System and method for testing a biological sample

Abstract

The method for testing a biological sample operates on a testing system. The testing system generally comprises an instrument that is configured to acquire data from a biological sample and a processor. In performing the method for testing, the instrument acquires data from the biological sample, and the processor compares the acquired data to predefined data criteria. Responsive to comparing the acquired data to the data criteria, the instrument may be adjusted, and another data set acquired. In one disclosed example of the testing system, a mass spectrometer acquires data from a biological sample. The acquired data is compared to predefined spectrum criteria. Responsive to the comparison, the mass spectrometer may be directed to resample the biological sample or proceed to another sample.

What is claimed is:  
     
         1 . A system for performing a biological assay, comprising: 
 an instrument configured to acquire biological data from a biological sample; and    a processor that communicates with the instrument, such that the processor 
 directs the instrument to acquire data indicative of the biological sample,  
 establishes a data spectrum criteria,  
 generates data parameters using the acquired data,  
 compares the data parameters to the spectrum criteria,  
 adjusts the instrument responsive to evaluating the data, and  
 directs the instrument to acquire other data for the biological assay.  
   
     
     
         2 . The system according to  claim 1  wherein the processor further performs the step of receiving an assay design.  
     
     
         3 . The system according to  claim 1  further including a database in communication with the processor, wherein the database holds assay information.  
     
     
         4 . The system according to  claim 3  wherein the processor further performs the steps of: 
 receiving a portion of the assay information from the database; and  
 using the received portion of the assay information to adjust the instrument.  
 
     
     
         5 . The system according to  claim 1  where the instrument is configured as a mass spectrometer.  
     
     
         6 . The system according to  claim 1  where the processor is configured as a computer device coupled to the instrument.  
     
     
         7 . The system according to  claim 1  where the processor is configured as a computer device in the instrument.  
     
     
         8 . The system according to  claim 1  wherein the step of generating the data parameters includes generating a data parameter indicative of standard deviation.  
     
     
         9 . The system according to  claim 1  wherein the processor generates the data parameters by generating a data parameter indicative of statistical probability.  
     
     
         10 . The system according to  claim 1  wherein the processor generates the data parameters by generating a data parameter indicative of allele probability.  
     
     
         11 . A system for testing a biological sample, comprising: 
 an instrument configured to acquire biological data from the biological sample;    a processor communicating to the instrument, the processor performing steps comprising: 
 directing the instrument to acquire data indicative of the biological sample;  
 evaluating the acquired data;  
 adjusting automatically the instrument responsive to evaluating the data; and  
 directing the instrument to acquire other data indicative of the biological sample.  
   
     
     
         12 . The system for testing a biological sample according to  claim 11  wherein the processor further performs the steps comprising: 
 establishing a spectral criteria; and  
 evaluating the acquired data using the spectral criteria.  
 
     
     
         13 . A system for performing a diagnostic assay using a set of biological samples, comprising: 
 an instrument configured to acquire biological data from the biological samples;    a processor communicating to the instrument, the processor performing the steps comprising: 
 directing the instrument to acquire data indicative of one of the biological samples in the set;  
 evaluating the acquired data;  
 determining if the acquired data supports a diagnostic conclusion; and  
 directing the instrument to acquire data indicative of a next one of the biological samples in the set responsive to the determining step.  
   
     
     
         14 . A system for performing a diagnostic assay using a set of biological samples, the system comprising: 
 a workstation that communicates with an instrument that is configured to acquire biological data from successive biological samples in the set, and that controls the instrument to acquire data indicative of each successive biological sample, determines if the instrument should be adjusted in response to evaluating the acquired data from a set, and directs the instrument to acquire other data indicative of the biological sample responsive to the determination; and    a database server that stores the acquired data from the biological samples.    
     
     
         15 . The system according to  claim 14 , wherein the workstation evaluates the acquired data, determines if the acquired data supports a diagnostic conclusion, and directs the instrument to acquire data indicative of a next one of the biological samples in the set, responsive to the determination.  
     
     
         16 . The system according to  claim 14 , wherein the workstation includes an assay design controller that acquires assay design specifications from the database server.  
     
     
         17 . The system according to  claim 14 , wherein the workstation includes an alignment controller that automatically aligns a laser of the instrument on one of the biological samples and controls movement of the sample in the instrument so as to receive biological data from the instrument.  
     
     
         18 . The system according to  claim 17 , wherein the workstation includes a data controller that receives a data signal from the alignment controller and makes the determination of directing the instrument to acquire other data indicative of the biological sample, in response to the determination.  
     
     
         19 . The system according to  claim 14 , wherein the workstation is constructed integrally with the instrument.  
     
     
         20 . A method of performing a diagnostic assay using a set of biological samples, the method comprising: 
 directing an instrument to acquire data indicative of one of the biological samples in the set;    evaluating the acquired data;    determining if the acquired data supports a diagnostic conclusion; and    directing the instrument to acquire data indicative of a next one of the biological samples in the set responsive to the determination.    
     
     
         21 . The method according to  claim 20 , further comprising: 
 establishing a data spectrum criteria;    generating data parameters using the acquired data;    comparing the data parameters to the spectrum criteria, and    adjusting the instrument responsive to evaluating the data.    
     
     
         22 . The method according to  claim 21 , wherein generating the data parameters includes generating a data parameter indicative of standard deviation.  
     
     
         23 . The method according to  claim 21 , wherein generating the data parameters includes generating a data parameter indicative of statistical probability.  
     
     
         24 . The method according to  claim 21 , wherein generating the data parameters includes generating a data parameter indicative of allele probability.  
     
     
         25 . The method according to  claim 21 , further including receiving an assay design.  
     
     
         26 . The method according to  claim 21 , further including storing the acquired data from the biological samples of the set in a database server.  
     
     
         27 . The method according to  claim 26 , further including: 
 receiving a portion of the assay information from the database server; and    using the received portion of the assay information to adjust the instrument.