Conclusions: Our results indicate that a Culture + PCR algorithm provides the optimal balance of cost and risk days averted at varying isolation, prevalence and screening coverage scenarios
Update: The confirmation and identification of suspect carbapenemases at North West London Pathology/ICNHT is now done by RESIST rather than PCR further reducing the cost per risk day averted for the preferred algorithm
Announcement of change from PCR to RESIST in the preferred screening algorithm :
Since the launch of several new products onto the market in 2017, Microbiology at NWLP have conducted an extensive evaluation of products currently available, testing time to result, accuracy, reproducibility, technical skill level required, cost and ease of workflow. A new testing pathway is currently being introduced with a live test of patient samples due to start imminently.
The new test being introduced is the Immunochromogenic lateral flow RESIST O.K.N test (Bioconnections), which can be performed on all enterobacteriaceae and will detect KPC, NDM and OXA48 direct from the screening agar – i.e. 90% of the confirmed CPEs detected to date..
The first immunochromatography tests to identify carbapenemases,
The test permits detection of, and differentiation between, the major carbapenemase families so the results are acceptable for entering into PHE's enhanced surveillance system for carbapenemase-producing Gram-negative bacteria
RESIST gives results from culture in 15 minutes. It is simple and reliable, matching market leading PCRs for both sensitivity and specificity at approximately one-third the consumables cost with no requirement for equipment
Patented in 2016 (WO 2016162564 A1) the process is a rapid and accurate way of identifying carbapenemases.
All products in the RESIST range are CE marked.
OXA-48 K-SeT was launched at ECCMID 2015 with presentations that support its efficacy. Subsequent UK evaluations have confirmed 100% sensitivity and specificity
KPC K-SeT was launched in August 2015, U.K & European evaluations confirm 100% sensitivity and specificity
RESIST-3 O.K.N. K-Set launched in November 2016 brings together OXA-48 & KPC K-sets and adds NDM to produce a product that covers 95% of isolated .carbapenemases in the UK. The first published evaluation of RESIST-3 confirms 100% sensitivity and specificity.
RESIST-4 O.K.N.V. K-Set launched in February 2018 adds VIM to the successful RESIST-3 O.K.N. kit. The kit covers over 98% of carbapenemases according to the PHE AMRHAI data updated October 2016