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

N/ANot Yet RecruitingNCT07430410

CorDx, Inc.200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

200

Conditions

SARS-CoV-2 Infection Influenza A Influenza B

Interventions

CorDx Tyfast Flu A/B & COVID-19 At-Home Multiplex Rapid TestDEVICE

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.

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

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

Data from ClinicalTrials.gov

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