Increasingly sensitive DNA identification technology underscores the importance of DNA-free solutions that forensic DNA casework labs can trust, from crime scene to courtroom. Low levels of DNA contamination are often present at crimes scenes but have only recently been more problematic during investigations. The Applied Biosystems brand has introduced more sensitive DNA typing solutions such as Quantifier Trio DNA Quantification Kit and QuantStudio 5 Real-Time PCR System for Human Identification, and the GlobalFiler PCR Amplification Kit with the 3500 Genetic Analyzer, lower levels of DNA are now being detected and may interfere with casework results. Suspects may be incorrectly included or excluded based on this evidence being incorrectly interpreted. Starting back in the 1990’s police in Germany and Austria were searching for a serial killer named ‘the phantom of Heilbronn’. After further investigation, it turned out that this DNA profile, which showed up in 40 separate crime scenes, came from a worker in factory that made swabs for collecting samples.
Then in 2009, the Scientific Working Group on DNA Analysis Methods (SWGDAM), the European Network of Forensic Science Institutes (ENFSI), the and the Biology Specialist Advisory Group (BSAG) formulated a request that manufacturers of disposables and reagents for the forensic market incorporate precautions to prevent contamination in their manufacturing processes. The new standard of ISO 18385 began to take shape and was published in February 2016. This standard sets expectations and establishes the baseline level for Risk Management, Release Lot Testing and Environmental Testing, amongst others.
“As a global leader in the forensics space, Thermo Fisher Scientific remains focused on serving its customers with products that meet the highest standards in the industry” says Rosy Lee, Vice President and General Manger, Human Identification. Our primary HID manufacturing site in Warrington, UK meets the ISO 18385 standard and is the first site to be verified by a third party inspection. This site manufactures PrepFiler, Quantifiler and STR kits. The Quantifiler, GlobalFiler and other STR products meet the new ISO 18385 standard. We have infrastructure and practices in place in Warrington that focus on three key areas to address the requirements of ISO 18385. These three areas are: (1) Personnel; (2) Processes; and (3) Facilities. You can take a virtual tour of our facility and see what we do every day, to help ensure that you get answers you can trust.