Lupus Anticoagulant
Conditions
Keywords
Lupus Anticoagulant, Coagulation, Phospholipid, Time activated partial thromboplastin (TCA), Cryocheck HexLA, Cephen LS
Brief 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.
Interventions
None listed
Sponsors
University Hospital, Strasbourg, France
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of Cryocheck HexLA compared to Cephen LS/Cephen reagents with regard to lupus anticoagulant (LA) | Up to 9 months | A Fisher or McNemar statistical test on paired samples will be performed by comparing the results (positive or negative) of the integrated Cephen LS/Cephen and Cryocheck HexLA TCA tests, performed on the same sample, in patients not receiving anticoagulant therapy. |
Countries
France
Contacts
Primary ContactAgathe HERB, PharmD
Outcome results
None listed