Integrated Diagnostic Instrument

Abstract

A pathogen detection device is provided. The pathogen detection device may include a pathogen detector circuit configured to detect a target analyte in a patient sample, determine the presence of a pathogen from the target analyte, and generate a detection result including the identity of the pathogen and resistance genes (if any); and a decision support generator circuit configured to generate decision support information for the pathogen by application of user configurable rules to the detection result, wherein each of the configurable rules include a logic expression that indicates the corresponding decision support information of the rule to be included in the detection report.

What is claimed is: 
     
         1 . A pathogen detection device comprising:
 a pathogen detector circuit configured to detect a target analyte in a patient sample, determine an identity of a pathogen from the target analyte, and generate a detection result including the identity of the pathogen; and   a decision support generator circuit configured to generate decision support information for the pathogen by application of a plurality of configurable rules to the detection result, wherein each of the configurable rules comprises a corresponding logic expression, the logic expression indicating if the corresponding decision support information is to be included in a detection report.   
     
     
         2 . The pathogen detection device of  claim 1 , further comprising a communications interface, wherein the decision support generator circuit is configured to cause the corresponding decision support information of the rule to be transmitted to a LIS host via the communications interface. 
     
     
         3 . The pathogen detection device of  claim 2 , wherein the decision support generator circuit is configured to cause the corresponding decision support information of the rule to be transmitted to the LIS host in a Note and Comments (NTE) Segment of an HL7 message or in a comment record of an ASTM message. 
     
     
         4 . The pathogen detection device of  claim 1 , wherein the decision support generator circuit is configured to allow a user to modify any of the rules via a graphical user interface. 
     
     
         5 , The pathogen detection device of  claim 1 , wherein the pathogen is a blood stream pathogen that causes or is suspected of causing sepsis. 
     
     
         6 . The pathogen detection device of  claim 1 , further comprising a rule reconciler that is configured to automatically compare a new rule to an existing rule in rule storage. 
     
     
         7 . The pathogen detection device of  claim 1 , wherein if the rule reconciler identifies a conflict between a new rule to an existing rule in rule storage, the new rule is sent to a rule management module. 
     
     
         8 . The pathogen detection device of  claim 1 , wherein the configurable rules are established by a user selecting from a series of selectable data elements to define IF statements. 
     
     
         9 . The pathogen detection device of  claim 1 , wherein the configurable rules are established by a user defining a THEN statement in free-form text. 
     
     
         10 . The pathogen detection device of  claim 1 , wherein configurable rules can be modified and the date of the modification and name of the modifier are stored in a logging module. 
     
     
         11 . The pathogen detection device of  claim 1 , wherein when a rule is evaluated a first assay target is considered first and then any rule children associated with the first assay target; a second assay target is considered second and then any rule children associated with the second assay target. 
     
     
         12 . The pathogen detection device of  claim 1 , wherein the rules are applied based on a user selectable scope of application. 
     
     
         13 . The pathogen detection device of  claim 1 , wherein the decision support generator circuit applies the rules using an administrative hierarchy. 
     
     
         14 . A method for providing treatment decision support for a patient having blood that is infected or possibly infected with a microorganism, the method comprising:
 detecting the microorganism in the patient's blood sample, wherein detecting the microorganism comprises detecting, by a diagnostic instrument, a target analyte in a patient sample;   generating, by the diagnostic instrument, a detection result, which includes an identity of the microorganism; and   generating decision support information by the diagnostic instrument, wherein generating the decision support information includes applying, by the diagnostic instrument, a set of configurable rules to the detection result, wherein each rule in the set of configurable rules comprises a corresponding IF condition, which when evaluated, indicates whether to include corresponding decision support information in a detection report.   
     
     
         15 . The method of  claim 14 , further comprising evaluating the decision support information generated by the diagnostic instrument and treating the patient. 
     
     
         16 . The method of  claim 14 , wherein the microorganism in the patient's blood causes or is suspected of causing sepsis. 
     
     
         17 . The method of  claim 14 , further comprising generating a graphical user interface configured to edit any rule in the set of configurable rules. 
     
     
         18 . The method of  claim 14 , wherein applying the set of configurable rules to the detection result comprises evaluating, for each rule the corresponding IF condition supplied with information included in the detection result. 
     
     
         19 . A non-transitory computer readable storage medium comprising computer executable instructions, the computer executable instructions executable by a processor, the computer executable instructions comprising:
 instructions executable to receive an identity of a pathogen detected in a patient sample by a detection device; and   instructions executable to generate decision support information from the identity of the pathogen detected by the detection device, the decision support information generated by an application of a set of rules to the identity of the pathogen, wherein each rule in the set of rules includes a corresponding condition for including a corresponding decision support information in a detection report, and wherein the corresponding condition of a rule in the set of rules is that a target assay matches the identity of the pathogen.   
     
     
         20 . The non-transitory computer readable storage medium of  claim 19 , further comprising instructions executable to apply any rules in the set of rules that are applicable to a genus level before any rules applicable to a corresponding species level.