Human Factors and Clinical Validation of the iHealth Labs Inc. Flu A&B/COVID-19/Respiratory syncytial virus (RSV) Rapid Test in Anterior Nares Nasal Samples For Over the Counter (OTC) Use. IH-018

This will be a prospective study conducted at three or more sites (with a simulated home environment) for the clinical validation of the iHealth Flu A&B/COVID-19/RSV Rapid Test for the differential detection of influenza A, influenza B, SARS-CoV-2, and respiratory syncytial virus (RSV) in anterior nares nasal samples. The study will evaluate the investigational test performance using subject-collected samples in symptomatic individuals compared to the comparator tests. Five Hundred or more subjects who are currently experiencing symptoms associated with influenza A & B COVID-19 and RSV may be enrolled. A minimum of 16-25 RSV positive study samples should be from subjects aged 6- 23 months, and a minimum of 16-25 RSV positive samples should be from individuals above 60 years of age. Each enrolled subject will either self-collect one sample from their anterior nares (from both nostrils) or have one sample collected from him/her by another individual. The subject/tester will run the sample on the investigational test using the provided test Quick Reference Instructions (QRI). Each subject will also provide another anterior nares sample (from both nostrils) collected by one of the study personnel for comparator testing. The comparator sample will be shipped to the reference laboratory for testing. If a standard of care (SOC) test sample is ordered or scheduled during the same study visit, a minimum wait of 15 minutes is required before any study samples are collected. A minimum wait of 15 minutes is required between the investigational and comparator sample collections. For the investigational test procedure the anticipated time needed to collect samples and complete the test using the test unit, is up to 15 minutes per sample, There will also be a 15 minute delay between sampling for the immediate investigational test and the comparator test. The location/setting of the testing will be at a minimum of three (3) clinical research locations and will provide all enrolled subjects, or testers testing another individual, a private area that resembles a home setting, “simulated home environment”. This will be in a private clinic room at the site. The 'simulated home environment’ site will be a private room with typical home furniture such as a table, chairs, good lighting and devoid of clinical equipment. The participant will utilize the chair provided. The private area that resembles a home setting, “simulated home environment”, will have such items sufficient to follow the instructions including e.g., hand washing, to perform all the study procedures without any assistance from the study personnel or another person. Test results from the iHealth Flu A&B/COVID-19/RSV Rapid Test (investigational test) will be compared to the test results generated from the comparator assay. Twenty five (25) or more subjects who are self-collecting and testing, and twenty-five (25) or more subjects collecting a sample and performing the testing on another subject (child or adult), will participate in the human factors assessment where the study personnel or a healthcare provider will evaluate the subject/tester’s ability to correctly prepare the test components for testing, collect a sample, perform the test and interpret the test results. The human factors assessment will occur on the same day as the sampling for investigational/comparator testing, The participants will complete one test as part of this assessment and the anticipated time needed to complete the human factors assessment is 15 minutes per participant. The location/setting of human factors assessments is the same as for the investigational test procedures described above. All subjects participating in the human factors assessment will also be required to complete a labeling and comprehension questionnaire and will be provided with a mock panel with different investigational test results for interpretation. All investigational and comparator results collected in the human factors assessment will be included in the study data analysis without any modifications. No investigational test results will be reported to a third party or used for any treatment decisions. An external positive and negative control sample is to be tested daily by the study personnel prior to any subject testing with the investigational test. The control results will be used to verify that the test device is performing as intended and that there is no contamination. If a daily external control test fails (invalid), testing may be repeated once. Invalid and failed tests will be recorded, and the study monitor is to be notified of any control failures and repeated testing. Upon repeated failed testing, notify the study monitor immediately. Timepoints The estimated length of the sample collection and testing phase is expected to be two (2) to 20 weeks with an additional two (2) to three (3) weeks of study preparation and two (2) weeks of final study closeout. The total estimated study duration is six (6) to 25 weeks.