Identifies the risk of periprosthetic joint infections within 15 minutes directly within the operating theatre.

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. The 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.

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

LYFSTONEⓇ ORTHOPEDIC TESTS

The number of joint prosthesis surgeries is increasing every year, among which the number of hip and knee replacement surgeries stands out. Total knee arthroplasty (TKA) rates have risen dramatically in recent decades, with Germany ranking among the top countries in terms of TKA prevalence. According to recent health studies on TKAs in Germany, the number of surgeries is expected to rise by 43% to 299 per 100,000 inhabitants by 2050, for a total of 225,957 primary TKAs.

CLINICALLY PROVEN

In a prospective clinical study of 123 patients at a leading US Hospital 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.

CLEAR AND RELIABLE RISK INDICATORS

To get the result, the user must place the smartphone on top of the test and line the screen layout with the support frame. Calprotectin concentration of the synovial fluid and risk stratification group will be presented on the screen.

There are 3 possible results:

• LOW risk of infection

• MODERATE risk of infection

• HIGH risk of infection

BENEFITS

Time-saving

Getting results from laboratories can take hours or even days. The Lyfstone^Ⓡ rapid test is an innovative diagnostic aid that identifies the risk of infection from the synovial fluid after 15 minutes. With the help of this method, the infection can be ruled out quickly, on the spot, in the presence of the patient. This saves lots of valuable time, which is extremely important in the case of prosthetic joint surgeries.

Precise results, directly within the theatre

Conventional blood cell test results can only show that there is an infection in the body, but not exactly where. For the Lyfstone^Ⓡ Calprotectin orthopedic test, the sample is taken directly from the joint fluid, so the location of the possible infection can be accurately determined from the result.

Lyfstone^Ⓡ Reader app

The first step in using the Lyfstone^Ⓡ orthopedic test is to take a sample from the patient’s synovial fluid. Because of the generally high viscosity of the joint fluid, the biopsy must be diluted before being placed on the test. This can be easily performed by the buffer tube that is part of the testing kit. The buffer tube also helps in the accurate measurement of the joint fluid sample.

The result of the test can be evaluated after 15 minutes, which is assisted by the Lyfstone^Ⓡ Reader app. The Lyfstone^Ⓡ app works on both iOS and Android devices and can be downloaded from Google Play or App Store.

ORDER FROM ENDOCON

Lyfstone^® has successfully developed a CE-IVD labelled Point of Care test. Contact endocon GmbH if you are interested in buying Lyfstone^® Calprotectin for Synovial Fluid in Germany and Austria by using the forms below.