Validation of an ELISA method for bovine plasma progesterone quantification, aimed at calibrating an embedded electronic biosensor
Abstract
The metrological approach used to develop an analytical method in a research laboratory must demonstrate the suitability of its performance to the analytical requirement. The aim of this project was to validate an ELISA (Enzyme-Linked Immuno Sorbent Assay) method for bovine plasma progesterone, as a reference method. The values measured using this method will be used as a reference in our laboratory to calibrate an on-board biosensor, developed in the SmartRepro project, developed to detect ovulations in cows and help farmers to know the best time to inseminate. Ovulations detection will be based on the sampling of interstitial fluids and the monitoring of hormones like progesterone that are involved in the regulation of the ovarian cycle and ovulation. Once the analytical method had been perfected, the validation process consisted in validating it for this project, following two metrological stages: 1/ Verifying its conformity with the performance levels recommended by the Food and Drug Administration (FDA), which proposes acceptability limits of ± 30% for its accuracy, and 2/ Validating the performance of the analytical method with regard to the scientific objective of SmatRepro project. This resulted in the following expanded measurement uncertainty (MI) model: U(Y) = 0.2004Y0.9684. Using the MI and the method’s discrimination threshold (DT), it was demonstrated that the method was capable of accurately describing changes in plasma progesterone levels. It is this ability that will be evaluated for the electronic sensor, in a second time, taking as a reference the values obtained by the analysis method presented in this article. In addition, the metrological information obtained will enable a rapid assessment of its suitability for use in future research projects.
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