JusChek SARS-CoV-2 Antigen Rapid Tests Nasal Swab INCP-502H | ARTG 374574 | TGA Approved

The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is a lateral flow chromatographic immunoassay single-use test kit intended to qualitative detect the SARS-CoV-2 that causes COVID-19 with self-collected nasal swab specimen.

INTENDED USE

• The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is intended for use in symptomatic individuals meeting the case definition for 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 to follow up care from their healthcare provider.
• Obtains a preliminary result only, an aid diagnosis of COVID-19, for the final confirmation should be based on clinical diagnostic results.
• Intended to be used by laypersons as a self-test for
  home and workplace (in offices, for sporting events, airports, schools, etc.)

MATERIALS PROVIDED

• Test cassette
• Package insert
• Sterile swab
• Extraction buffer
• Biosafety bag

Materials required but not provided: Timing device

SUMMARY

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

FAQs

1. How does the SARS-CoV-2 Antigen Rapid Test work?

The test is for the qualitative detection of SARS-CoV-2 antigens in self-collected swab specimens. A positive result indicates SARS-CoV-2 antigens present in the specimen.

2. When should the test be used?

A SARS-CoV-2 antigen can be detected in acute respiratory tract infection, it is recommended to run the test when symptoms include sudden onset of at least one of the following: cough, fever, shortness of breath, fatigue, decreased appetite, myalgia.

3. Can the result be incorrect?

The results are accurate as far as the instructions are carefully respected. Nevertheless, the result can be incorrect if inadequate sampling volume or the SARS-CoV-2 Antigen Rapid Test gets wet before test performing, or if the number of extraction buffer drops are less than 3 or more than 4. Besides, due to immunological principles involved, there exist the chances of false results in rare cases. A consultation with the doctor is always recommended for such tests based on immunological principles.

4. How to interpret the test if the colour and the intensity of the lines are different?

The colour and intensity of the lines have no importance for result interpretation. The lines should only be homogeneous and clearly visible. The test should be considered as positive whatever the colour intensity of the test line is.

5. What do I have to do if the result is negative?

A negative result means that you are negative or that the viral load is too low to be recognized by the test. However, it is possible for this test to give a negative result that is incorrect (a false negative) in some people with COVID-19. This means you could possibly still have COVID-19 even though the test is negative. If you experience symptoms such as headaches, migraines, fever, loss of sense of smell and taste, contact the nearest medical facility using the rules of your local authority. In addition, you can repeat the test with a new test kit. In case of suspicion, repeat the test after 1-2 days, as the coronavirus cannot be precisely detected in all phases of infection. Distance and hygiene rules must still be observed. Even with a negative test result, distance and hygiene rules must be observed, migration/travelling, attending events etc. should follow your local COVID guidelines/requirements.

6. What do I have to do if the result is positive?

A positive result means the presence of SARS-CoV-2 antigens. A positive result means it is very likely you have COVID-19. Immediately go into self-isolation in accordance with the local guidelines and immediately contact your general practitioner/doctor or the local health department in accordance with the instructions of your local authorities. Your test result will be checked by a PCR confirmation test and you will be explained the next steps.

7. Information on how to contact locally available support services.

For advice on how to seek medical help or get tested for coronavirus (COVID-19) you can contact your state or territory health authority, Please see your local contact numbers.

JusCheck SARS-CoV-2 Antigen Rapid Tests (Nasal Swab) is one of the COVID-19 rapid antigen self-tests approved in Australia. TGA Approved.

Directions

PRECAUTIONS

Please read all the information in this package insert before performing the test.

• For self-testing in vitro diagnostic use only. Do not use it after the 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 it.
• This test kit is intended to be used as a preliminary test only and repeatedly abnormal results should be discussed with a 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.
• 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.

Store as packaged in the sealed pouch at room temperature or refrigerated (2-30 °C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use it beyond the expiration date.

For further information please click this official government site link.