Evaluation of Automated Assays for Measuring Serum Hyaluronic Acid: For the Diagnosis of Rheumatoid Arthritis

ABSTRACT

BACKGROUND: Hyaluronic acid (HA) is present in the connective tissues wherein it functions as a lubricant. HA is known to be increased in both synovial fluid and serum when inflammation occurs in the joint. We measured serum HA concentrations by automated assays and determined its reference interval and its usefulness as a diagnostic marker in patients with rheumatoid arthritis (RA). METHODS: Serum specimens collected from 121 healthy individuals and 253 patients with various arthritis were used for measuring HA with two automated assays, namely, LPIAACE (Mitsubishi, Japan) and LT Auto Wako (Wako, Japan). The association between serum HA concentration and the diagnosis of RA was estimated by receiver operator characteristic (ROC) analysis and multivariate logistic regression. RESULTS: The 95th percentile upper reference limit of serum HA was 57.28 ng/mL (90% confidence interval [CI], 46.30-68.20 ng/mL) for LPIAACE and 72.64 ng/mL (90%% CI, 57.30-85.70 ng/mL) for LT Auto Wako. Area under the ROC curve values of serum HA for discriminating the RA group from the non-RA group were 0.68 for LPIAACE and 0.70 for LT Auto Wako. The odds ratio for serum HA in predicting RA was 1.02 (95% CI, 1.02-1.04) for LPIAACE and 1.03 (95% CI, 1.02-1.05) for LT Auto Wako. CONCLUSIONS: This study provides a reference interval for serum HA concentrations in Koreans. This result suggests that the serum HA concentrations could be helpful as a complementary marker for discriminating RA from other types of arthritis, as well as distinguishing patients with RA from healthy controls.