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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm: CorDx Tyfast Flu A/B & COVID-19 At-Home Test | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CorDx Tyfast Flu A/B & COVID-19 At-Home Multiplex Rapid Test | Device | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| The estimated length of the sample collection and testing phase is expected to be 6~35 weeks |
| 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |