Development and validation of an ATP method for rapid estimation of viable units in lyophilised BCG Danish 1331 vaccine

被引：18

作者：

Jensen, Sten E. ^{[1
]}

Hubrechts, Peter ^{[1
]}

Klein, Bjarke M. ^{[2
]}

Haslov, Kaare R. ^{[1
]}

机构：

[1] Statens Serum Inst, Qual Control Dept, DK-2300 Copenhagen S, Denmark

[2] Statens Serum Inst, Biostat Unit, DK-2300 Copenhagen S, Denmark

来源：

BIOLOGICALS | 2008年 / 36卷 / 05期

关键词：

ATP assay; validation; BCG viability; rapid alternative microbiological method; colony forming units;

D O I：

10.1016/j.biologicals.2008.05.001

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

An assay for quantifying viability in BCG vaccine by determining intracellular ATP content was developed and validated. ATP content was determined by measuring bioluminescence in the presence of luciferin/luciferase. During development and validation the ATP method was compared to the conventional viable count method. A key step to obtain correlation between ATP content and CFU was found to be a period of pre-incubation in a growth medium before ATP determination. During the validation, the robustness, linearity, accuracy, precision, and range were studied. The method validation study showed that the method applied was robust and applicable to determine ATP content in lyophilised BCG for estimating viability in the BCG samples. By comparison with a conventional viable count method, a high correlation between ATP content and the viable count was found this relationship can be applied in routine quality control to estimate viable count from the ATP content determined in a sample. (C) 2008 The International Association for Biologicals. Published by Elsevier Ltd. All rights reserved.

引用

页码：308 / 314

页数：7

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