Table 2.

Contemplation on Prof. Kahlmeter's criteria for new technologies (Kahlmeter, 2016).

Criteria	Contemplation
Generally applicable or restricted to certain infections?	In principle all growth-based rapid AST systems are generic and work with culture isolates. However, for polymicrobial clinical samples they must be coupled with specific probes or antibodies which provide ID. Therefore, specific test panels have been developed e.g., for respiratory, urinary, and blood samples. The pathogen load may not be high enough for direct analysis, and especially blood samples may require culturing prior to analysis. AST for fastidious, non-culturable, or intracellular pathogens call for NAAT. The complexity of the sample matrix affects the choice of the diagnostic system and the methods for sample preparations.
Capacity: how many organisms/agents per hour can be processed	DNA-arrays and PCR systems (including multiplexed cassette designs) have a high throughput capacity. Mass-spectrometry performed on PCR products can handle hundreds of samples per hour in central laboratories. In outpatient clinics speed is more essential than the capacity. High multiplexing (parameters per sample) and high-throughput capacity (number of samples) may be challenging to combine. Progress in NAAT, immunodiagnostics, biosensor technologies and microfluidics has yielded several systems capable of analyzing tens of samples per day or even during a single work shift.
Has the technology been validated against reference methods?	So far quite few quick technologies have received FDA-approval. Currently they include PCR-tests, cartridge-based NAAT-systems and Accelerate Pheno (automated microscopy). Several clinical trials are in progress to achieve CE-marking or FDA-clearance.
Are there any reference installations?	Commercial analysis systems in general do have, and manufacturers tend to publish successful clinical trials. However, finding a lab which lines up to the specific needs may be challenging.
Is scientific literature available?	For mature commercial systems scientific references can be fairly easily found. For near-market products this is much more challenging. Companies often only declare on-going tests, but provide only limited info about the progress. Scientific articles typically present proof-of-concept level data obtained with isolated cultures spiked into sample matrices.
When on market?	Many systems are already available, but they may have a limited scope for ID/AST. Due to lack of clinical data, some systems have a “research use only” status. Some have been accepted only for veterinary use. Commercially mature products include several NAAT systems, FISH-systems and immunodiagnostic system.