Method and laboratory system to provide control samples for validating a diagnostics test

Abstract

A computer implemented method to allocate control samples for validating a diagnostic test within a laboratory system is provided. The laboratory system comprises a storage, a transport system, and at least two analyzers. A total number of control sample aliquots and an aliquot volume for each control sample aliquot is determined based on a validation time schedule. Information is presented for distributing the total control sample volume into the determined total number of control sample aliquots with the determined aliquot volumes. Information is also presented for distributing the control sample aliquots to one or more of the at least two analyzers according to the validation time schedule.

We claim: 
     
         1 . A computer implemented method for allocating control samples for validating a diagnostic test within a laboratory system having at least two analyzers configured to execute the diagnostic test and to validate the diagnostic test by measuring control samples according to a validation time schedule, the method comprising:
 a) determining a total number of control sample aliquots and an aliquot volume for each control sample aliquot based on a validation time schedule, wherein each aliquot volume comprises a dead volume and a volume comprising a determined number of control samples, each with a volume required for validating the diagnostic test once;   b) causing the generation of unique identification tags for tagging one or more vessels for containing the total control sample volume, wherein the total control sample volume is at least the sum of aliquot volumes of the total number of control sample aliquots;   c) displaying information for distributing the one or more vessels to a storage to store control sample aliquots or to one of the at least two analyzers for validating the diagnostic test through measuring one control sample of the at least one control sample aliquot according to the validation time schedule.   
     
     
         2 . The method according to  claim 1 , wherein the validation time schedule comprises a defined time period and at least one time segment, wherein the validation time schedule defines for each of the at least two analyzers and for each of the at least one time segment a number of validation time points at which a control sample aliquot is scheduled to be transported to one or more of the at least two analyzers for validating the diagnostic test by measuring one control sample of the control sample aliquot. 
     
     
         3 . The method according to  claim 2 , wherein the time segment is a control sample aliquot onboard stability time or a fraction of the control sample onboard stability time. 
     
     
         4 . The method according to  claim 2 , wherein the total number of control sample aliquots is determined based on the number of the at least one time segment and a number of control sample aliquots per time segment, wherein the aliquot volume of a control sample aliquot of one of the at least one time segment is determined based on the number of validation time points of the one of the at least one time segment. 
     
     
         5 . The method according to  claim 4 , wherein the number of control sample aliquots per time segment is determined by a maximum number of the at least two analyzers for which at least one same validation time point is defined per time segment, wherein the aliquot volume of a control sample aliquot of one of the at least one time segment is determined by the maximum number of the at least two analyzers for which at least one same validation time point is defined for the one of the at least one time segment. 
     
     
         6 . The method according to  claim 5 , wherein the information for distributing the one or more vessels is timed according to the determined number of control samples required for the number of validation time points of one of the at least one time segment and the determined number of control sample aliquots of the one of the at least one time segment so that the aliquot volume difference of each control sample aliquot of the one of the at least one time segment is equal or less than one volume of a control sample. 
     
     
         7 . The method according to  claim 1 , wherein displaying information for distributing the one or more vessels comprises information for distributing the at least one control sample aliquot between the storage and the at least two analyzers for validating the diagnostic test by displaying measurement information for one control sample of the at least one control sample aliquot according to the validation time schedule. 
     
     
         8 . The method according to  claim 1 , wherein the laboratory system comprises an additional storage, wherein the storage is configured for temporary storage of control sample aliquots and the additional storage is configured for long-term-storage of control sample aliquots, wherein the information for distributing the one or more vessels comprises information for distributing the at least one control sample aliquot to the storage for temporary storage or to one of the at least two analyzers for validating the diagnostic test by measuring one control sample of the at least one control sample aliquot and further control sample aliquots to the additional storage for long-term storage according to the validation time schedule and the at least one control sample aliquot and the further control sample aliquots to the additional storage for long-term storage before the at least one control sample aliquot is transported to the storage for temporary storage or to one of the at least two analyzers for validating the diagnostic test by measuring one control sample of the at least one control sample aliquot according to the validation time schedule. 
     
     
         9 . The method according to  claim 8 , wherein the information for distributing the one or more vessels comprises information for distributing:
 at least one further control sample aliquot from the additional storage to the storage for temporary storage or to one of the at least two analyzers for validating the diagnostic test by measuring one control sample of the at least one further control sample aliquot according to the validation time schedule; and   the at least one further control sample aliquot between the storage for temporary storage and the at least two analyzers for validating the diagnostic test by measuring one control sample of the at least one further aliquot according to the validation time schedule.   
     
     
         10 . The method according to  claim 1 , wherein each generated control sample aliquot comprises a unique control sample aliquot identity associated with at least a control sample aliquot onboard stability time, wherein the laboratory system further comprises a disposal unit which is operatively connected to the transport system, wherein the storage, the at least two analyzers, and the transport system have defined temperatures, wherein the storage and the at least two analyzers comprise a reader configured to read the unique control sample aliquot identity, the method further comprising:
 reading, by the reader, the unique control sample aliquot identity each time a control sample aliquot arrives at or leaves the storage and one or more of the at least two analyzers;   generating, by the reader, a time stamp when reading the unique control sample aliquot identify;   calculating a time duration at which the control sample aliquot was kept at one or more defined temperatures, a time duration during which the control sample aliquot had undergone a number of temperature changes, or a time duration during which the control sample aliquot was transported a number of times to the one or more of the at least two analyzers based on the generated time stamps;   comparing the calculated time duration with the control sample aliquot onboard stability time; and   wherein the information for distributing the one or more vessels comprises information for distributing the control sample aliquot to the disposal unit if the calculated time period exceeds the control sample aliquot onboard stability time.   
     
     
         11 . A laboratory system for validating a diagnostic test, the laboratory system comprising:
 a storage configured to store control sample aliquots;   at least two analyzers configured to execute the diagnostic test and to validate the diagnostic test by measuring one control sample;   one or more processors programmed and configured to execute the method according to  claim 1 .   
     
     
         12 . The laboratory system according to  claim 11 , further comprising:
 an additional storage, wherein the one or more processors are programmed to execute the method of  claim 9 .   
     
     
         13 . The laboratory system according to  claim 11 , further comprising:
 a disposal unit wherein the one or more processors are configured to execute the method of  claim 10 .   
     
     
         14 . A computer program product, the computer program product comprising instructions to cause the laboratory system according to  claim 11  to execute method of  claim 1 . 
     
     
         15 . A non-transitory computer-readable storage medium having stored thereon the computer program product of  claim 14 .