The test Process

Point of Care Test (POCT) diagnostics by Lateral Flow Devices (LFD) provides reliable test results within minutes of biopsy collection. The speed and ease of use of the test platform allow near patient testing to aid diagnostics.

This allows rapid diagnosis and identifies treatment alternatives for the patient. This technology empowers clinicians to make decisions at the “point-of-care” and can have significant impact on health care delivery and the ability to address challenges of health disparities.

Fast and easy

A small amount of synovial fluid is subtracted from the patient's joint. The fluid can be analyzed within the hospital lab, and the results will be available within 15 minutes.

The results are categorized into three groups:

  • LOW risk of infection - CLP levels <14 mg/L
  • MODERATE risk of infection - CLP levels 14<50 mg/L
  • HIGH risk of infection - CLP levels ≥50 mg/L

The results are highly accurate and help the surgeon to create the right treatment plan for the patient.

Use in consultancy

Ruling out PJI is the number one priority at orthopedic consultancy. A missed PJI can have serious consequences, such as permanent loss of joint function, amputation, or loss of life.

Radiographs, medical history, and blood based diagnostic aids, such as C-Reactive protein (CRP) and erythrocyte sedimentation rate (ESR), are important tools for identifying PJI in consultancy. However, these available diagnostic tools are not capable of ruling out PJI.

Investigation of synovial fluid specimens increase the diagnostic accuracy for PJI, and synovial specimen testing allows the orthopedic consultant to make an informed patent management decision prior to surgery.

Lyfstone calprotectin for synovial fluid test has produced excellent diagnostic performance in clinical studies, and is available in a near patient testing format*.

* Near patient testing or point of care testing must always be carried out in accordance with the quality system at each institution.

Use in PRE-op

Pre-operative testing is vital for planning of surgical intervention and has dramatical influence on treatment cost and outcome for patients. Treatment of an infected prothesis should be customized for each patient and clinical procedure, where DAIR, one-stage or two-stage exchanges are possible surgical intervention alternatives.

As an example, the cost for a two-stage operation is significantly higher than a one-stage exchange and confirmation of high infection risk prior to operation by a highly accurate diagnostic test has a high potential for reducing number of two-stage procedures.

Use in intra-op

The final commitment to the surgical plan is based on intra-operational findings that confirms or conflicts with the tentative diagnosis. By adaptation of the near patient testing format*, the Lyfstone for Synovial fluid test can an on-site diagnostic aid on risk for infection within 15 minutes, and therefore assist evidence-based decision on patient management per-op.

Current diagnostic methodology is heavily dependent on culturing results from multiple intraoperation specimens and may require up to 14 days for confirmation of findings. As an intra-operational test, or a test performed on an interoperative synovial specimen, offers a rapid and reliable result assisting patient- management decisions in the early post-operative period.