Developing quality control with human forensic suppliers30 May 2016
An Australian owned company, Sanax Medical has been operating for over 35 years providing first aid, safety, medical and forensic products to users in industry, government and the general community. They have become a respected partner in OH&S material supply, using quality as their top priority demonstrated by getting their quality management system ISO 9001 certified.
Sanax’s DNA forensics product line started in 2002 and it now supports operations across Western Australia’s law enforcement agencies. The entry into forensics had an unusual starting point – it all begun by suppling Plaster of Paris to a local detective who used it in tyre track moulds. From there supplying police agencies expanded to providing gloves and evidence tapes, and when DNA testing became necessary, a collaboration to create sampling kits opened new doors for Sanax.
The need for genomic testing
In 2012, Sanax recognised what customers really needed was confidence that trace DNA levels in their sampling kits were were so small that its presence wouldn’t impede investigations. This was mainly driven by new testing sensitivity considerations through advances in DNA technology used by the forensics community.
This need is made famous by the “Phantom of Heilbronn” in Europe from ‘93-’09, when a suspected female serial killer’s DNA was found in over 40 serious crime scenes. This was later confirmed as contamination by the swab manufacturers. This serious production variable clearly needed addressing, and Sanax began to consider ways in which to enhance their product. Around the same time it became clear that a new Australian testing standard was imminent –now known as “AS 5483 - Minimizing the risk of contamination in products used to collect and analyse biological material for forensic DNA purposes”. With this criterion in mind a higher testing methodology needed to be created that proved contamination via preparation of their forensic kits was absent.
Identifying a partner
“We really wanted to be an early-mover and take this technology further, but we needed a commercially saavy genomics partner that could fulfil commercial needs of our business. We needed reliable reporting, turnaround times that met our production schedule, quality accreditation, as well as a group that could provide technological knowledge and advice to create the method”, explains Gavin.
A website search on the National Association of Testing Authorities (NATA) led Gavin to AGRF, and a new venture was underway. Working closely with Dr David Chandler at the AGRF Perth node, a method was designed that takes swabs of various kit components and extracts them for DNA. This was then quantified using real time PCR, and processed using a specialised DNA marker panel that produces unique DNA ‘fingerprint’ patterns. A report then records if there is evidence of DNA presence, and where it’s come from – including the ability to match patterns against Sanax technicians, providing quality control in handling methodology so that a “Phantom” could not be possible!
Becoming the first in Australia
Skill sets needed for the method development and DNA analysis were not present at Sanax, and the end users of the kits were not well suited to the commercial production needs of the company, which meant outsourcing the work was necessary. The collaboration with AGRF made it possible for Sanax to become certified to the Australian standard, which was granted to Sanax in March 2016.
Sanax is the first Australian provider of forensics sampling kits to have reached and been granted this level of production confidence, giving the organisation a competitive advantage and a unique product. With this certification Sanax plans to expand supply nationally. Further, indications this standard will be converted into an international standard (known as “ISO”) makes Sanax’s forensics products internationally relevant, thereby opening a far larger market for the Western Australian operation.
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