体外诊断试剂样本释放剂

广州健仑生物科技有限公司

使用说明书

【Product Name】 Sample Release Agent

【Packing】 20 test / box (solution I: 20 × 1 Test / bottle; solution II: 20 Test / bottle)

50 test / box (solution I: 50x1 Test / bottle; solution II: 50 Test / bottle X1)

        100 test / box (solution I: 100 x 1 Test / bottle; solution II: 50 Test / bottle x 2)

【expected usage】

For pre-treatment of the test sample of sensitized erythrocytes, the antibody to be detected in the sample of sensitized erythrocytes is released from the state of being bound to the cell. In order to facilitate the use of in vitro diagnostic reagents or instruments to be tested for the detection of antibodies.

【Test principle】

The antigen on the red blood cells and the antibody in the serum are sensitized under suitable conditions, which under certain conditions are reversible. The sensitized erythrocytes are suspended in a low pH glycine solution and the antibody proteins are released from the bound erythrocytes. Centrifuged to take the supernatant dissociation of the discharge solution, which contains the dissociation of red blood cell surface from the release of the antibody protein by Tris buffer to adjust the pH to neutral after the supernatant of the liquid can be used for the detection and identification of antibodies; and Dissociated release of red blood cells after washing can be used for blood type stereotypes, autoantibody absorption and so on.

【The main components】

1. Solution I: The main components of glycine (C2H5NO2), sodium chloride (NaCl).

2. Solution II: The main component is Tris base, indicator.

【Storage Conditions and Validity】

Room temperature (10 ~ 30 ℃) storage, valid for 1 year. Reagent After opening the bottle at room temperature (10 ~ 30 ℃) conditions can be stored for 6 months.

Sample Requirements

Fresh or anticoagulated blood samples stored at 2-8 ° C for no more than 72 hours.

Detection method

(A) discharge antibody detection

 Test tube method

(1) Label the test tube and add 1 drop of erythrocyte suspension of 2% known blood type, add 2 drops of the bleaching solution, mix and incubate at 37 ℃ for 30 minutes.

(2) Remove the test tube and wash the cells 3 times with saline. After the last wash, thoroughly decant the washing solution and blot the water in the test tube with absorbent paper.

(3) Add 2 drops of anti-human globulin reagent and mix well and centrifuge at 1000g for 15 seconds.

(4) gently shake the test tube, naked eye or under the microscope to read the results of agglutination.

2. Micro-column gel method

(1) Take anti-human globulin test card and make the mark, add 50μL of 0.8 ~ 1% red blood cell suspension of known blood type to the hole.

(2) Add 50 μL of the dispersion to the wells and incubate at 37 ° C for 15 minutes. Centrifuge using a card-type centrifuge.

(3) Remove the microcolumn gel card, the naked eye or interpreter read the agglutination results.

(B) detection of red cell antigen released after dissociation

1. To IgM monoclonal antibody detection of red blood cell antigen

(1) The dissociated red blood cells were washed 6 times with physiological saline, and then prepared into about 2% erythrocyte suspension with normal saline.

(2) Add 2 drops of antibody to a clean tube and label.

(3) Add 1 drop of 2% of the above suspension of erythrocytes to the test tube, gently mix and centrifuge at 1000g for 15 seconds.

(4) gently shake the test tube, naked eye or under the microscope to read the results of agglutination.

2. IgG monoclonal antibody detection of red blood cell antigen

(1) The dissociated red blood cells were washed 6 times with physiological saline, and then prepared into about 2% erythrocyte suspension with normal saline.

(2) Add 2 drops of antibody to a clean tube and label.

(3) Add 1 drop of 2% of the suspension of erythrocytes to be tested to the test tube and mix well and incubate in a water bath at 37 ° C. for 30 minutes.

(4) Remove the test tube and wash the cells three times with saline. After the last wash, thoroughly decant the washing solution and blot the water in the test tube with absorbent paper.

(5) Add 2 drops of anti-human globulin reagent and mix well and centrifuge at 1000g for 15 seconds.

(6) Gently shake the tube and read the agglutination results either naked or under the microscope.

【Reference】 This product is qualitative reagent, do not need to set the reference value.

[Interpretation of test results]

1. Positive reaction: the discharge and the corresponding erythrocytes in the test tube or agglutination of the corresponding agglutination of the distribution of the red blood cells in the gel surface or gel, indicating that the red blood cells have been sensitized by the antibody, the antibody solution.

2. Negative reactions: the discharge solution and the corresponding red blood cells in the test tube does not appear agglutination or the corresponding deposition of all red blood cells in the bottom of the gel tube, indicating that the red blood cells were not sensitized by the antibody, the discharge solution does not contain antibodies.

Limitations of test methods

1. Diluent can not be used to identify Duffy blood group antibody.

2. The erythrocytes treated by this kit can not be used for the phenotype detection of Kell's blood group system.

【Product Performance Index】

1. pH value (25 ° C ± 1 ° C): 1.7 ± 0.2 (Solution I) 9.0 ± 0.2 (Solution II)

2. Osmolarity: 450 ± 20 mOsm / L (Solution I) 130 ± 20 mOsm / L (Solution II)

【Precautions】

1. Diluent and the last wash cell supernatant to do parallel testing to confirm the serum free antibody has been completely removed.

2. Dissolution liquid test tube method, if the negative reaction, you need to add human IgG anti-D sensitized erythrocytes to confirm the test to ensure the effectiveness of anti-human globulin reagents.

3. Dissolution liquid added to the solution II to adjust the pH to neutral prone to sediment turbidity can be centrifuged to remove the precipitate after supernatant antibody detection.

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【公司名称】 广州健仑生物科技有限公司
【联系电话】 13802525278 020-82574011  杨永汉

【公司传真】 020-32206070
【腾讯 QQ 】 2042552662
【公司地址】 广州清华科技园创新基地番禺石楼镇创启路63号二期2幢101-103室