Evaluation of the performance of a new serum amyloid A chemiluminescence immunoassay

Serum amyloid A (SAA) is a protein involved in the acute phase of inflammation. SAA expression is upregulated in humans during the acute phase of various viral infections; in addition, SAA can be a useful biomarker to predict the severity and prognosis of COVID-19 patients. This study aimed to evaluate a new chemiluminescence test for SAA detection. All serum samples were measured for SAA on a Maglumi 800 (Snibe, Shenzhen, China) and compared with a BN ProSpec (Siemens, Munich, Germany) in the routine of the clinical laboratory of the University Hospital of the Tor Vergata University of Rome (Rome, Italy). Analytical precision, the correlation coefficient, and linearity were assessed. Statistical analyses were performed. The linearity test was performed via serial dilutions and revealed a correlation coefficient equivalent to 0.9998. The results of the Snibe SAA test correlated well with those obtained by the SAA Siemens test, with a correlation coefficient of 0.974 ( P <0.001). The intra- and interrun precision, as well as carryover, were assessed. The results obtained from this study demonstrated that the new Snibe SAA test has reliable analytical performance and good accuracy and could represent a valid tool for routine hospital laboratory analysis.