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A biochemical luminescence quality control method

A quality control method and biochemical technology, applied in the direction of analysis materials, instruments, etc., can solve the problems of difficult duplication operation, unclear standards, high cost, etc., and achieve accurate and stable values, good practical operation effect, and guaranteed precision Effect

Inactive Publication Date: 2017-11-10
CHANGSHA KINGMED MEDICAL DIAGNOSTICS INST
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The main problem to be solved in this application is to provide a quality control method of biochemical luminescence, which is simple to operate, scientific in process, clear in standards, good in practical operation effect, and ensures the accuracy, stability and uniformity of its value, thereby ensuring the precision of test results; To solve a bioluminescent quality control method with high cost, unscientific quality control method process, unclear standards, high difficulty in operation, difficult to replicate operation, poor practical operation effect, inaccurate results, and insufficient stability in the accuracy of the value, Technical problem of low precision of test results

Method used

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Experimental program
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Embodiment 1

[0040] When selecting quality control substances, the concentration of quality control substances at or near the clinical decision value level is preferred to ensure the validity of the decision value; independent third-party quality control substances are preferred, as provided by reagent or instrument manufacturers. Substitution or addition to controls.

[0041] The quality control products currently used in the biochemical / luminescent room include: Bio-Rad chemical substance quality control, Landox special protein control, TOSOH glycosylated hemoglobin control, Bio-Rad myocardial marker material control, Bio-Rad immunology quality control, Bio-Rad tumor marker material control, Roche HE4 quality control Control, Roche PCT quality control, Abbott SCC quality control, New World TSGF quality control, Roche thyroid-related autoantibody quality control.

[0042] For the above quality control products, biochemical / luminescent personnel should pay attention to whether the delivery...

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Abstract

The objective of the invention is to disclose a biochemical luminescence quality control method. The method is characterized in that the method includes 1) a step of selecting a quality control product having a concentration of or near a clinical decision value; 2) a step of storing and redissolving the quality control product in the step 1); 3) a step of subjecting a product of the step 2) to sample reserving and reexamination, namely a step of reserving one sample having an abnormal high value in one week for detection if the product is TBA and HCY, reserving one sample having a normal low value in one week for detection if the product is TSGF, detecting a deviation between a new value and a former value, with the detection value being less than 1 / 3TEA if the detection value is above the inflection point, and resolving a decision limit according the minimum detection difference if the detection value is below the inflection point; and 4) performing quality control analysis, determination and processing, and performing quality control analysis before sample detection everyday; and operation is simple, the process is scientific, criterions are definite, practical operation effects are good, and value accuracy, stability and uniformity are ensured, thus ensuring precision of a detection result.

Description

technical field [0001] The invention belongs to the field of biochemical luminescence quality control, and specifically refers to a biochemical luminescence quality control method. Background technique [0002] At present, the research and development technology of reagents is developing rapidly, and automatic biochemical analyzers can detect more and more biochemical items, so they are more and more widely used. The detection of the automatic biochemical analyzer is divided into two types: sample detection and quality control detection. [0003] Sample testing means that the doctor bills the patient and specifies the blood test items. After the patient collects blood, the corresponding personnel of the hospital send the collected blood sample to the laboratory for testing. The laboratory doctor puts the blood sample on the biochemical instrument. Use the biochemical analyzer to test the items to be tested in the blood sample, and get the test result, which is the sample te...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N35/00
CPCG01N35/00623
Inventor 李慧源代冰陈晶陈玲玮秦康
Owner CHANGSHA KINGMED MEDICAL DIAGNOSTICS INST
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