Systems and methods for multi-analysis

Abstract

Systems and methods are provided for sample processing. A device may be provided, capable of receiving the sample, and performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing multiple assays. The device may comprise one or more modules that may be capable of performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing the steps using a small volume of sample.

1 - 8 . (canceled) 
     
     
         9 . A method for detecting an analyte in a biological sample comprising:
 providing a biological sample suspected of comprising an analyte to a cartridge, wherein the cartridge comprises:
 an assay unit for performing a chemical reaction that yields a signal indicative of the presence or absence of the analyte; 
 a capture surface coated with a first molecule specific for the analyte; 
 a first reagent unit comprising a detection reagent comprising a second molecule coupled to a label, wherein the second molecule is capable of binding to the analyte; 
 a second reagent unit comprising a substrate for reacting with the label and generating a signal; 
 a third reagent unit comprising a wash buffer; 
 a dilution unit comprising a sample diluent; and 
 one or more sample collection units for receiving the biological sample; 
   and inserting the cartridge into a biological sample processing device comprising an optical detector and a centrifuge, wherein the biological sample processing device performs the steps comprising:
 centrifuging the biological sample in the centrifuge to obtain a centrifuged sample; 
 diluting in the cartridge at least a portion of the centrifuged sample with the diluent to obtain a diluted sample; 
 contacting in the cartridge the diluted sample with the capture surface; 
 washing in the cartridge the capture surface; 
 contacting in the cartridge the capture surface with the detection reagent; 
 contacting in the cartridge the capture surface with the substrate; and 
 detecting the signal indicative of the presence or absence of the analyte in the diluted sample with the optical detector. 
   
     
     
         10 . The method of  claim 9 , wherein the biological sample is a blood sample. 
     
     
         11 . The method of  claim 10 , wherein the blood sample is a whole blood sample. 
     
     
         12 . The method of  claim 11 , wherein the whole blood sample is a whole blood sample obtained by a fingerstick. 
     
     
         13 . The method of  claim 12 , wherein the fingerstick sample is obtained by collecting the whole blood sample in a first vessel comprising a single entry port connected to at least two segregated chambers, the whole blood sample in the at least two segregated chambers is transferred into at least two further fluidically isolated vessels, and the at least two further fluidically isolated vessels are inserted into the one or more sample collection units. 
     
     
         14 . The method of  claim 9 , wherein the centrifuged sample is a blood plasma sample. 
     
     
         15 . The method of  claim 9 , wherein the centrifuged sample is a blood serum sample. 
     
     
         16 . The method of  claim 9 , wherein the analyte is a first antibody, the first molecule is an antigen specific for the first antibody, and the second molecule is a second antibody. 
     
     
         17 . The method of  claim 16 , wherein the label is alkaline phosphatase and the substrate is a chemiluminescent alkaline phosphatase substrate. 
     
     
         18 . The method of  claim 16 , wherein the antigen is a viral antigen. 
     
     
         19 . The method of  claim 18 , wherein the viral antigen is selected from a retroviral antigen, HIV antigen, herpes simplex viral antigen, varicella zoster viral antigens, Japanese encephalitis viral antigen, hepatitis viral antigen, influenza viral antigen, measles viral antigen, rubella viral antigen, rotaviral antigen, cytomegaloviral antigen, respiratory syncytial viral antigen, rabies viral antigen, and papillomavirus antigen. 
     
     
         20 . The method of  claim 18 , wherein the first antibody is an antibody against the viral antigen. 
     
     
         21 . The method of  claim 9 , wherein the cartridge further comprises at least one tip and the biological sample processing device further comprises a sample handling system, wherein the sample handling system comprises at least one head that engages with the tip. 
     
     
         22 . The method of  claim 21 , wherein the sample handling system further engages with the assay unit and moves the assay unit from the cartridge to the optical detector. 
     
     
         23 . The method of  claim 9 , wherein the assay unit, the first, second, and third reagent units, the dilution unit, and the one or more sample collection units are each independently fluidically isolated and movable. 
     
