Validation method for automated analyzers

摘要

Method for validating the accuracy of automated analyzers by performing an improved dual dye ratio method procedure that uses at least first and second dye solutions in combination with gravimetric measurement of selected test solutions.

主权项

1. A method for validating the accuracy of an automated analyzer comprising:
designating one of a plurality of dispensing pipettes of the automated analyzer as a dispensing pipette under test; aspirating a first dye solution having first and second dye components based on a volume predefined by a user (VU) using the dispensing pipette under test into one of a plurality of optical analysis cells, wherein the first dye component absorbs light of a first wavelength while the second dye component absorbs light of a second wavelength; dispensing a second dye solution having a third dye component into the optical analysis cell containing the first dye solution, wherein the first and second dye solutions form a measurement target liquid; removing the measurement target liquid from the optical analysis cell and transferring the measurement target test liquid into one of a plurality of retention wells in a measurement microplate which is separated and independent from the optical analysis cell; performing photometric measurement on the same measurement target test liquid contained in the microplate to measure absorbance values of the first, second and third dye components; determining the actual dispense volume of the dispensing pipette under test (VAC) based on a dual dye ratio calculation method taking into consideration the measured absorbance values; and validating the accuracy of the dispensing volume of the dispensing pipette under test by comparing the calculated actual dispense volume against the volume predefined by the user to determine any deviation between these two volumes.