NMR analyzers for clinical evaluation of biosamples

• US 10,365,339 B2
• Filed: 03/06/2014
• Issued: 07/30/2019
• Est. Priority Date: 04/01/2004
• Status: Active Grant

• Current Assignee: LipoScience, Inc. (Laboratory Corporation Of America Holdings)
• Original Assignee: LipoScience, Inc. (Laboratory Corporation Of America Holdings)
• Inventors: Otvos, James D., Jeyarajah, Elias J., Markham, Stephen, Matyus, Steven P., Morgan, David R., Silberman, Bruce D., Deuel, Donald R.
• Primary Examiner(s): Vargas, Dixomara
• Application Number:
  US14/198,940
• Publication Number:
  US 20140184223A1
• Time in Patent Office: 1,972 Days
• CPC Class Codes: G01R 33/307 specially adapted for moving the sample relative to the MR system, e.g. spinning mechanisms, flow cells or means for positioning the sample inside a spectrometer
• CPC Class Codes: G01R 33/465 applied to biological material, e.g. in vitro testing

Abstract

The clinical analyzers automatically electronically monitor selected parameters and automatically electronically adjust parameters to maintain the analyzer within desired operational ranges. The clinical NMR analyzers can be configured as a networked system with a plurality of clinical NMR analyzers located at different use sites.

Claims

1. A networked system of clinical NMR analyzers, comprising:

a plurality of clinical NMR analyzers located at different local use sites, wherein the clinical NMR analyzers are configured to obtain NMR derived concentration measurements of lipoproteins in a blood plasma and/or serum sample; and

at least one remote control system in communication with the plurality of clinical NMR analyzers configured to monitor selected local operating parameters associated with each clinical NMR analyzer and wherein said remote control system is configure to automatically execute a start-up self-diagnostic and tuning/calibration routine and relay abnormal data regarding each clinical NMR analyzers to the remote control system

wherein the clinical NMR analyzers and/or remote system are configured to automatically monitor process variables and statistically analyze data corresponding to measurements of the monitored process variables to thereby perform an automated quality control analysis.

2. A system according to claim 1, wherein each of the clinical NMR analyzers includes a high field NMR superconducting magnet, and wherein the remote system automatically obtains data corresponding to homogeneity of the magnetic field generated by the superconducting magnet.

3. A system according to claim 1, wherein the clinical NMR analyzers generate and store an electronic history file of selected operational parameters, the history file configured to be accessed by the remote system.

4. A system according to claim 1, wherein the clinical NMR analyzers are configured to automatically adjust operating equipment to keep the process variables within a predetermined statistical variation responsive to the monitored data.

5. A system according to claim 1, wherein the clinical NMR analyzers are configured to automatically generate an alert when an abnormal operating condition is detected.

6. A system according to claim 1, wherein the remote system is configured to automatically generate an alert when an abnormal operating condition is detected.

7. A system according to claim 1, wherein the clinical NMR analyzers are configured to generate an electronic service log that is accessible by the remote system.

8. A system according to claim 1, wherein the clinical NMR analyzers are configured to automatically detect temporally relevant data of selected operational parameters at desired intervals and generate an electronic maintenance file thereof, and to electronically store the maintenance files for interrogation by the remote system.

9. A system according to claim 8, wherein the selected operational parameters include the NMR signal lineshape and/or scaling thereof of a patient sample.

10. A system according to claim 8, wherein the maintenance file includes respective patient sample identifiers correlated to selected operational parameters measured at a time the NMR signal of the patient sample was obtained.

11. A system according to claim 8, wherein an electronic maintenance file of selected operational parameters is generated for each sample.

12. A system according to claim 1, wherein the clinical NMR analyzers generate an electronic log of NMR sample data corresponding to the samples processed by the respective analyzers over a desired interval, the log configured to be electronically accessible by the remote system.

13. A system according to claim 1, wherein an operator at the remote system determines when to send technical support on-site to the clinical NMR analyzers.

14. A system according to claim 1, wherein the remote system automatically controls selected parameters of the clinical NMR analyzers.

15. A system according to claim 1, wherein the clinical NMR analyzers electronically store sample data correlated to an accession patient identifier and sample dilution factor.

16. A system according to claim 1, wherein the clinical NMR analyzers are configured with a user interface that accepts local user input to select a report format and/or sample variables of interest for NMR analysis.

17. A system according to claim 1, wherein the NMR analyzers include program code configured to generate patient reports from each clinical NMR analyzer site, the program code including a site identifier that is correlated to the patient reports from respective clinical NMR analyzer sites, and wherein the computer program code is configured to allow the report to be generated in electronic and/or paper form.

18. A system according to claim 1, wherein the remote system is configured to automatically obtain data regarding the number of patient samples analyzed over a desired interval on each clinical NMR analyzer.

19. A system according to claim 1, wherein the clinical NMR analyzers are configured to obtain NMR derived concentration measurements of LDL and/or HDL subclass particles in a blood plasma and/or serum sample.

20. A system according to claim 1, wherein the clinical NMR analyzers are configured to determine a patient'"'"'s risk of having and/or developing CHD based on the lipoprotein measurements.

21. A system according to claim 1, wherein the clinical NMR analyzers are configured to determine a patient'"'"'s risk of having and/or developing Type II diabetes.

22. A system according to claim 21, wherein the clinical NMR analyzers are configured to determine a patient'"'"'s risk of having an insulin resistance disorder.

23. A system according to claim 1, wherein the clinical NMR analyzers are configured to automatically monitor the NMR signal lineshapes to determine a height and/or width thereof.

24. A system according to claim 23, wherein the clinical NMR analyzers comprise a high field superconducting magnet, and wherein the clinical NMR analyzers automatically shim the NMR spectroscopic magnetic field to provide increased homogeneity if the line widths degrade.

25. A system according to claim 24, wherein the clinical NMR analyzers are configured to automatically adjust scaling of the NMR signal height when signal height and/or width is outside a desired range.

26. A system according to claim 1, wherein one of the selected operational parameters is RF excitation pulse power, and wherein the clinical NMR analyzers are configured to automatically adjust the RF excitation pulse power if the power is outside a desired operating range and/or varies from pulse to pulse by more than a predetermined amount and/or percentage.

27. A system according to claim 26, wherein the clinical NMR analyzers are configured to invalidate NMR signal data obtained when power variation of the RF pulses is greater than a predetermined amount.

28. A system according to claim 1, wherein the remote system is configured to automatically order consumables for the clinical NMR analyzers based on monitored data.