Quality Aspects and Applications for Multiplex Immunossays

Speaker

Abstract

Background:
The NMI applies miniaturized multiplex immunoassays for more than two decades. At the NMI commercially available multiplex immunoassays are applied for sample screening as well as newly developed custom specific assays. Over the last years a standard validation procedures was established which is routinely applied to our “home brew” as well as to commercially available multiplex immunoassays.

Methods:
Multiplex bead-based immunoassays on the Luminex platform were developed and thoroughly validated based on bioanalytical guidelines (EMA, FDA). To guarantee long term reproducibility and validity of assay performance a quality control system based on the Westgard Rules and Levey-Jennings-Plots was implemented.

Results:
Established assay development and validation procedures allow us a robust assessment of the capabilities of an assay and the evaluation of lot-to-lot variances during long term screening periods.

Conclusion:
In the time of extensive discussions on the lack of repeatability of scientific results, validation of reagents and assays, no matter whether they are commercially available or newly generated “home brew” assay, is a mandatory step forward to address such issues and allows to identify  strengths’ and weaknesses of the applied assay reagents during any sample screening process.


Show Resources
You May Also Like
SEP 10, 2020 9:00 AM PDT
C.E. CREDITS
SEP 10, 2020 9:00 AM PDT
Date: September 10, 2020 Time: 9:00am (PDT), 12:00pm (EDT) Osmolality testing is relevant throughout the entire bioprocessing workflow. As customers look to refine mAb and gene therapy workf...
JUL 22, 2020 10:00 AM PDT
C.E. CREDITS
JUL 22, 2020 10:00 AM PDT
DATE: July 23, 2020 TIME: 10:00 am PDT The SARS-CoV-2 pandemic has taken a toll on many sectors of the medical community. As the pandemic took a grip on the laboratory, the need for diagnost...
MAY 12, 2020 9:00 AM PDT
C.E. CREDITS
MAY 12, 2020 9:00 AM PDT
NEW DATE: Date: May 12, 2020 Time: 9:00am PDT, 12:00pm EDT...
MAY 08, 2020 10:00 AM PDT
C.E. CREDITS
MAY 08, 2020 10:00 AM PDT
DATE: May 8, 2020 TIME: 10:00am PT, 11:00am MT, 1:00pm ET The application of next generation sequencing to interrogate immune repertoires and methods in which these highly complex dataset...
SEP 03, 2020 9:00 AM PDT
C.E. CREDITS
SEP 03, 2020 9:00 AM PDT
DATE: September 3, 2020 TIME: 09:00am PT, 12:00pm ET xxx Learning Objectives: xxx Webinars will be available for unlimited on-demand viewing after live event. LabRoots is approved as a provi...
JUN 30, 2020 9:00 AM PDT
C.E. CREDITS
JUN 30, 2020 9:00 AM PDT
DATE: June 30, 2020 TIME: 9:00am PDT, 12:00pm EDT QC laboratories perform a critical role in demonstrating pharmaceutical products are consistently manufactured, safe, potent, and pure. At t...
Loading Comments...
Show Resources