Proposed reduction of the in vivo pyrogen test by the in vitro LAL assay for the quality control of anticrotallic, antiscorpion, antirabies and antitetanus sera
| Autor: | Fernando F. Fingola, Sheila R.G. Albertino, Shirley de Mello Pereira Abrantes, Helena Pereira da Silva Zamith |
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| Rok vydání: | 2019 |
| Předmět: |
Quality Control
0301 basic medicine National health Serial dilution Pyrogens business.industry Scorpion Venoms General Medicine Pharmacology Toxicology In vitro Endotoxins Food and drug administration 03 medical and health sciences 030104 developmental biology 0302 clinical medicine Tetanus Toxin Rabies virus In vivo 030220 oncology & carcinogenesis Crotalid Venoms Animals Medicine Antitoxins business |
| Zdroj: | Toxicology in Vitro. 59:292-299 |
| ISSN: | 0887-2333 |
| Popis: | The rationale for a formal study of the LAL (kinetic chromogenic method) assay for anticrotallic (SAC), antirabies (SAR), antitetanus (SAT) and antiscorpion (SAE) sera involved the determination of parameters required by the Brazilian National Health Surveillance Agency (ANVISA), the USA Food and Drug Administration (FDA), USP (United States Pharmacopeia, 39) and ICH (International Conference on Harmonization). The curve correlation coefficients obtained with the standard endotoxin control ranged from -0.980 to -1.000 in all experiments. Endotoxin recovery added to the SAC, SAR, SAT and SAE samples, at the working dilutions (1:10, 1:10, 1:10 and 1, 100 respectively), met the criteria required by the FDA, USP and Brazilian ANVISA for the Inhibition-Potentiation test. The applied methodology for the four analyzed sera fulfilled the required criteria for all performance parameters. Thus, the present study demonstrated that the in vivo pyrogen test can be potentially replaced by the LAL assay for all assessed sera samples displaying higher sensitivity and following the 3 Rs principle, in addition to maintaining quality control in Sanitary Surveillance. |
| Databáze: | OpenAIRE |
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