Urinary albumin/urinary creatinine composite quality control product and production method thereof

Abstract

The invention provides a urinary albumin / urinary creatinine composite quality control product and a production method thereof. The urinary albumin / urinary creatinine composite quality control product comprises the following components: 50-100 mmol / L of a buffer solution, 5-15 g / L of salt, 5-15 g / L of flufenamic acid, 5-15 g / L of dimethyl sulfoxide, 5-15 g / L of a reducing agent, 5-15 g / L of dextran, 5-15 g / L of a defoaming agent; 0.5-1 g / L of a tackifier, 100-200 mg / L of human serum albumin, 10-20 mmol / L of creatinine, and 1 g / L of a preservative. A pH value of the quality control product is 7.2-7.4. The product can be used for evaluating the accuracy of the urinary albumin / urinary creatinine detection reagent based on a microfluidic technology, and plays an important role in guaranteeing the laboratory detection result quality of the urinary albumin / urinary creatinine detection reagent and reducing errors.

Description

technical field [0001] The invention relates to the field of analysis and detection, in particular to a urine albumin / urine creatinine composite quality control product and a preparation method thereof. Background technique [0002] Diabetic nephropathy is one of the most common chronic diseases in my country, and the gold standard for its diagnosis is to measure the excretion rate of urinary microalbumin in 24 hours. However, this method is troublesome and time-consuming for specimen collection, poor patient compliance, and poor repeatability and accuracy of test results, which have limited its clinical application. Urine creatinine has an excellent correlation with urine concentration and is not affected by renal basement membrane lesions. Therefore, correction with urine creatinine can eliminate the influence of sampling method and urine concentration on urinary albumin excretion. Therefore, KDOQI Both the guidelines for diabetic nephropathy and the American Diabetes Ass...

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Problems solved by technology

In fact, POCT has gradually become an important research project in the field of in vitro diagnostic reagents and instruments in the European and American markets. For such a country with a large primary medical system and a large amount of reagents used, the current instruments and supporting reagent consumables developed in Europe and the United States are obviously facing challenges.

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