Investigational Flu A/B Covid-19 and RSV Diagnostic Test
Diagnostic TestA diagnostic test in lateral flow cassette format designed to detect Influenza A, Influenza B, SARS-CoV-2 and respiratory syncytial virus from anterior nasal swab specimens.
NCT Number: NCT07308158
The goal of this observational study is to evaluate the diagnostic performance of an investigational Flu A/B, COVID-19 and RSV test in patients with signs and symptoms of respiratory infection.
The main questions it aims to answer are:
1. What is the sensitivity and specificity of the investigational test compared with an FDA-cleared reference method for detection of Influenza A, Influenza B, , SARS-CoV-2 and respiratory syncytial virus antigen. 2. What is the overall positive and negative percent agreement between the investigational test and the reference method?
Participants will:
1. Provide a respiratory specimen (e.g., nasal or nasopharyngeal swab) for testing with the investigational device. 2. Provide an additional specimen for testing with the FDA-cleared reference method.
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Notify Me6 month and older
All sexes
Observational
iHealth Site 001, Quebradillas, Puerto Rico
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A diagnostic test in lateral flow cassette format designed to detect Influenza A, Influenza B, SARS-CoV-2 and respiratory syncytial virus from anterior nasal swab specimens.
Time frame: Within approximately 5 days of specimen collection (time needed for both investigational and comparator test results)
iHealth Labs inc
Industry
Human Factors and Clinical Validation of the iHealth Labs Inc iHealth Flu A&B/COVID-19/RSV Rapid Test in Anterior Nares Nasal Samples For Over the Counter (OTC) Use
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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