The International Normalized Ratio (INR) can be unreliable in patients with lupus anticoagulants (LAC) or other conditions affecting baseline testing. Alternative methods to assess anticoagulation on warfarin through measures of vitamin K dependent factor activity by clot based or chromogenic assays may be necessary. In this patient population, the ideal method is unknown.
Methods
Thirty-six patients stable on warfarin with LAC or unreliable INR testing had an INR, a prothrombin time based clotting assay for factor II (FII) activity, and a chromogenic assay for factor X (CFX) activity performed simultaneously.
Results
Eighty-nine sets of measurements were obtained of which 83 sets included all three assays. CFX and FII levels were well correlated (r=0.92) in all patients and in 26 patients with a documented antiphospholipid antibody (r=0.93). Parallel testing was seen in 99% of FII assays. Sixty one percent of CFX and 57% of FII were within the therapeutic range. In 32 CFX and FII pairs where assessment of anticoagulation was discordant, 16 CFX agreed with INR and 13 FII agreed with INR (McNemar’s, χ2=0.14, p=0.7). The number of times tests were discrepant was not statistically different between CFX and FII (p=0.36).
Conclusions
Chromogenic factor X and factor II activity are well correlated in patients that require alternative monitoring of warfarin. Either test can be used in this population.