Lugosi L
Acta Microbiol Hung. 1987;34(1):11-8.
The stability of the viability of the Hungarian BCG Reference Preparations (Vaccine Bch. Nos: 265, 456, 505) was tested according to the recommendation of the World Health Organization. The BCG viable units of the vaccines were estimated from the colony counts determined on solid medium. The control data of the BCG viable units expressing the stability in 10(6)/ml values were analysed up to 7 years in a three-step statistical model applying unbiased parameter estimates, valid hypothesis test and multiple comparison. The presented model verifying the stability of the reference preparations ensures the reliability of the assays to accept or reject the viability at controlling routine BCG vaccines in comparison with the reference preparations.
根据世界卫生组织的建议，对匈牙利卡介苗参考制剂（疫苗批次编号：265、456、505）的活力稳定性进行了测试。通过在固体培养基上测定的菌落计数来估算疫苗的卡介苗活单位。采用无偏参数估计、有效假设检验和多重比较的三步统计模型，对以10(6)/ml值表示稳定性的卡介苗活单位的对照数据进行了长达7年的分析。所提出的验证参考制剂稳定性的模型确保了与参考制剂相比，在控制常规卡介苗疫苗时接受或拒绝活力检测的可靠性。
