Prospective clinical study conducted at three or more geographically diverse sites (witha simulated home environment) in the United States for the clinical validation of theNowFuture Digital Flu / COVID Test. Results from the investigational test will becompared to results from a 510(k) cleared highly sensitive reverse transcriptasepolymerase chain reaction (RT-PCR) test for SARS-CoV-2, Influenza A and Influenza B. Theprimary objective of this study is to evaluate the clinical performance (positive percentagreement, negative percent agreement and 95% confidence intervals for upper and lowerbounds) of the NowFuture Digital Flu / COVID Test for the qualitative detection anddifferentiation of SARS-CoV-2 nucleocapsid antigen, Influenza A and Influenza Bnucleoproteins antigens using AN swab samples collected and processed in the test by layusers. The secondary objective is to evaluate the usability of the investigational testand the user comprehension of the investigational test lay user instructions whenperformed by the lay users.
Not Provided
Inclusion Criteria:
- Written informed consent obtained prior to study enrollment.
- Male or female aged 2 years of age and older.
- Participant is currently exhibiting at least one symptom (i.e. symptomatic)
associated with COVID-19 or influenza (such as, but not limited to, fever, headache,
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) and must present within 6 days of symptom onset (equates to 5 DPSO).
Subject must still be exhibiting symptom(s) on the day of sample collection.
Exclusion Criteria:
- Participant or participant's legally acceptable representative (for minors) who is
18 years of age (or the state's legal age of majority) or older and does not
understand or is not able and willing to sign the study informed consent.
- Participant who has had a positive SARS-CoV-2, Influenza A and/or Influenza B result
within the past 30 days.
- Participant has had seasonal influenza vaccine such as the FluMist/FluMist
Quadrivalent live intranasal influenza vaccine and/or the SARS-CoV-2 vaccine within
the past 5 days.
- Participant is not able to tolerate sample collection or is not willing to
contribute the required swab samples for testing or complete the study procedures.
- Participant is currently undergoing antiviral treatment such as baloxavir marboxil
(Xofluza), oseltamivir (Tamiflu®), zanamivir (Relenza®), and peramivir (Rapivab®).
- Participant currently undergoing treatment and/or has undergone treatment within the
past thirty (30) days with prescription medication to treat 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.
- Participant who has 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.
- Participant who has had recent craniofacial injury or surgery, including to correct
deviation of the nasal septum, within the previous six (6) months.
Not Provided
Not Provided