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A detection kit, creatine phosphate technology, applied in the field of biomedicine, can solve the problem of low sensitivity, achieve high sensitivity, good stability, and meet the actual clinical needs
Pending Publication Date: 2020-05-15
SHANGHAI HIGH TRACK MEDICAL EQUIP CO LTD
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At present, enzymatic quantitative detection is the most common method, but the latex particle-enhanced turbidimetric method has low sensitivit...
Method used
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[0030] Instrument: AL104 precision electronic balance: sensitivity 0.1mg, used for weighing process;
[0031] TC30K precision electronic balance: sensitivity 10mg, used for weighing process;
[0032] T1000Y electronic balance: sensitivity 10mg, used for weighing process;
[0033] Magnetic stirrer: Type 99-1, used for dissolution process.
[0034] Precision acidity meter: FE20, used in PH process.
[0035] Electronic scale: sensitivity 20g, used for constant volume proces...
Embodiment
[0051] 3. Performance test
[0052] 3.1 Batch number and specifications of creatine phosphokinase isoenzyme detection kit (CKMB kit for short)
[0053] Different batches of the kits in the aforementioned preparation examples were made respectively, named according to the batches, namely sample 1, sample 2, and sample 3. There are 6 packaging specifications for this product, but the size and packaging are different, which has no effect on the performance evaluation results , so only one of the most commonly used specifications was tested, and the specification was 50ml (the first reagent: 1×40ml, the second reagent: 1×10ml). The first reagent and the second reagent are transparent liquids without precipitation and floc.
[0054] 3.2 Calibrators and quality controls
[0055] Calibrator for performance evaluation: Calibration with factor, K factor value 8360;
[0056] Reference material for accuracy performance evaluation: Japan Toyobo, Lot: J234, marked value: 179U / L;
[005...
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Abstract
The invention discloses a phosphocreatine kinase isoenzyme detection kit, and relates to the technical field of biomedicine. The kit includes a first reagent, wherein the first reagent comprises the following components: imidazole with concentration of 124 to 126mmol/L; magnesium acetate with concentration of 2 to 3mmol/L; ethylenediamine tetraacetic acid with concentration of 12-13 mmol/L; mannitol with concentration of 34 to 34.3 mmol/L; adenosine monophosphate with concentration of 6 to 6.5 mmol/L; lithium diadenosine pentaphosphate with concentration of 0.01 to 0.015 mmol/L, reductive coenzyme II with concentration of 2 to 3mmol/L, Proclin150 with concentration of 0.8 to 1.2 g/L, hexokinase with concentration of 3.5 to 4ku/L, N-acetylcysteine with concentration of 24 to 26mmol/L, sodium sulfite with concentration of 2 to 3mmol/L, and anti-human CK-M antibody with concentration of 2 to 3 ml/L. The improved phosphocreatine kinase isoenzyme detection kit provided by the invention is higher in sensitivity, better in repeatability, higher in accuracy and better in stability.
Description
technical field [0001] The invention relates to the technical field of biomedicine, in particular to a creatine phosphokinase isoenzyme detection kit. Background technique [0002] Phosphocreatine kinase isoenzyme (CKMB) exists in the cytoplasm and mitochondria of human cells, and the content in different tissues is different, and the content in the myocardium is the highest. CK-MB is a kind of myocardial marker with strong specificity. Creatine kinase has three isozymes, CK-BB, CK-MB, and CK-MM. CK-MB is by far the best serum enzyme index for the diagnosis of myocardial infarction. Except for the gastrocnemius muscle, only the myocardium contains a high level of CK-MB, which can reach more than 40%. Therefore, the specificity of this isoenzyme for the diagnosis of myocardial infarction can be as high as 100%. When myocardial infarction occurs, serum CK-MB can be increased by 10-25 times, exceeding the times (10-12) times of the increase of total activity of CK. [0003]...
Claims
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