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

Part of paid clinical trials in Alpharetta, Georgia.

Sponsor
CorDx, Inc.
Study ID
NCT07875270
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

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

Eligibility Criteria

Sex
ALL
Age
6 Months - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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).

Key Dates

First listed
Oct 15, 2026
Start date
Nov 1, 2026
Status verified
Oct 2026
Primary completion
Oct 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
1,500 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Investigational Diagnostic Testing
    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.

Primary Outcome Measure

Performance of CorDx Tyfast Flu A/B & COVID-19 + RSV Multiplex Rapid Test measured by agreement with RT-PCR [ Time Frame: The estimated length of the sample collection and testing phase is expected to be 6~35 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
CorDxAlpharettaGeorgia30005
Angie Han
[email protected]
8588886916

Find similar trials in Alpharetta, GA

By research site
CorDx· Alpharetta, GA

Related Studies