Assay validation
Assay validation is a prerequisite to prove that a given assay satisfies the specification criteria for the intended study, gives reliable results and fulfills the regulatory requirements.
MicroCoat routinely performs full, partial, cross and transfer validations on assays developed in-house and commercially available tests.
For each analytical method, a validation program is chosen which best fits assay type and intended use and complies with most recent regulatory requirements and recommendations.
A typical validation may include:
- limit of detection
- limit of quantification
- precision (inter- and intra-run)
- accuracy
- dilutional linearity
- high dose hook effect
- matrix effect
- cross-reactivity
- stability of analyte in matrix
- cut point determination
Assay validations are generally offered as GLP or non-GLP service.
For more information, please contact MicroCoat by phone, email or fax.
