Usability and Clinical Validation of the Flu A/B/COVID-19 + RSV Multiplex Rapid Test

NCT07875270 | Not Yet Recruiting FDA Device

• 1 other identifier: 17602
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a prospective study for the clinical validation of the CorDx Tyfast Flu A/B/COVID-19 + RSV Multiplex Rapid Test for the qualitative detection and differentiation of SARS-CoV-2, Influenza A, Influenza B and RSV in AN samples. Results from the CorDx Tyfast Flu A/B/COVID-19 + RSV Multiplex Rapid Test will be compared to results from a 510(k) cleared highly sensitive, multi-analyte reverse transcriptase polymerase chain reaction (RT-PCR) test for SARS-CoV-2, Influenza A, Influenza B and RSV, such as the 510(k) cleared Cepheid Xpert Xpress CoV-2/Flu/RSV plus (K250995).

Conditions

SARS-CoV-2 Infection; Influenza A; Influenza B; RSV

Outcome Measures

Primary Outcomes (1)

• Performance of CorDx Tyfast Flu A/B & COVID-19 + RSV 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 + RSV Multiplex Rapid Test for qualitative and differential detection of SARS-CoV-2, Influenza A, and Influenza B antigens in anterior nasal 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, COVID-19, and RSV.

  The estimated length of the sample collection and testing phase is expected to be 6~35 weeks

Secondary Outcomes (1)

• Usability of investigational test measured by observation of task completion

  The estimated length of the sample collection and testing phase is expected to be 6- 35 weeks.

Study Arms (1)

Investigational Diagnostic Testing

EXPERIMENTAL

Participants enrolled in this study will perform testing using the investigational Flu A/B/COVID-19 + RSV Multiplex Rapid Test according to the study protocol. The study will evaluate the clinical performance and usability of the investigational device, including the ability of intended users to perform the test and interpret the results. Investigational test results will be compared with results obtained using the reference molecular assay, Cepheid Xpert Xpress CoV-2/Flu/RSV plus, to assess diagnostic performance.

Device: Flu A/B/COVID-19 + RSV Multiplex Rapid Test

Interventions

Flu A/B/COVID-19 + RSV Multiplex Rapid Test DEVICE

The Flu A/B/COVID-19 + RSV Multiplex Rapid Test is an investigational lateral flow immunoassay intended for the qualitative detection and differentiation of Influenza A, Influenza B, SARS-CoV-2, and respiratory syncytial virus (RSV) antigens. Participants will perform the investigational test according to the provided instructions. Test results will be evaluated for diagnostic performance against a reference molecular assay, and usability assessments will be conducted according to the study protocol.

Investigational Diagnostic Testing

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent obtained prior to study enrollment.
• Male or female aged 6 months of age and older.
• Participant, aged 2 years and older, is currently exhibiting at least one or more symptoms (i.e. symptomatic) associated with COVID-19, influenza and RSV (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 6 days of symptom onset (equates to 5 DPSO). Subject must still be exhibiting symptom(s) on the day of sample collection.
• or Participant, aged 6 to \<24 months, is currently exhibiting one or more symptoms (i.e. symptomatic) associated with COVID-19, influenza or RSV (such as, but not limited to, fever, cough, short and shallow breathing, unusual tiredness, decrease in appetite, runny nose, vomiting, irritability, diarrhea, flaring of the nostrils\*, straining of the chest or stomach while breathing\*, or turning blue around the lips and fingertips\*) and must present within 6 days of symptoms onset. Participant must still be exhibiting symptoms on the day of sample collection.
• \* These symptoms (i.e. flaring of the nostrils, straining of the chest or stomach while breathing or turning blue around the lips and fingertips) may be signs of possible severe RSV infection or advanced disease such as bronchiolitis, pneumonia and possible progression to respiratory failure and participants should seek medical attention immediately.

You may not qualify if:

• Participant who has had a positive SARS-CoV-2, Influenza A, Influenza B and/or RSV result within the past 14 days.
• 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 has had seasonal influenza, SARS-CoV-2, and/or RSV 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 (trade name Xofluza®), oseltamivir (Tamiflu®), zanamivir (Relenza®), peramivir (Rapivab®), and ribavirin (Copegus®, Rebetol®, Virazole®).
• Participant is currently undergoing treatment with prescription medication to treat RSV which may include antiviral treatment such as Ribavirin (tribavirin) or monoclonal antibodies such as Palivizumab (Synagis) and Nirsevimab (Beyfortus).
• Participant currently undergoing treatment and/or has undergone treatment 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.
• 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.

Sponsors & Collaborators

• CorDx, Inc.: lead

Study Sites (1)

CorDx

Alpharetta, Georgia, 30005, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Angie Han

CONTACT

8585683281; angie@cordx.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective single-group diagnostic device clinical study designed to evaluate the clinical performance and usability of the investigational Flu A/B/COVID-19 + RSV Multiplex Rapid Test. All enrolled participants will undergo investigational testing according to the study protocol. The clinical performance of the investigational device will be evaluated by comparing its results with those obtained using the reference molecular assay, Cepheid Xpert Xpress CoV-2/Flu/RSV plus. The study will also evaluate the ability of intended users to perform the test and interpret the results correctly. No randomization or assignment to separate treatment groups is planned.

Study Record Dates

• First Submitted: October 8, 2026
• First Posted: October 15, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 15, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)