Quality Systems and Quality Assurance

Today, the food safety testing laboratory is challenged by escalating demands measured against declining budgets and resource constraints. To combat these challenges, quality systems and quality assurance are vital to maintain accurate, valid and reproducible food pathogen testing results. Roka Bioscience has integrated advanced system process controls in the Atlas System and its assays, making it easier than ever for laboratories to achieve the highest levels of quality, speed and confidence in their food safety testing.

Atlas® System
This system is a fully automated molecular pathogen detection system that provides the flexibility and efficiency to help laboratories meet mounting pressures without having to add resources. By combining a proven molecular technology with a complete “samples in, results out” system, the system eliminates the time-consuming upstream manual processing associated with traditional methods while providing a rapid and accurate result. It includes a number of integrated quality process controls that ensure accuracy and reliability of sample results.

Internal Process Controls
Retesting samples due to operator error in processing can cost significant time and resources to any laboratory. The Atlas System has a series of internal process controls that ensures accuracy and reliability of results that eliminates steps prone to operator error. Every reaction also includes an internal control that confirms that the purification, amplification and detection of the target have been performed properly. This guarantees that all automated and molecular processes have been performed accurately.

Liquid Level Sensing
Utilizing liquid level-sensing technology, the system can detect the dispensing and aspiration of each reagent and sample into the reaction tube, ensuring the accuracy and reproducibility of each result. This eliminates inaccurate pipetting while ensuring the appropriate amount of liquid is pipetted.

Sample Tube Bar Coding
A comprehensive bar code system allows full traceability from enrichment to result, eliminating any chance of transcription errors or mislabeling of samples. All reagent and system fluids on board are tracked and inventoried by the instrument. This ensures that an expired or mislabeled reagent is not mistakenly added to the process.

Reagent Dispense Verification
This provides accurate and reproducible dispensing of assay fluids. It eliminates potential operator pipetting errors found in non-automated systems. This verification also ensures that accurate amounts of sample and reagent are dispensed into every single reaction tube.

Reagent and Inventory Monitoring
All on-board reagents are monitored through bar codes and radio-frequency identification tags. It minimizes waste by optimizing reagent usage. Expiration dates are also monitored to ensure all reagents are valid. This monitoring provides complete electronic audit trail linking the sample result to reagents.

Proven Technology
Automation partnered with powerful molecular technology provides a complete testing solution. Roka technology provides levels of specificity that ensure only the target pathogen is detected. The Atlas System Detection Assays combine the advantages of rRNA amplification with an innovative target-capture step to further increase the detection of low-level bacterial species in even the most difficult food and environmental samples. This is a postlysis step that cross-links the specific target rRNA to the magnetic capture bead, allowing concentration and purification of only the target rRNA for amplification. Target capture is followed by transcription-mediated amplification, a robust, isothermal amplification in only 30 minutes. Finally, a specific probe is added to the amplified target and presented for detection. This allows for a low background wide, signal-to-noise platform that minimizes false positives.

As testing volumes have increased, the number of available platforms and diverse complexity of the associated tests have also. Amid this complexity, one molecular platform stands out: the Atlas System by Roka Bioscience. Roka delivers the most accurate and reliable test results for food pathogens regardless of sample type. By combining automation with the full power of molecular technology and its internal quality controls, the Atlas System enables laboratories to make more confident, informed decisions.