Table 4.

Typical end-user requirements for assays that determine MOs in the food-chain. The order of listed requirements is arbitrary.

Requirement	Note
Low cost	Test outcome should provide sufficient information to make a contemplated decision at costs that balances investments and consequences. Costs include overhead, maintenance, personnel, laboratory footprint, disposables, etc.
One-pot reaction	Complete preparation and processing in a single vial/tube. No addition of reagents required (~ easy-to-use).
Range of application/ operation	Versatile: sensu lato applicable to fresh and processed food matrices, and/or for samples from feed, plants, and animals. Suitable for all relevant bioagents.
Multi-analyte/multiplex	Able to determine multiple targets in a single analysis run.
High-throughput	Multiple samples run simultaneously.
(relative) accuracy	Free from systematic and random errors.
Reproducible (precise)	No or insignificant variation (in-)between runs, days, machines, analysts, etc.
Repeatable	No or insignificant variation between laboratories, batches, lots.
(Relative) specificity	100% specific compared to the reference method (no false positives); able to distinguish at the strain level.
(Relative) sensitivity	100% sensitive compared to the reference method (no false negatives); able to detect (viable) MO at required sensitivity a. Excellent signal-to-noise ratio.
Confirmation of analyte	Juridical problems arise when the identity of the analyte is not confirmed. There should be a reliable answer to the question: what is the degree of certainty of the identity of the aimed target giving the result?
Automable	A stand-alone instrument with limited hands-on time. The frequency of personnel attention is low.
Portable/Point-of-care (PoC)	Ambulant, performing analysis in/at/on-line of the food-chain with interpretable results available on site.
User-friendly and fail-safe	Easy-to-use, performed by non-skilled personnel, preventing facultative and inherent errors. In other words, the assay is rugged and gives the same result even when test conditions such as incubation times, operator, pH, reagent concentrations, temperature, etc. vary. This also includes safe to use.
Easy to interpret	Analysis data give a transparent, unambiguous, and understandable result
Instantaneous result	Results available real- or near-time. Although not meaning the same, time needed for the whole analytical process from sample collection to result (TTR) should be short. In practice, TTR can imply a result within a working day/before the next phase in the food-chain.
No sample treatment	The test portion is obtained directly from the laboratory sample.
Robust	Reliable operation under e.g., humid, varying temperatures, bumping conditions. No drift/long-term stability.

^a Required sensitivity: Detection level at which the MO does not pose a health risk or at the legislative norm.