US 12,140,601 B2
Calibration management of an in-vitro diagnostic system
Juliane Drobnik, Zurich (CH); Mirko Klingauf, Schlieren (CH); and Regula Krieg, Immensee (CH)
Assigned to Roche Diagnostics Operations, Inc., Indianapolis, IN (US)
Filed by Roche Diagnostics Operations, Inc., Indianapolis, IN (US)
Filed on Dec. 16, 2019, as Appl. No. 16/714,865.
Claims priority of application No. 18213587 (EP), filed on Dec. 18, 2018.
Prior Publication US 2020/0191811 A1, Jun. 18, 2020
Int. Cl. G01N 35/00 (2006.01); G01N 35/04 (2006.01)
CPC G01N 35/00693 (2013.01) [G01N 35/00623 (2013.01); G01N 35/04 (2013.01); G01N 2035/00673 (2013.01); G01N 2035/00702 (2013.01); G01N 2035/0443 (2013.01)] 16 Claims
OG exemplary drawing
 
1. A method of automatically managing calibration of an in-vitro diagnostic system, the method comprising:
determining, by the in-vitro diagnostic system, a lot calibration time period in which a lot calibration is applicable to reagent containers of the same lot, having a predefined time length starting from the time when the lot calibration becomes available;
upon making a reagent container of the lot available to the in-vitro diagnostic system, determining, by the in-vitro diagnostic system, whether at least one lot calibration that has not exceeded the lot calibration time period is available and linking the reagent container to a most recent available lot calibration of the at least one lot calibration, wherein each different lot calibration of a plurality of lot calibrations used by the in-vitro diagnostic system is associated with a different calibration result file that is stored at a respective memory location in a memory of the in-vitro diagnostic system, and wherein linking the reagent container to the most recent available lot calibration comprises creating a dynamic virtual link between the reagent container and the respective memory location for the calibration result file of the most recent available lot calibration;
determining, by the in-vitro diagnostic system, an individual linked-container time period corresponding to the reagent container linked to the most recent available lot calibration, wherein the individual linked-container time period is different from the lot calibration time period, has a predefined time length starting from a time when the reagent container becomes available to the in-vitro diagnostic system, and runs at least partially concurrently with the lot calibration time period;
linking, by the in-vitro diagnostic system, one or more other reagent containers of the same lot to the most recent available lot calibration by creating one or more respective dynamic virtual links between each of the one or more other reagent containers of the same lot and the respective memory location for the calibration result file of the most recent available lot calibration for the same lot;
determining, by the in-vitro diagnostic system and subsequent to linking the reagent container to a most recent available lot calibration, that a new lot calibration is available for the reagent containers of the same lot;
determining, by the in-vitro diagnostic system and in response to a determination that the new lot calibration is available, whether the individual linked-container time period of the reagent container and the lot calibration time period have expired; and
replacing, by the in-vitro diagnostic system and in response to determining that the individual linked-container time period of the reagent container and the lot calibration time period have not expired, the dynamic virtual link between the reagent container and the respective memory location for the calibration result file of the most recent available lot calibration with a new dynamic virtual link between the reagent container and the respective memory location for the calibration result file of the new lot calibration for the same lot.