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Preparation method of humanized whole blood matrix quality control product for portable blood glucose meters

A technology of quality control products and blood glucose meters, which is applied in the field of quality control products of human whole blood matrix for various blood glucose meters, and can solve the hidden dangers hidden in the management and treatment of diabetic patients, the cost of matching calibration products or quality control products, and the detection As a result, there are problems such as incompatibility, achieving the value of large market promotion and application, meeting the requirements of quality control, and good interoperability

Active Publication Date: 2019-03-15
北京市临床检验中心 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, most of the blood glucose calibration products or quality control products used to verify the precision, stability and accuracy of the blood glucose meter are non-human whole blood matrix, while the portable blood glucose meter mainly detects glucose in human whole blood, and uses non-human The test results obtained by using whole blood matrix as a quality control product will be different from the actual results; secondly, different brands of blood glucose meters have different quality control products, and even different models of blood glucose meters of the same brand also have different quality control products. The same quality control product measured on different brands of instruments will have different results, and the target value will also be different when measured on the same brand of different models of instruments, indicating that the test results of quality control products cannot be interoperable.
Not only that, the supporting calibrators or quality control products provided by the manufacturer are expensive, and some imported reagents are also limited by transportation conditions and supply chains
This not only increases medical costs, but also lays hidden dangers for the management and treatment of diabetic patients

Method used

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  • Preparation method of humanized whole blood matrix quality control product for portable blood glucose meters
  • Preparation method of humanized whole blood matrix quality control product for portable blood glucose meters
  • Preparation method of humanized whole blood matrix quality control product for portable blood glucose meters

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preparation example Construction

[0028] The method for preparing the human whole blood matrix quality control product provided by the present invention specifically comprises the following steps:

[0029] (1) Take normal whole blood and centrifuge at 1500g for 10 minutes in a low-speed centrifuge. The upper layer is plasma and the lower layer is whole blood cells. Separate the plasma and whole blood cells for use;

[0030] (2) Add the whole blood cells obtained in step (1) to a fixative, and fix at room temperature for 24-48h; the volume ratio of the whole blood cells to the fixative is 1:(5-10);

[0031](3) Centrifuge at 1500g for 10min after fixation, discard the upper fixation solution, add 0.9% normal saline to wash the lower fixation for 3-5 times, the volume ratio of fixation to normal saline is 1:(5-10), wash Specifically: fully mix the fixation with normal saline, centrifuge at 1500g for 10 min, discard the upper layer of washing solution, and leave the layer of fixation; then filter the washed lower ...

experiment example 1

[0038] Experimental example 1. The homogeneity verification of the human whole blood matrix quality control substance prepared by the method of the present invention and used in a portable blood glucose meter

[0039] Referring to the CNAS-GL29 standard issued by the China National Accreditation Service for Conformity Assessment - "General Principles and Statistical Methods for Valuation of Standard Materials / Standard Samples" on the evaluation of uniformity research, use HORIBA glucose electrode analyzer (LP-150C ) were tested, and 10 samples (No. 1-10) were randomly selected from the quality control products of each blood glucose concentration (low, medium, high) as samples for uniformity evaluation, and each sample was repeatedly measured 3 times. The order of the first determination in the measurement process is: 1-3-5-7-9-2-4-6-8-10; the order of the second determination is: 10-9-8-7-6-5 -4-3-2-1; the order of the third measurement is: 2-4-6-8-10-1-3-5-7-9, the results ar...

experiment example 2

[0055] Experimental Example 2. Stability verification of the human whole blood matrix quality control product prepared by the method of the present invention

[0056] With reference to the CNAS-GL29 standard issued by the China National Accreditation Service for Conformity Assessment——"General Principles and Statistical Methods for Valuation of Standard Materials / Standard Samples" about the stability evaluation requirements for the human-derived whole blood matrix quality control product prepared by the method of the present invention A short-term 2-8°C stability evaluation was performed. Randomly select 3 quality control substances for each blood glucose concentration (low, medium, high) as samples, repeat the measurement twice for each sample, and complete each measurement within 10 minutes, then immediately store the remaining samples at 2-8°C. Use the HORIBA glucose electrode analyzer (LP-150C) to measure continuously for 20 days, and observe the difference between the res...

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Abstract

The invention discloses a preparation method of a humanized whole blood matrix quality control product for portable blood glucose meters. The preparation method comprises the steps: separating whole blood cells, fixing the whole blood cells, and preparing quality control products with high, medium and low blood pressure concentrations. By using the quality control products with high, medium and low blood glucose concentration levels, the possible errors of the portable blood glucose meters in the detection of the high, medium and low blood glucose concentrations in medical blood glucose determination value level can be timely and effectively detected. Through fixing human blood cells, the quality control product prepared by the method is enabled to be whole blood matrixes and is consistentwith the type of a specimen recognized by the blood glucose meter on one hand, and the problem that the blood sugar can cause glycolysis in the blood is solved on the other hand so as to stabilize the blood sugar values. The quality control product prepared by the method has high interoperability, and can be applied to a plurality of portable blood glucose meters of different brands and differentmodels.

Description

technical field [0001] The invention relates to the technical field of standard products used in the clinical testing process, in particular to a method for preparing a human whole blood matrix quality control product used in a portable blood glucose meter, in particular to the preparation of a variety of blood sugars suitable for different brands or models The method of the human whole blood matrix quality control material of the instrument. Background technique [0002] Today, POCT (point-of-care testing, point-of-care testing) technology is more and more favored by clinicians due to its advantages of bedside detection such as rapidity, simplicity, small sample volume, and potential improvement of patient prognosis. As the most frequently used POCT instrument in medical institutions, the accuracy and reliability of portable blood glucose meters play a vital role in the monitoring and management of patients' blood glucose in medical institutions. [0003] However, due to t...

Claims

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Application Information

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IPC IPC(8): G01N1/28
CPCG01N1/28
Inventor 周睿王清涛王艳张顺利
Owner 北京市临床检验中心