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Diagnostic Test

Panbio™ for COVID-19 and Flu

N/A

Waitlist Available

Research Sponsored by Abbott Rapid Dx

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up "up to 24 months"

Awards & highlights

Study Summary

This trial tests devices to detect COVID-19, flu A, and flu B in nasal swabs. It helps assess device safety & performance to support CE conformity.

Eligible Conditions

COVID-19
Coronavirus
Flu
Flu Type B

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ "up to 24 months"

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~"up to 24 months"

This trial's timeline: 3 weeks for screening, Varies for treatment, and "up to 24 months" for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sensitivity and specificity of the Panbio™ COVID-19/Flu A&B Rapid Panel device.

Secondary outcome measures

Concordance of self-test and professional use device

Usability of the professional use device

Usability of the self test device

Trial Design

1Treatment groups

Experimental Treatment

Group I: Nasal sampling/Testing (Self-Test) + Nasopharyngeal sampling/Testing (Professional Use)Experimental Treatment1 Intervention

Lay users (self-tester or caregiver) will be provided with a Panbio™ COVID-19/Flu A&B Rapid Panel Self-Test kit. Each lay user will collect one mid-turbinate nasal swab from both nostrils, perform and interpret the Panbio™ COVID-19/Flu A&B Rapid Panel Self-Test. All procedures for testing and result interpretation, including sample collection and extraction will be conducted by the lay user following the Instructions for Use provided in the kit. The first NP swab sample will be used to conduct a Panbio™ COVID- 19/FluA&B Rapid Panel Professional Use test. The second NP swab sample will be eluted in Universal Transport Medium (UTM) provided by Abbott/the Core Laboratory, labelled and stored, according to the laboratory manual. UTM samples will be shipped to the Core Laboratory for testing with RT-PCR protocols for Flu A, Flu B and SARS-CoV-2, according to the laboratory manual.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Panbio™

2023

N/A

~2040

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Abbott Rapid DxLead Sponsor

5 Previous Clinical Trials

6,828 Total Patients Enrolled

4 Trials studying COVID-19

5,805 Patients Enrolled for COVID-19

Media Library

Panbio™ (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT05715515 — N/A

COVID-19 Research Study Groups: Nasal sampling/Testing (Self-Test) + Nasopharyngeal sampling/Testing (Professional Use)

COVID-19 Clinical Trial 2023: Panbio™ Highlights & Side Effects. Trial Name: NCT05715515 — N/A

Panbio™ (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05715515 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people have signed up for participation in this clinical research?

"Affirmative. Clinicaltrials.gov's data reveals that recruitment for this study is ongoing and commenced on March 1st 2023. The most recent update was dated February 3rd 2023, with the aim of finding 1531 participants from just one site."

Answered by AI

Are there any open slots for volunteers in this trial?

"Affirmative. The clinical trial data hosted on clinicaltrials.gov confirms that this experiment is currently recruiting participants, with the original post date of March 1st 2023 and the most recently updated information being from February 3rd 2023. 1531 people are required to be enrolled at just one medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Rapid Panel Professional Use Device and the Panbio™ COVID-19/Flu A&B Rapid Panel Self-Test Device

2023. "Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Rapid Panel Professional Use Device and the Panbio™ COVID-19/Flu A&B Rapid Panel Self-Test Device". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05715515.