Vivaspin® and Vivapore® Devices for General Laboratory Use Pre-Validation Guide
Last updated: April 2023
Overview
The detection of certain proteins in human body fluids is a critical tool for the diagnosis of various disease states.
These so-called disease markers are usually present at very low quantities in the early stages of disease, which can make detection difficult. However, early diagnoses are preferable, since these typically lead to better patient outcomes. Therefore, it is often necessary to concentrate or filter the protein content of body fluid samples prior to analysis.
In this pre-validation guide, we introduce Vivaspin® and Vivapure® for general laboratory use, outlining how and why these ultrafilters can be effectively used in diagnostic applications.
- Document type: Pre-Validation Guide
- Page count: 11
- Read time: 22 minutes
Key Takeaways
- Applications for ultrafiltration in diagnostic sample preparation workflows
- The current regulatory landscape for in vitro diagnostics, according to (EU) IVDR 2017/746
- Classification of Vivaspin® and Vivapore® as general laboratory use products
- How to use and validate Vivaspin® or Vivapore® for diagnostic sample preparation
- Ultrafiltration qualification and troubleshooting guides
This Resource is Designed for:
- Diagnostic scientists and technicians working in hospital/clinical laboratories, who are responsible for testing human body fluids to aid disease diagnoses.
Applications Supported:
- Sample preparation for diagnostic testing
- Concentration of disease markers from human specimens
