Clinical Validation of an At-Home Flu A/B and COVID-19 Rapid Test

Human Factors and Clinical Validation of the CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test Using Anterior Nares Nasal Samples for Over-The-Counter (OTC) Use

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 samples collected by lay users, compared to 510(k)-cleared RT-PCR tests. Secondary objectives are to assess usability and instruction comprehension and reproducibility with untrained operators at Clinical Laboratory Improvement Amendments (CLIA)-waived sites.

Study Overview

• Status: Not yet recruiting
• Conditions: SARS-CoV-2 Infection; Influenza A; Influenza B
• Intervention / Treatment: Device: CorDx Tyfast Flu A/B & COVID-19 At-Home Multiplex Rapid Test

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single Arm: CorDx Tyfast Flu A/B & COVID-19 At-Home Test; All participants will provide two anterior nares samples. One sample will be tested using the investigational CorDx Tyfast Flu A/B & COVID-19 At-Home Multiplex Rapid Test, and the other sample will be tested using a 510(k)-cleared high-sensitivity Reverse transcriptase polymerase chain reaction (RT-PCR) assay for Influenza A/B and SARS-CoV-2. This arm evaluates the diagnostic performance, usability, and reproducibility of the investigational test in lay users.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test measured by agreement with RT-PCR	The primary objective is to evaluate the performance of the CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test for qualitative and differential detection of SARS-CoV-2, Influenza A, and Influenza B antigens in anterior nasal (AN) samples collected by lay users. Performance will be assessed by calculating positive percent agreement (PPA), negative percent agreement (NPA), and corresponding 95% confidence intervals, compared to FDA-cleared high-sensitivity RT-PCR tests for Influenza A/B and COVID-19.	The estimated length of the sample collection and testing phase is expected to be 6~35 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability of investigational test measured by observation of task completion	Study personnel will observe and record all procedures completed by the subject/tester, including critical and non-critical tasks and any difficulties encountered with labeling.	The estimated length of the sample collection and testing phase is expected to be 6- 35 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of mock test interpretation	The subject/tester will interpret a panel of mock investigational tests with various results prepared according to FDA premarket validation guidance (e.g., negative, positive for Flu A/COVID-19, Flu B/COVID-19, etc.).	The estimated length of the sample collection and testing phase is expected to be 6~35 weeks
Comprehension and labeling understanding measured by questionnaire	Comprehension and labeling understanding assessed using a study-specific usability and labeling comprehension questionnaire. Upon completion of testing, subjects complete a questionnaire evaluating usability, labeling clarity, and comprehension related to sample collection, test operation, and result interpretation. For usability and clarity questions (Questions 1-3 and 6-12), responses are reported as the percentage of subjects selecting "Clear and easy to follow/perform." For labeling comprehension questions (Questions 4-5 and 13-18), outcomes are reported as the percentage of subjects who selected the correct answer for each question. Higher percentages indicate better usability, labeling comprehension, and understanding of the test instructions.	The estimated length of the sample collection and testing phase is expected to be 6~35 weeks

Collaborators and Investigators

• Sponsor: CorDx, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): February 12, 2026
• Primary Completion (Estimated): December 12, 2026
• Study Completion (Estimated): February 12, 2027

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 18, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: 2512158

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes