eazyplex SuperBug kits for detecting carbapenemase-producing organisms

Level of innovation

Two specialist commentators noted that several kits are available for detecting carbapenemase-producing organisms (CPOs) and 1 considered that the eazyplex SuperBug kits are only a minor variation on these technologies. However, 2 specialist commentators described the use of loop-mediated isothermal amplification in this application as innovative and 1 added that this makes it faster than other polymerase chain reaction based tests.

Potential patient impact

Four of the specialist commentators considered that quicker identification of people with CPOs would allow more appropriate antimicrobial therapy. Broad spectrum antibiotic use in people with negative results may be avoided, whereas optimised antimicrobial therapy could be used in people with positive results. One specialist commentator advised that detection of CPOs in rectal swabs only indicates colonisation which may not need antibiotic therapy. Therapy should only be considered if CPOs are detected in a clinically significant specimen type, which is possible using the SuperBug CRE kit.

All 5 specialist commentators suggested that quicker identification of people with CPOs would also improve infection control. Being able to rule out CPOs would avoid the need to treat the person in isolation, so that they would have a better healthcare experience. One commentator added that faster rule-out may also prevent people being refused admission to long-term residential care or transfer to other hospitals.

One specialist commentator considered that people with positive results would also benefit from better infection control regarding planning of surgery and avoidance of urinary catheterisation.

Potential system impact

One specialist commentator highlighted that the technology could be used by laboratory staff of any discipline or grade, and it is possible to do the testing at any time of the day. One commentator advised that the Genie II platform is very small so takes up little space in the laboratory, however 1 other indicated that space and staff resources would be needed to run the test in the laboratory.

One specialist commentator highlighted that the real benefit of this test would be in getting a negative result, which could allow patients to be released from isolation at an earlier stage, so freeing up a limited resource and resulting in significant cost savings. Two specialist commentators also suggested that using these tests could reduce the risk of transmission of CPOs to other people.

Two specialist commentators did not consider that the tests would result in cost savings because they are significantly more expensive than current practice. However, 2 commentators considered that there could be overall cost savings because of the early release of patients from isolation facilities, despite the greater direct costs to the laboratories. One considered that the prevalence of CPOs would need to be above 2% for this to happen. They also considered that the higher test cost would have to be offset by the reduced risk of CPO transmission, which would in turn depend on isolation room availability in the first instance.

General comments

Three commentators considered that the major limitation of these tests is that their diagnostic accuracy with rectal swab samples has not been evaluated. Two also highlighted that no evidence is currently available to show that a single eazyplex SuperBug test has the same sensitivity as 3 successive culture tests. However, they thought that it was plausible that the eazyplex SuperBug tests could be more sensitive than culture.

One specialist commentator considered that the SuperBug complete A kit would be more suitable for testing cultures than rectal swabs, because OXA-58 variants are associated with Acinetobacter, a hospital-acquired pathogen. However, 1 commentator also noted that the absence of the OXA-181/-232 variant in the SuperBug complete A kit reduces its effectiveness especially in the UK.

One specialist commentator also identified patients' refusal to have rectal swabs as a possible limitation of the eazyplex SuperBug kits, and considered that the technology may need to include stool samples as potential test material.

Two specialist commentators highlighted that CTX enzymes are the most common extended-spectrum beta-lactamases (ESBLs) found in E. coli, and are therefore the most common ESBL circulating outside hospitals. They considered that finding a positive result for these isolates in people in hospital might prompt different infection control, in which patients who would not typically be isolated are isolated. Another added that this could cause problems if patients with positive results were to be isolated, which would block single rooms needed for patients with higher priority pathogens.