title: Report of an international collaborative study to evaluate the suitability of multiplex PCR as an identity assay for different sub-strains of BCG vaccine.
abstract: Current methods for the identification of BCG vaccine in quality control settings involve acid-fast staining with microscopic examination. However, this method is unable to distinguish the many different sub-strains of BCG, or to differentiate BCG strains from virulent members of the Mycobacterium tuberculosis complex. A multiplex PCR (mPCR) which uses six target regions in mycobacteria has been developed to identify specific sub-strains of BCG. This study reports the findings from an international collaborative study to assess the accuracy, robustness and reproducibility of this mPCR method to differentiate BCG sub-strains. The method was found to fulfil these criteria successfully and was able to distinguish BCG sub-strains in vaccine preparations. The majority of the participants in the study generated the expected PCR product profiles indicating the method is also robust.
authors: Bacteriology Division, NIBSC-HPA, Blanche Lane, South Mimms, Potters Bar, Hertfordshire EN6 3QG, UK. kevin.markey@nibsc.hpa.org.uk
authors: Kevin
authors: K
authors: Markey
authors: Mei M
authors: MM
authors: Ho
authors: Babna
authors: B
authors: Choudhury
authors: Masaaki
authors: M
authors: Seki
authors: Liu
authors: L
authors: Ju
authors: Luiz R R
authors: LR
authors: Castello-Branco
authors: Sunil
authors: S
authors: Gairola
authors: Aihua
authors: A
authors: Zhao
authors: Keigo
authors: K
authors: Shibayama
authors: Murielle
authors: M
authors: Andre
authors: Michael J
authors: MJ
authors: Corbel
mesh_terms: D001500:BCG Vaccine / Q000235:genetics*; D015373:Bacterial Typing Techniques / Q000379:methods; D004269:DNA, Bacterial / Q000032:analysis; D007391:International Cooperation; D009163:Mycobacterium bovis / Q000145:classification* / Q000235:genetics; D016133:Polymerase Chain Reaction / Q000379:methods*; D015203:Reproducibility of Results
chemical_list: D001500:BCG Vaccine; D004269:DNA, Bacterial