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Certification of a reference material with Enterococcus faecalis (CIP 106877) at a target level of 1000 colony forming units per material sphere

Funded under: FP7-JRC

Abstract

Certified Reference Materials (CRMs) for microbiological analysis are indispensable tools for development and validation of detection methods and for the implementation and support of internal and external quality control in the area of microbiological analysis. IRMM already offers microbiological reference materials (RMs) with certified colony forming unit (cfu) numbers per capsule covering six different food and water micro-organisms. Measurement effects, such as Poisson distribution at low cfu counts, encouraged us to consider alternative approaches for development and certification of reference materials. The production of freeze-dried BioBalls is not based on aliquoting but rather on transferring a counted number of bacterial or yeast cells into a single BioBall with a modified flow cytometer. The IRMM's portfolio of CRMs in the BioBall format currently consists of two low cfu materials (IRMM-351, containing E. coli O157 and IRMM-352, containing S. enteritidis) and one material at a target level of 1000 cfu (IRMM-354, containing C. albicans). IRMM currently extends the range of these CRMs to more micro-organisms at a level of 1000 cfu per material sphere for water control laboratories. Enterococcus faecalis is a gram-positive, opportunistic bacterium that inhabits the gastrointestinal tracts of humans and many animals. Because of their ability to acquire high-level resistance to antimicrobial agents, enterococci have emerged as nosocomial pathogens worldwide. Enterococcus faecalis causes 80 to 90% of human enterococcal infections.
This report describes the certification of a batch of 1000 vials (IRMM-355) containing E. faecalis at a target level of 1000 cfu per material sphere. Homogeneity and stability of the produced batch were analysed at IRMM following in house procedures applying a quality management system according to ISO Guide 34. Batch characterisation was performed by IRMM and five external laboratories.

Additional information

Authors: DE BAETS L, European Commission, Joint Research Centre, Institute for Reference Materials and Measurements, Geel (BE);MEEUS N, European Commission, Joint Research Centre, Institute for Reference Materials and Measurements, Geel (BE);SCHIMMEL H, European Commission, Joint Research Centre, Institute for Reference Materials and Measurements, Geel (BE)
Bibliographic Reference: EUR 23938 EN (2009), 25 pp. Free of charge
Availability: Available from European Commission, JRC Knowledge Management Unit, Ispra (IT) Tel: +39 033278 9893 Fax: +39 033278 5409 E-mail: jrc-info@ec.europa.eu or Bruxelles (BE) Tel: +32 2 295 76 24 Fax: +32 2 299 63 22
ISBN: ISBN: 978-92-79-12811-0
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