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QIAGEN’s Investigator Human Identity Testing Products Meet New ISO Standard

Existing framework allows to immediately offer highest quality DNA products to forensic customers

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Hilden, Germany, and Germantown, Md. QIAGEN GmbH announced on Feb. 3 that the company’s Investigator sample and assay technology kits for human identity testing and the associated manufacturing facilities meet the requirements of the newly published ISO 18385:2016 standard

QIAGEN’s Investigator kits, which were developed for forensic, human identity, and paternity testing, are used in casework analysis during criminal and other investigative work, and rapidly and reliably generate DNA profiles from blood, buccal swabs and forensic stains. Compliance with the new standard means that only products meeting strictest requirements for absence of exogenous DNA are allowed to leave the QIAGEN manufacturing facilities. 

The new international standard, which was developed starting in 2012 with contributions from QIAGEN, was published on February 1. It specifies requirements for the manufacture of products used in the collection, storage, and analysis of human DNA during forensic testing. These requirements seek to improve the quality of forensic testing around the world by minimizing the risk of human DNA contamination during the manufacturing process. Manufacturers that comply with the requirements can label their products “Forensic DNA Grade.” 

As a result of the publication of the new standard, QIAGEN announced the availability of ISO 18385:2016 Forensic DNA grade products covering the entire workflow of sample and assays technologies, and both manual and automated methods. QIAGEN confirms that all of the associated manufacturing sites are operating under the new standard. The ISO 18385:2016 products continue QIAGEN’s commitment to the highest quality standards. QIAGEN established a forensic-grade quality framework for its Investigator kits in 2013. This framework covered the fundamental quality standards outlined in draft ISO 18385 standards and ensured compliance with all customary contamination exclusion requirements. QIAGEN has been affixing “forensic grade” seals to its Investigator kits since 2014. 

“QIAGEN is delighted that our commitment to the highest product quality enables us to immediately offer Forensic DNA grade products that are compliant with ISO 18385:2016,” said Dr. Thomas Schnibbe, senior director and head of QIAGEN’s Global Forensic Business. “Our Investigator sample and assay technology kits have set a new standard for quality in forensic testing in their use around the world. Our Investigator ISO 18385:2016 Forensic DNA grade products continue the long QIAGEN tradition of quality and we are pleased to be able to offer these industry leading kits to customers so quickly after the publication of the new ISO standard.” 

QIAGEN is a global leader in Sample to Insight solutions for human identification workflows. The company’s Investigator® STR assay kits incorporate the Investigator® Quality Sensor to evaluate the quality of DNA in each sample, a novel QIAGEN technology that enables labs to decide quickly which evidence may provide valuable results. 

No Investigator product component formulation is changing, so customers can continue to use the Investigator products without the need for revalidation. For more information about QIAGEN’s forensic grade quality, please don’t hesitate to go to