Evaluation of the Cryocheck HexLA Integrated TCA for the Detection of Lupus Anticoagulant
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Sensitivity of Cryocheck HexLA compared to Cephen LS/Cephen reagents with regard to lupus anticoagulant (LA)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient of legal age (≥ 18 years)
- •Sample sent to the HUS Hematology Laboratory and analyzed for LA detection as part of routine care.
排除标准
- •- Insufficient sample volume
结局指标
主要结局
Sensitivity of Cryocheck HexLA compared to Cephen LS/Cephen reagents with regard to lupus anticoagulant (LA)
时间窗: 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.
次要结局
未报告次要终点