Specificity and detection limit of a dermal temperature histamine sensitization test for absence of residual pertussis toxin in vaccines
| Autor: | Kristin E. Engelhart Illigen, Sten E. Jensen, Kaare R. Hasløv, Jens Henrik Badsberg |
|---|---|
| Rok vydání: | 2011 |
| Předmět: |
Bioengineering
Body temperature measurement Pertussis toxin Applied Microbiology and Biotechnology Sensitivity and Specificity Histamine agonist Microbiology Histamine Agonists chemistry.chemical_compound Mice Medicine Bioassay Animals Humans Sensitization Pharmacology Detection limit Pertussis Vaccine General Immunology and Microbiology business.industry General Medicine medicine.anatomical_structure chemistry Pertussis Toxin Pertussis vaccine Biological Assay business Drug Contamination Skin Temperature Histamine Biotechnology medicine.drug |
| Zdroj: | Biologicals : journal of the International Association of Biological Standardization. 40(1) |
| ISSN: | 1095-8320 |
| Popis: | Currently, an assay based on fatal sensitization of mice to histamine challenge is widely used for testing absence of residual pertussis toxin in acellular pertussis containing vaccines. For replacement of this lethal end-point assay, an alternative method based on body temperature measurement in mice has been presented, and in this study the specificity and detection limit of a dermal temperature-based assay were assessed. Test preparations containing pertussis toxin were prepared in aluminum-adjuvanted pertussis toxoid vaccine and injected intraperitoneally in histamine sensitive mice. Later the mice were challenged with histamine and the pertussis toxin-induced decrease in dermal temperature recorded. By comparison of mice treated with pertussis toxoid vaccine spiked with pertussis toxin with mice treated with pertussis toxoid vaccine alone, the assay gave a response that specifically could detect presence of pertussis toxin. The acellular pertussis containing vaccine did not interfere with the pertussis toxin-induced temperature response recorded. In tests for presence of pertussis toxin in the pertussis vaccine preparation, the detection limit of the assay was estimated to approximately 5 ng pertussis toxin per human dose of pertussis toxoid. The dermal temperature-based assay was found to be a valid method to be applied in routine quality control of vaccines. |
| Databáze: | OpenAIRE |
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