Clinical Evaluation of the Rapid Syphilis Antibody Test Card: Accuracy and Diagnostic Performance in a Point-of-Care Setting

Abstract

This study evaluates the clinical accuracy of the Rapid Syphilis Antibody Test Card, a lateral flow immunoassay designed for the detection of syphilis antibodies in human serum and plasma. The evaluation was conducted using 537 clinical samples (178 positive and 359 negative) collected from patients at Zhongshan Hospital Xiamen University. The test results were compared with the Elecsys® Syphilis (ECLIA) reference method, a widely recognized laboratory-based assay. The Rapid Syphilis Antibody Test Card demonstrated an overall accuracy of 98.7%, with a positive agreement of 98.3% and a negative agreement of 98.9%. These findings underscore the test card’s reliability and suitability for point-of-care (POC) settings, particularly in resource-limited environments where rapid and accurate diagnosis is critical for effective syphilis management.