SYSTEMS AND METHODS FOR COLLECTING AND TRANSMITTING ASSAY RESULTS
Systems and methods are provided for collecting, preparing, and/or analyzing a biological sample. A sample collection site may be utilized with one or more sample processing device. The sample processing device may be configured to accept a sample from a subject. The sample processing device may perform one or more sample preparation step and/or chemical reaction involving the sample. Data related to the sample may be sent from the device to a laboratory. The laboratory may be a certified laboratory that may generate a report that is transmitted to a health care professional. The health care professional may rely on the report for diagnosing, treating, and/or preventing a disease in the subject.
1 - 54 . (canceled)
55 . A method comprising:
(a) receiving raw data at a laboratory location, wherein said raw data is obtained from a biological sample collected at a designated sample collection site and said raw data is transmitted from a device placed at the designated sample collection site, said device having a housing, said raw data being obtained by the device from the biological sample, wherein the device is configured to process the biological sample within said housing by:
(i) receiving the biological sample, wherein the biological sample is provided to the device in a cartridge, wherein said cartridge also contains at least one reagent and at least one disposable component for use in analyzing the sample;
(ii) preparing the biological sample using said reagent and said disposable component, and yielding raw data within said housing for a subsequent qualitative or quantitative evaluation of the biological sample, wherein yielding raw data comprises performing physical processes or chemical reactions for at least two different assays selected from a chemical assay, an immunoassay, a nucleic acid assay, a receptor-based assay, an enzymatic assay, and a cytometric assay, said assays performed with the biological sample or portion thereof within said disposable component and within said housing, said raw data comprising at least one of (1) numerical values representative of said physical processes or said chemical reactions, or (2) electronic data representative of an image of the biological sample or portion thereof; and
(iii) transmitting electronically the raw data from said designated sample collection site to said laboratory location for performance of said subsequent evaluation at the laboratory location; and
(b) analyzing the raw data transmitted from the device at the laboratory location, to provide said evaluation of the biological sample, wherein said analyzing is performed using a processor alone or in conjunction with an individual affiliated with the laboratory.
56 . The method of claim 55 , further comprising providing oversight of integrity of said analysis and oversight of the operation of the device such that results generated from said analysis can be utilized by a health care professional for screening, diagnosis or treatment of said subject, wherein said oversight is performed at said laboratory location using a processor alone or in conjunction with an individual affiliated with the laboratory location.
57 . The method of claim 55 , wherein said laboratory location comprises an authorized analytical facility or an affiliate thereof.
58 . The method of claim 55 , wherein said biological sample comprises a fingerstick blood sample having a volume of less than about 250 microliters (μL).
59 . The method of claim 55 , wherein said designated sample collection site is a site selected from the group consisting of a retailer site, the subject's home, a health assessment location, and a health treatment location.
60 . The method of claim 55 , wherein said analyzing of the raw data is performed using a laboratory information system (LIS) or a laboratory automation system (LAS) located at said laboratory location.
61 . The method of claim 56 , wherein a) the operation of the device is controlled remotely using a laboratory information system (LIS) or a laboratory automation system (LAS) located at said laboratory location, b) the oversight of integrity of the analysis is performed remotely using a laboratory information system (LIS) located at said laboratory location, or both.
62 . The method of claim 55 , wherein the evaluation of said biological sample is effected without physically transporting said biological sample from the site where the biological sample is collected to the authorized analytical facility or affiliate thereof.
63 . The method of claim 55 , wherein the evaluation of said biological sample is performed remotely using a laboratory information system (LIS) or a laboratory automation system (LAS) located at said laboratory location and is effected without physically transporting said biological sample from the site where the biological sample is collected to the authorized analytical facility or affiliate thereof.
64 . The method of claim 55 , wherein receiving data comprises receiving data from an image of a physical process or chemical reaction performed by the device with said biological sample.
65 . The method of claim 55 , wherein the biological sample or a portion thereof comprises a cell, and wherein said electronic data representative of an image of the biological sample or portion thereof comprises electronic data representative of an image of a cell in said biological sample.
66 . The method of claim 65 , wherein said electronic data representative of an image of a cell is derived from an optical assessment of histology of said cell, morphology of said cell, hematology, or cell count.
67 . The method of claim 55 , wherein preparing the biological sample and yielding raw data within said housing comprises yielding raw data within said housing from at least two assays selected from a chemical assay, an immunoassay, a nucleic acid assay, a receptor-based assay, and an enzymatic assay.
