Multi-application approach for photometric determination of an analyte in a fluid sample on an automated analyzer

Patent metadata

Field	Value
Publication number	US-10132805-B2
Application number	US-201414524700-A
Country	US
Kind code	B2
Filing date	Oct 27, 2014
Priority date	Apr 26, 2012
Publication date	Nov 20, 2018
Grant date	Nov 20, 2018

Abstract

A method for determining the amount of specific analyte of a sample which may show interferences by photometric assays, wherein the analyte is quantified from the change in the optical signal of the reaction mixture after the interaction of the analyte with analyte specific reagents. Multiple calibration curves are generated for multiple wavelengths for the specific analyte. An interference test is performed simultaneously to the determination of the specific analyte, for quantifying the amount of interfering substances present in the sample. The amount of each interfering substances is compared to predetermined cut-off values. The optical signal for the specific analyte is measured in the reaction mixture at multiple wavelengths over the complete reaction time, and a calibration curve is selected depending on the interfering substances. The amount of specific analyte is quantified by comparison with the selected calibration curve for the chosen wavelengths.

First claim

What is claimed is:

1. A method for reducing interference caused by presence of one or more interfering substances (IS) in an automated photometric platform for measuring an amount of a specific analyte in a biological sample, the method comprising:
a) generating a data base of calibration curves, the data base comprising at least one calibration curve for at least the following samples:
a sample comprising specific analyte free of IS;
a sample comprising specific analyte and IS, for each IS;
a sample comprising specific analyte and a combination of IS, for each combination of IS; and, optionally,
the samples in replicate for more than one concentration of specific analyte;

b) depositing the database into a data management system of the automated platform;
c) adding a measuring sample to a photometric assay of the platform without pre-treating the measuring sample to remove or neutralize IS, and without initiating a blanking procedure;
d) photometrically generating a series of optical signals at multiple wavelengths selected to measure the specific analyte in the measuring sample across a time frame;
e) simultaneously generating a series of optical signals at the multiple wavelengths to quantify each of the one or more IS across the time frame and quantifying an amount of each of the one or more IS;
f) selecting a calibration curve from the data base in accordance with the quantification result of step d); and
g) measuring the amount of specific analyte in the measuring sample according to the calibration curve selected.

2. The method according to claim 1 , wherein the quantification result of step (e) shows no interferences and step (f) comprises selecting a calibration curve 1 recorded at a wavelength 1 for a sample showing no interferences.

3. The method according to claim 1 , wherein the quantification result of step (e) shows hemolytic interference and step (f) comprises selecting a calibration curve 2 recorded at a wavelength 2, which is optimized for a sample showing hemolytic interference.

4. The method according to claim 1 , wherein the quantification result of step (e) shows icteric interference and step (f) comprises selecting a calibration curve 3 recorded at a wavelength 3, which is optimized for a sample showing icteric interference.

5. The method according to claim 1 , wherein the quantification result of step (e) shows lipemic interference and step (f) comprises selecting a calibration curve 4 recorded at a wavelength 4, which is optimized for a sample showing lipemic interference.

6. The method according to claim 1 , wherein the quantification result of step (e) shows a combination of two or more of hemolytic, icteric and lipemic interferences and step (f) comprises selecting a calibration curve 5 recorded at a wavelength 5, which is optimized for a sample showing the combination of interferences.

7. The method according to claim 1 , wherein the data base comprises calibration curves for samples in replicate for at least a low concentration and a high concentration of specific analyte.

8. The method according to claim 7 , wherein the quantification result of step (e) shows hemolytic interference and step (f) comprises selecting a calibration curve 6 recorded at a wavelength 6, which is optimized for a sample showing hemolytic interference at low analyte concentrations.

9. The method according to claim 8 , wherein the quantification result of step (e) shows hemolytic interference and step (f) comprises selecting a calibration curve 7 recorded at a wavelength 7, which is optimized for a sample showing hemolytic interference at high analyte concentrations.

10. The method according to claim 1 , wherein the interfering substances derive from one or more of hemolytic (H), icteric (I) and lipemic (L) interferences and the data base comprises calibration curves for:
sample comprising specific analyte free of H, I and L;
sample comprising specific analyte and H;
sample comprising specific analyte and I;
sample comprising specific analyte and L;
sample comprising specific analyte, H and I;
sample comprising specific analyte, H and L;
sample comprising specific analyte, I and L;
sample comprising specific analyte, H, I and L; and
each sample in replicate for more than one concentration of specific analyte.

11. The method according to claim 1 , wherein the photometric assay comprises a colorimetric assay and the optical signal comprises light absorbance.

12. The method according to claim 1 , wherein the photometric assay comprises a turbidimetric assay and the optical signal comprises intensity of transmitted light.

13. The method according to claim 1 , wherein the photometric assay comprises a nephelometric assay and the optical signal comprises intensity of scattered light.

Assignees

• Roche Diagnostics Operations Inc

Inventors

• Kurz Georg
• Lopez-Calle Eloisa

Classifications

• G01N21/78

  producing a change of colour · CPC title

• G01N21/63

  optically excited · CPC title

• G01N21/274 Primary

  Calibration, base line adjustment, drift correction · CPC title

• G01D18/00

  Testing or calibrating apparatus or arrangements provided for in groups G01D1/00 - G01D15/00 · CPC title

• G01N33/54393 Primary

  Improving reaction conditions or stability, e.g. by coating or irradiation of surface, by reduction of non-specific binding, by promotion of specific binding · CPC title