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 - 31 . (canceled)
32 . A system of evaluating a biological sample collected from a subject, said system comprising:
(a) a communication unit placed at a laboratory location configured to receive data from a device placed in or on the subject or at a designated sample collection site, 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 for the evaluation within said housing, 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 a
(iii) transmission unit configured to transmit the raw data from said sample collection site to an authorized analytical facility and/or an affiliate thereof at said laboratory location;
(b) a processor at said laboratory location that processes said data alone or in conjunction with an individual affiliated with the authorized analytical facility for (a) the evaluation of said biological sample at the authorized analytical facility and/or the affiliate thereof, 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 screening, diagnosis or treatment of said subject;
wherein sample processing unit further includes an oversight software program comprising computer-executable instructions for calibration and diagnostics of the sample processing unit.
33 . The system of claim 32 , wherein said sample preparation unit comprises a fluid handling system comprising a pipette within said housing.
34 . The system of claim 32 , wherein said sample preparation unit comprises a centrifuge within said housing.
35 . The system of claim 32 , wherein the device is a Clinical Laboratory Improvement Amendments (CLIA)-waived device.
36 . The system of claim 32 , wherein the device is a Clinical Laboratory Improvement Amendments (CLIA)-compliant device, is operated in compliance with CLIA, is operated by a CLIA-compliant laboratory, or is operated in a CLIA-compliant location.
37 . The system of claim 32 , wherein the device is a Clinical Laboratory Improvement Amendments (CLIA)-certified device, is operated by a CLIA-certified laboratory, or is operated in a CLIA-certified location.
38 . The system of claim 32 , wherein the device is a device that has been cleared for use by the U.S. Food and Drug Administration.
39 . The system of claim 32 , wherein the device has been classified as exempt by the U.S. Food and Drug Administration.
40 . (canceled)
41 . The system of claim 32 , wherein the authorized analytical facility and/or affiliate thereof is a Clinical Laboratory Improvement Amendments (CLIA)-compliant laboratory or a CLIA-certified laboratory.
42 . The system of claim 32 , wherein the device is operated under the control or oversight of a Clinical Laboratory Improvement Amendments (CLIA)-compliant or CLIA-certified laboratory.
43 . The system of claim 32 , wherein the device is a Clinical Laboratory Improvement Amendments (CLIA)-waived device operated under the control of a CLIA-compliant or CLIA-certified laboratory.
44 . The system of claim 32 , wherein the device is a Clinical Laboratory Improvement Amendments (CLIA)-waived device operated under the oversight of a CLIA-compliant or CLIA-certified laboratory.
45 . The system of claim 32 , wherein the device is operated under the oversight or control of a CLIA-compliant or CLIA-certified laboratory, and wherein the device is a Clinical Laboratory Improvement Amendments (CLIA)-compliant device; or a CLIA-certified device; or a device that has been cleared for use by the U.S. Food and Drug Administration; or a device that has been classified exempt by the U.S. Food and Drug Administration; or a device that has not been cleared or approved by any regulatory body.
46 . (canceled)
47 . (canceled)
48 . The system of claim 32 , wherein said designated sample collection site is a site selected from the group consisting of a retailer site, the subject's home, and a health assessment/treatment location.
49 . The system of claim 32 , wherein said electronic data representative of an image of a cell in said biological sample comprises electronic data derived from an optical assessment of histology or morphology of said cells, and said raw data comprises raw data from an image of a physical process or chemical reaction performed by the device with said biological sample.
50 . The system of claim 32 , wherein said raw data comprises raw data from at least two assays selected from an immunoassay, a nucleic acid assay, a receptor-based assay, and an enzymatic assay.
51 . The system of claim 32 , wherein the evaluation of said biological sample is effected without physically transporting said sample from the site where the sample is collected to the authorized analytical facility or an affiliate thereof.
52 . The system of claim 32 , wherein said processor at said laboratory location is configured to generate a report.
53 . The system of claim 32 , wherein the processor is configured to communicate with a record database comprising one or more medical records of, or insurance information for, the subject.
54 . The system of claim 32 , wherein the processor is configured to communicate with a payer database comprising the insurance information for the subject.