Cell misidentification and cross-contamination have plagued biomedical research for as long as cells have been employed as research tools. Examples of misidentified cell lines continue to surface to this day. Efforts to eradicate the problem by raising awareness of the issue and by asking scientists voluntarily to take appropriate actions have not been successful. Unambiguous cell authentication is an essential step in the scientific process and should be an inherent consideration during peer review of papers submitted for publication or during review of grants submitted for funding. In order to facilitate proper identity testing, accurate, reliable, inexpensive, and standardized methods for authentication of cells and cell lines must be made available. To this end, an international team of scientists is, at this time, preparing a consensus standard on the authentication of human cells using short tandem repeat (STR) profiling. This standard, which will be submitted for review and approval as an American National Standard by the American National Standards Institute, will provide investigators guidance on the use of STR profiling for authenticating human cell lines. Such guidance will include methodological detail on the preparation of the DNA sample, the appropriate numbers and types of loci to be evaluated, and the interpretation and quality control of the results. Associated with the standard itself will be the establishment and maintenance of a public STR profile database under the auspices of the National Center for Biotechnology Information. The consensus standard is anticipated to be adopted by granting agencies and scientific journals as appropriate methodology for authenticating human cell lines, stem cells, and tissues.

This "white paper" was prepared and widely disseminated in an attempt to sound an alarm about the long-term existence of a grave, unresolved and growing problem that affects a significant portion of biomedical research, namely, the use of misidentified and cross-contaminated cell cultures. The "white paper" shows how bold action could bring about a profession-wide change in practice that would prevent further erosion. Misidentification and inter- and intra-specific cross-contamination of mammalian cell cultures used in research continues as a widespread problem despite an awareness that dates back more than 45 years. Awareness of the problem has led to a good understanding of the causes of cross-contamination and appropriate preventive measures. It has also led to the application of robust methods for the authentication of cell lines. Yet the problem continues unabated. Estimates of the incidence of research papers flawed by the use of misidentified and cross-contaminated cell cultures approximate 15-20%. The gravity of the situation calls for a strategy that would deliver a remedial message of authentication to virtually all cell culture researchers and also ensure compliance with the message. At the core of the strategy proposed herein is having cell line authentication as a condition for the award of research grants and for the publication of research findings.

A son's challenge started an emeritus professor of biology on a three-year odyssey to get biological researchers to correct a decades-long problem with cross-contaminated and misidentified cell lines. These errors may account for more than 15% of mammalian cultures, wasting resources and undermining the integrity of research.