English to Spanish Medical Other Validation of the in vitro ELISA potency test

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Assay Specifications
Assay specifications including specifying dilution series, plate layout, and incubation time and temperature ranges were studied during development.

To obtain a full dose response curve from plateau to extinction the samples are diluted lengthwise on the plate (starting with a 1:3 dilution in the first column) from column 1 to column 11 (column 12 are reserved for blanks) with 1:3 serial dilutions.

Master reference, Assay Control, and vaccines are prediluted before entering the plate.

Identification of assay controls; including reagent blank and an RP assay control were determined during development.
This assay control was chosen for validation of each session.
This assay control has a well characterized RP.

It was found during assay development that there is no meaningful difference between short (15hr) or long (24hr) capture incubation times; therefore no additional validation testing related to capture antibody incubation time was performed as part of this validation study.


Description of Approach
Optimization was performed to determine assay performance, assay criteria for parallelism, and to set optimal use conditions for the MR and Assay Control.
To prepare for Verification of the ELISA, the following analytical parameters were evaluated:



control de valoración o ensayo?

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