COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)

For professional healthcare providers and in vitro diagnostic use only. [INTENDED USE] The COVID-19 IgG/IgM Rapid Test Cassette (Device) is a lateral flow immunoassay designed for the qualitative detection of IgG and IgM antibodies to the SARS-CoV-2 virus in whole blood, serum or plasma specimens. The Device provides an aid for identifying persons who may have been exposed to, and developed an immune response to the SARS- CoV-2 virus. [SUMMARY] SARS-CoV-2 is a new strain of coronavirus causing the disease COVID-19 in humans. The symptoms range from a mild respiratory infection to more severe pneumonia with acute respiratory distress. The…

Post-market validation of a further two serological assays for COVID-19

Updated Report

Post-market validation of a further two serological assays for COVID-19

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13th October 2020 Report prepared for:

Office of Health Protection, Commonwealth Government of Australia The Therapeutics Goods Administration (TGA) of Australia

Report prepared by:

Dr Katherine Bond
Ms Suellen Nicholson
Ms Tuyet Hoang
Dr Mike Catton
Professor Benjamin Howden Professor Deborah Williamson

 

Clongene’s Rapid on-Site Test provides

FOR PROFESSIONAL USE ONLY Clongene’s Rapid on-Site Test provides COVID-19 screening results in 10 – 15 minutes SARS-CoV-2 is a new strain of coronavirus causing the disease COVID-19 in humans. The symptoms range from a mild respiratory infection to more severe pneumonia with acute respiratory distress. Contents Each Test kit includes: • Test Cassette, which holds the test strip where detection of the IgM and IgG antibodies take place • Lancet & alcohol pad • Dropper/Pipette • Buffer solution • IFU/Product insert Listed with TGA, TRIM Reference: E20-49236 The Australian Department of Health have decided to include the Clongene COVID-19…

APACs COVID-19 Antibody test kit has been evaluated by a renown institute

The Doherty Institute in Melbourne has published a Report regarding the APAC COVID-19 Antibody test kit The Doherty Institute, which is a joint venture between The University of Melbourne and The Royal Melbourne Hospital has published a report regarding the APAC COVID-19 Antibody test kit. As part of the TGA listing with the Federal Government, each supplier has to provide their test kits for evaluation, where the Doherty Institute compares the reported characteristics from the manufacturer with their own testing. The Doherty Institute finding was that the APAC COVID-19 antibody test kit "met, or where within the acceptable confidence interval…

Instruction video – APAC Urine screening device

A few clients have asked us how to use the APAC urine screening cup. The instructions for usage, IFU, can be quite challenging to read, so hopefully this video clip will assist you. Click here to see instruction video A few things to remember: Read the temperature strip as soon as there is urine in the cup. The temperature should be between 32 - 38 degrees Celsius. Start the timer and read the results after five minutes but before 10 minutes All detection strips MUST have a visible Control line. This indicates that the strip is working. Below the C-line…