     
         24 . The method of  claim 9 , wherein the cartridge further comprises reagent controls for performing control assays. 
     
     
         25 . The method of  claim 9 , wherein the capture surface is on a bead. 
     
     
         26 . A cartridge for detecting an analyte in a biological sample comprising:
 an assay unit for performing a chemical reaction that yields a signal indicative of the presence or absence of the analyte;   a capture surface coated with a first molecule specific for the analyte;   a first reagent unit comprising a detection reagent comprising a second molecule coupled to a label, wherein the second molecule is capable of binding to the analyte;   a second reagent unit comprising a substrate for reacting with the label and generating a signal;   a third reagent unit comprising a wash buffer;   a dilution unit comprising a sample diluent;   one or more sample collection units for receiving the biological sample;   at least one tip; and   at least one centrifugation vessel;   wherein the assay unit, the first, second, and third reagent units, the dilution unit, the one or more sample collection units, and the centrifugation vessel are not in fluid communication with each other; and the assay unit is movable.   
     
     
         27 . The cartridge of  claim 26 , wherein the analyte is a first antibody, the first molecule is an antigen specific for the first antibody, and the second molecule is a second antibody. 
     
     
         28 . The cartridge of  claim 26 , wherein the label is alkaline phosphatase and the substrate is a chemiluminescent alkaline phosphatase substrate. 
     
     
         29 . A system for detecting an analyte in a biological sample comprising:
 a cartridge comprising:
 an assay unit for performing a chemical reaction that yields a signal indicative of the presence or absence of the analyte; 
 a capture surface coated with a first molecule specific for the analyte; 
 a first reagent unit comprising a detection reagent comprising a second molecule coupled to a label, wherein the second molecule is capable of binding to the analyte; 
 a second reagent unit comprising a substrate for reacting with the label and generating a signal; 
 a third reagent unit comprising a wash buffer; 
 a dilution unit comprising a sample diluent; 
 one or more sample collection units for receiving the biological sample; 
 at least one tip; and 
 at least one centrifugation vessel; 
   and a biological sample processing device comprising:
 an optical detector for detecting the signal indicative of the presence or absence of the analyte in the diluted sample with the optical detector, and a centrifuge; 
   wherein the cartridge is insertable and removable into the biological sample processing device.   
     
     
         30 . The system of  claim 29 , wherein the assay unit, the first, second, and third reagent units, the dilution unit, the one or more sample collection units, and the centrifugation vessel are not in fluid communication with each other; and the assay unit is movable. 
     
     
         31 . The system of  claim 29 , wherein the analyte is a first antibody, the first molecule is an antigen specific for the first antibody, and the second molecule is a second antibody. 
     
     
         32 . The system of  claim 29 , wherein the label is alkaline phosphatase and the substrate is a chemiluminescent alkaline phosphatase substrate. 
     
     
         33 . The system of  claim 29 , wherein the biological sample is a blood sample. 
     
     
         34 . The system of  claim 31 , wherein the antigen is a viral antigen. 
     
     
         35 . The system of  claim 34 , wherein the viral antigen is selected from a retroviral antigen, HIV antigen, herpes simplex viral antigen, varicella zoster viral antigens, Japanese encephalitis viral antigen, hepatitis viral antigen, influenza viral antigen, measles viral antigen, rubella viral antigen, rotaviral antigen, cytomegaloviral antigen, respiratory syncytial viral antigen, rabies viral antigen, and papillomavirus antigen. 
     
     
         36 . The system of  claim 29 , wherein the biological sample processing device further comprises a sample handling system, wherein the sample handling system comprises at least one head that engages with the tip. 
     
     
         37 . The system of  claim 36 , wherein the sample handling system further engages with the assay unit and moves the assay unit from the cartridge to the optical detector. 
     
     
         38 . The system of  claim 29 , wherein the cartridge further comprises reagent controls for performing control assays.