THE OBVIOUS CHOICE FOR HIGH QUALITY SOLUTIONS

IVD IMMUNOASSAY DEVELOPMENT

G-Bio develops full IVD immunoassays on demand and offers flexible support in feasibility & optimization, verification & validation projects and technical transfer to manufacturing for third parties.


The development of an immunoassay involves choosing a format, gathering the right components, and constructing a good working protocol. Furthermore, the optimization of assays involves the adjustment and testing all the components and variables to ensure that the results are robust and accurate. For this, various immunoassay formats provide different levels of specificity, sensitivity, simplicity, and speed each with their different numbers and varieties of components.


Expertise and Experience

G-Bio is strongly familiar with various types of immunoassays, such as:

●  ELISA / EIA

●  EMIT (Enzyme multiplied immunoassay technique)

●  Automated Platform based assays

●  Microarray assays

●  LIA

The assays are developed under ISO 13485 standard and are ready for CE/IVD approval.

The complete design history file is provided with the Design input Document, Risk Management Reports, Verification Report, Validation Report, Stability Report and Final Manufacturing Documents.