Di Paolo Antonella, Liberti Rosario, Anzalone Lucia, Colabella Claudia, Felici Andrea, Severi Giulio, Cagiola Monica
Istituto Zooprofilattico Sperimentale Dell'Umbria e Delle Marche "Togo Rosati", via G. Salvemini 1, 06126 Perugia, Italy.
Laboratorio Analisi "Ospedale S. Matteo Degli Infermi", USL Umbria 2, Via Loreto, 3, 06049 Spoleto, Italy.
Vet Sci. 2024 Dec 21;11(12):673. doi: 10.3390/vetsci11120673.
Veterinary autogenous vaccines, similar to all injectable pharmaceutical products, must be tested to assess endotoxin concentrations. The Limulus Amebocyte Lysate Test (LAL test) is widely used in in vitro quality control assays for endotoxin detection, although it presents some ethical issues related to the production of reagents and is also characterized by a low specificity due to other contaminants that can activate the reaction. For all these reasons, a new recombinant factor C LAL test was developed.
In this study, we described the comparison between two LAL test methods for in vitro quality control of veterinary autogenous vaccines, with the aim of evaluating the most suitable method and establishing an endotoxin concentration range for two different matrices.
Two hundred batches of two different vaccine matrices were tested using the kinetic chromogenic LAL test and recombinant factor C endotoxin detection assay commercial kits.
Statistical analysis conducted after the validation of the recombinant factor C test exhibited a statistically significant correlation between the two methods and for both vaccine matrices, suggesting that the animal-free assay can be used as a routine quality control test for veterinary autogenous vaccines.
与所有注射用药品类似，兽用自体疫苗必须经过检测以评估内毒素浓度。鲎试剂检测法（LAL检测法）广泛用于内毒素检测的体外质量控制分析，尽管该方法存在一些与试剂生产相关的伦理问题，并且由于其他可能激活反应的污染物而具有较低的特异性。基于所有这些原因，开发了一种新的重组C因子LAL检测法。
在本研究中，我们描述了两种LAL检测方法在兽用自体疫苗体外质量控制方面的比较，目的是评估最合适的方法，并确定两种不同基质的内毒素浓度范围。
使用动态显色LAL检测法和重组C因子内毒素检测分析商业试剂盒对200批两种不同的疫苗基质进行检测。
重组C因子检测法验证后进行的统计分析表明，两种方法之间以及两种疫苗基质之间均存在统计学上的显著相关性，这表明无动物检测法可作为兽用自体疫苗的常规质量控制检测方法。
Zotero 插件