International Council for Standardization in Haematology (ICSH) Recommendations for Laboratory Measurement of Direct...

Area of Science:

• Clinical Laboratory Science
• Hematology
• Pharmacology

Background:

• Direct-acting oral anticoagulants (DOACs) are increasingly prescribed, necessitating standardized laboratory monitoring.
• Accurate measurement of DOACs is crucial for effective anticoagulation therapy and patient safety.
• Existing laboratory guidelines for DOAC measurement are limited, creating a need for consensus recommendations.

Purpose of the Study:

• To provide consensus recommendations for the laboratory measurement of DOACs (dabigatran, rivaroxaban, apixaban, edoxaban).
• To guide clinical laboratories in assessing DOAC anticoagulation across all measurement phases.
• To ensure the reliable implementation and quality assurance of DOAC laboratory assays.

Main Methods:

• Development of consensus recommendations by an ad hoc committee of international DOAC experts.
• Review and assessment of pre-analytical, analytical, and post-analytical phases of DOAC measurement.
• Evaluation of various laboratory methods, including screening tests, viscoelastic measurements, and point-of-care testing.

Main Results:

• Established recommendations for sample collection, stability, and types for DOAC assays.
• Defined gold standard, screening, and quantifying methods for laboratory DOAC measurement.
• Addressed reporting units, quality assurance, and validation/verification of laboratory assays.

Conclusions:

• Standardized laboratory measurement of DOACs is essential for safe and effective anticoagulation.
• The guidance provides a framework for consistent and reliable DOAC testing in clinical laboratories.
• Implementation of these recommendations will enhance patient care through improved anticoagulation monitoring.