Rapid Antigen Australia

JusChek Single Pack COVID-19 Rapid Antigen (Nasal Swab) For Self-Testing

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JusChek Single Pack COVID-19 Rapid Antigen (Nasal Swab) For Self-Testing

Short Specifications

ARTG: 374574
Date Approved: 31 December 2021
Clinical Sensitivity: High Sensitivity
Format: Test Cassette
Quantity: 1 Test/Kit
Time to result: 10 to 15 Minutes
Storage Condition: 2-30ºC
Shelf Life: As stated on box
Sample: Nasal Swab
Comprehensive instructions included
For self-testing in the home or other environment
Negative test results do not exclude infection with SARS-CoV-2 (COVID-19)
Follow current government health messaging regarding polymerase chain reaction (PCR) testing requirements

ARTG	374574
BRAND	JusChek
FORMAT	Test Cassette
QUANTITY	1 Test/Kit
TIME TO RESULT	10 to 15 Minutes
STORAGE CONDITION	2-30ºC
CONTENTS	1 x Test cassette 1 x Sterile swab 1 x Extraction buffer 1 x Package insert 1 x Biosafety bag
INTENDED USE	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. The test 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 contact your State or Territory Coronavirus testing services to get a laboratory PCR test. 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 COVID testing centre. The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) obtain a preliminary result only, an aid diagnosis of COVID-19, for the final confirmation should be based on clinical diagnostic results. 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.). The COVID-19 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.).
INSTRUCTION VIDEO
PACKAGE INSERT	Download HERE
OTHER RESOURCES	For information on COVID-19 in your state or territory, click HERE To find out more about COVID-19, visit the Commonwealth Department of Health website HERE For a fact sheet explaining how to use COVID-19 home test kits and what to do when you get a result, click HERE
SAFETY INFORMATION	For self-testing in the home or other environment Negative test results do not exclude infection with SARS-CoV-2 (COVID-19) 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