AQT90 FLEX D-dimer Clinical Sensitivity and Specificity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-04

Study Completion Date

2025-06-30

Brief Summary

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The goal of this study is evaluate the clinical performance of the AQT90 FLEX D-dimer Test as an aid in the diagnosis of Venous Thromboembolism.

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Detailed Description

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The objective is to evaluate the clinical performance of the AQT90 FLEX D-dimer Test as an aid in the diagnosis of VTE in patients presenting with low or moderate pretest probability (PTP), by determining the clinical sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), positive likelihood ratio (LR+) and negative likelihood ratio (LR-) of the assay.

Conditions

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VTE (Venous Thromboembolism)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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D-dimer test

Blood sample collection for D-dimer testing

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Subject is 18 years of age and older
* Subject, who presents with signs and symptoms of VTE and had low or moderate pre-test probability of DVT or PE assessed by Well's score
* Subject must be able to understand information given, and be willing and able to voluntarily give their consent to participate in this study

Exclusion Criteria

* Subject, who is pregnant
* Subject, who has received fibrinolytic therapy within the previous seven days
* Subject, who has received treatment with anticoagulants (unfractionated heparin, LMWH, VKA (vitamin K-antagonists), DOACs (direct oral anticoagulants) within the previous seven days
* Subject, who has had trauma or surgery within the previous four weeks
* Subject with malignancy
* Subject with disseminated intravascular coagulation (DIC)
* Subject, who has an invalid written informed consent or has withdrawn consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No