Advice

Summary

Summary

The BD MAX Enteric Bacterial Panel (EBP) is an assay that detects common enteric bacterial pathogens (which can cause gastroenteritis) from stool samples in 2–3 hours; current standard culture methods take several days. Three fully‑published diagnostic test accuracy studies suggested that the BD MAX EBP has higher sensitivity than culture‑based methods for detecting bacterial pathogens in gastroenteritis. The cost of running each sample using the BD MAX EBP is £22.50, excluding VAT. The list price for the BD MAX System platform, on which several molecular diagnostic tests can also be run, is £85,000 excluding VAT.

Likely place in therapy

  • The BD MAX Enteric Bacterial Panel (EBP) is an assay using polymerase chain reaction (PCR) testing to detect bacterial pathogens in stool specimens from people with contagious gastroenteritis.

  • The BD MAX EBP would be used in microbiology laboratories, before, or instead of, bacterial culture methods, to test stool samples from people with suspected gastroenteritis in hospital and community settings.

  • If the test is negative, bacterial culture of the specimen is not normally indicated, but may be needed in some circumstances to test for other pathogens.

Effectiveness and safety

  • Three fully‑published diagnostic test accuracy studies were identified for the BD MAX EBP. Nine further studies were available as abstracts.

  • One manufacturer‑sponsored study (Harrington et al. 2015) compared the BD MAX EBP to routine diagnostic culture in 4242 specimens from adults and children.

  • One study conducted in the UK (Biswas et al. 2014) investigated the diagnostic accuracy and laboratory turnaround time of 3 different PCR assays for detecting bacterial gastroenteritis compared with routine culture techniques in 434 specimens.

  • One study (Anderson et al. 2014) evaluated the performance of the BD MAX EBP in preserved stool specimens that were then artificially spiked with pathogen strains at different concentrations.

  • The results from these studies suggest that the BD MAX EBP had higher sensitivity than existing culture‑based methods for detecting bacterial pathogens in gastroenteritis. Specificity was either equivalent or superior to culture methods. It was also reported to be substantially faster than those techniques.

Technical factors

  • The BD MAX EBP is run using the BD MAX System platform. Testing is automated, including cell lysis, nucleic acid extraction, PCR set‑up, target amplification and detection. Results are available in 2–3 hours, compared with several days for standard bacterial culture methods.

  • The BD MAX EBP detects pathogens including Salmonella spp., Campylobacter spp. (jejuni or coli), Shigellosis disease‑causing agents (Shigella spp. and enteroinvasive Escherichia coli) and Shiga‑toxin‑producing E. coli.

Cost and resource use

  • The list price of each BD MAX EBP assay is £22.50 per sample, excluding VAT.

  • The list price for capital purchase of the BD MAX System is £85,000, excluding VAT. The manufacturer produces several different assays that can be run on this system.

  • No published evidence on resource consequences solely attributable to the BD MAX EBP was identified.