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

Condition(s) studied

Study 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

Primary outcome measure(s)

• 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.

Trial sites (1)

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