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!