Selling unit: per 100ml
Product Name
- Common name: α-amylase(AMY) assay kit (rate method)
- English name: AMY Reagent Kit (Kinetic Method)
Package Specification
Single, 3:1, 4:1, 5:1, other ratios need to be customized
Intended Use
This kit is used to determine the viability of AMY in human serum, plasma or urine.
AMY is mainly derived from salivary glands and exocrine pancreas and catalyzes the hydrolysis of α-1→4 glycosidic bonds of starch and other related polysaccharides to produce maltose and other oligosaccharides; AMY levels are mainly used in the diagnosis of acute pancreatitis. AMY is often considered to be an indicator of acute pancreatitis, with a significant increase in serum and urinary AMY activity. elevated AMY activity can also be caused by severe renal tubular failure, severe diabetes mellitus, etc.
Test Principle
EPS-G7 generates p-nitrophenyl maltotriose, p-nitrophenyl maltotetraose, maltotriose, and maltotetrasaccharide in the presence of AMY. The former continued to be hydrolyzed to p-nitrophenol and glucose under the action of α-glucosidase, and the rate of p-nitrophenol production was proportional to AMY activity.
Main Components
Reagent components included in the product.
*Components are not interchangeable in kits with different lot numbers.
*Reagent components not included in the product, but necessary for the test: outsourced normal and abnormal QCs and calibrators.
Storage Conditions And Expiration Date
The kit is stored at 2-8°C away from light and is valid for one year.
Reagents that have been opened are taken care not to be contaminated and the reagents are stabilized in the instrument compartment (2-8°C) for one month.
The reagents must not be frozen.
Applicable Instruments
Hitachi 7180/7600; Olympus AU680/2700; Toshiba TBA120; Myriad BS2000M/480; Siemens ADVIA 1800/2400 series automatic biochemical analyzers.
Sample Request
Serum or heparin anticoagulated plasma should be separated promptly after blood collection to avoid hemolysis. The enzyme activity of blood specimens can be stable for 7 days at room temperature (15-25℃) and for 1 month at 2-8℃.
The urine specimen was adjusted to pH 7.0 with 0.1 mol/L NaoH or 0.1 mol/L HCl, and the enzyme activity was stable for 2 days at room temperature (15-25℃) and 10 days at 2-8℃.
Test Method
- Reagent preparation: liquid reagents are ready to use out of the bottle.
- test conditions: (different test instruments can be requested according to the different parameters on the machine)
Single reagent operation procedure.
Dual reagent operation procedure.
*Reagents and sample volumes can be increased or decreased in proportion to the requirements of different biochemical analyzers.
- Calibration procedure.
The Randox calibration serum is recommended. the Randox calibration serum of choice is Landau liquid stabilized pNPG7 37°C.
- QC control procedures.
It is recommended that each laboratory establish its own quality control system and select appropriate quality control products for quality control. The measured values of QC products should be within the specified range. If outside the specified range, it is necessary to take appropriate measures or contact the manufacturer.
- Calculation.
Sample concentration = (sample ΔA /min) / (standard ΔA /min) × standard concentration
Positive Judgment Value
Serum: 0 to 130 U/L; Urine: 0 to 590 U/L
It is recommended that each laboratory establish its own reference range of normal values.
Interpretation Of Test Results
The determination of AMY in serum, plasma or urine is only one of the indicators used by the clinician to diagnose the patient. The clinician must also make a comprehensive judgment based on the patient’s physical symptoms, medical history and other diagnostic items and diagnostic tools.
Limitations Of The Test Method
Ascorbic acid ≤ 30 mg/dL, bilirubin ≤ 40 mg/dL and hemoglobin ≤ 500 mg/dL had no effect on the assay.
Product Performance Index
Absorbance of reagent blank: wavelength 404 nm, optical diameter 1.0 cm, temperature 37°C, A0 ≤ 0.35.
Absorbance change rate of reagent blank: △A/min≤ 0.002 at wavelength 404 nm and optical diameter 1.0 cm.
Analytical sensitivity: the kit tests 100 U/L of the test substance, the absorbance change rate ΔA/min ≥ 0.005.
Linearity interval: for the serum samples tested, the linearity of the reagent should be within the interval of 5~3500 U/L: the linear correlation coefficient|r| should be not less than 0.990; in the interval of 5~50 U/L, the absolute deviation of linearity should not exceed 5 U/L; in the interval of (50~3500 U/L, the relative deviation of linearity should not exceed ±10%;
Precision: repeatability CV≤ 5%; relative extreme difference between batches≤ 10%;
Accuracy: Relative deviation ≤ 10%.
Caution
- 1. This product is for in vitro diagnosis only.
- 2. Avoid contamination when using the reagent, the container used must be clean, and please take necessary precautions, do not swallow, and avoid contact with skin and mucous membrane.
- 3. Please dispose of the measured samples and waste liquids in accordance with the relevant national and local laws and regulations.
- 4. When changing the reagent lot number, please recalibrate.
- 5. If ∆A/min > 0.39 A, the sample should be diluted with saline or the sample amount should be reduced and tested again, and the result should be multiplied by the dilution factor or adjusted by the factor value.
Reference
- 1. IFCC Approved Recommendation on IFCC Methods for the Measurement of Catalytic Concentration of Enzymes Part 9. IFCC Method for α-Amylase.ClinChem And Lab Med 1998,36(3):185-203.
