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 sample preparation unit in the housing comprising (i) a pipette, and ii) 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;
Then;
(a) receiving said raw data at said laboratory location separate from said designated sample collection site;
then(b) analyzing the raw data at the laboratory location, to provide said evaluation of said biological sample, wherein said analysis is performed using a processor alone or in conjunction with an individual affiliated with the laboratory; and
(c) providing oversight of integrity of said analysis and operation of said device such that results generated from said analysis 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
30 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 sample preparation unit in the housing comprising (i) a pipette, and ii) 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; Then; (a) receiving said raw data at said laboratory location separate from said designated sample collection site;
then(b) analyzing the raw data at the laboratory location, to provide said evaluation of said biological sample, wherein said analysis is performed using a processor alone or in conjunction with an individual affiliated with the laboratory; and (c) providing oversight of integrity of said analysis and operation of said device such that results generated from said analysis 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, 19)
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20. A system of evaluating a biological sample collected from a subject, said system comprising:
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(a) a communication unit placed at a laboratory location configured to receive raw data from a device placed at a designated sample collection site separate from said laboratory location, wherein the device comprises a housing and is configured to process a biological sample within said housing, said biological sample comprising a cell, said processing by said device generating raw data for a subsequent qualitative and/or quantitative evaluation of said biological sample, and wherein the device comprises; (i) a sample collection unit within said housing configured to receive the biological sample; (ii) a sample preparation unit within said housing configured to prepare the biological sample and to yield raw data from multiplexed assays performed on a single sample for the evaluation within said housing, wherein the sample preparation unit comprises (i) a pipette, and ii) a centrifuge, a thermal controller, and a cytometer, said sample is provided to the device in a cartridge, wherein said raw data (1) comprises numerical values representative of a physical process or chemical reaction performed by the device and (2) and electronic data representative of an image of a cell in said biological sample; and (iii) a transmission unit configured to transmit the raw data from said designated sample collection site to said laboratory location; (b) a processor at said laboratory location that processes said data alone or in conjunction with an individual affiliated with the laboratory for (A) the evaluation of said biological sample at the laboratory location, and (B) the oversight of said integrity of 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. - View Dependent Claims (21, 22, 23, 24, 25, 26, 27, 28, 29, 30)
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Specification