A kind of d-dimer and fdp composite quality control product and preparation method thereof

A dimer, quality control product technology, applied in the preparation of test samples, material inspection products, biological testing and other directions, can solve the problems of affecting the accuracy of quality control, inconvenient use, etc., and achieve low production cost, low cost, Good reconstitution uniformity

Active Publication Date: 2019-03-26
SHANGHAI LONG ISLAND BIOTEC CO LTD
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  • 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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  • A kind of d-dimer and fdp composite quality control product and preparation method thereof
  • A kind of d-dimer and fdp composite quality control product and preparation method thereof

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preparation example Construction

[0027] refer to figure 1 , a kind of preparation method of D-dimer and FDP composite quality control product, comprises the steps: 1) under the condition that calcium ion exists, add thrombin in blood plasma, make blood plasma coagulation process occur naturally at room temperature until complete coagulation ; At this time, the soluble fibrinogen in the plasma is completely converted into insoluble fibrin.

[0028] Plasma was purchased from human plasma as a commercial fibrinogen (FIB) quality control product or bovine plasma. A commercially available fibrinogen (FIB) quality control is preferably used. When bovine plasma is used, the bovine plasma comes from fresh blood from animal slaughterhouses, prepared by mixing blood with 0.109M trisodium citrate at a ratio of 9:1, centrifuging at 2000g-3000g for 30 minutes, and the upper layer is bovine plasma.

[0029] The calcium ion solution is 0.1mol / L-0.5mol / L calcium chloride reagent, and the added volume of the calcium ion sol...

Embodiment 1

[0033] Embodiment 1 A kind of preparation method of D-dimer and FDP composite quality control product

[0034] 1) Calcium chloride solution preparation: weigh 0.22g CaCl 2 .2H 2 0, add 5ml purified water, stir to make it dissolve, obtain the calcium chloride solution of 0.3mol / L.

[0035] Fibrin clot preparation: Take 10 purchased FIB quality control products of 2 batches each, add 1ml of purified water to each tube and redissolve for 15 minutes, shake well in between to fully dissolve, group by batch number, respectively as group 1 (10ml), group 2 (10ml); take another 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 respectively recorded as group 3, group 4, and group 5. 1ml of 0.3mol / L calcium chloride solution and 500IU thrombin were added to the plasma of the 5 groups, shaken well, and left at room temperature for 4 hou...

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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, in particular to a composite quality control product of D-dimer and FDP and a preparation method thereof. Background technique [0002] In the hemagglutination test, it is often necessary to simultaneously measure the contents of D-dimer and fibrin (ogen) degradation products (Fibrin / Fibringen Degradation Products, FDP for short). 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, quality control products of D-dimer and fibrin (original) degradation products are needed. . [0003] Direct isolation of D-dimer, fibrin (ogen) degradation products (FDP) from human plasma has limited sources and low yields. Although the preparation of D-dimer and fibrin (ogen) degradation product quality control products from animal plasma can solve the source probl...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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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