| Author |
Coble, M. D. Buckleton, J. Butler, J. M. Egeland, T. Fimmers, R. Gill, P. Gusmão, L. Guttman, B. Krawczak, M. Morling, N. Parson, W. Pinto, N. Schneider, P. M. Sherry, S. T. Willuweit, S. Prinz, M. |
| Description |
Author Affiliation: Coble MD ( National Institute of Standards and Technology, Applied Genetics Group, Gaithersburg, MD, USA. Electronic address: mcoble@nist.gov.); Buckleton J ( ESR, Private Bag 92021, Auckland 1142, New Zealand); Butler JM ( National Institute of Standards and Technology, Special Programs Office, Gaithersburg, MD, USA.); Egeland T ( Norwegian University of Life Sciences, Oslo, Norway.); Fimmers R ( Institute for Medical Statistics, Informatics, and Epidemiology, University Bonn, Germany.); Gill P ( Norwegian Institute of Public Health, Oslo, Norway); Gusmão L ( State University of Rio de Janeiro (UERJ), Rio de Janeiro, Brazil); Guttman B ( National Institute of Standards and Technology, Software and Systems Division, Gaithersburg, MD, USA.); Krawczak M ( Institute of Medical Informatics and Statistics, Christian-Albrechts University of Kiel, Germany.); Morling N ( Section of Forensic Genetics, Department of Forensic Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.); Parson W ( Institute of Legal Medicine, Medical University of Innsbruck, Innsbruck, Austria); Pinto N ( IPATIMUP, Institute of Molecular Pathology and Immunology of the University of Porto, Portugal); Schneider PM ( Institute of Legal Medicine, Faculty of Medicine, University of Cologne, Germany.); Sherry ST ( National Center for Biotechnology Information, National Library of Medicine, NIH, Bethesda, MD, USA.); Willuweit S ( Department of Forensic Genetics, Institute of Legal Medicine and Forensic Sciences, Charité-Universitätsmedizin, Berlin, Germany.); Prinz M ( John Jay College of Criminal Justice, New York, USA.) |
| Abstract |
The use of biostatistical software programs to assist in data interpretation and calculate likelihood ratios is essential to forensic geneticists and part of the daily case work flow for both kinship and DNA identification laboratories. Previous recommendations issued by the DNA Commission of the International Society for Forensic Genetics (ISFG) covered the application of bio-statistical evaluations for STR typing results in identification and kinship cases, and this is now being expanded to provide best practices regarding validation and verification of the software required for these calculations. With larger multiplexes, more complex mixtures, and increasing requests for extended family testing, laboratories are relying more than ever on specific software solutions and sufficient validation, training and extensive documentation are of upmost importance. Here, we present recommendations for the minimum requirements to validate bio-statistical software to be used in forensic genetics. We distinguish between developmental validation and the responsibilities of the software developer or provider, and the internal validation studies to be performed by the end user. Recommendations for the software provider address, for example, the documentation of the underlying models used by the software, validation data expectations, version control, implementation and training support, as well as continuity and user notifications. For the internal validations the recommendations include: creating a validation plan, requirements for the range of samples to be tested, Standard Operating Procedure development, and internal laboratory training and education. To ensure that all laboratories have access to a wide range of samples for validation and training purposes the ISFG DNA commission encourages collaborative studies and public repositories of STR typing results. |
