SYSTEMS AND METHODS FOR MULTI-ANALYSIS
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 system for analyzing a sample having a volume of less than about 250 microliters (μL), said system being configured to perform an immunoassay, a nucleic acid assay, and a general chemistry assay, the system comprising:
a housing suitable for placement on a benchtop, said housing containing:
a sample handling system configured to transport said sample, or portion thereof, within said housing;
one or more sample preparation stations configured to perform a plurality of sample reparation procedures on said sample or portion thereof, said sample preparation procedures comprising sample processing and chemical processing;
one or more assay components configured to perform an immunoassay, a nucleic acid assay, and a general chemistry assay for the detection of two or more analytes in said sample or portion thereof, wherein said two or more analytes have concentrations ranging over two orders of magnitude or more, wherein each assay is configured to yield a detectable optical signal indicative of the analyte concentration; and
one or more detectors comprising at least one optical sensor configured to detect optical signals from each assay, wherein characteristics of said optical signals may range over two or more orders of magnitude.
10 . The device of claim 9 , further comprising a communication unit configured to perform two-way communication with external devices, said two-way communication comprising receiving instructions from an external device and sending data to external devices.
11 . The device of claim 9 , configured to perform three or more assays on a single sample having a volume of less than about 250 μL, or portions thereof, wherein said three or more assays are selected from an immunoassay, a nucleic acid assay, and a general chemistry assay.
12 . The device of claim 9 , configured to perform each of an immunoassay, a nucleic acid assay, and a general chemistry assay on a single sample having a volume of less than about 250 μL, or portions thereof.
13 . The device of claim 9 , wherein at least one assay component is configured to receive one or more individually addressable assay units, each assay unit being fluidically isolated from one another, wherein at least one type of assay may be performed within said individually addressable assay unit effective to yield an optical signal.
14 . The device of claim 9 , wherein said device is located at a point-of-service location.
15 . The device of claim 10 , wherein said device is located at a point-of-service location.
16 . The device of claim 13 , wherein said sample handling system is configured to transport one or more individually addressable assay units to a detector.
17 . The device of claim 9 , wherein said sample handling system comprises a pipette, wherein said pipette is configured to uptake, transport, and dispense said sample, or portion thereof.
18 . The device of claim 9 , comprising local memory containing a protocol effective to control the operation of the device for analyzing said sample.
19 . The device of claim 14 , comprising local memory containing a protocol effective to control the operation of the device for analyzing said sample.
20 . The device of claim 10 , configured to receive a protocol from an external device effective to control the operation of the device for analyzing said sample.
21 . The device of claim 15 , configured to receive a protocol from an external device effective to control the operation of the device for analyzing said sample.
22 . The device of claim 9 , comprising an output for providing a result of said analyzing of said sample.
23 . The device of claim 14 , comprising an output for providing a result of said analyzing of said sample, wherein said output is located at said point-of-service location.
24 . The device of claim 10 , comprising an output for providing a result of said analyzing of said sample, wherein said output is located at said point-of-service location.
25 . The device of claim 15 , comprising an output for providing a result of said analyzing of said sample, wherein said output is located at said point-of-service location.
26 . The device of claim 10 , wherein said communication unit is operably connected to an external device, wherein said external device comprises an output for providing a result of said analyzing of said sample.
27 . The device of claim 15 , wherein said communication unit is operably connected to an external device, wherein said external device comprises an output for providing a result of said analyzing of said sample.
28 . The device of claim 10 which is configured to communicate with a Laboratory Information System (LIS), a Laboratory Information System (LIS), a Electronic Medical Records system (EMR), or combinations thereof.
29 . The device of claim 15 which is configured to communicate with a Laboratory Information System (LIS), a Laboratory Information System (LIS), a Electronic Medical Records system (EMR), or combinations thereof.
