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
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
- COVID-19
- Influenza A
- Influenza Type B
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
More Related Trials
-
A Study of mRNA-1020 and mRNA-1030 Seasonal Influenza Vaccines in Healthy Adults
NCT05333289 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study to Evaluate the Safety and Immunogenicity of COVID-19 and Influenza Combination Vaccine
NCT05519839 ·Status: COMPLETED ·Phase: PHASE2
-
Randomized, Double Blinded, Placebo Control Clinical Trial of Pandemic Influenza Inactive Vaccine on Healthy Subjects
NCT00356798 ·Status: COMPLETED ·Phase: PHASE1
-
Panblok H7 Vaccine Adjuvanted With AS03 or MF59
NCT03283319 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults
NCT01612000 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Assessment of the Clinical Performance of the ARROW-FLU System
NCT02996136 ·Status: UNKNOWN ·Phase: NA
-
QuickVue Influenza A+B Clinical Field Trial
NCT00491283 ·Status: COMPLETED ·Phase: NA
-
A Study to Evaluate the Safety and Immunogenicity of Two Doses of a Novel H5 Central Antigen mRNA-LNP in Healthy Adults
NCT07019883 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Clinical Performance Study of the Ultra Influenza A&B Test Using Nasal Swabs for Identifying Subjects Who Are Infected With the Influenza Virus Strain Type A or Type B
NCT01753531 ·Status: COMPLETED
-
FLU A+B Nasal Swab Clinical Study
NCT00636662 ·Status: COMPLETED
-
A Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine and Influenza Combination Vaccine
NCT06291857 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Clinical Performance Evaluation of the NeuMoDx™ FluA/FluB/RSV/Severe Acute Respiratory Syndrome-CoV-2 Assay
NCT05162547 ·Status: COMPLETED
-
Study to Evaluate Safety and Immunogenicity of a Pandemic Flu H5 mRNA Vaccine in Healthy Adults Aged 18 Years and Older
NCT06727058 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study to Find and Confirm the Dose and Assess Safety, Reactogenicity and Immune Response of a Vaccine Against Pandemic H5N1 Influenza Virus in Healthy Younger and Older Adults
NCT06382311 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Influenza A+B Test Kit Performance Study
NCT03895268 ·Status: UNKNOWN
-
A Phase I/II Study on Safety AND Immunogenicity of AZD4117 and AZD5315 Vaccines (PANDA)
NCT07128615 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Safety and Immunogenicity Study of Self-Amplifying RNA Pandemic Influenza Vaccine in Adults
NCT06602531 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Immunogenicity Study of Adenovirus-vectored, Intranasal Pandemic Influenza Vaccine.
NCT00755703 ·Status: COMPLETED ·Phase: PHASE1
-
Clinical Study on the Immune Response Characteristics of Novel Coronavirus and Influenza Virus Infection
NCT06667063 ·Status: RECRUITING
-
Analysis of the Results From Influenza Rapid Test A Positive and H1N1 Real Time RT-PCR
NCT01277380 ·Status: UNKNOWN
-
e- Ab Sensor - Based Real-time Diagnosis of Influenza Virus
NCT01388062 ·Status: UNKNOWN ·Phase: NA
-
A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1073 (COVID-19/Influenza) Vaccine in Adults 18 to 75 Years Old
NCT05375838 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study of mRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy Adults
NCT05972174 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age
NCT06097273 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (Influenza and COVID-19) Vaccine in Adults ≥18 to <65 Years of Age
NCT06864143 ·Status: COMPLETED ·Phase: PHASE2