Distribution of serum amyloid A and establishment of reference intervals in healthy adults

BACKGROUND: Serum amyloid A (SAA) plays a critical role in acute or chronic and is used in clinical laboratories as an indicator of inflammation. The elevated SAA is closely related to inflammation‐mediated diseases, such as liver diseases, autoimmune diseases, metabolism‐related diseases, amyloidosis, and tumors. However, there is no unified population reference interval for SAA. This study aimed to investigate the distribution of SAA in healthy Chinese adults 20‐79 years of age and to establish its population reference interval. METHODS: A total of 2365 healthy subjects met the requirements of this study. The levels of SAA were detected using an AU5821 automatic biochemical analyzer and its original reagents. According to the recommended methods of CLSI C28‐A3 and WS/T 402‐2012, the population reference interval of SAA was established using the unilateral 95th percentile (P(95)), and the 90% confidence interval of upper limits was calculated. RESULTS: The distributions of SAA levels were not significantly different between sexes (P> .05) and also did not differ by age (P> .05). Therefore, the population reference interval for SAA was established as an upper limit of 11.0 mg/L (90% confidence interval: 9.3‐12.3 mg/L) by using the method of latex immunoturbidimetry. CONCLUSIONS: Serum amyloid A is closely related to the occurrence and progression of various diseases. The preliminary establishment of a population reference interval for SAA can fully exert its potential clinical value.