Testing for Pathogens
In 2013, Bio-Rad Laboratories, a Calif.-based food safety solutions provider, introduced a technology that marries process innovation and advanced data collection. The iQ-Check Prep is an automated PCR solution that tests for foodborne pathogens. The first element of the process is a line of highly nutritive broths that minimize enrichment time. After enrichment, the user takes samples from the broth and transfers them to a 96-deep well plate. The batch of samples is placed on the automated processing instrument which takes over the sample preparation and places it on the PCR plate. The user then removes the plate, seals it, and places it in the thermal cycler for PCR detection.
The system provides several advances, such as minimal handling of the sample to reduce error. In addition, the iQ-Check Prep uses air displacement pipettes that operate like plungers instead of a conventional vacuum system. This means there is no liquid passing through the system which could cause contamination. The instrument also features a liquid detection sensor that verifies if the lab technician did, in fact, transfer the liquid samples. The user can be confident therefore that a negative reading means that a sample is clean because no pathogenic bacteria are in the sample, not because there was no sample present to be tested.
This last innovation is part of the traceability capability the iQ-Check Prep offers. The machine documents each step of the process and exports information to the user’s laboratory information management system. At a later date, users can look up previously tested samples and find that a sample was actually present in the instrument, as well as review the results of the PCR assay. This documentation is valuable to meet documentation requirements.
Offering a variety of pricing solutions for companies, Wendy Lauer, senior product manager of the Bio-Rad Food Science Division, explains, “We look at it from a process standpoint. We want to help our customers optimize their workflow and traceability, so we work with them to make sure it is a fit for their lab.”
Another facet of FSMA is the requirement for preventative control systems modeled on Hazard Analysis and Critical Control Points (HACCP) for facilities that manufacture, process, pack, or hold food for human consumption. “We think that the proposed rule provides a science- and risk-based, as well as flexible, approach to preventing hazards in foods,” states Jenny Scott, senior advisor, office of food safety of the FDA. “It is based on internationally recognized principles of HACCP and best practices of industry.”
Preventing these food hazards would include sanitation controls. Providing HACCP management capabilities, BioControl Systems recently launched LIGHTNING MVP ICON system to test for cleanliness through the detection of adenosine triphosphate (ATP), a molecule found in most food residues as well as bacteria, yeast, and mold. The system consists of a handheld device to take readings and PC software for data analysis and tracing. The handheld unit can be used as follows to validate cleaning effectiveness and manage HACCP parameters.
Surfaces. A proprietary sampling device containing a luciferin/luciferase reagent is used to swab a surface. The reagent reacts with any ATP it finds on the swab to produce light. The ICON reads the light signal and interprets its intensity to determine where it falls within Pass/Warn/Fail parameters.
Rinse Water. A device designed specifically for sampling liquids collects a rinse water sample that is tested by the ICON to verify ATP thresholds in liquid samples are not exceeded.
Other HACCP Parameters. External probes to test for pH, temperature, and concentration can be connected via USB connection to the ICON. Acceptable thresholds for each can be entered into device and stored, and measurements are compared to these metrics to produce Pass/Fail results.
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