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Multi-level quality control substance production method and traceability calibration method of blood gas analyzer

A technology for a blood gas analyzer and a calibration method, which is applied to the production method of multi-level quality control substances and the traceability calibration field of the blood gas analyzer, can solve the problems affecting the machine inspection qualification judgment, the inability to form an open standard, and the incomplete gas-liquid balance, etc. To achieve the effect of achieving accuracy and validity, realizing data comparison and judgment, and ensuring validity and accuracy

Active Publication Date: 2021-08-10
南京普朗生物医学有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, most of the blood quality control substances in the domestic market are based on electrolyte aqueous solution, but there are the following defects: (1) The manufacturer's machine is only suitable for the quality control of its own machine, and the foreign level quality control is used as a reference, and a unified open standard cannot be formed (2) The oxygen partial pressure and carbon dioxide partial pressure in the water matrix are easily interfered by the machine detection liquid circuit; (3) When the water matrix level quality control is performed, the gas-liquid phase balance is not complete, and it is easy to form measurement errors and affect the machine inspection. Judgment; (4) Water matrix quality control cannot simulate the important reference calibration data of hematocrit (HCT)
[0004] Today, ordinary perfluorocarbons can only be used to replace the oxygen-carrying function of hemoglobin by virtue of their high oxygen-carrying capacity; therefore, it is urgent to produce a multi-level quality control substance of a special matrix in order to calibrate the blood gas electrolyte analyzer

Method used

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  • Multi-level quality control substance production method and traceability calibration method of blood gas analyzer
  • Multi-level quality control substance production method and traceability calibration method of blood gas analyzer
  • Multi-level quality control substance production method and traceability calibration method of blood gas analyzer

Examples

Experimental program
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Effect test

Embodiment 1

[0052]Step 1: Taking the preparation of 100ml fluorocarbon emulsion as an example, choose perfluorotributylamine 20%-40%w / v, perfluorotripropylamine 20%-40%w / v, perfluorodecalin 15%-30%w One of / v is used as a matrix substance, where w / v is a commonly used unit, representing mass concentration, that is, the mass per unit volume; the configuration methods of the three matrix substances are as follows:

[0053] (1), 30g of perfluorotributylamine; 1.5g of nonionic polyethylene glycol octyl phenyl ether; 0.1g of nonionic perfluorooctyl polyether surfactant; 2g of glycerol; High-speed shearing for 20 minutes, after primary emulsification, ultrasonic emulsification with 750W power for 60 minutes, the particle size of the fine emulsified emulsion is 0.1μm-0.15μm, and filtered with a 0.22μm filter membrane for use;

[0054] (2) Perfluorotripropylamine 35g; Nonionic polyoxyethylene sorbitan monolaurate 2g; Nonionic perfluorooctyl polyether surfactant 0.1g; Glycerin 2g; 2 High-pressure...

Embodiment 2

[0060] Embodiment 2: This embodiment also provides a traceable calibration method for a blood gas analyzer, comprising the following steps:

[0061] Step 1: Set a variety of different levels of quality control solutions, and set the K in each level of quality control solution + 、Na + , Ca 2+ , Cl - , lactic acid, glucose concentration and oxygen partial pressure, carbon dioxide partial pressure, H + , the concentration value of hematocrit, and configured through the steps in Example 1;

[0062] During the configuration process, each set level of quality control liquid corresponds to the configuration of steel gas cylinders with different gas components;

[0063] Step 2: Use a qualified blood gas analyzer to test the data of multiple quality control solutions at different levels, and compare and judge the detection data of each level of quality control solution with the corresponding set value; If the configuration is wrong, it needs to be reconfigured; if it is consistent...

Embodiment 3

[0078] Embodiment 3: In order to verify the accuracy of the traceability calibration method of the present invention, three different levels of quality control substances are specially set, as shown in the following table:

[0079]

[0080] The steps to verify the accuracy and validity of the traceable calibration method are as follows:

[0081] Step 1: Through the formula in Example 2, PO in the quality control substance according to the above three levels of settings 2 , PCO 2 The numerical derivation of the gas combination ratio of the required corresponding configuration of the steel gas cylinder is shown in the table below:

[0082] PO 2

PCO 2

N 2

Level 1 Steel Gas Cylinders 8.4％ 8.4％ remaining Level 2 Steel Gas Cylinders 14.0％ 5.6％ remaining Level 3 Steel Gas Cylinders 19.6％ 2.8％ remaining

[0083] Steel gas cylinder manufacturers produce qualified steel gas cylinders according to the content of the above gas c...

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Abstract

The invention discloses a production method of a multi-level quality control substance. The production method comprises the following steps: 1, emulsifying one of perfluorotributylamine, perfluorotripropylamine and perfluorodecalin as a matrix; 2, putting a prepared horizontal quality control liquid into a proper amount of fluorocarbon emulsion matrix to obtain a quality control liquid; 3, sealing the quality control liquid, placing the sealed quality control liquid in a water bath kettle at 30-39 DEG C for 10-30 min, and carrying out ventilation replacement through a steel gas cylinder with a fixed proportion; and 4, bottling and sealing the quality control liquid. The invention further discloses a traceability calibration method of the blood gas analyzer. According to the invention, the fluorocarbon emulsion is used as the matrix, so that the interference of a detection liquid path on oxygen partial pressure and carbon dioxide partial pressure is effectively avoided; horizontal quality control gas-liquid phase balance is thorough, and measurement errors are avoided; and reference calibration data of the hematocrit specific volume can be effectively simulated, and the accuracy and effectiveness of the traceability calibration method can be realized.

Description

technical field [0001] The invention relates to the fields of production of horizontal quality control substances and traceability calibration of blood gas analyzers, in particular to a production method of multilevel quality control substances and a traceability calibration method of blood gas analyzers. Background technique [0002] The blood gas electrolyte analyzer mainly detects K in human arterial blood + 、Na + , Ca +2 , Cl - 、H + , plasma concentration of lactic acid (LAC), glucose (GLU) and other biochemical concentrations, as well as gas partial pressures such as oxygen and carbon dioxide partial pressures, and hematocrit ratio (HCT), are often used in intensive care units and emergency laboratories. How to ensure that the machine detects values To be accurate, it is necessary to perform multi-level quality control on the machine with a fixed target value every day to check whether the machine is accurate and qualified. [0003] At present, most of the blood qu...

Claims

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Application Information

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IPC IPC(8): G01N1/28G01N33/48
CPCG01N1/28G01N33/48
Inventor 楼田甜李安生李富雨
Owner 南京普朗生物医学有限公司
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