Synovasure® Alpha Defensin Lateral Flow Test Kit
Topic Status Complete
Synovasure® Alpha Defensin Lateral Flow Test Kit for the assessment of periprosthetic joint infection.
Outcome of the appraisal
The use of Synovasure® alpha defensin testing shows promise in the diagnosis of peri-prosthetic hip and knee infection but the evidence does not currently support routine adoption. Synovasure® has the potential to further the diagnosis in patients with equivocal results from conventional testing but more convincing evidence is needed. HTW therefore recommends further research in this group of patients to define diagnostic accuracy, clinical outcomes and cost consequences of the use of synovasure® in addition to standard investigations.
Why was this topic appraised?
This topic was referred to HTW by the manufacturer of the Synovasure® alpha defensin test (Zimmer Biomet). Periprosthetic Joint Infection (PJI) is an uncommon but serious complication of hip and knee replacement surgery, affecting approximately 1% of hip arthroplasties and 1% to 2% of knee arthropIasties. PJI is difficult to diagnose and the use of the Synovasure® alpha defensin test may improve detection rates and ultimately result in more appropriate patient management.
Plain language summary
HTW assessed the Synovasure® Alpha Defensin Test to help decide whether it should be made available to NHS Wales for diagnosing Periprosthetic Joint Infection.
Periprosthetic Joint Infection isn’t common, but it’s a serious complication that can happen after hip and knee replacement surgery. It can be difficult to diagnose in some people, but straightforward in others.
Synovasure® has the potential to give more people the correct diagnosis than current tests. This could mean that more people get the care they need, without delay. Synovasure® could be particularly useful in people who are hard to diagnose using the tests we currently use. However, there needs to be more evidence to prove this.
HTW’s Guidance doesn’t support routine use of this diagnostic test. HTW suggests that new research in this group of people should consider how use of Synovasure® in addition to standard tests compares to using the standard tests alone in terms of accuracy, outcomes for patients and costs.
Topic Exploration Report
TER015 10.2018
Evidence Appraisal Review
EAR008 06.2019
Guidance
GUI008 06.2019
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