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270 products
Alltest SARS-Covid-2 Rapid Antigen Test Kit Nasal Swab Single Test
TGA Reference: INCP-502H
The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is a single-use test kit intended to detect the SARS-CoV-2 that causes COVID-19 with self-collected nasal swab specimen from symptomatic individuals who are suspected of being infected with COVID-19 within the first 7 days of symptom onset. Results are for the detection of SARS-CoV-2 Nucleocapsid protein Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results are indicative of the presence of SARS-CoV-2. Individuals who test positive should self-isolate and seek additional care from their healthcare provider. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not preclude SARS-CoV-2 infection. Individuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider. The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is intended to be used by laypersons as a self-test for home and workplace (in offices, for sporting events, airports, schools, etc.).
For further information visit the TGA listing found here
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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.
Alltest SARS-Covid-2 Rapid Antigen Test Kit Oral Fluid Single Test
TGA Reference: ICOV-802H
The COVID-19 Antigen Rapid Test (Oral Fluid) is a single-use test kit intended to detect the novel coronavirus SARSCoV-2 that causes COVID-19 in human oral fluid. This test is designed for home use1 with self-collected oral fluid samples from symptomatic individuals who are suspected of being infected with COVID-19 within the first 7 days of symptom onset. The COVID-19 Antigen Rapid Test (Oral Fluid) obtain a preliminary result only, the final confirmation should be based on clinical diagnostic results. The COVID-19 Antigen Rapid Test (Oral Fluid) is intended to be used by laypersons as a self-test for home and workplace (in offices, for sporting events, airports, schools, etc.).
For further information visit the TGA listing found here
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ITEMS PROVIDED
Test device
Buffer Package
insert Biosafety
Bag Collection device (Funnel, tube and tube tip)
ITEMS NOT PROVIDED
Timer
1. Read the entire package insert prior to performing test.
2. For self-testing in vitro diagnostic use only.
3. The test is for one time use only, do not reuse the test. Do not use after expiration date.
4. Do not eat, drink or smoke in the area where the specimens or kits are handled.
5. 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.
6. Do not use test if pouch is damaged.
7. Wash hands thoroughly before and after handling.
8. If the result is preliminary positive, share your test result with your healthcare provider and carefully follow your local
COVID guidelines/requirements.
9. Test for children and young people should be used with an adult.
10.The used test should be discarded according to local regulations.
Store the test at 35.6-86°F (2-30°C). Do not open the pouch until ready for use. DO NOT FREEZE.
1. Failure to follow the testing steps may give inaccurate results.
2. The COVID-19 Antigen Rapid Test (Oral Fluid) is for self-testing in vitro diagnostic use only.
3. The results obtained with the test should be considered with other clinical findings from other laboratory tests and
evaluations.
4. 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 test 1-2 days later or go to the hospital to rule out
infection.
5. Positive results of COVID-19 may be due to infection with non-SARS-CoV-2 coronavirus strains or other interference
factors.
6. The COVID-19 Antigen Rapid Test (Oral Fluid) is less reliable in the later phase of infection, it is recommend to use
the test within the first 7 days of symptom onset.
7. Negative results may not mean that a person is not infectious and if symptoms are present you must seek immediate
further testing Via the PCR Method.
8. A negative result does not rule out infection with another type of respiratory virus
9. The test is for one time use only, do not reuse the test.
10.Test for children and young people should be supervised with an adult.
11.Please keep out of reach of children
12.If a Positive result is given the immediate requirement is to present to your nearest Covid Testing Clinic for a
confirmatory PCR Test. For advice on how to seek medical help or get tested for coronavirus (COVID-19) Please
refer to last page of this Instruction for use to see your state or territory contact details .
13.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 36
Innoscreen Covid-19 Rapid Antigen Test Kit Nasal 2 Pack
TGA Reference: SCOV-23/H002 & SCOV-23/H020
The InnoScreenTM COVID-19 Antigen Rapid Test Device (Self-test) is a rapid lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens from individuals with or without symptoms suspecting a COVID-19 infection. This test is authorized for non-prescription home use on individuals aged 2 years or older suspected of COVID-19 by their healthcare provider in a non-laboratory setting. If the test is being used for testing individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection, testing should be scheduled twice over two (or three) days with at least 24 hours (and no more than 36 hours) between tests.
For further information visit the TGA listing found here
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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 % |
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 %
