Latest NICE Medical Innovation Briefing published


Superbug kit could result in quicker diagnosis of carbapenemase-producing organisms such as E. coli

A ‘superbug kit’ which can detect carbapenemase-producing organisms such as E. coli, Kebsiella, and Enterobacter is the subject of a newly-released Medtech Innovation Briefing published by the National Institute for Health and Care Excellence.

The document – exploring the eazyplex SuperBug kit manufactured by Optigene - aims to support NHS and social care commissioners and staff who are considering using new medical devices and other medical or diagnostic technologies. The information provided includes a description of the technology, how it’s used, and its potential role in the treatment pathway.

It also includes a review of relevant published evidence and the likely costs of using the technology, but it is only meant as guidance and does not make any recommendations on the value of using the technology. Whether or not to use the product described is entirely the choice of local staff.

However, the briefing will help to avoid the need for organisations to produce similar information, so saving staff time, effort and resources.

The latest briefing concerns the The eazyplex SuperBug kits, which are qualitative in vitro diagnostic tests that detect bacteria that carry genes for the production of carbapenemases and selected extended-spectrum beta-lactamases (ESBL).

These kits would be used to determine the presence of carbapenemase-producing organisms (CPOs) and ESBL genes in people when colonisation with these organisms is suspected.

These are Gram-negative bacteria that are usually resistant to carbapenems, the 'drugs of last resort' for many bacterial infections.

They include enterobacteriaceae and non-fermenting bacteria which have acquired genes that make carbapenemases, enzymes that break down the carbapenem class of antibiotics.

However, many of these carbapenemase enzymes can also cause resistance or reduced susceptibility to all or most members of the beta-lactam class of antibiotics.

Detection of ESBL genes can also identify possible resistance to the extended-spectrum cephalosporin class of antibiotics.

The eazyplex SuperBug kits and the Genie II platform are molecular diagnostic systems, which use LAMP to detect and identify carbapenemase- and selected ESBL-encoding genes in rectal swab samples within 30 minutes. They would give results faster than the first stage of standard microbiological culturing used to identify CPO colonisation and would also provide more information about the type of carbapenemase present.

The briefing states: “The eazyplex SuperBug kits would be used in place of standard culture-based tests to determine the presence or absence of CPOs, although supplementary and confirmatory tests such as antimicrobial-resistance testing may still be needed for CPO-positive samples.

Using these kits could result in a quicker diagnosis of CPO colonisation (in rectal swabs) or infection (from other specimen types) and allow healthcare providers to implement local infection control protocols to prevent transmission to other susceptible people.

This could also allow CPO carriage to be more quickly excluded, so that people do not have to wait so long to be released from isolation.

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NICE Medtech Innovation Briefings are commissioned by NHS England and produced in support of the NHS 5 Year Forward View, specifically as one of a number of steps that will accelerate innovation in new treatments and diagnostics.