Development of microbiological reference materials

Kurzfassung

A Spanish company has developed several reference materials for different microbial species as Escherichia Coli, Enterococcus, Legionella pneumophila, etc. These materials can be designed in easy-to-use formats, ready to use in any laboratory. Its main characteristics are high homogeneity, long-term stability, known concentration and easy storage. Environmental and clinical laboratories to establish technical co-operation agreements for these and/or new applications are sought.

Details

In analytical laboratories, the necessity to offer precise and accurate results, together with the proliferation of new protocols and analytical tests has made necessary the introduction of quality control systems in which the use of Reference Materials is a powerful tool.A Reference Material is defined as any material or substance, one or more of whose property values are sufficiently homogeneous and well establish to be used for the calibration of an apparatus, the assessment of a measurement method or for assigning values to a material (ISO guide 30, Anonymous 1992). These materials are an important tool for performing a number of aspects of quality measurement and can be used in the validation of a method, in the calibration of a device, for training purposes and of course, for internal quality control and external quality assurance purposes.Reference materials were first implemented in chemistry, where they are used widely. Nevertheless, in microbiology the process of implementation is slower and much more complex. In addition, the preparation of microbiological reference materials is more complicated especially because of the need to keep microorganisms alive and able to grow after long latency periods. In this sense, the components of the preparation media, cryoprotective agents and storage temperature are crucial factors in the development of microbiological reference materials.Another important difference with chemical reference materials is the difficulty to obtain in microbiology a homogeneous material due to random variations and to the behaviour of the microorganisms as living organisms, especially when they are in low concentration. It is well known that the chemical samples also present variations but generally below the detection limit, so the results obtained are in the practice homogeneous. Its numerous applications and the difficulty in manufacturing have made that microbiological reference materials, and companies with experience in the field are in great demand. The company has been working on the development of microbiological reference materials that meet the established requirements. These materials can be designed in easy-to-use formats, ready to use in any laboratory. Its main characteristics are high homogeneity, long-term stability, known concentration and easy storage. The company has developed reference materials for different microbial species: Escherichia coli, Enterococcus, Legionella pneumophila, etc., but can potentially work with any microorganism of interests in the water, food and clinical fields. Each manufactured batch undergoes homogeneity and stability tests, as well as certification studies using data from several credited laboratories.Innovative Aspects:The development of microbiological reference materials requires some experience in the subject in order to meet the material quality requirements. Its numerous applications and the difficulty in manufacturing have made that microbiological reference materials, and companies with experience in the field are in great demand. These new materials present important advantages compared to the traditional reference materials provided in glass ampoules and, in particular:- Simplicity: The preparation of the material is extremely simple since it presents a tablet format that is provided in a sterile plastic device of very easy use, avoiding the necessity of bothersome manipulations.- Rapidity: The reconstitution time is reduced to 10 minutes.- Safety: Since the manipulations are reduced to the minimum, contamination risk does not exist.- Traceability: The used strains are traceable to different Type Culture Collections.- Quality: All the provided material include a Fast User Guide and the corresponding Certificate of Analysis.- Flexibility: The material can be provided in different formats and is available in 2 concentration ranks, low (<2 log.) and high concentration (>2 log.) allowing to fit into your specific necessities.- Service: In addition to the available species, they offer the possibility of preparing reference material of any microorganism in a concentration predetermined by the customer.- Available reference material: Citrobacter freundii, Clostridium perfringens, Enterococcus faecium, Escherichia coli, Legionella pneumophila, Staphylococcus aureus, Pseudomonas aeruginosa, Salmonella spp. (...)The company has several years of experience in developing, testing and using microbiological reference materials, to be at other laboratories service and also for internal quality testing purposes.