Patent ID: 9619627
Date: 2017-04-11
CPC Classifications: C12Q,G01N,G16H,Y02A

Claim:
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.