LGC Standards has launched ATCC Certified Reference Materials (CRMs), issued under ISO Guide 34 and ISO 17025:2005-accredited and ISO 9001:2008-certified laboratories.
'The availability of certified materials for the improved control and assessment of biological-based measurements will benefit our customers working in both research-and-development and quality-control laboratories,' said Jeffrey Anthony, ATCC business development manager for Europe at LGC Standards.
ATCC CRMs are intended to be used to challenge assay performance, validate or compare test methods and to establish sensitivity, linearity and specificity during assay validation or implementation.
Liz Kerrigan, director of standards and certification at ATCC, said: 'ATCC CRMs are an important tool for method validation and method performance verification.
'They also provide the consistency needed for testing and calibration performed in ISO 17025-accredited laboratories,' she added.
Dr Rosemarie Pruden, director of quality at ATCC, said: 'ISO Guide 34 accreditation represents an objective measure of confidence in the consistency and quality of ATCC reference cultures.
'It expands ATCC's ability to produce internationally recognised standards for biological research and development, including CRMs,' she added.
Under ISO Guide 34 accreditation, ATCC CRMs are qualitative standards that are tested to a high level of quality control.
The CRMs are: optimised for homogeneity and consistency from lot to lot; verified using polyphasic characterisation; and tested to a stated level of confidence, where appropriate.
Detailed certificates of analysis are provided with CRMs.
The serialised vials have up to a five-year stability and the pedigree is traceable to the CRM seed lot.
The ATCC quality system ensures that the organisation maintains a high level of accreditations: the ISO Guide 34 Reference Material Producer; the ISO 17025:2005 Testing Laboratory; and the ISO 9001:2008 Quality Management System.
ATCC CRMs include cell lines, bacteria and fungi and yeast.
