IP Library Granted Patent US 9,176,154
Granted Patent B2
US 9,176,154 · App. 14/100,397 · Granted Nov 3, 2015

Calibration process and system

Inventors: Adam Darmstadt (Hercules, CA); Michael Waite (Hercules, CA); Theresa Forni (Hercules, CA)
Assignee: Bio-Rad Laboratories, Inc.
G01N35/00693G01N2035/00702
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Quick Facts
Patent No.
US 9,176,154
App. No.
14/100,397
Granted
Nov 3, 2015
Kind
B2
Abstract

An improved calibration process for a medical testing machine. The machine automatically recognizes that a package of calibration material has been inserted into it, and performs a calibration sequence to ascertain a calibration parameter to be used in performing future tests with the medical testing machine. The calibration package may include machine-readable indicators that the package is to be used for calibration, and of a calibration setpoint of a calibration material in the package. A calibration material may be stored in a lyophilized state in the package, and the medical testing machine may automatically reconstitute the lyophilized material.

Claims (33)

1. A method of performing a calibration in a medical testing machine, the method comprising:

automatically detecting that a package of calibration material has been inserted into the medical testing machine;

performing, by the medical testing machine, a calibration sequence using the calibration material to ascertain a calibration parameter for the medical testing machine; and

storing the calibration parameter in electronic storage for use in later tests performed by the medical testing machine;

wherein the calibration material is provided in a lyophilized state, the method further comprising controlling the medical testing machine to automatically reconstitute the lyophilized material before performing the calibration sequence.

2. The method of claim 1 , further comprising reading a calibration setpoint from the package of calibration material.

3. The method of claim 1 , wherein the medical testing machine performs liquid chromatography that uses a washing solution, and wherein the washing solution is also used to reconstitute the lyophilized material.

4. The method of claim 1 , further comprising agitating the reconstituted material by aspirating at least some of the reconstituted material from its vial and re-injecting the aspirated reconstituted material into its vial.

5. The method of claim 1 , wherein the medical testing machine performs high performance liquid chromatography.

6. The method of claim 1 , wherein the medical testing machine performs a test that measures a level of HbAlc hemoglobin in blood.

7. The method of claim 1 , further comprising:

comparing the calibration parameter with a predetermined condition; and

automatically re-running the calibration if the calibration parameter does not meet the predetermined condition.

8. The method of claim 1 , further comprising:

comparing the calibration parameter with a predetermined condition; and

automatically re-running the calibration if the calibration parameter meets the predetermined condition.

9. The method of claim 1 , wherein the calibration is a two-point calibration, and wherein two calibration parameters are ascertained.

10. The method of claim 9 wherein the calibration parameters include a slope and an intercept.

11. A medical testing machine, comprising:

a testing system for performing a medical test on media sampled from patients;

a media handling mechanism;

a processor; and

a memory, the memory holding instructions that when executed by the processor cause the medical testing machine to:

automatically recognize that a package of calibration material has been inserted into the medical testing machine, wherein the package holds two materials, at least one of which is a calibration material in a lyophilized state, and the package includes a respective container for each of the materials, the containers maintaining separation between the materials before use of the calibration package, and wherein the package is received from outside the medical testing machine;

automatically reconstitute the lyophilized calibration material;

after the lyophilized calibration material is reconstituted, perform a calibration sequence using the calibration material to ascertain a calibration parameter for the medical testing machine; and

store the calibration parameter in the memory for use in later tests performed by the medical testing machine.

12. The medical testing machine of claim 11 , further comprising a STAT input, wherein the medical testing machine automatically recognizes that the package of calibration material has been inserted into the STAT input.

13. The medical testing machine of claim 11 , wherein the medical testing machine performs high performance liquid chromatography.

14. The medical testing machine of claim 11 , wherein the medical testing machine performs a test that measures a level of HbAlc hemoglobin in blood.

15. The medical testing machine of claim 11 , further comprising a display, and wherein the instructions, when executed by the processor, further cause the medical testing machine to present a user interface screen on the display indicating the progress of the calibration sequence.

16. The medical testing machine of claim 15 , wherein the display is a touchscreen display.

17. The method of claim 1 , wherein the package holds two materials, at least one of which is calibration material, and the package includes a respective container for each of the materials, the containers maintaining separation between the materials before use of the calibration package, and wherein the package is received from outside the medical testing machine.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 10, 2013
From: DARMSTADT, ADAM; WAITE, MICHAEL; FORNI, THERESA
To: BIO-RAD LABORATORIES, INC.
Reel/Frame 031753/0900 →
Continuity (2)
Provisional Application 61736389 · Dec 12, 2012
Related Publication 20140157859A1 · Jun 12, 2014