NONPROFIT, NONPARTISAN PLATFORM OF ACCURATE SCIENCE-BASED SOLUTIONS TO COVID-19

LifeAssay Diagnostics Pty Ltd

Business Name: LifeAssay Diagnostics Pty Ltd
Business Genre:
Business Description:

“Manufacturer of medical devices, specializing in diagnostics” [1]

State: Cape Town
Country: South Africa
Data/Evidence of Effectiveness: N/A This test was added to the FDA list of COVID19 serology tests that should not be distributed until they obtain EUA [3-4]
Complimentary Products Needed to Perform Test: N/A
Setting of Care: Point of care settings [2]
Current Status / Clinical Development Stage / Expected Milestones: The company needs to obtain EUA before distributing tests [3]
Funding & Ownership : Unknown; Investors [5]
Business Model: The company has several human (Test-it™ Brucella IgM, Test-it™ Leptospirosis IgM, and Test-it™ Typhoid Lateral flow devices) and veterinary (Test-it™ Brucella IgTotal (ovine, porcine, caprine, bovine)) rapid IgM and IgG lateral flow tests [2]
IP: N/A
History & Origins : The company has two manufactoring branches. One is devoted to urinalysis tests and the other to lateral flow tests [1]
Date EUA Issued: N/A
Sources: [1]http://www.lifeassay.com/about.php; [2] http://www.lifeassay.com/products_lateral_flow.php; [3] https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2#nolonger; [4]https://www.labpulse.com/index.aspx?sec=sup&sub=mic&pag=dis&ItemID=801254; [5]http://www.lifeassay.com/news.php
Organization: Unknown/Unavailable information
Time to Result: N/A
Test Sample Type: N/A
Technology Overview: No description found for specific test, however Test-it Lateral Flow Rapid tests trademarked and are used to detect antigens or antibodies in a “robust, reliable and user-friendly way” [2]
Testing Type: IgM/IgG antibodies [2]
Test Category: SEROLOGY
Test Name: Test-it COVID-19 IgM/IgG Lateral Flow Assay
Clinical Application & Need: recent/prior infection [2]

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