Realy Tech

20 X 25/Pack Realy Tech Covid-19 Rapid Antigen Test Kit Nasal - Very High Sensitivity Exp. 12/2023

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$2,871.00 Inc GST

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Product details

ARTG	334501
FORMAT	Test Cassette
QUANTITY	25 Tests/Kit
TIME TO RESULT	10 Minutes
CONTENTS	Individually packed test devices Sterilised swabs Extraction buffer Extraction tube Nozzle with filter Tube stand Positive control swab Negative control swab Package insert
INTENDED USE	The Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) is an in vitro diagnostic test for the qualitative detection of novel coronavirus antigens in Nasopharyngeal swab, using the rapid immunochromatographic method. The identification is based on the monoclonal antibodies specific for the novel coronavirus antigen. The easy to use and rapid point of care application of the test facilitates deployment of large-scale screening in environments where rapid, on-site testing is vital to ensure public health safety.
WHO CAN PURCHASE	Registered medical practitioners or paramedics, or an organisation, business or institution that employs or engages a registered medical practitioner or paramedic to perform or oversee performance of the test. The tests can only to be used to test employees or contractors of the organisation, business or institution, or a patient under the direct care of the medical practitioner or the paramedic. Residential care (disability and rehabilitation facilities) and aged care facilities that employ or engage health practitioners (for example, nurses) to conduct or perform the test. If the residential care or aged care facilities provide care in the home this condition would also allow for performance of the test to be conducted by a health practitioner or paramedic. The tests can only be used to test residents, staff of, or visitors to, the residential care or aged care facility, or clients and staff of the home care service provider. Organisations, businesses, or institutions that employ or engage health practitioners or paramedics to conduct or oversee performance of the tests. For example, rapid antigen tests are being used in the mining sector consistent with these conditions. The tests can only be used to test staff or students of the organisation, business or institution. The Australian Health Practitioner Regulation Agency (AHPRA) is the national organisation responsible for implementing the National Registration and Accreditation Scheme (the National Scheme) across Australia. The AHPRA works with 15 National Boards to help protect the public by regulating Australias registered health practitioners. The AHPRAs primary role is to protect the public and set standards and policies that all registered health practitioners must meet. They ensure the community has access to a safe health workforce across all professions registered under the National Registration and Accreditation Scheme. What National Boards are under AHPRA? Aboriginal and Torres Strait Islander Health Practice Board of Australia Chinese Medicine Board of Australia Chiropractic Board of Australia Dental Board of Australia Medical Board of Australia Medical Radiation Practice Board of Australia Nursing and Midwifery Board of Australia Occupational Therapy Board of Australia Optometry Board of Australia Osteopathy Board of Australia Paramedicine Board of Australia Pharmacy Board of Australia Physiotherapy Board of Australia Podiatry Board of Australia Psychology Board of Australia
WHAT ARE THE REQUIREMENTS FOR TESTING SUPERVISION	Where it is not possible for a health practitioner to be physically present at the point of care the trained staff member may be someone who is not a health practitioner but is trained by a registered health practitioner. Businesses only need to have a health practitioner such as a nurse or pharmacist to be available on the phone or by video conference to provide assistance or advice, as required, to persons under their supervision. For a small business, this may only need access to a couple of hours of a health practitioners time (e.g. a pharmacist or nurse).
STORAGE AND STABILITY	Store the Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) at room temperature or refrigerated (2-30°C). Do not freeze. All reagents are stable until the expiration dates marked on their outer packaging and buffer vial. The collected clinical nasopharyngeal swab should be used immediately. If the test cannot be performed immediately, the swab can be stored in a clean airtight container, and can be stored in a normal temperature environment(15 to 25°C) for 2 hours, and at the same time stably stored for 24 hours under refrigerated environment.
INTERPRETATION OF RESULTS	POSITIVE: Two red lines appear. One red line appears in the control region(C), and one red line in the test region(T). The shade of color may vary，but it should be considered positive whenever there is even a faint line. NEGATIVE: Only one red line appears in the control region(C), and no line in the test region(T). The negative result indicates that there are no Novel coronavirus particles in the sample or the number of viral particles is below the detectable range INVALID: No red line appears in the control region(C). The test is invalid even if there is a line on test region(T). Insufficient sample volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the test procedure and repeat the test using a new test device. If the problem persists, discontinue using the test kit
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 point of care testing only - the therapeutic goods must be used by relevant practitioners, or persons under their supervision, who are trained in the correct use of the goods and the interpretation of the test results Negative test results do not exclude infection with SARS-CoV-2 (COVID-19); and Follow current government health messaging regarding polymerase chain reaction (PCR) testing requirements;

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$2,871.00Inc GST

20 X 25/Pack Realy Tech Covid-19 Rapid Antigen Test Kit Nasal - Very High Sensitivity Exp. 12/2023

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