Self-diagnosis method and apparatus for measuring results from blood analyzers

Patent metadata

Field	Value
Publication number	US-10114006-B2
Application number	US-201214355548-A
Country	US
Kind code	B2
Filing date	Oct 25, 2012
Priority date	Oct 31, 2011
Publication date	Oct 30, 2018
Grant date	Oct 30, 2018

Abstract

A self-diagnosis method and apparatus for measuring results from blood analyzers, the method comprising: generating an acquisition transmittance curve according to the changes in transmittance rate of sample during a sample acquisition process; determining whether there is an anomaly in the acquisition process according to the acquisition transmittance rate curve; if there is no anomaly in the acquisition process, determining that the measurement results of the blood sample are credible; and if there is an anomaly in the acquisition process, determining that there is a doubt about the measured results of the blood samples, the self-diagnosis method and apparatus for measuring results from blood analyzer can improve the accuracy of self-diagnosis of measured results from blood analyzers, and reducing the false positive rate, at the same time, the workload of users in examining and verifying the measured results is reduced, thereby saving on measuring costs.

First claim

What is claimed is:

1. A method for self-diagnosis of measurement results of a blood sample from a blood analyzer comprising an acquisition driver and a pipeline, the method comprising:
flowing the blood sample from a sample tube through the pipeline to the acquisition driver for a sample acquisition;
detecting changes with time in an optical transmittance of the blood sample in the pipeline by using a photoelectric sensor during the sample acquisition;
generating an acquisition transmittance curve according to the changes versus time in the optical transmittance of the blood sample; and
determining whether there is an anomaly in the acquisition process according to the acquisition transmittance curve.

2. The method of claim 1 , further comprising: determining whether the measurement results are within a threshold range; if the measurement results are within the threshold range, determining that the measurement results are not credible; if the measurement results are outside-the threshold range, determining that the measurement results are credible.

3. The method of claim 2 , wherein the threshold range is set by clinical statistics.

4. The method of claim 3 , wherein the threshold range is: HGB (hemoglobin)<120 g/L and MCHC (Mean Corpuscular Hemoglobin Concentration)<310 g/L; or RBC (red blood cell)<3×1012/L and MCHC>400 g/L; or HGB<120 g/L and MCHC<Kc*310 g/L; or RBC<3×1012/L and MCHC>Kc*400 g/L;

Kc
=

HGB
⁢

⁢
calibration
⁢

⁢
factor

RBC
⁢

⁢
calibration
⁢

⁢
factor
*
MCV
⁢

⁢
calibration
⁢

⁢
factor

if the measurement results are within the threshold range, determining that the measurement results are not credible; otherwise, determining that the measurement results are credible, wherein MCV stands for Mean Corpuscular Volume.

5. The method of claim 2 , further comprising: outputting the measurement results if the measurement results are determined to be credible; shielding the measurement results if the measurement results are determined to be not credible, and outputting alarm information.

6. The method of claim 1 , wherein determining whether there is an anomaly in the acquisition process acquisition comprises:
if the acquisition transmittance curve is smooth, determining that there is no anomaly in the acquisition process; if there is a pulse in the acquisition transmittance curve, determining that there is an anomaly in the acquisition process.

7. An apparatus with self-diagnosis of measurement results of a blood sample, the apparatus comprising:
an acquisition driver for a sample acquisition;
an acquisition monitoring module comprising a photoelectric sensor unit for detecting changes with time in an optical transmittance of the blood sample in a pipeline coupled between a sample tube and the acquisition driver, for generating an acquisition transmittance curve according to the changes versus time in an optical transmittance of the blood sample during an acquisition process, and determining whether there is an anomaly in the acquisition process according to the acquisition transmittance curve; and
a first determination module coupled to the acquisition monitoring module, for determining whether the measurement results of the blood sample are credible according to whether there is an anomaly in the acquisition process; if there is no anomaly in the acquisition process, determining that the measurement results are credible; if there is an anomaly in the acquisition process, determining that there is a doubt about the measurement results.

8. The apparatus of claim 7 , further comprising:
a second determination module coupled to the first determination module, for determining whether the measurement results are within a threshold range;
if the measurement results are within the threshold range, determining that the measurement results are not credible; if the measurement results are outside the threshold range, determining that the measurement results are credible.

9. The apparatus of claim 8 , wherein the second determination module comprises:
a threshold value storage unit, for storing a threshold range, which is based on clinical statistics, the threshold range is used for determining whether the measurement results are credible; and
an anomaly diagnostic module coupled to the threshold value storage unit, for determining whether the measurement results of the blood sample are within the threshold range; if the measurement results are within the threshold range, determining that the measurement results are not credible; if the measurement results are outside the threshold range, determining that the measurement results are credible.

10. The apparatus of claim 8 , further comprising:
an automatic alarm module coupled to the first and/or second determination module, for outputting alarm information when the measurement results are determined to be not credible by the second determination module; and
an information output module coupled to the automatic alarm module, for outputting the measurement results when the measurement results are determined to be credible by the first determination module and/or the second determination module; shielding the measurement results when the measurement results are determined to be not credible by the second determination module.

11. The apparatus of claim 7 , wherein the acquisition monitoring module further comprises:
an acquisition driving unit coupled to the photoelectric sensor unit, for driving the blood analyzer to acquire the blood sample;
a curve generating unit coupled to the photoelectric sensor unit, for generating the acquisition transmittance curve according to the changes in the optical transmittance rate of the blood sample versus time; and
an anomaly identification unit coupled to the curve generating unit, for determining whether there is an anomaly in the acquisition process according to the acquisition transmittance curve.

12. The apparatus of claim 11 , wherein the anomaly identification unit determines that there is no anomaly in the acquisition process when the acquisition transmittance curve is smooth, and determines that there is an anomaly in the acquisition process when there is a pulse in the acquisition transmittance curve.

Assignees

• Shenzhen Mindray Biomedical Electronics Co Ltd

Inventors

• Dai Yong
• Huang Daxin

Classifications

• G01N33/49 Primary

  Blood {(chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80)} · CPC title

• G01N2201/12

  Circuits of general importance; Signal processing · CPC title

• G01N21/84

  Systems specially adapted for particular applications · CPC title

• G01N35/00594

  Quality control, including calibration or testing of components of the analyser · CPC title

• A61B5/0059

  using light, e.g. diagnosis by transillumination, diascopy, fluorescence (photoacoustic A61B5/0093; optical measurement of heart rate A61B5/02416; optical measurement of blood flow A61B5/0261; optical measurement of analytes A61B5/1455) · CPC title