The Leukocyte Esterase Test Strip Is a Poor Rule-Out Test for Periprosthetic Joint Infection.
The urinary leukocyte esterase (LE) test strip has been suggested as a good screening test for periprosthetic joint infection (PJI). The purpose of this study is to compare the diagnostic profile of LE assays from different manufacturers and determine whether the LE test strip is a good rule-out test. Synovial fluid samples (N = 344), sent to 1 laboratory for PJI testing, were used in this prospective study. Four different tests for synovial fluid LE were simultaneously evaluated for their performance in detecting white blood cell (WBC) positive samples (>3000 cells/µL). Both neutrophil elastase immunoassays demonstrated greater sensitivity than urinary LE test strips (92.0% and 90.8% vs 72.4% and 80.3%; all P < 0.011). Fifty-three percent of false-negative urinary LE test strip results clearly missed the presence of elevated levels of synovial fluid LE. Invalid urinary LE test strip results were 4-fold more likely among WBC (+) compared with WBC (-) samples (27.0% vs 6.8%; P < 0.0001). The combined failure to detect an elevated WBC count, because of either false-negative or invalid results, was 47.1% and 41.4% for the Roche and Siemens test strips, respectively. This study agrees with the existing literature demonstrating that the LE test strips are among the lowest sensitivity tests for PJI. The urinary LE tests strips should not be used to rule-out PJI, as they often fail to detect abundant levels of LE in synovial fluid. Instead, it is more appropriate to use the (++) LE test strip result as a secondary confirmatory rule-in test for PJI because of its high specificity.