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The Modernization of Diagnostic Testing
by Caitlin Cromley
The demand for rapid and reliable pathogen testing in the food industry has steadily increased, and the latest diagnostic tests are willing to rise up to the challenge. The rules have drastically changed with the implementation of the Food Safety Modernization Act (FSMA). Among some of the major alterations is the shift from Hazard Analysis and Critical Control Points to Hazard Analysis and Risk-based Preventive Controls, which aims to make sure the U.S. food supply is safe by changing the focus from response to contamination, to prevention itself.
Companies must adapt to the modernized regulations, and it could prove to be a difficult task. Wendy Lauer, senior product manager of Bio-Rad’s Food Science Division, states, “The whole process is very new and requires a great deal of effort. We’re seeing more of an emphasis on traceability and verification.”
Benjamin Pascal, co-founder and chief business officer at Invisible Sentinel, Inc., adds that creating diagnostics for the food market can be difficult due to the challenge of making tests compatible across a wide variety of matrices. However, the end goal reflects the shifting priorities. Pascal says, “While speed is important, ease of use and reduced costs are our top priority, and there is now a greater push to build rapid tests for other targets including spoilage organisms.”
In addition, firms are responding to FSMA by developing new solutions to suit the market’s latest demands. Lauer says Bio-Rad has come out with iQ-Check Prep automation system, “a robot that provides traceability, flags errors, and prevents cross-contamination.”
Invisible Sentinel’s novel technology, Veriflow, keeps the focus on cost-effective molecular testing. And there’s plans to announce a custom diagnostic test for a spoilage organism in December.
The future of diagnostic testing is one of uncertainty due to the numerous directions it could take. However, Lauer presumes, “It will be more of the same, with continued emphasis on accuracy, traceability, and verification. Specific results will need to be documented.”
Pascal is confident that pathogen testing volume will continue to increase, “with an emphasis on accessible molecular diagnostics, which can be quickly targeted to pathogens but also to quality indicator organisms."
Cromley is an editorial intern for Wiley.
Bio-Rad PCR Solution: Your Solution for Rapid and Accurate Results
The Bio-Rad PCR solution brings real-time PCR pathogen detection to low, medium and high throughput labs. The iQ-Check Prep combines the power of automation with a full range of real-time PCR test kits designed to reduce the time and cost associated with food pathogen detection without disrupting an existing workflow.
Veriflow™ – Innovative Molecular Detection made Simple, Accessible and Affordable
Veriflow™ represents the FIRST AOAC-RI certified Molecular Flow-based Assay. The patented vertical flow technology allows for the sensitivity of PCR, but with the ease-of-use of a handheld flow-based test. Veriflow™ delivers reliable results within 18-24 hours streamlining workflow and providing cost-savings. Test Kits include:
- Veriflow™ Campylobacter
- Veriflow™ Listeria monocytogenes
- Veriflow™ Listeria
- Veriflow™ Salmonella
Randox Food Diagnostics
Randox Food Diagnostics provide reliable, cost effective food safety screening solutions
Randox Food Diagnostics offer food safety screening solutions using the multi-analyte, semi-quantitative drug residue analyser; the Evidence Investigator. This multiplex platform detects antimicrobials, growth promoters and drugs of abuse in animals and foodstuffs. The Evidence Investigator provides simultaneous detection of an extensive list of compounds within various sample matrices.