Evaluation of the Cryocheck HexLA Integrated TCA for the Detection of Lupus Anticoagulant

Lupus anticoagulant (LA) testing is performed using two screening tests: activated partial thromboplastin time (APTT) and diluted Russell's viper venom time. If one of the screening tests is positive, a confirmation test based on the same principle is performed. The HUS Hematology Laboratory uses an integrated APTT for LA testing, consisting of a screening reagent: Cephen LS, and a confirmation reagent: Cephen (Hyphen Biomed). The aim of this study is to determine whether another integrated activated partial thromboplastin time (APTT) test, Cryocheck HexLA, offers better performance than Cephen LS/Cephen, both in terms of sensitivity to lupus anticoagulant (LA) and susceptibility to interference from anticoagulant treatments.

NCT Number	NCT07313475
Lead Sponsor	University Hospital, Strasbourg, France
Conditions	Lupus Anticoagulant
Enrollment	200 participants
Start Date	2024-12-04
Primary Completion	2026-02 (estimated)
Study Completion	2026-02 (estimated)
Updated on ClinicalTrials.gov	2026-01-02