LGC Standards announces ATCC SDO release of ground-breaking standards for human cell lines

23 February 2012

LGC Standards, a supplier of laboratory reference materials and exclusive European distributor for ATCC products, has announced the publication of a new consensus standard for human cell line authentication.

The ATCC Standards Development Organization (ATCC SDO), an entity of ATCC, has published its second voluntary consensus standard, ASN-0002: Authentication of Human Cell Lines: Standardization of STR Profiling. This consensus standard is expected to have broad impact across basic cell research, drug discovery, and translational medicine.

This approved American National Standard represents a major step forward in correcting the long standing problem of cell line misidentification. The standard’s intent is to delineate a standardised, universally applicable method for authenticating new and established human cell lines and human primary tissue used in research. A living document, the standard will be subject to revisions over time to reflect changes in the field and new methodologies.

“This new standard is one example of our commitment to the program mission for the ATCC SDO — to develop and publish stakeholder-proposed, industry-relevant standards for biomaterials and related processes,” said Raymond Cypess, DVM, PhD, Chief Executive Officer for ATCC.

“We are creating and maintaining biological standards that protect public interests,” said Dr Cypess, “and we endeavour to ensure that government, regulatory agencies, industry and academia have the tools and resources to ensure the importance of properly authenticated material for biological research and product development.”

Use of human cell lines

Human cell lines are used in research and development as models of normal and cancer tissues. However, a significant proportion of cell lines are misidentified, as a result of contamination or poor laboratory techniques and practices. The consequences of using misidentified cell lines have included the retraction of published papers and the inability to reproduce research results when incorrect cell lines are used, both of which leads to a waste of resources in support of research.

The publication of the standard for the authentication of human cell lines using STR profiling represents an important step in the remediation of this problem. “ATCC has been at the nexus of responding to the recognised problem of cell line misidentification, delivering standardised methods that can be used to test cell lines early and often,” said Brian Pollok, PhD, President of ATCC.

An international workgroup of scientists representing academia, regulatory agencies, major cell repositories, government agencies and industry, chaired by John R. W. Masters, PhD, of University College London, and Yvonne A. Reid, PhD, of ATCC, worked together to develop the standard. “The standard represents a collective experience and expertise that led to a refinement and consolidation of methods that should be of critical value to investigators who are working with human cell lines,” said Dr Masters.

Standardisation fosters the reproducibility and comparability of research employing human cells, leading to a marked decrease in the misidentification of human cells used by the scientific community.

“The most important aspects of the standard are the discussions on the numbers and types of loci to be evaluated, quality control of the data, interpretation of the results (matching criteria, loss of alleles, etc.), and implementation of an STR database,” said Dr Reid.

In 2007, the ATCC SDO became the first biological resource organization to become accredited by the American National Standards Institute (ANSI) as a standards developing organisation (SDO). Accreditation by ANSI signifies that the procedures used by the SDO in connection with the development of American National Standards meet the Institute’s essential requirements for openness, balance, consensus and due process.

Further information

Authentication of Human Cell Lines: Standardization of STR Profiling is available at: http://standards.atcc.org/kwspub/standards/published_standards/