68 . The method of claim 55 , comprising evaluating a plurality of types of biological samples collected from a subject, wherein said data transmitted from said device comprises raw data from said plurality of types of biological samples, wherein at least one of said biological samples comprises a cell.
69 . The method of claim 55 , wherein preparing the biological sample and yielding raw data within said housing comprises yielding raw data within said housing from assays selected from a cytometric assay and an assay selected from a chemical assay, an immunoassay, nucleic acid assay, receptor-based assay, and an enzymatic assay.
70 . The method of claim 68 , wherein the evaluation of said plurality of types of biological samples is effected without physically transporting any of said samples from the site where the sample is collected to the authorized analytical facility or an affiliate thereof.
71 . The method of claim 55 , wherein preparing the biological sample and yielding raw data within said housing comprises transporting a reagent, or a biological sample, or portion thereof with a pipette within said housing.
72 . The method of claim 55 , wherein preparing the biological sample and yielding raw data within said housing comprises centrifuging a biological sample or portion thereof within said housing.
73 . The method of claim 55 , wherein the device is remotely operated in compliance with Clinical Laboratory Improvement Amendments (CLIA) by a CLIA-certified laboratory, or is operated in a CLIA-certified laboratory.
74 . A system for evaluating a biological sample collected from a subject at a designated sample collection site, said system comprising:
(a) a sample processing device having a housing and placed at said designated sample collection site, said device being configured to obtain raw data within said housing from said biological sample for qualitative or quantitative evaluation of the biological sample, wherein said raw data comprises data from at least two different assays selected from a chemical assay, an immunoassay, a nucleic acid assay, a receptor-based assay, an enzymatic assay, and a cytometric assay, said raw data comprising at least one of (1) numerical values representative of a physical process or chemical reaction with the biological sample or a portion thereof, said process or reaction performed by the device within a disposable component, or (2) electronic data representative of an image of the biological sample or portion thereof, and wherein the device comprises (i) a sample collection unit configured to receive the biological sample; (ii) a sample preparation unit configured to prepare the biological sample and to yield raw data for the evaluation; and (iii) transmission unit configured to transmit the raw data to a laboratory location;
(b) a communication unit for communication between said device and said laboratory location, said communication unit being configured to receive raw data from said device, to transmit instructions to said device, or both; and
(c) a processor located at said laboratory location and operably connected with said communication unit, said processor configured to process said raw data alone or in conjunction with an individual affiliated with said laboratory for the evaluation of the biological sample at the laboratory location.
75 . The system of claim 74 , wherein said processor is further configured for the oversight of the integrity of evaluation and of the operation of the device such that results generated from said evaluation can be utilized by a health care professional for diagnosis or treatment of said subject.
76 . The system of claim 74 , further comprising a) a transport assembly configured to transport a reagent, or a biological sample, or portion thereof with a pipette within said housing, b) a centrifuge within said housing, c) a record database comprising one or more medical records or insurance information pertaining to the subject, wherein said processor is configured to communicate with said record database, or combinations thereof.
77 . The system of claim 74 , further comprising an imaging assembly configured to obtain electronic data representative of an image of the biological sample or portion thereof.
78 . The system of claim 77 , wherein said imaging assembly is configured to provide one or more of an optical assessment of histology of said cell, morphology of said cell, hematology, or cell count.
79 . The system of claim 74 further comprising a laboratory information system (LIS) or a laboratory automation system (LAS) located at the laboratory location, wherein said LIS or LAS is configured to control the operation of the sample processing device at the sample collection site, or to perform said qualitative or quantitative evaluation of the raw data.
80 . The system of claim 75 further comprising a laboratory information system (LIS) or a laboratory automation system (LAS) located at the laboratory location, wherein said LIS or LAS is configured to perform the oversight of integrity of the analysis of the raw data.
81 . The system of claim 74 , wherein the sample processing device is configured to process a biological sample comprising a fingerstick blood sample having a volume of less than about 250 microliters (μL).
82 . The system of claim 74 , wherein the sample processing device is configured to provide raw data obtained from at least two assays selected from an immunoassay, a nucleic acid assay, a receptor-based assay, and an enzymatic assay.
83 . The system of claim 74 , wherein said laboratory location comprises an authorized analytical facility or the affiliate thereof.
84 . The system of claim 74 , wherein said designated sample collection site is a site selected from the group consisting of a retailer site, the subject's home, a health assessment location, and a health treatment location.