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Immuno-Assay Validation Report Page 1 of 4
Version 2.0 January 2015
Immuno-Assay Validation Report
Facility: Study director:
TYPE OF ASSAY:
Microtiter-competitive ELISA
Microtiter-sandwich ELISA
Bead-
based immunoassay
Microtiter multiplex MSD
BIOMARKER / ANALYTE: Precise the most common
names of the analyte which will be measured by the assay.
TYPE OF VALIDATION:
Pre-exploratory validation (for PoT studies)
Exploratory validation (during PoT studies)
Pre-confirmatoryvalidation (for PoP studies)
REAGENTS:
Kit…………………….………Source:…………………………….Batch number:…………..............Date of production:……………
Antibody…….….……….Source:…………………………….Batch number:…………..............Date of production:……………
Antigene……….…..……Source:…………………………….Batch number:…………..............Date of production:……………
Standard……….…..……Source:…………………………….Batch number:…………..............Date of production:……………
Date of validation study completed:
Operator(s):
Date:
Validation procedure
See SOP: SAFE-T Standard Validation Procedure for Biomarker immunoassays.
Objectives / Intended use of the assay:
To demonstrate that the performance characteristics of the assay make it fit for the intended analytical application.
Define the intended use of the immune-assay (biological fluid, disease, etc).
Immuno-assay validation plan
Related to Immuno-Assay Validation Plan N°:
Immuno-Assay validation plan written by:
Validation results
Attach all data record forms and charts (table of all analytical runs with analysis dates).
Validation standards:
Description of the validation standards and matrix used for validation study.
The source and lot number, expiration date, certificates of analyses when available, and/or internally or externally generated
evidence of identity and purity should be furnished for each reference standard.
Calibration curve
The calibration curve should be shown with the fitting model clearly indicated (e.g. 4PL, 5PL, etc...).
A table for observed and fitted data should be provided.
Assay Report Template
source: imi-safe-t.eu
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