Interlaboratory study for the establishment of Brazilian Bothrops Reference Venom and Antivenom for potency evaluation of Bothrops antivenom
| Autor: | Wlamir Corrêa de Moura, Josefina Farina Morais, Humberto Pinheiro de Araújo, Raquel Joane Rodrigues, Maria Aparecida Affonso Boller, Joseana Zaja Almada, Elizabeth Porto Reis Lucas, Barbara Carino Guimarães, Antonio Eugenio Castro Cardoso de Almeida, Celia de Fátima Barbosa |
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| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
Antivenom Bioengineering Venom Applied Microbiology and Biotechnology Toxicology 03 medical and health sciences Crotalid Venoms Medicine Potency Animals Bothrops Inter-laboratory Reference standards Pharmacology 030102 biochemistry & molecular biology General Immunology and Microbiology Traditional medicine biology business.industry Antivenins General Medicine Reference Standards biology.organism_classification 030104 developmental biology business Brazil Biotechnology |
| Zdroj: | Biologicals : journal of the International Association of Biological Standardization. 49 |
| ISSN: | 1095-8320 |
| Popis: | A collaborative study was performed for the establishment of the 5th lot of Brazilian Bothrops Reference Venom and the 1st lot of Brazilian Bothrops Reference Antivenom. All Brazilian manufacturers of Antibothrops Immunoglobulins and the National Control Laboratory participated of the study. The declared potency of the 5th lot of the Bothrops Reference Venom is 40.29 μg/0.5 ml, and the potency of the 1st lot of Bothrops Reference Antivenom is 6.51 mg/ml. For the potency evaluation of Bothrops Reference Venom the inter assay precision (gCV) was 3.25% in lab 01; 3.51% in INCQS; 4.71% in lab 03 and 25.11% in lab 02, and the inter laboratory precision was 13.76%. The intra assay precision of Bothrops Reference Antivenom determinations was 4.38% in INCQS; 8.47% in lab 02; 10.51% in lab 03 and 20.05% in lab 01. The inter assay precision was 3.51% in INCQS; 9.65% in lab 02; 18.03% in lab 01 and 20.23% in lab 03. The inter laboratory precision was 15.85%. Despite the high number of invalid results (55.6% for the pharmacopoeial method and 69.4% for the proposed method) the parallel line assay, have better inter laboratorial precision (gCV = 16.62%) than the pharmacopoeial potency assay (gCV = 38.28%). |
| Databáze: | OpenAIRE |
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