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Kit and method for measuring creatinine

A kit and reagent technology, applied in the field of biomedicine, can solve the problems of poor specificity of picric acid method, negative interference of creatinine detection, poor repeatability of results, etc., and achieve the effect of good stability, high accuracy and stable accuracy

Inactive Publication Date: 2019-04-12
SHANGHAI HIGH TRACK MEDICAL EQUIP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] 1. Product performance structure and composition of creatinine determination kit (picric acid method) Sodium hydroxide 120mmol / l, picric acid 2.9mmol / l, preservative; There are many interfering substances, which are especially obvious when measuring low-value samples, which can easily lead to poor repeatability of results
[0006] 2. Isotope dilution liquid chromatography tandem mass spectrometry (ID-LC-MS / MS); however, this method is expensive and requires specific instruments, which limits its application to a certain extent
[0007] 3. Dry chemical method, but this method is less accurate for the results of clinical high-value samples
[0008] 4. Product performance structure and composition of creatinine determination kit (enzymatic method) Reagent 1: creatinase, sarcosine oxidase, N-(3-sulfopropyl)-3-methoxy-5-methylaniline; reagent 2: Creatinase, 4-aminoantipyridine, peroxidase, sodium azide; however, this method has negative interference on the detection of creatinine by creatinase-coupled sarcosine oxidase method

Method used

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  • Kit and method for measuring creatinine
  • Kit and method for measuring creatinine

Examples

Experimental program
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Effect test

Embodiment 1

[0038] according to figure 1 The shown process preparation kit generally includes the following steps:

[0039] 1. Main materials and instruments

[0040] First reagent: potassium dihydrogen phosphate, dipotassium hydrogen phosphate, ethylenediaminetetraacetic acid, Brij 35, Tween 80, ascorbate oxidase, creatinase, sarcosine oxidase, TOOS, peroxidase, ferrous Potassium cyanide, gentamicin sulfate, and Tween 30.

[0041] Second reagent: trisaminomethane, 3-morpholine propanesulfonic acid, 4-AAP, Brij 35, creatinase, Tween 30, ProClin150.

[0042] Instruments: AL104 precision electronic balance (sensitivity 0.1mg), TC30K precision electronic balance (sensitivity 10mg), T1000Y electronic balance (sensitivity 10mg), magnetic stirrer (99-1 type), precision acidity meter (FE20), electronic scale (Sensitivity 20g), glass beaker, graduated cylinder.

[0043] 2. Method

[0044] 1) Add 0.8L industrial water to a 1L container, then add 1.5mmol potassium dihydrogen phosphate, 28.5mmo...

Embodiment 2

[0050] The method for detecting human blood using the first reagent and the second reagent prepared in Example 1 is briefly described as follows:

[0051] 1. Add the dissolved first reagent to the sample to be tested;

[0052] 2. Add the dissolved second reagent;

[0053] 3. Measure the colorimetry and absorbance (△A) at the wavelength of 546nm in the solution.

[0054] The principle of the above method is as follows:

[0055]

Embodiment 3

[0057] Make different batches of the kits described in Example 1 respectively, named according to the batches, respectively sample 1 (20141119), sample 2 (20140918), sample 3 (20140721), as the experimental group;

[0058] Calibrator for performance evaluation: RANDOX-Calibrator SERUM CAL 2, Lot: 900UN, marked value 137μmol / L;

[0059] Reference material for accuracy performance evaluation: Cobas-Calibrator for automated systems, Lot: 171650, marked value: 340μmol / L;

[0060] The quality control products are: RANDOX company HUM ASY CONTROL, Lot: 844UN, target: 129 μmol / L, range: 104-154 μmol / L; Lot: 506UE, target: 372 μmol / L, range: 297-447 μmol / L.

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Abstract

The invention discloses a kit and method for measuring creatinine. The kit comprises a first reagent, and the first reagent is prepared from monopotassium phosphate, dipotassium phosphate, ethylenediamine tetraacetic acid, Brij 35, Tween 80, ascorbic acid oxidase, creatinase, sarcosine oxidase, TOOS, peroxidase, potassium ferrocyanide, gentamicin sulphate and Tween 30. The method comprises the following steps: (1) the first reagent and a second reagent are dissolved according to the raw material components and content; (2) the dissolved first reagent is added into a to-be-measured sample; (3)the dissolved second reagent is added; and (4) the absorptivity of a solution under the wavelength of 546 nm is measured. According to the kit and method for measuring the creatinine, the precision and accuracy are high, and stability is achieved.

Description

technical field [0001] The invention relates to the field of biomedicine, in particular to a kit and method for measuring creatinine. Background technique [0002] Creatinine (Cr) detection kit is used by medical institutions to quantitatively detect the content of creatinine (Cr) in human serum samples in vitro for auxiliary diagnosis. After the creatinine produced by muscle metabolism in the human body is released into the blood, it is called blood creatinine. Serum creatinine and creatinine clearance rate are not completely consistent, and creatinine clearance rate is more sensitive than serum creatinine. In the early stage of renal impairment (compensatory phase), creatinine clearance rate decreased while serum creatinine was normal. When the glomerular filtration rate drops to more than 50% of the normal level, the serum creatinine begins to rise rapidly. Therefore, when the serum creatinine is significantly higher than normal, it often indicates that the renal functi...

Claims

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Application Information

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IPC IPC(8): G01N33/70
CPCG01N33/70
Inventor 高国华
Owner SHANGHAI HIGH TRACK MEDICAL EQUIP CO LTD
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