. If the test result is negative or non-reactive and clinical symptoms persist, it is because
the very early infection virus may not be detected, It is recommended to test again with
a new kit or test with a molecular diagnostic device to rule out infection in these
individuals.
4. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have
been in contact with the virus. Follow-up testing with a molecular diagnostic should be
considered to rule out infection in these individuals.
5. Positive results of COVID-19 may be due to infection with non- SARS-CoV-2
coronavirus strains or other interference factors.
6. Failure to follow these procedures may alter test performance.
7. False negative results may occur if a specimen is improperly collected or handled.
8. False negative results may occur if inadequate levels of viruses are present in the
specimen.
9. The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is less reliable in the later phase of
infection, it is recommended to use the test within the first 7 days of symptom onset.

5x Test Cassette

5x Extraction Reagent Tube

5x Swab

5x Waste Bag

5x Instructions for Use

Do not use this test if you are prone to nosebleeds.

Warnings and precautions

1. For in vitro diagnostic use only.
2. Do not use this test as the only guide to manage your illness. Please contact your State or Territory
Coronavirus testing services to get a laboratory PCR test if your symptoms are persisting or
worsening, or if you are concerned at any time.
3. The test is less reliable in the later phase of infection and in asymptomatic individuals.
4. Negative results may occur if testing is not performed within the first 7 days of symptom onset.
5. If the test is to be used on a person under 15 years of age, the test must be undertaken by an adult.
6. Keep out of reach of children to reduce the risk of accidentally drinking the extraction reagent or
swallowing small parts.
7. Do not use this product after the expiration date.
8. Only use the test once and only with the provided parts.
9. Do not undertake testing in direct sunlight.
10. Avoid contact with Extraction Reagent. If the extraction reagent is accidentally exposed to a person’s
skin or eye, rinse with plenty of running water immediately. If irritation persists, seek medical assistance.
11. This test involves taking a sample from deep inside your nose. When doing the test, pay particular
attention to the instructions on how to swab your nose. Incorrect swabbing may lead to an inaccurate
test result.
12. The test cassette should remain in the sealed pouch until use.
13. Wash hands thoroughly before and after testing.
14. Dispose all parts of the used test kit into the waste bag, then discard the waste bag in the general waste

Limitations

1. The test should be used for the qualitative detection of SARS-CoV-2 antigens in nasal swab
specimens only. The intensity of the T-line does not necessarily correlate to SARS-CoV-2 viral titer in
the specimen.
2. Failure to follow the instructions for use may adversely affect test performance and/or invalidate the test result. 

3. The test is a presumptive test only. If you get a positive result, you must immediately seek a laboratory
PCR test and follow-up clinical care.
4. Negative results may occur if the level of antigen in the specimen is below the detection limit of the test.
Repeat testing after 1-2 days is recommended, if there is an ongoing suspicion of infection, being in a
high risk setting or where there is an occupational risk or have a known exposure to COVID-19.
5. Negative results do not rule out SARS-CoV-2 infection, if you are experiencing COVID-like symptoms,
you must immediately seek further laboratory PCR testing.
6. A Negative result does not rule out infection with another type of respiratory virus.
7. A Positive result cannot determine whether a person is infectious.
8. Positive results do not rule out co-infections with other pathogens.
9. Positive results may occur, particularly in areas with low numbers of COVID-19 infections and
confirmation with a PCR testing should be considered.

HAZARDOUS INGREDIENTS FOR LIQUID REAGENT

You must follow the test instructions carefully to get an accurate result. Rapid antigen test is less reliable than PCR when testing an
asymptomatic patient or testing patient after 7 days of symptom onset as it may produce false negative result. Do not use the test
for child under 2 years old. For children 2-15 years old, the test should be performed by an adult. For in vitro diagnostic use only.
IMPORTANT: Swabbing the nostrils is critical. If you do not swab your nose, the device will produce a false negative result.

PRECAUTIONS

• For in vitro diagnostic use only.
• Read the Package Insert prior to use. Directions should be read and
  followed carefully.
• Children or teenagers aged 2 to 15 years old should have their samples
  collected and tested by an adult. Do not use the tests for anyone under 2
  years of age.
• Do not use on anyone who is prone to nosebleeds or has had facial or
  head injury/surgery in the last 6 months.
• Wear a safety mask or other face-covering when collecting anterior
  nasal swab specimen from a child or another individual.
• Keep testing kit and kit components away from children and pets before
  and after use.
• Do not use kit or components beyond the expiration date.
• Do not operate your test outside of storage conditions.
• Test devices are packaged in foil pouches that exclude moisture during
  storage. Leave the test device in the sealed pouch until just before use.
  Do not use the test device if pouch is damaged or open.
• All kit components are single use items. Do not use with multiple
  specimens. Do not reuse the used kit components.
• Do not mix components from different kit lots.
• Do not touch swab tip when handling the swab sample.
• Perform the test immediately after collecting the sample.
• Excess blood or mucus on the swab specimen may interfere with test
  performance and may yield a false-positive result. Avoid touching any
  bleeding areas of the nasal cavity when collecting specimens.
• When collecting a nasal swab sample, use only the Nasal Swab
  provided in the kit.
• Keep foreign substances and household cleaning products away from
  the test during the testing process. Contact with foreign substances and
  household cleaning products may result in an incorrect test result.
• Use appropriate precautions in the collection, handling, storage, and
  disposal of patient samples and used kit contents.
• Handle all specimens as though they contain infectious agents.
• Do not use the Extraction buffer if it is discolored or turbid.
• Avoid skin contact with buffer as it contains trace amount of sodium
  azide. Buffer solution should not be ingested.
• Keep the test device on a flat surface during the testing.
• Do not interpret the test result before 15 minutes and after 20 minutes
  of starting the test.
• Dispose of used kit components and patient samples in household trash.
• INVALID RESULTS can occur when an insufficient volume of
  extraction reagent is added to the test card. To ensure delivery of
  adequate volume, hold vial vertically, 1 cm above the sample well, and
  add drops slowly.

HAZARDOUS INGREDIENTS FOR LIQUID REAGENT
Chemical
Name/CAS GHS Code for each ingredient Concentration
Sodium
azide/
26628-22-8
Acute Tox. 2 (Oral), H300
Acute Tox. 1 (Dermal), H310 <0.02 %