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. A method of evaluating a biological sample collected from a subject, said method comprising:
(a) receiving at a laboratory location data transmitted from a device having a housing, said device placed at a designated sample collection site, said data comprising raw data obtained from said 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 in a cartridge, wherein said cartridge also contains a reagent and a disposable component for use in analyzing the biological sample;
(ii) preparing the biological sample using said reagent and said disposable component, and yielding raw data within said housing for a subsequent qualitative and/or quantitative evaluation of the biological sample, wherein yielding raw data comprises a process or reaction performed with the biological sample or a portion thereof within said housing, said raw data comprising (1) numerical values representative of a physical process or chemical reaction regarding the biological sample or a portion thereof, said process or reaction performed by the device within a disposable component, and (2) electronic data representative of an image of the biological sample or a portion thereof; and
(iii) transmitting electronically the raw data from said sample collection site to an authorized analytical facility and/or an affiliate thereof for performance of said subsequent evaluation at said laboratory location;
(b) analyzing the raw data transmitted from the device at the authorized analytical facility and/or the affiliate thereof, to provide said evaluation of said biological sample, wherein said analyzing comprises applying cartridge-specific and device-specific calibration information to the raw data in the performance of automated analyses performed using a processor; and
(c) providing automated oversight of integrity of said analysis and operation of said device, said oversight comprising monitoring of the device environment, automated evaluation of an image of the sample within the device, and automated review of the data comprising scaling and calibration of raw data, wherein the automated oversight is performed at said laboratory location using a processor effective to determine whether or not said data requires further review; wherein, if no further review is required, said oversight is effective to verify the validity of the data to insure that values and observations obtained from said raw data are correct, consistent, and reproducible, and to verify the validity of the results obtained from the analysis of said data, such that results generated from said analysis can be utilized by a health care professional for screening, diagnosis or treatment of said subject.
2. The method of claim 1 , wherein the biological sample comprises a cell, and said raw data comprises electronic data representative of an image of a cell.
3. The method of claim 2 , 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 of said cell, morphology of said cell, hematology, or cell count.
4. The method of claim 1 , wherein preparing the biological sample and yielding raw data within said housing comprises transporting a reagent or a biological sample with a pipette within said housing.
5. The method of claim 1 , wherein preparing the biological sample and yielding raw data within said housing comprises centrifuging a biological sample within said housing.
6. The method of claim 1 , wherein the device performs a Clinical Laboratory Improvement Amendments (CLIA)-waived test.
7. The method of claim 1 , 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.
8. The method of claim 1 , wherein the device is a Clinical Laboratory Improvement Amendments (CLIA)-certified device, is operated by a CLIA-certified laboratory, is operated in a CLIA-certified location, is operated under the oversight of a CLIA-compliant laboratory, or is operated under the oversight of a CLIA-certified laboratory.
9. The method of claim 1 , wherein the device is a device that has been cleared for use by the U.S. Food and Drug Administration.
10. The method of claim 1 , wherein the device has been classified as exempt by the U.S. Food and Drug Administration.
11. The method of claim 1 , wherein the device is a device that has not been cleared or approved by any regulatory body.
12. The method of claim 1 , wherein the authorized analytical facility and/or affiliate thereof is a Clinical Laboratory Improvement Amendments (CLIA)-compliant laboratory or a CLIA-certified laboratory.
13. The method of claim 1 , wherein the device is operated under the control or oversight of a Clinical Laboratory Improvement Amendments (CLIA)-compliant or CLIA-certified laboratory.
14. The method of claim 1 , wherein the device is a Clinical Laboratory Improvement Amendments (CLIA)-waived device operated under the control of a CLIA-compliant or CLIA-certified laboratory.
15. The method of claim 1 , wherein the device is operated under the oversight or control of a CLIA-compliant laboratory, and wherein the device is a Clinical Laboratory Improvement Amendments (CLIA)-compliant device; or CLIA-certified device; or a device that has been cleared for use by the U.S. Food and Drug Administration; or a device which has been classified as exempt by the U.S. Food and Drug Administration; or a device that has not been cleared or approved by any regulatory body.
16. The method of claim 1 , wherein the device is a sample processing device or a sample processing unit.
17. The method of claim 1 , wherein the device has been classified by a regulatory body as a sample processing device or a sample processing unit.
18. The method of claim 1 , 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.
19. The method of claim 1 , wherein receiving data comprises receiving data from an image of a physical process or chemical reaction performed by the device with said biological sample.
20. The method of claim 1 , 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 an immunoassay, a nucleic acid assay, a receptor-based assay, and an enzymatic assay.