ISO 18385:2016 external certification achieved!

SYM_0167_HID_ISOForensicGrade 1015 WW

As innovation and technology development in DNA profiling permit increased sensitivity during short tandem repeat (STR) analysis, minute levels of exogenous DNA that were previously undetected may now generate partial profiles. Such contamination can prevent successful analysis and jeopardize the integrity of irreplaceable casework samples. Therefore, ISO 18385:2016 was developed to assure and, where necessary, improve the quality of production of forensic DNA testing kits and consumables by addressing this concern of potential low-level DNA contamination.

So, what is ISO 18385:2016? This latest ISO standard specifies stringent guidelines for the production of forensic products used prior to the post-amplification process, thereby helping to reduce the risk of detectable human DNA contamination from the manufacturing procedure. This international standard covers products used to collect, store and analyze biological material for forensic purposes including, swabs, containers and packaging for evidence collection, as well as plasticware, disposable laboratory coats, gloves and other consumables during the pre-amplification process.

As an innovative and quality-driven market and technology leader, QIAGEN has pioneered forensic production standards for many years. All of QIAGEN’s Investigator branded products, which carry the QIAGEN Forensic Grade label, have been produced to ISO 18385:2016 since these standards were published in 2016. With our dedication to continuing to provide the best products for our customers, QIAGEN is now proud to announce that, after a three-day audit, it has achieved external certification to ISO 18385:2016 through Bureau Veritas!

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Angela Cacioppo, MPS

Global Market Manager, Demand Generation

Angela joined QIAGEN in 2017. She received her Master's Degree in Forensic Science (biology track) from Pennsylvania State University. Before joining QIAGEN, Angela worked at The Bode Technology Group (a.k.a Bode Cellmark Forensics) as a DNA analyst, where she processed thousands of DNA samples and traveled the United States to testify as an expert witness. Afterwards, she joined LGC, where she was involved in the rollout and deployment of new and innovated technology, ParaDNA Systems, that facilitates the screening and triage of DNA samples.

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