Human urine glucose detection standard substance and preparation and valuing thereof

By preparing and calibrating standard substances for human urine glucose, the problem of inaccurate urine glucose test results has been solved, achieving accuracy and comparability in urine glucose testing, and supporting early diagnosis and monitoring of diabetic nephropathy.

CN121113632APending Publication Date: 2025-12-12CHINESE ACAD OF INSPECTION & QUARANTINE
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Patent Information

Application Number
CN202511391283.1
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2025-07-25
Filing Date
2025-09-26
Publication Date
2025-12-12

AI Technical Summary

Technical Problem

Current technology lacks standard substances for human urine glucose, resulting in inaccurate and incomparable urine glucose test results, which affects the early diagnosis and monitoring of diabetic nephropathy.

Method used

Human urine glucose standard material was prepared by high-speed refrigerated centrifugation, addition of preservatives, uniform aliquoting and low-temperature storage, and value determination by high-performance liquid chromatography-isotope dilution mass spectrometry to ensure the stability and accuracy of the urine glucose standard material.

Benefits of technology

It provides highly accurate standard materials for urine glucose testing, improving the comparability of test results and the accuracy of clinical judgment, and supporting the traceability of urine glucose test results and the consistency of methods.

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Abstract

The invention relates to a human urine glucose detection standard substance as well as preparation and valuing thereof. The method comprises the following steps: processing and preparing the standard substance; performing uniformity test on the urine glucose standard substance; testing the stability of the urine glucose standard substance; determining a standard value of the urine glucose standard substance by a high performance liquid chromatography-isotope dilution mass spectrometry method; and carrying out statistical calculation on the determination value of the urine glucose standard substance and carrying out uncertainty evaluation on the determination result. The invention provides a method for preparing and valuing a urine glucose standard substance, aiming at the problem that the urine glucose detection result is inaccurate and incomparable because no human urine glucose standard substance exists at present, so that the method is used for developing a urine glucose detection reagent and verifying the performance of the method. And the kit can be used for measuring value traceability of urine glucose detection results, so that accuracy and comparability of clinical urine glucose detection results are guaranteed, and clinical examination of diseases such as chronic kidney diseases is facilitated.
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