Results Released: Multicenter Clinical Study for Lupus Anticoagulant Reagents

Shanghai Sun Biotech Co., Ltd. recently announced the release of results from a multicenter clinical study for its Lupus Anticoagulant (LA) Detection Kit (dRVVT Clotting Assay). Conducted jointly by The Second Hospital of Anhui Medical University and Jiangxi Provincial People's Hospital, the study has established a standardized reference system specific to the Chinese population, providing robust evidence-based medical support for the diagnosis of Antiphospholipid Syndrome (APS) and Systemic Lupus Erythematosus (SLE).

Strictly Adhering to Expert Consensus to Establish LA Standardized Reference Intervals and Thresholds

The study was executed in strict accordance with the guidelines of the International Society on Thrombosis and Haemostasis (ISTH) and the Chinese Expert Consensus on the Standardization of Lupus Anticoagulant Testing and Reporting. Researchers successfully established reference intervals for Screen Time (dRVVT-S), Confirm Time (dRVVT-C), Screen Ratio, Confirm Ratio, and Normalized Ratio. Furthermore, specific detection cut-off values were defined for the Screen, Confirm, and Normalized ratios. This comprehensive interpretation system fully meets clinical requirements for the standardization of LA testing and reporting.

100% Positive and Negative Agreement in Clinical Samples

The study enrolled 216 valid clinical samples with an age span of 1 to 86 years. The cohort included patients with suspected or confirmed APS and SLE, covering cases of vascular thrombotic events, pregnancy morbidity, and other related clinical manifestations.

Results demonstrated that the kit's Positive Percent Agreement (PPA), Negative Percent Agreement (NPA), and Total Agreement all reached 100% (Kappa = 1.00) when compared to the reference method. This confirms the product's high clinical diagnostic value and reliability in real-world application scenarios.