Evaluation of the Cryocheck HexLA Integrated TCA for the Detection of Lupus Anticoagulant (HEXLA)

University Hospital, Strasbourg, France

Status: Enrolling

Conditions: Lupus Anticoagulant

Study type: Observational

Funder types: Other

Identifiers

NCT07313475

9486

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient of legal age (≥ 18 years)
• Sample sent to the HUS Hematology Laboratory and analyzed for LA detection as part of routine care.

Exclusion criteria

- Insufficient sample volume