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D-dimer and FDP (Fibrin/Fibringen Degradation Product) composite quality control material and preparation method thereof

A dimer and quality control product technology, which is applied in the preparation of test samples, material inspection products, biological testing, etc., can solve the problems affecting the accuracy of quality control and inconvenient use, and achieve low production cost, low cost, Stable degradation with controllable effect

Active Publication Date: 2015-03-25
SHANGHAI LONG ISLAND BIOTEC CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is no quality control product containing D-dimer and FDP at the same time. Therefore, two quality control products need to be used, which is inconvenient to use, and the accuracy of quality control is affected due to operational errors in the process of preparing quality control products separately.

Method used

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  • D-dimer and FDP (Fibrin/Fibringen Degradation Product) composite quality control material and preparation method thereof
  • D-dimer and FDP (Fibrin/Fibringen Degradation Product) composite quality control material and preparation method thereof

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preparation example Construction

[0027] refer to figure 1 , a preparation method of D-dimer and FDP composite quality control product, comprising the following steps:

[0028] 1) In the presence of calcium ions, thrombin is added to the plasma, and the plasma naturally undergoes a coagulation process at room temperature to complete coagulation; at this time, the soluble fibrinogen in the plasma is completely converted into insoluble fibrin.

[0029] Plasma was obtained from commercial fibrinogen (FIB) quality control material or bovine plasma from purchased human plasma. A commercial fibrinogen (FIB) quality control is preferably used. When using bovine plasma, the bovine plasma comes from the fresh blood of the animal slaughterhouse. The preparation method is to mix the blood with 0.109M trisodium citrate at 9:1, centrifuge at 2000g-3000g for 30 minutes, and the upper layer is the bovine plasma.

[0030] The calcium ion solution is a calcium chloride reagent of 0.1 mol / L-0.5 mol / L, and the added volume of ...

Embodiment 1

[0034] Embodiment 1 A kind of preparation method of D-dimer and FDP composite quality control substance

[0035] 1) Preparation of calcium chloride solution: Weigh 0.22g CaCl 2 .2H 2 O, add 5 ml of purified water, stir to dissolve, and obtain 0.3 mol / L calcium chloride solution.

[0036] Fibrin clot preparation: Take 10 pieces of the purchased FIB quality control material from 2 batches, add 1ml of purified water to reconstitute each for 15 minutes, shake well at intervals to fully dissolve, and group them according to the batch number as group 1. (10ml), group 2 (10ml); take 9ml of fresh bovine blood from 3 cows, mix with 1ml of 0.109M trisodium citrate respectively, centrifuge at 2000g for 30 minutes, carefully extract the supernatant, 3 cows The obtained bovine plasma was recorded as group 3, group 4, and group 5, respectively. 1ml of 0.3mol / L calcium chloride solution and 500IU of thrombin were added to the plasma of the 5th group, shaken well, and placed at room tempera...

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Abstract

The invention discloses a D-dimer and FDP (Fibrin / Fibringen Degradation Product) composite quality control material and a preparation method thereof. The method for preparing the D-dimer and FDP composite quality control material comprises the following steps: adding thrombin into plasma in the presence of calcium ions, so that the plasma completely coagulates; mashing the coagulated plasma, adding an enzyme solution to carry out an enzymatic hydrolysis reaction so as to degrade fibrous proteins; destructing the enzymatic activity so as to stop the enzymatic hydrolysis reaction after the reaction is complete, thereby obtaining a D-dimer and FDP composite mother solution; and diluting the D-dimer and FDP composite mother solution by using a protective solution till the concentration of D-dimer and FDP in the composite mother solution reaches the target concentration, thereby obtaining the composite quality control material. The composite quality control material which can be simultaneously used for testing two items including the D-dimer and FDP is prepared at a time, the preparation method is simple, and the production cost is low. The freeze-dried composite quality control material is high in re-dissolving uniformity, is uniformly mixed within 15 minutes, can replace an imported product and is simultaneously used for quality control of the D-dimer and FDP.

Description

technical field [0001] The invention belongs to the technical field of in vitro diagnostic reagents, and in particular relates to a D-dimer and FDP composite quality control product and a preparation method. Background technique [0002] In the blood coagulation test, it is often necessary to measure the content of D-dimer and fibrin (ogen) degradation products (Fibrin / Fibringen Degradation Porducts, referred to as FDP) at the same time. With the development of technology, more and more blood coagulation tests are completed by automated blood coagulation analyzers. In order to monitor the operation of the instrument, it is necessary to use the quality control products of D-dimer and fibrin (ogen) degradation products. . [0003] Direct isolation of D-dimer, fibrin(ogen) degradation product (FDP) from human plasma has limited sources and low yield. The preparation of D-dimer and fibrin (ogen) degradation products from animal plasma can solve the source problem, but the syst...

Claims

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Application Information

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IPC IPC(8): G01N1/28G01N33/96
Inventor 艾峰肖国伟潘仁斌
Owner SHANGHAI LONG ISLAND BIOTEC CO LTD
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