Technology ID
TAB-4656

Application Chimeric Antibodies as Training and Quality Management Tools for Serology-based Tests

E-Numbers
E-113-2020-0
Lead Inventor
Kohatsu, Luciana
Lead IC
CDC
Co-Inventors
Parekh, Bharat
ICs
CDC
Applications
Research Materials
Diagnostics
Development Stages
Pre-Clinical (in vitro)
Research Products
Antibodies

This technology includes a novel application of chimeric monoclonal antibodies (i.e.animal-human) as substitutes for patient /organism specimens to create standardized training (TP), proficiency testing (PT), quality control (QC), lot-to-lot validation, and new serologic test evaluation and validation panels to support the implementation of quality management systems (QMS) of serology-based tests. Although humanized and chimeric antibodies are being used for therapeutic applications, or as controls in the development of therapeutics, their application for serological laboratory or waived test's QMS has not been previously described. This is a novel approach in response to experienced difficulty on finding quality materials for production of TP, PT, and QC for HIV testing, high cost of obtaining commercially available specimens, and increased challenges finding specimens from recently infected HIV patients, as the epidemic gets under control. This new application is equally needed to assure quality of several tests, especially rapid or Point of Care (PoC) tests, while lowering the cost.

Commercial Applications
Panels can be developed in less than a year for hundreds of different tests. The technology can revolutionize implementation of PoC and rapid tests, with great impact on improving the quality of test results. Access to well characterized monoclonal antibodies will also allow to have a standardized panel to compare similar test kits for testing consistency and limit of detection, which was impossible to do when using human specimens.

Competitive Advantages
Allows for the bypass the challenging collection/purchase of hard-to-find and costly patient specimens while assuring continuous availability of standardized materials for TP, PT, QC, and test kit evaluation/validation, decrease transportation cost given stability/ease of room temperature transportation of lyophilized/dried purified monoclonals vs need for cold transport of human specimens. This will facilitate implementation of QMS in thousands of sites conducting tests, including Point-of-Care (PoC) and rapid test testing implementation.
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