Abstract

Syphilis, a sexually transmitted infection caused by the bacterium Treponema pallidum, remains a significant public health concern due to its global prevalence and related complications. Timely screening of syphilis is crucial for its diagnosis and intervention. Rapid and point-of-care tests, requiring just a single blood sample, offer promising prospects for efficient detection. Such innovations can amplify the accessibility and efficacy of syphilis screening.

This study evaluates the performance of the Syphilis Rapid Test, developed by Hangzhou AllTest Biotech Co., Ltd, in comparison to the Treponema pallidum Particle Agglutination (TPPA) method. Clinical trials, employing human whole blood, serum, plasma samples, aimed to ascertain the sensitivity, specificity, and accuracy of the Syphilis Rapid Test.

The findings of this study demonstrate that the Syphilis Rapid Test Cassette (Whole Blood/Serum/Plasma) demonstrated ultra-high sensitivity of 99.9% and a specificity of 99.7%, underscoring its accuracy and reliability in identifying syphilis infections. Such performance metrics highlight the viability as a supplementary diagnostic tool in syphilis detection and management.

The comparative analysis conducted in this study provides valuable insights into the concordance between the Syphilis Rapid Test and the TPPA method. These insights are crucial for clinicians to make diagnostic and therapeutic decisions related to the diagnosis and management of syphilis. The adoption of rapid testing methods, like the Syphilis Rapid Test, can expedite the screening process, enable timely diagnosis, and facilitate prompt initiation of appropriate treatment strategies. Ultimately, this contributes to the cumulatively control and prevention of syphilis, furthering global public health objectives.

Keywords: Syphilis; Rapid test; TPPA; Diagnosis; Comparative analysis