Lyfstone
calprotectin

A new advancement in diagnosing PJI

The Lyfstone Calprotectin for synovial fluid is an accurate diagnostic aid that identifies the risk of infection within 15 minutes.

The problem with infections

Perisprosthetic Joint Infection (PJI) is one of the greatest challenges in orthopaedics. PJI can lead to emotional, financial and physical trauma for patients. A fast and accurate diagnosis of PJI is vital to making the right treatment decisions.

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A new advancement in diagnosing PJI

In a prosthetic joint, the first priority is to reliably rule out infection.The Lyfstone test is a CE-IVD labelled Point of Care test, which measures the amount of Calprotectin in Synovial Fluid. Calprotectin is abundantly present in neutrophils. Presence of neutrophils is a hallmark of PJI, and a massive release of calprotectin occurs upon encounter with pathogens. Elevated levels of calprotectin are proven indicators of both acute and chronic PJI.

Fast and easy

To assess the risk of periprosthetic joint infection, a small amount of synovial fluid is extracted from the patient's joints.

The Lyfstone test requires only 20 μl and generates results in 15 minutes. The easy sample work-up allows implementation at any stage of care, from consulting to pre-op to per-op.

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Clear and reliable risk indicators

The lateral flow rapid test is combined with the Lyfstone app to give an exact quantitative measurement of the level of calprotectin in Synovial fluid. Just hold the smartphone above the sample and align the screen layout with the support frame.
The calprotectin concentration and the risk stratification group of the sample is displayed on the screen.

  • LOW risk of infection - CLP levels <14 mg/L
  • MODERATE risk of infection - CLP levels 14-49 mg/L
  • HIGH risk of infection - CLP levels ≥50 mg/L

Clinic­ally proven

In a prospective clinical study of 123 patients at a leading US Hospital system using the MSIS-13 criteria as comparator, the Lyfstone Calprotectin test showed excellent sensitivity (98.1%) and specificity (95.7%). The calprotectin test outperformed blood-based PJI diagnostic tests such as CRP and ESR, confirming its diagnostic utility.

Source: Diagnostic Utility of a Novel Point-of-Care Test of Calprotectin for Periprosthetic Joint Infection after Total Knee Arthroplasty: A Prospective Cohort Study. https://clinicaltrials.gov/ct2/show/NCT03694925