Clinical Validation of an At-Home Flu A/B and COVID-19 Rapid Test
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2+
SponsorCorDx, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent obtained prior to study enrollment.
Male or female aged 2 years or older.
Subjects were tested with a Food Drug and Administration (FDA) cleared molecular assay no more than 2 days prior to the study visit.
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.
Disqualifiers
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.
Subject has had seasonal influenza vaccine within the past 5 days.
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.
Subject is currently undergoing antiviral treatment such as baloxavir marboxil (trade name Xofluza®), oseltamivir (Tamiflu®), zanamivir (Relenza®), and peramivir (Rapivab®).
Trial design
Design model
Single group
Treatments tested in this trial
CorDx Tyfast Flu A/B & COVID-19 At-Home Multiplex Rapid Test
DeviceEach 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.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Single Arm: CorDx Tyfast Flu A/B & COVID-19 At-Home TestExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 weeksSecondary outcomes
1
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 weeksOther outcomes
1
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.
Time frame
The estimated length of the sample collection and testing phase is expected to be 6~35 weeks2
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.).
Time frame
The estimated length of the sample collection and testing phase is expected to be 6~35 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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