Method for analysis of a medical sample

• US 5,455,177 A
• Filed: 08/20/1993
• Issued: 10/03/1995
• Est. Priority Date: 02/05/1992
• Status: Expired due to Fees

• Current Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Original Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Inventors: Gfrorer, Andreas, Krause, Friedemann
• Primary Examiner(s): Snay, Jeffrey R.
• Application Number:
  US08/104,160
• Time in Patent Office: 774 Days
• Field of Search: 422/82.09, 436/164, 436/8, 436/166, 436/171, 436/172, 250/252.1, 73/1 R, 73/61.48, 356/39, 356/433-436
• US Class Current: 436/8
• CPC Class Codes: G01N 21/272 for following a reaction, e.g. for determining photometrically a reaction rate (photometric cinetic analysis)
• CPC Class Codes: G01N 21/359 using near infrared light
• CPC Class Codes: G01N 2201/1211 for temperature
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing

Abstract

A method for the analysis of a medical sample, particularly a body fluid, with the aid of an analyzing instrument, in which a test fluid, which contains an aliquot part of the sample and reagents, is in an optical cuvette and the temperature of the test fluid is determined in the cuvette. In order to determine the temperature of the test fluid directly and without contact, in a temperature calibration step the optical absorption of a calibrator fluid is determined at various temperatures at at least two wavelengths within the NIR range in order to obtain a calibration data set relating to the temperature-dependency of the optical absorption. In a temperature-measuring step the optical absorption of a test fluid of unknown temperature is measured at the same wavelengths and its temperature is determined by comparison of the absorption data obtained in the measuring step with the calibration data set.

Claims

1. A method for analysis of a liquid medical sample with the aid of an analysis instrument, said method comprising:

an analytical measurement step for the determination of a measurable variable, said measurable variable being characteristic of an analytical value of the sample in an optical cuvette, said cuvette containing a test fluid, said test fluid comprising an aliquot part of the sample and reagents which are a part of a reagent system which is specific for the analysis of the sample, said analytical measurement step comprising reacting the sample and the reagents to cause a measurable temperature dependent change in the test fluid, and measuring said measurable change as the measurable variable;

a temperature measuring step wherein an optical absorption of said test fluid of unknown temperature is measured in the optical cuvette by irradiating the test fluid with at least two wavelengths within the NIR-range between 800 nm and 2500 nm, and the temperature is determined by comparing absorption data obtained in the temperature measuring step with a calibration data set relating to a temperature dependence of the optical absorption of the test fluid,

said calibration data set being generated in a temperature calibration step in which the optical absorption of a calibrator fluid, different from the test fluid and having a known temperature, is determined at various temperatures at at least two wavelengths.

2. Method according to claim 1, wherein the optical absorption in the temperature calibration step is measured a plurality of times on a specific calibrator fluid and at a specific temperature.

3. Method according to claim 1, wherein the optical absorption in the temperature-measuring step is measured a plurality of times on a test fluid for the determination of a temperature value.

4. Method according to claim 1, wherein the wavelengths at which the optical absorption is measured include one wavelength on the short-wave and one on the long-wave flank of an absorption band of water.

5. Method according to claim 1, wherein the wavelengths at which the optical absorption is measured include a wavelength within an absorption band of water and a wavelength outside the absorption bands of water.

6. Method according to claim 1, wherein a multivariate analysis is performed to compare the calibration data set obtained in the temperature calibration step with the absorption data obtained in the temperature-measuring step.

7. Method according to claim 1, wherein the sample is analysed for a plurality of different components (parameters) and, for the determination of a parameter-specific calibration data set, the calibration step is carried out separately for each component to be analysed, the calibrator fluid containing, in each case, all constituents of the reagent system required for the determination of the particular component which are important for the optical absorption.

8. Method according to claim 7, wherein the calibration step includes two partial steps, in a first partial step, which is performed independently of the analysing instrument, the parameter-specific calibration data set being determined, and in a second partial step within the analysing instrument the optical absorption on a parameter-neutral calibration medium being determined for at least one known temperature in order to obtain additionally parameter-neutral calibration data.

9. Method according to claim 1, wherein the analytical measurement step is performed at an approximately predetermined temperature, an a temperature adjustment of the measurable variable is performed by means of the temperature of the test fluid determined in the temperature-measuring step.

10. Method according to claim 9, wherein the measurable variable is the optical absorption of the test fluid and the optical absorption of the test fluid is determined in the analysis mesurement step at at least one wavelength which is different from the wavelengths of light used in the temperature measuring step and the temperature calibration step.

11. Method according to claim 9, wherein the measurable variable is measured on a test fluid a plurality of times in sucession and the temperature adjustment is carried out in order to determine the time dependent change of the measurable variable at a reference temperature as a measure of reaction kinetics.