Diagnostic Reagent Blisters White Papers

Design, Development, and Validation of Point-of-Care Reagent Blisters

by: J-Pac Medical

Design, Development, and Validation of Point-of-Care Reagent Blisters

Introduction

Within the design and development activities for a Point-of-Care Diagnostic Test and the associated microfluidic consumable, the complexities related to on-boarding the needed reagents are often underestimated or overlooked. These reagent filled blisters are required to interact with the entire test system, and are a critical component to efficacy and repeatable performance of a given point-of-care diagnostic test. This white paper is intended to provide an overview of the design, qualification, and validation considerations related to these reagent blisters.

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September 11, 2020


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