Thursday, July 15, 2010

ZyGEM Introduces Microbial Fingerprinting Diagnostic Technology

ZyGEM Corp. Ltd., has introduced its new microbial fingerprinting diagnostic technology that is expected to dramatically reduce the complexity and time needed to identify unknown infectious agents in mixed population samples. The approach is designed to run on the company’s new MicroLab platform and has the potential to accurately identify up to 30 types of microbes simultaneously from a single sample in less than an hour. The ZyGEM system combines ZyGEM’s proprietary DNA extraction and microbial detection technologies with PCR amplification in a single automated reaction that occurs in its integrated ZyGEM/MicroLab microfluidic device. This device miniaturizes the entire DNA testing process within a single closed system, which significantly reduces the amount of sample and reagents needed while virtually eliminating the chance for handling error or contamination. ZyGEM researchers have developed a catalog of “fingerprints,” or DNA markers, for a broad range of microorganisms. Special software developed for the system uses these fingerprints to identify and discriminate between the microorganisms in mixed microbial populations.

Thursday, July 08, 2010

French Committee for Accreditation (Cofrac) Authorizes the Use of Kits for Water Microbiological Analysis When Certified Under the AFNOR VALIDATION Scheme

Cofrac was requested to recognize the rapid analytical methods that were validated under the AFNOR VALIDATION scheme in the field of water microbiological analysis. These methods are mainly used in the area of auto-control for the following types of water: process water (production of water for human consumption), bathing water, thermal water and cooling towers. Based upon a presentation of the AFNOR VALIDATION Scheme as well as a description of the Technical Board for water microbiology (nomination of members, principles of certification, validation protocols …) and following exchanges with several technical assessors in this field, the members of the Technical Accreditation Commission “Chemistry and Environment” decided to approve this accreditation.

Consequently the Technical Accreditation Commission “Chemistry and Environment” authorizes accreditation of laboratories using AFNOR validated kits on condition that (i) validation has been conducted by comparing the kit with a standardized reference method; (ii) the laboratory using the kit has been accredited upon the reference method (or required simultaneously an extension of accreditation for the reference method); and (iii) the technical protocol of the kit enters the area of competence of the technical assessor. Assessors in water microbiology could be mandated in order to assess this activity. The laboratory assessment should be done according to the requirements stated in EN ISO/CEI 17025 standard (and its application document LAB REF 02) paying a particular attention to the capacitation of the staff, to the management of the equipment and to the of the quality insurance of the results.

Remark : the case of PCR kits for the detection/enumeration of Legionella is apart as it does not deal with validation in comparison to a reference analytical method. When these PCR kits are certified under the AFNOR VALIDATION scheme, Cofrac takes into account the contents of their validation file (recovery , linearity, specificity,…).

Advanced Analytical Opens Sales Office and Laboratory in Heidelberg, Germany

Advanced Analytical has opened a new sales office and laboratory in Heidelberg Germany. The new facility is located in the Technologiepark on the campus of the Heidelberg University. By opening this office, the company will be able to provide better representation over sales for their suite of products sold as well as provide better support and service for their current and future customer base. The office in Heidelberg will serve as both the European headquarters for the company and as a Center of Excellence. Furnished with analytical instruments, AATI will be able to serve the growing European pharmaceutical/biopharmaceutical industry as well as the biotechnology and university research communities. The company’s product portfolio includes instruments for the rapid detection and enumeration of microbes by flow cytometry, and the parallel analysis of pharmaceutical compounds, biomolecules, proteins, DNA, RNA by capillary electrophoresis with UV absorbance or fluorescence detection.