The laboratory's 2015 perspective on direct oral anticoagulant testing

Area of Science:

• Clinical Chemistry
• Hematology
• Pharmacology

Background:

• Direct oral anticoagulants (DOACs) have revolutionized anticoagulation therapy.
• Their introduction has significantly impacted clinical laboratory practices and testing.
• Early laboratory testing recommendations for DOACs require reassessment due to evolving clinical use.

Purpose of the Study:

• To evaluate the reliability of existing laboratory testing recommendations for DOACs.
• To compare results from drug-spiked plasma versus patient samples undergoing DOAC therapy.
• To present updated laboratory assays and algorithms for DOAC drug presence and concentration measurement.

Main Methods:

• Analysis of reagent sensitivity using both drug-spiked and patient-derived samples.
• Development and presentation of laboratory assays for DOAC detection and quantification.
• Review of specialty coagulation assays potentially affected by DOACs.

Main Results:

• Significant variations in reagent sensitivity were observed between drug-spiked and patient samples.
• Data from drug-enriched samples should be interpreted with caution.
• DOAC therapy can influence the results of specialty coagulation assays, leading to false positives/negatives.

Conclusions:

• Early recommendations for laboratory testing in the context of DOACs need revision.
• Patient samples provide more clinically relevant data than drug-spiked samples for DOAC testing.
• Updated testing algorithms and awareness of assay interferences are essential for accurate DOAC management.