30 . The device of claim 9 , wherein said sample is a biological sample selected from blood, serum, saliva, urine, gastric fluid, digestive fluid, tears, stool, semen, vaginal fluid, interstitial fluid, fluid derived from tumorous tissue, ocular fluid, sweat, mucus, earwax, oil, glandular secretions, breath, spinal fluid, hair, fingernails, skin cells, plasma, fluid obtained from a nasal swab, fluid obtained from a nasopharyngeal wash, cerebrospinal fluid, a tissue sample, fluid or tissue obtained from a throat swab, biopsy tissue, placental fluid, amniotic fluid, cord blood, lymphatic fluids, cavity fluids, sputum, pus, microbiota, meconium, and breast milk.
31 . A method of analyzing a sample, said analysis comprising detecting analytes in said sample, or portion thereof, the method comprising:
Receiving a sample having a volume of less than about 250 microliters (μL) to a benchtop device of claim 9 , said device comprising a housing suitable containing a sample handling system; one or more sample preparation stations; one or more assay components configured to perform an immunoassay, a nucleic acid assay, and a general chemistry assay for the detection of two or more analytes in said sample or portion thereof; and one or more detectors comprising at least one optical sensor configured to detect optical signals from each assay, wherein characteristics of said optical signals may range over two or more orders of magnitude;
Performing a first assay selected from an immunoassay, a nucleic acid assay, and a general chemistry assay on said sample, or portion thereof, said first assay being performed for the detection of a first analyte having a first analyte concentration;
Performing a second assay selected from an immunoassay, a nucleic acid assay, and a general chemistry assay on said sample, or portion thereof, said second assay being performed for the detection of a second analyte having a second analyte concentration;
Wherein said first concentration and said second concentration differ from one another by more than two orders of magnitude; and
Detecting said first analyte and said second analyte.
32 . A method of analyzing a sample, said analysis comprising detecting analytes, the method comprising:
Receiving a sample having a volume of less than about 250 microliters (μL) to a benchtop device of claim 10 , said device comprising a housing suitable containing a sample handling system; one or more sample preparation stations; one or more assay components configured to perform an immunoassay, a nucleic acid assay, and a general chemistry assay for the detection of two or more analytes in said sample or portion thereof; one or more detectors comprising at least one optical sensor configured to detect optical signals from each assay, wherein characteristics of said optical signals may range over two or more orders of magnitude; and a communication unit configured to perform two-way communication with external devices;
Performing a first assay selected from an immunoassay, a nucleic acid assay, and a general chemistry assay on said sample, or portion thereof, said first assay being performed for the detection of a first analyte having a first analyte concentration;
Performing a second assay selected from an immunoassay, a nucleic acid assay, and a general chemistry assay on said sample, or portion thereof, said second assay being performed for the detection of a second analyte having a second analyte concentration;
Wherein said first concentration and said second concentration differ from one another by more than two orders of magnitude; and
Detecting said first analyte and said second analyte.
33 . The method of claim 32 , further comprising receiving a protocol from an external device effective to control the operation of the benchtop device for analyzing said sample.
34 . The method of claim 31 , further comprising communicating results of said detecting step with a Laboratory Information System (LIS), a Laboratory Information System (LIS), a Electronic Medical Records system (EMR), or combinations thereof.
35 . The method of claim 32 , further comprising communicating results of said detecting step with a Laboratory Information System (LIS), a Laboratory Information System (LIS), a Electronic Medical Records system (EMR), or combinations thereof.
36 . The method of claim 34 , comprising performing an immunoassay, a nucleic acid assay, and a general chemistry assay on said sample, or portion thereof.
37 . The method of claim 35 , comprising performing an immunoassay, a nucleic acid assay, and a general chemistry assay on said sample, or portion thereof.
38 . The method of claim 32 , wherein said sample is a biological sample selected from blood, serum, saliva, urine, gastric fluid, digestive fluid, tears, stool, semen, vaginal fluid, interstitial fluid, fluid derived from tumorous tissue, ocular fluid, sweat, mucus, earwax, oil, glandular secretions, breath, spinal fluid, hair, fingernails, skin cells, plasma, fluid obtained from a nasal swab, fluid obtained from a nasopharyngeal wash, cerebrospinal fluid, a tissue sample, fluid or tissue obtained from a throat swab, biopsy tissue, placental fluid, amniotic fluid, cord blood, lymphatic fluids, cavity fluids, sputum, pus, microbiota, meconium, and breast milk.