Having been on the market for over 25 years, lateral flow test strips are widely accepted as a format for the development of diagnostic assays. Devices range from simple test strips dipped into a sample to long format tests used with quantitative readers. Lateral flow test strips are easy to run, often requiring no more than application of a liquid sample, but reliability of performance depends on how consistently the strips are constructed. This involves the materials, the chemistries, the overall design, and the assembly processes. The materials comprising lateral flow tests are made at a scale orders of magnitude greater than what is used in a single strip. The chemistries are made in bulk and then used in very small amounts on individual test strips. If the assembly processes are not properly designed and executed, consistency of performance within a single lot of strips may be unacceptable. In this webinar, I will be discussing some of the critical features of test strip design that affect the consistency of performance. These will be related back to strategies for minimizing variation where possible and managing variation where it must be accepted.
Michael Mansfield, Ph.D.
Applications Development Scientist
Dr. Mansfield is in his 32nd year at MilliporeSigma in Bedford, Massachusetts, and is currently an Applications Development Scientist in the Biosystems and Regulated Materials R&D Group. His initial work focused on interactions of biomolecules with membrane surfaces for western, Southern, and northern blotting. That was followed by work on sample processing and concentration of protein solutions using centrifugal filtration devices. For the past 20 years, he has been working on the utilization of membranes and other porous materials in immunodiagnostic tests and medical devices.
Clinical testing and diagnostics manufacturing
Session 1:presented April 15, 2021
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