The study's primary objective is to evaluate the performance of the CorDx Tyfast Flu A/B& COVID-19 At-Home Test for detecting SARS-CoV-2, Influenza A, and B in nasal samplescollected by lay users, compared to 510(k)-cleared RT-PCR tests. Secondary objectives areto assess usability and instruction comprehension and reproducibility with untrainedoperators at Clinical Laboratory Improvement Amendments (CLIA)-waived sites.
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Device: CorDx Tyfast Flu A/B & COVID-19 At-Home Multiplex Rapid Test
Each subject will provide two anterior nares samples (both nostrils). One sample will be
tested using the investigational CorDx Tyfast At-Home Test by the subject or a lay tester
following the Quick Reference Instructions. The second sample will be collected by study
personnel and sent to a reference laboratory for comparator RT-PCR testing.
Inclusion Criteria:
1. Written informed consent obtained prior to study enrollment.
2. Male or female aged 2 years or older.
3. Subjects were tested with a Food Drug and Administration (FDA) cleared molecular
assay no more than 2 days prior to the study visit.
4. Subject, aged 2 years or older, is currently exhibiting one or more symptoms
associated with COVID-19 or influenza such as, but not limited to, fever, 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 5 days of symptom onset. Subject must still be exhibiting
symptoms on the day of sample collection.
Exclusion Criteria:
1. Subject 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.
2. Subject has had seasonal influenza vaccine within the past 5 days.
3. Subject is not able to tolerate sample collection, or is not willing to contribute
the required swab samples for testing or complete the study procedures.
4. Subject is currently undergoing antiviral treatment such as baloxavir marboxil
(trade name Xofluza®), oseltamivir (Tamiflu®), zanamivir (Relenza®), and peramivir
(Rapivab®).
5. Subjects 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.
6. Subjects 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.
7. Subjects who have had recent craniofacial injury or surgery, including to correct
deviation of the nasal septum, within the previous six (6) months.
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