What is the Accuracy of a Rapid Strip Test That Detects D-lactic Acid in Synovial Fluid for the Diagnosis of Periprosthetic Joint Infections?

Abstract

BackgroundD-lactic acid is a specific marker produced almost exclusively by bacterial species; thus, the appearance of this marker in synovial fluid may indicate periprosthetic joint infection (PJI). Recently, studies have investigated the accuracy of enzyme-linked laboratory tests that detect D-lactic acid in synovial fluid to diagnose PJI. However, to our knowledge, no studies have determined the usefulness of rapid strip tests that detect D-lactic acid in synovial fluid in the diagnosis of PJI.Questions/purposes(1) What is the best cutoff value for the rapid D-lactic acid strip test for diagnosing PJI? (2) What are the diagnostic accuracies (sensitivity, specificity, positive predictive value [PPV], and negative predictive value [NPV]) of the rapid D-lactic acid strip test and two different rapid leukocyte esterase (LE) strip tests?MethodsThis prospective study enrolled 157 patients who underwent revision THA or TKA from May 2021 to February 2022 at a single orthopaedic center. Seventy percent (110 of 157) were eligible for analysis; 10% of these patients (15 of 157) were excluded based on the exclusion criteria (causes of revisions and additional comorbidities that may interfere with the results), and 20% (32 of 157) of the synovial fluid samples could not be tested (dry taps and blood-contaminated samples that could not be centrifuged). We performed the following off-label diagnostic tests on synovial fluid samples collected from all patients: the D-lactic acid strip test (QuantiQuickTM, BioAssay System), two different LE strip tests (10 EA from ARKRAY and BM 10 from BioMaxima). Differently colored strips were marked with symbols (from [-] to [++++] for D-lactic acid and from [-] to [+++] for LE tests) according to the manufacturers’ instructions. For the LE tests, results were different for (++), which corresponds to a minimal value of 250 leu/mL for 10 EA and 125 leu/mL for BM 10 tests. The diagnostic standard for the presence or absence of PJI in this study was the International Consensus Meeting (ICM) 2018 criteria; based on these criteria (without the application of an LE test as a minor criterion), all patients were assessed and divided into two groups. Patients who did not meet the criteria for PJI and underwent revision for aseptic loosening, implant malposition, instability, or implant damage were included in the aseptic revision total joint arthroplasty group (68 patients). Patients with a fistula penetrating the joint, those with two positive culture results of the same pathogen, or those with ≥ 6 points according to ICM 2018 minor criteria were enrolled in the PJI group (42 patients). To ascertain the best cutoff value for the rapid D-lactic acid and both LE strip tests for diagnosing PJI, we used collected results, generated a receiver operating characteristic curve, and calculated the Youden index. To determine the accuracies of the diagnostic tests, we calculated their sensitivities, specificities, PPVs, and NPVs against the diagnostic standard (the ICM 2018 criteria).ResultsThe best cu...

CORR Insights®: What is the Accuracy of a Rapid Strip Test That Detects D-lactic Acid in Synovial Fluid for the Diagnosis of Periprosthetic Joint Infections?

“…The authors concluded that a rapid off-label DLA strip test is valuable for diagnosing PJI, even though it has limitations, such as observer interpretation of the colorimetric aspect of the test and obliteration of the color change by blood. The study by Grzelecki et al [1] is important for several reasons. First, their work moves clinicians closer toward a specific, real-world practical information test.…”

“…Going forward, improved infection diagnosis will likely depend on identifying the unique biophysical properties of bacteria and its biofilm. We now know from Grzelecki et al [1] that DLA is unique to bacteria, and it can be used for the diagnosis of infection if the colorimetric limitations can be overcome and once we determine whether DLA production is universal across all bacteria.…”

“…In their article, Grzelecki et al [1] discussed the utility of serum or synovial sample centrifugation before strip testing. Centrifugation permits removal of color contaminating red blood cells.…”

“…Daniel Schlatterer DO, MS 1 Where Are We Now? P eriprosthetic joint infection (PJI) is a devastating complication for which effective treatment begins with an accurate diagnosis.…”

“…P eriprosthetic joint infection (PJI) is a devastating complication for which effective treatment begins with an accurate diagnosis. Various synovial and serum markers are used for the diagnosis of PJI and are included in the newest definitions of PJI [1][2][3][4]6], but current diagnostic tests and scoring systems have limitations [1][2][3][4][5]6]. For example, various serum tests take time to complete, and scoring systems require knowledge or memorization of each metric and its range of accepted values.…”