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Positive serum national standard substance used for newcastle disease hemagglutination inhibition test and preparation method thereof

A technology of national standard product and positive serum, which is applied in the field of national standard product and preparation of positive serum for chicken Newcastle disease hemagglutination inhibition test, can solve the problem of high quality requirements

Inactive Publication Date: 2014-03-05
CHINA INST OF VETERINARY DRUG CONTROL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Moreover, the quality requirements of standard products are high, the preparation methods and inspection or calibration methods are strict, and the relevant preparation procedures and calibration methods have not been reported so far.

Method used

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  • Positive serum national standard substance used for newcastle disease hemagglutination inhibition test and preparation method thereof
  • Positive serum national standard substance used for newcastle disease hemagglutination inhibition test and preparation method thereof
  • Positive serum national standard substance used for newcastle disease hemagglutination inhibition test and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Preparation of National Standards of Positive Serum for Chicken Newcastle Disease Hemagglutination Inhibition Test

[0048] 1 Preparation of Candidates

[0049] Purchasing 20 12-week-old SPF chickens (all roosters) from the Beijing Experimental Animal Center, after the 20 chickens were determined to be negative by the HI test, they were infected with chicken Newcastle disease La Sota strain virus (Qianyuanhao Biological Co., Ltd. February 5, 2007) Newcastle disease La Sota strain production with seed virus (wet poison) virus) and chicken Newcastle disease inactivated vaccine (Newcastle disease La sota strain oil inactivated vaccine prepared by Beijing Veterinary Biopharmaceutical Factory on June 05, 2007, lot number No local and systemic adverse reactions occurred in the test chickens after immunization in Table 1.

[0050] Table 1 Immunization program

[0051]

[0052] After each immunization, 1 mL of blood was collected from wing vein every other day to monitor the...

Embodiment 2

[0068] Finished product inspection, collaborative calibration and value determination of the national standard substance of positive serum for chicken Newcastle disease hemagglutination inhibition test

[0069] 1 Inspection of national standard products

[0070] 1.1 Physical properties: All freeze-dried positive serums are light yellow loose clumps, which are easy to separate from the bottle wall, dissolve quickly after adding diluent, and become light yellow clear liquid after dissolution.

[0071] 1.2 Sterility test, vacuum degree measurement and residual moisture measurement

[0072] The test results of sterility test and vacuum degree all meet the requirements, and the test results of residual moisture are 1.6%, 1.4%, 1.2% and 2.6%, respectively, which are all lower than 4%, meeting the requirements.

[0073] 1.3 Potency determination: 5 freeze-dried sera were randomly selected, and the HI titers were determined to be 1:160 with reference to the NIBSC International Standa...

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Abstract

The invention relates to a positive serum national standard substance used for a newcastle disease hemagglutination inhibition test and a preparation method thereof. In the positive serum national standard substance used for the newcastle disease hemagglutination inhibition test, Newcastle Disease Virus (NDV) La Sota strain virus and inactivated vaccine immune SPF (Specific Pathoge Free) chicken are utilized to prepare hyperimmune serum to be used as a candidate, through the processes of candidate detection, standard substance preparation, detection, split charging, freeze-drying and the like, the positive serum international standard substance used for the newcastle disease hemagglutination inhibition test obtained by NIBSC (National Institute for Biological Standards and Control) is taken as a reference to carry out a red blood cell agglutination inhibition test to determinate a valence of the standard substance, and through a uniformity test, a stability test, cooperation calibration and data statistics, a constant valence value is ensured to be accurate, and the positive serum national standard substance used for the newcastle disease hemagglutination inhibition test is prepared. The method disclosed by the invention makes the standard substance preparation more scientific, rigorous and perfect according to the standard substance preparation process.

Description

technical field [0001] The invention relates to a national standard product of positive serum for chicken Newcastle disease hemagglutination inhibition test and a preparation method thereof, and belongs to the technical fields of standard substance technology and veterinary biological products. Background technique [0002] Chicken Newcastle disease (ND), also known as Asian chicken plague, is a highly contagious and fatal disease caused by avian parainfluenza virus type Newcastle disease virus (NDV), which mainly affects chickens, turkeys, wild birds and ornamental birds. It is a global trend and has brought serious economic losses to many countries and regions in the world. The World Organization for Animal Health (OIE) lists it as an animal disease that must be reported, and my country lists it as a first-class animal disease. At present, hemagglutination inhibition (HI) test is a common method for Newcastle disease diagnosis. In order to promote the international integr...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/96
Inventor 李翠关孚时王在时张秀英戴志红蒋卉陆连寿温芳
Owner CHINA INST OF VETERINARY DRUG CONTROL
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