I. I. Mechnikov Research Institute of Vaccines and Sera, Moscow, Russia.
Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of the Health of the Russian Federation, Moscow, Russia.
Bull Exp Biol Med. 2022 Apr;172(6):718-720. doi: 10.1007/s10517-022-05463-w. Epub 2022 May 2.
We studied activity of Bordetella pertussis LPS in the LAL test. The mean activity of various series of LPS preparations obtained from B. pertussis cells ranged from 1,950,000 to 2,940,000 endotoxin units/μg (EU/μg). Activity of the LPS preparation obtained from the culture medium supernatant was significantly higher (4,640,000 EU/μg). Activity of the control standard E. coli 055:B5 LPS was 19,500±500 EU/μg. These data indicate that activity of the obtained preparations of B. pertussis LPS in the LAL test is 100-200 times higher than activity of E. coli LPS used as a reference control. It was concluded that the results of the LAL test when assessing the permissible content of B. pertussis endotoxins require correction, probably by introducing a correction factor.
我们研究了百日咳博德特氏菌 LPS 在 LAL 测试中的活性。从百日咳博德特氏菌细胞中获得的各种 LPS 制剂的平均活性范围为 195 万至 294 万内毒素单位/μg(EU/μg)。从培养基上清液中获得的 LPS 制剂的活性明显更高(464 万 EU/μg)。对照标准大肠杆菌 055:B5 LPS 的活性为 19500±500 EU/μg。这些数据表明,在 LAL 测试中,所获得的百日咳博德特氏菌 LPS 制剂的活性比用作参考对照的大肠杆菌 LPS 高 100-200 倍。因此得出结论,在评估百日咳博德特氏菌内毒素允许含量时,LAL 测试的结果需要校正,可能需要引入校正因子。