Systems and methods for collecting and transmitting assay results
First Claim
1. A method of evaluating a biological sample collected from a subject, said method comprising:
- obtaining raw data at a designated sample collection site, said designated sample collection site being separate from a laboratory location, said raw data obtained from said biological sample usinga device having a housing, said device placed at said designated sample collection site said biological sample comprising a cell, wherein the device comprises a pipette, a centrifuge, a thermal controller, and a cytometer, wherein the device is configured to process the biological sample within said housing by;
(i) receiving the biological sample at said designated sample collection site, wherein said biological sample is provided to the device in a cartridge, said cartridge containing a disposable component and all reagents used in processing the biological sample;
(ii) preparing the biological sample and yielding raw data from multiplexed assays performed on a single sample within said housing for a subsequent qualitative and/or quantitative evaluation of said biological sample, wherein said raw data comprises (1) numerical values representative of a physical process or chemical reaction performed by the device and (2) electronic data representative of an image of a cell in said biological sample; and
(iii) transmitting electronically the raw data from said designated sample collection site to said laboratory location for performance of said subsequent evaluation at said laboratory location;
providing oversight of integrity of said evaluation and operation of said device such that results generated from said evaluation can be utilized by a health care professional for diagnosis or treatment of said subject, wherein the oversight is performed at the laboratory location using a processor alone or in conjunction with an individual affiliated with the laboratory.
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Accused Products
Abstract
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.
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Citations
20 Claims
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1. A method of evaluating a biological sample collected from a subject, said method comprising:
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obtaining raw data at a designated sample collection site, said designated sample collection site being separate from a laboratory location, said raw data obtained from said biological sample using a device having a housing, said device placed at said designated sample collection site said biological sample comprising a cell, wherein the device comprises a pipette, a centrifuge, a thermal controller, and a cytometer, wherein the device is configured to process the biological sample within said housing by; (i) receiving the biological sample at said designated sample collection site, wherein said biological sample is provided to the device in a cartridge, said cartridge containing a disposable component and all reagents used in processing the biological sample; (ii) preparing the biological sample and yielding raw data from multiplexed assays performed on a single sample within said housing for a subsequent qualitative and/or quantitative evaluation of said biological sample, wherein said raw data comprises (1) numerical values representative of a physical process or chemical reaction performed by the device and (2) electronic data representative of an image of a cell in said biological sample; and (iii) transmitting electronically the raw data from said designated sample collection site to said laboratory location for performance of said subsequent evaluation at said laboratory location; providing oversight of integrity of said evaluation and operation of said device such that results generated from said evaluation can be utilized by a health care professional for diagnosis or treatment of said subject, wherein the oversight is performed at the laboratory location using a processor alone or in conjunction with an individual affiliated with the laboratory. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18)
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19. A method of evaluating a biological sample collected from a subject, said method comprising:
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obtaining raw data at a designated sample collection site, said designated sample collection site being separate from a laboratory location, said raw data obtained from said biological sample using a device having a housing, said device placed at said designated sample collection site said biological sample comprising a cell, wherein the device comprises a pipette, a centrifuge, a thermal controller, and a cytometer, wherein the device is configured to process the biological sample within said housing by; (i) receiving the biological sample at said designated sample collection site, wherein said biological sample is provided to the device in a cartridge, said cartridge containing a disposable component and all reagents used in processing the biological sample; (ii) preparing the biological sample and yielding raw data from multiplexed assays performed on a single sample within said housing for a subsequent qualitative and/or quantitative evaluation of said biological sample, wherein said raw data comprises (1) numerical values representative of a physical process or chemical reaction performed by the device and (2) electronic data representative of an image of a cell in said biological sample; and (iii) transmitting electronically the raw data from said designated sample collection site to said laboratory location for performance of said subsequent evaluation at said laboratory location; providing oversight of integrity of said evaluation and operation of said device such that results generated from said evaluation can be utilized by a health care professional for diagnosis or treatment of said subject, wherein the oversight is performed at the laboratory location using a processor alone or in conjunction with an individual affiliated with the laboratory; wherein preparing the biological sample and yielding raw data within said housing comprises transporting a reagent, the biological sample, or a portion of the biological sample, with a pipette within said housing.
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20. A method of evaluating a biological sample collected from a subject, said method comprising:
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obtaining raw data at a designated sample collection site, said designated sample collection site being separate from a laboratory location, said raw data obtained from said biological sample using a device having a housing, said device placed at said designated sample collection site said biological sample comprising a cell, wherein the device comprises a pipette, a centrifuge, a thermal controller, and a cytometer, wherein the device is configured to process the biological sample within said housing by; (i) receiving the biological sample at said designated sample collection site, wherein said biological sample is provided to the device in a cartridge, said cartridge containing a disposable component and all reagents used in processing the biological sample; (ii) preparing the biological sample and yielding raw data from multiplexed assays performed on a single sample within said housing for a subsequent qualitative and/or quantitative evaluation of said biological sample, wherein said raw data comprises (1) numerical values representative of a physical process or chemical reaction performed by the device and (2) electronic data representative of an image of a cell in said biological sample; and (iii) transmitting electronically the raw data from said designated sample collection site to said laboratory location for performance of said subsequent evaluation at said laboratory location; providing oversight of integrity of said evaluation and operation of said device such that results generated from said evaluation can be utilized by a health care professional for diagnosis or treatment of said subject, wherein the oversight is performed at the laboratory location using a processor alone or in conjunction with an individual affiliated with the laboratory; wherein the processor is configured to communicate with a payer database comprising insurance information for the subject.
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Specification