22 February 2024 (as updated)
COVID-19 Rapid Antigen Test (RAT) – approved for Australia
Involution Healthcare Pty Ltd has obtained regulatory approval in Australia to import and distribute LUCA NK COVID-19 Ag Nasal LLB Self-Test, which is a Rapid Antigen Test (RAT) used to test humans for infection with the SARS-CoV-2 virus (which is the virus that causes COVID-19 disease).
Involution Healthcare Pty Ltd is the Australian Sponsor and Distributor of the Test.
The regulatory approval was confirmed by the Therapeutic Goods Administration (TGA) in Australia arranging for the Test to be added to the Australian Register of Therapeutic Goods (ARTG). The TGA is a division of the Australian Government Department of Health and Aged Care.
The Test has ARTG ID 412730.
Very long Shelf Life – 36 months
The Test has a Shelf Life of up to 36 months from the date of manufacture. This has been confirmed by a scientific study which ran for 36 months to confirm the Shelf Life of the Test.
This is the longest Shelf Life of any COVID-19 Self-Test RAT approved for use in Australia.
Very fast result – 5 minutes
The Test produces a very fast result in only 5 minutes. Many other Tests require the User the wait for 10 or 15 minutes (or longer) before obtaining the result of the Test.
A Test result in 5 minutes means people can get on with the other things they need to do more quickly. When multiplied by using multiple tests (for example in an aged care or medical facility), the overall time saved by having a Test result in 5 minutes could lead to substantial time and cost savings.
NO OTHER COVID-19 RAT IN THE AUSTRALIAN MARKET GIVES THE USER A SHELF LIFE OF UP TO 36 MONTHS AND A TEST RESULT IN ONLY 5 MINUTES.
Test approved for Self-Test use
The Test has been approved for use in Australia for:
- Self-Test use by laypersons (people who are untrained in the use of medical devices).
On 6 July 2023, Involution Healthcare Pty Ltd obtained regulatory approval in Australia to import and distribute the Test for Point-of-Care use. So, this regulatory approval has extended that regulatory approval to cover the Self-Test version of the Test.
As a result, the Test is now approved for use in Australia for both Self-Test use and Point-of-Care Test use.
The Self-Test product is available for sale to the general public.
The Point-of-Care Test products are not available for sale to the general public. The Point-of-Care Test products are only available for sale to certain types of persons and organisations who are authorised by the Australian Government to purchase this type of product.
Test is made in South Korea by LUCA AICell, Inc.
The Test is manufactured in South Korea by LUCA AICell, Inc., which is a South Korean-based biotech company using the type of technical innovation that has made South Korean manufacturing world famous for high quality, use of new technologies and reliability. In particular, LUCA AICell, Inc. is a bio platforms company which has been developing broad spectrum antiviral treatments, drug delivery systems and diagnostic/preventive medical devices using nano-based lipid technologies.
2nd Generation Test and World first
The Test is a 2nd Generation Test that, unlike existing 1st Generation Tests, has improved accuracy by applying an artificial cell membrane coating as a World first using LUCA’s Lipid Bilayer (LLB) technology.
Inspired by Nature – Environment friendly
The Test is produced from highly biocompatible, eco-friendly materials.
“Inspired by Nature” is the motto of LUCA AICell, Inc.. “Inspired by Nature” is a guiding principle behind the technology that LUCA AICell, Inc. uses to create its products and also in the materials used in its products.
Involution Healthcare Pty Ltd & LUCA AICell, Inc.
Involution Healthcare Pty Ltd is delighted to have worked together with its manufacturing partner, LUCA AICell, Inc., to enable Involution Healthcare Pty Ltd to bring this Very High Quality Test to Australia and to assist in addressing the ongoing need to test people in Australia for infection with the SARS-CoV-2 virus.
Test is available in Australia from Involution Healthcare Pty Ltd
Please contact Involution Healthcare Pty Ltd regarding any enquiries to purchase the Test in Australia.
Contact Involution Healthcare today.
Involution Healthcare Pty Ltd
Level 36 Gateway
1 Macquarie Place
Sydney NSW 2000
Australia
