The SmartWound® RESOLVE Infection Sensor[1]

A pilot clinical study was carried out using the SmartWound swab test (referred to as the SPaCE diagnostic) on patient volunteers in 4 NHS hospitals.

The SPaCE pilot diagnostic study tested the accuracy of the novel point of care sensor on volunteers with a burn wound infection.

The results of the pilot study were published in November 2020 in The Journal of hospital infection 106(4):726-733 (DOI: 10.1016/j.jhin.2020.09.033).

This  pilot study concluded that the diagnostic provided valuable  and timely data to support clinical decision-making on wound infection  at point of care (PoC) .

The Technology – brief overview.

The SPaCE PoC (point of care) swab sensor kit is a cost effective, fast method of assessing wound health. Wounds are swabbed as part of standard care, the swab placed in our patented vesicle gel, left for up to 15 minutes in the hand-held device while awaiting colour change. Bright green colour means that virulence factors associated with SPaCE pathogens were detected.

The SPaCE wound swab sensor responds to the four key microbial pathogens found in infected wounds:

  • Staphylococcus aureus
  • Pseudomonas aeruginosa
  • Candida species
  • Enterococcus faecalis

The colour change is easily seen by eye (right): Fluorescent green response = SPaCE pathogen positive; dull orange: SPaCE pathogen negative.

Virulence factor detection

These virulence factors are secreted as the microorganism invades and colonises host tissue at the so-called Critical Colonisation Threshold, CCT [2] . The virulence factors lyse the vesicle releasing fluorescent dye which is easily detectable by eye. Recent studies at Bath have shown that a different approach to CCT detection could be used: The wound can be swabbed, the swab immersed in the vesicle suspension, and the result observed in under 1 hour.

References

[1] Patent number US9499852 B2 Priority date12/01/12

[2] N.T. Thet, D. R. Alves, J. E. Bean, S. Booth, J. Nzakizwanayo, A.E.R. Young, B. V. Jones, A.T.A. Jenkins, ACS Applied Materials & Interfaces 2016, 8, 14909- 14919

How SmartWound® RESOLVE sensor works