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abioSCOPE IgE Assay to Aid in the Diagnosis of Allergies

NCT04442932 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2020-10-05

No results posted yet for this study

Summary

This is a multicenter, prospective, observational study designed to determine the clinical sensitivity and specificity of the Abionic IVD CAPSULE Allergic Asthma panel performed on Abionic's abioSCOPE device using K3-EDTA anticoagulated plasma samples from atopic and non-atopic pediatric and adult patients. Patients' sensitization determined with the abioSCOPE will be compared to the clinical assessment of allergy.

Conditions

  • Allergy
  • Allergic Asthma
  • Allergy to Cats
  • Allergy to House Dust
  • Allergy to Dog Dander
  • Allergy Cockroach

Interventions

DEVICE

Blood Collection

K3-EDTA venous whole blood 9 mL 1 venous draw

Sponsors & Collaborators

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-15
Primary Completion
2020-12-31
Completion
2021-03-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04442932 on ClinicalTrials.gov