Overview
The iHealth COVID-19/Flu A&B Rapid Test Pro is a lateral flow immunochromatographic assay for the simultaneous detection and differentiation of influenza A, influenza B, and SARS-CoV-2 viral antigens from anterior nasal swab specimens.
Intended Use
The test is intended for use in individuals with signs and symptoms of respiratory infection consistent with COVID-19, within the first four days of symptom onset, and is authorized for use at the Point of Care (POC) in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Test Procedure
The test involves collecting a nasal swab sample, mixing it with a solution, and then applying it to the Test Card. Results are read visually after 15 minutes, and a control line must appear for the results to be valid.
Results Interpretation
Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Negative results are presumptive and should be confirmed with a molecular assay if necessary.
Manual:
Download: iHealth COVID-19/Flu A&B Rapid Test Pro Instructions for Use
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