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