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ERM-AD456_SFCC buffer pancreatic alpha starch Enzyme standardThe starting material is purified human pancreatic starch from human tissue Enzymes. The enzyme is diluted in a buffer solution containing human serum albumin. Certified reference materials can contain 1.0 mL of alpha starch Obtained from freeze-dried powder of enzyme solution in a glass bottle.
Use IFCC starch The main reference measurement program for enzyme catalytic activity concentration (PRMP) was characterized (Schumann et al, Clin。 Chemical Laboratory Medicine 44 (2006) 1146-1155 and Schumann et al, Clin。 Chemistry Laboratory Medicine 48 (2010) 615-621) The automatic version of this PRMP is used for stability and homogeneity measurement.
Security information:
Normal laboratory safety measures should be adopted. Alpha starch from human pancreas used in the production of this material Enzyme and human serum albumin were detected, and hepatitis B surface antigen, HIV 1 and 2, and hepatitis C antibody were negative. However, the product must be handled with sufficient care as a material of any human origin. It is only used for in vitro analysis.
Instructions for Use
ERM-AD456_SFCC buffer pancreatic alpha starch Enzyme standardThe main purpose of this method is to evaluate the catalytic activity concentration of PRMP at IFCC 37 ° C. In addition, if the relevant analysis has demonstrated exchangeability, the material can also be used as a authenticity control or external quality control material for conventional measurement systems. It is not recommended to use this material and its certified values for calibration. If used, the uncertainty of the certified value should be considered when estimating measurement uncertainty. When the material is used as a calibration agent in conventional measurement procedures, the interchangeability of the relevant analysis should be verified.
To prepare the materials for use, they must be reorganized according to the following procedure:
1. Remove the frozen bottle from the refrigerator and let it equilibrate to room temperature (20-25 ° C).
2. Gently tap the vertically positioned small bottle to ensure that the freeze-dried material is located at the bottom of the bottle. Remove the screw cover.
3. Weigh the small bottle with a rubber stopper and record the weight to the maximum Approaching 0.1 milligrams (i.e. m1).
4. Carefully lift the rubber stopper to avoid losing the freeze-dried material.
5. Prepare with (1.00 ± 0.01) mL of distilled water (20-22 ° C) and carefully close the small bottle again with a rubber stopper.
6. Weigh the small bottle after adding water and record the weight to the maximum Approaching 0.1 milligrams (i.e. m2). Calculate the mass of water (mH2O) added during the reconstruction process by subtracting m1 from m2. Use this mH2O to calculate the volume of added water (vH2O), taking into account temperature dependent density.
7. Starch in solution The catalytic concentration of the enzyme, calibrated based on the recombination volume, can be obtained by multiplying the certified value with the expected/vH2O and the expected volume to be added (1.0000 mL) by 8.
8. Dissolve the freeze-dried substance by gently rotating and carefully flipping the small bottle at least 5 times. Allow it to stand at room temperature for 10 minutes.
If not measured directly, it is recommended to refrigerate the small bottle (2-8 ° C). Before starting the measurement, carefully flip the small bottle five times.
10. Starch The catalytic activity concentration of the enzyme must be measured within 4 hours after recombination.
store
ERM-AD456_IFCCThe material should be stored in the dark at (-20 ± 5) ° C. After restructuring, the materials must be used within four hours. However, the European Commission cannot be held responsible for any changes that occur during the storage of materials at the customer's premises, especially for opened samples.

eastBaishun Biotechnology, Dongguan CityTechnology Co., Ltd. isERMThe agent is responsible forERMStandard products are sold domestically.
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