Rapid and quantitative detection of neutrophil gelatinase-associated lipocalin in synovial fluid using fluorescence immunochromatographic test strips for diagnosing prosthetic joint infections.

ABSTRACT

OBJECTIVES: We developed a rapid and highly sensitive method for quantitatively analyzing neutrophil gelatinase-associated lipocalin (NGAL) levels in synovial fluid and assessed its diagnostic performance for prosthetic joint infection (PJI). DESIGNS OR METHODS: We conducted a preliminary analysis of the performance of the developed test strips utilizing clinical specimens to verify their sensitivity, precision, specificity and accuracy. RESULTS: The standard curve of the test strip NGAL values was linear. The detection limit and the limit of quantification (LOQ) were 12.37 and 29.49 ng/mL, respectively, and the approximate detection range was 12.37 to 1250 ng/mL. The interbatch and intrabatch precision of the test strips were each less than 10%, and the cross-reaction rate with competitors' systems was less than 1%. CONCLUSIONS: The test strips can be used for the determination of synovial fluid NGAL levels; the test strips are highly sensitive, precise, specific, and stable. Furthermore, they demonstrated good performance in clinical verification.