SARS-CoV-2 and Influenza A/B in Point-of-Care and Non-Laboratory Settings

Completed · Not applicable

Conditions studied: SARS-CoV-2 Infection, Influenza A, Influenza B

In brief

The Metrix COVID/Flu Test will be evaluated for use in Point-of-Care and Non-Laboratory settings in a home testing environment utilizing the clinical study design described herein. The study will take place in simulated home environments which will be set up within or near active clinical settings (e.g., urgent care facilities). This will be a prospective study conducted at three or more investigational sites located within the United States for the clinical validation of the Metrix COVID/Flu Test for the differential detection of SARS-CoV-2, Influenza A, and Influenza B in AN swab or saliva samples. Additional sites may be added to the study in order to meet minimum subject/sample enrollment requirements and geographic prevalence of respiratory virus infections. One or more investigational sites outside of the US (at which participants are required to be fluent in English) may also be included in the study depending on enrollment needs and geographical/seasonal prevalence of respiratory virus infections. Comparator testing will be performed to determine the infection status of each sample for comparison to results generated by the candidate test. The primary comparator for the study will be an FDA-cleared assay for the detection of SARS-CoV-2, Flu A, and/or Flu B.

Key facts

Study ID: NCT06191393
Run by: Aptitude Medical Systems
People needed: 614
Starts: 2023-11-20
Expected to finish: 2025-03-11
Last updated by the study team: 2025-05-13

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Participant or guardian understands and is able and willing to provide written informed consent, and assent where applicable, prior to study enrollment.
Male or female aged 2 years or older
Participant is currently exhibiting fever, or one or more symptoms associated with COVID-19 and/or influenza (such as, but not limited to, chills, cough, shortness of breath or difficulty breathing, fatigue, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting or diarrhea). Participant must still be exhibiting symptoms on the day of sample collection.
Participant has not eaten, consumed a beverage, smoked, brushed their teeth, gargled with mouth wash, or chewed gum for 30 minutes prior to collecting a saliva sample.
Participant or guardian agrees to read, and is able to read with understanding, each of the saliva and/or AN swab QRI prior to beginning the operation of each of the Metrix COVID/Flu Test.
Participant or guardian is able and willing to contribute the required saliva and/or swab samples for testing and understands and is able and willing to sign the study informed consent.

You may not qualify if…

Participant does not understand and/or is not able and willing to sign the study informed consent and/or assent.
Participant or guardian is not able to comply with saliva or nasal swab collection requirements following the QRI.
Participant has previously provided a sample for the study.
Participant has had seasonal influenza and/or the SARS-CoV-2 vaccine within the past 5 days.
Participant is not able to tolerate sample collection.
Participant is currently undergoing antiviral treatment such as baloxavir marboxil (trade name Xofluza®), oseltamivir (Tamiflu®), zanamivir (Relenza®), and peramivir (Rapivab®).
Participants currently undergoing treatment and/or within the past thirty (30) days with prescription medication to treat novel Coronavirus SARS-CoV-2 infection, which may include but is not limited to Remdesivir (Veklury), Paxlovid, molnupiravir or receiving convalescent plasma therapy for SARS-CoV-2.
Participants who have had a nasal wash or aspirate as part of their standard of care treatment on day of study visit prior to the study sample collection.
Participants who have had recent craniofacial injury or surgery, including to correct deviation of the nasal septum, within the previous six (6) months.
Participants who do not understand/read the English language.

Where it is running

American Family Care — Trussville, Alabama, United States
Central Coast Laboratories — Goleta, California, United States
American Family Care — Chelmsford, Massachusetts, United States

Full record on ClinicalTrials.gov

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