RecruitingNCT07313475

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


Sponsor

University Hospital, Strasbourg, France

Enrollment

200 participants

Start Date

Dec 4, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

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

Exclusion Criteria1

  • \- Insufficient sample volume

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Locations(1)

Laboratoire d'Hématologie - CHU de Strasbourg - France

Strasbourg, France

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NCT07313475