NICE has developed a medtech innovation briefing (MIB) on the Xpert Carba-R to identify people carrying carbapenemase-producing organisms.
Xpert Carba-R is a qualitative in vitro diagnostic test that detects organisms that have carbapenemase genes and differentiates between the 5 most prevalent carbapenemase gene families. Three diagnostic accuracy studies were identified involving a total of 990 clinical bacterial isolates and faecal samples. One study reported an overall test sensitivity of 94%. Reported test results for individual carbapenemase genes ranged from 71% to 100% for sensitivity, 77% to 99% for specificity and 81% to 93% for positive predictive values. Negative predictive values were only reported in 2 studies, but both reported a value of 100%. The Xpert Carba-R test must be run on the GeneXpert molecular diagnostic system, which costs between £18,077 and £121,308 depending on the module configuration, excluding VAT. Each single-test Xpert Carba-R cartridge costs £30, excluding VAT.
MIBs provide a description of the medical technology, including its likely place in therapy, the costs of using the technology and a critical review of the strengths and weaknesses of the relevant published evidence.
Their purpose is to provide objective information on device and diagnostic technologies to aid local decision-making by clinicians, managers and procurement professionals. By making this information available, NICE helps to avoid the need for NHS organisations to produce similar information for local use.
MIBs are not NICE guidance. They differ in format, contain no judgement on the value of the technology and do not constitute a guidance recommendation.
MIBs are commissioned by NHS England and produced in support of the NHS 5 Year Forward View, specifically as one of a number of steps which will accelerate innovation in new treatments and diagnostics.