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

Official title: Evaluation of the Cryocheck HexLA Integrated TCA for the Detection of Lupus Anticoagulant

Summary: 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.

Conditions: Lupus Anticoagulant

Keywords: Lupus Anticoagulant, Coagulation, Phospholipid, Time activated partial thromboplastin (TCA), Cryocheck HexLA, Cephen LS

Study type: OBSERVATIONAL

Enrollment: 200 (ESTIMATED)

Status: RECRUITING

Completion: 2026-02 (ESTIMATED)