Clinical Evaluation of the Panbio™ COVID-19/ Flu A&B Rapid Panel

NCT05163730 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2472

Last updated 2022-07-20

No results posted yet for this study

Summary

This study is designed as a prospective, multicentric, clinical study to investigate the performance of the Panbio™ COVID-19/ Flu A\&B Rapid Panel for the qualitative detection of COVID-19 antigen, Influenza A antigen (H1N1 and H3N2), and Influenza B antigen in human nasal swabs.

This study is part of the performance evaluation to support the CE conformity assessment procedures.

Conditions

Interventions

DEVICE

COVID-19/ Flu A&B Rapid Panel

Rapid Diagnostic Device

Sponsors & Collaborators

  • Abbott Rapid Diagnostics Jena GmbH

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2022-02-11
Completion
2022-02-11
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT05163730 on ClinicalTrials.gov