Work

Protocol for a laboratory-developed chromogenic anti-Xa assay for rivaroxaban monitoring

Year: 2026

Type: article

Abstract: Rivaroxaban monitoring is essential in specific clinical scenarios, such as renal impairment or emergency surgery. While LC-MS/MS is the gold standard, its high-cost limits accessibility. This study describes the development and validation of a cost-effective, laboratory-developed chromogenic anti-Xa assay suitable for automated platforms. The assay utilizes the competitive inhibition of Factor Xa, where residual enzyme activity is measured via the cleavage of a specific chromogenic substrate, with absorbance being inversely proportional to the rivaroxaban concentration.Dual-Range Quantification: Validated for both routine therapeutic levels (30–500 ng/mL) and an extended range (500–1500 ng/mL) via automated dilution.Kinetic Optimization: Employs a specific 180-second incubation and a stabilized measurement window (20–80 s) to maximize linearity.Reference Comparability: Demonstrates high correlation with LC-MS/MS (r=0.997) and meets CLSI precision requirements.

Source: MethodsX

DOI: 10.1016/j.mex.2026.103829

Authors: Lin Sun, Wenfei Lu, Guohong Jiang, Chao Zhu, Hui Rong, Limin Lun

Institutions: Qingdao University, Affiliated Hospital of Qingdao University

Language: English

Topic: Blood Coagulation and Thrombosis Mechanisms

Subfield: Hematology

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $1,260