Introduction
The iHealth COVID-19 Antigen Rapid Test Pro is a lateral flow immunoassay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swab specimens.
Intended Use
The test is intended for use by healthcare professionals or operators who are proficient in performing tests in a point of care setting, and is only for in vitro diagnostic use under the Food and Drug Administration’s Emergency Use Authorization.
Test Procedure
The test involves collecting a nasal swab sample, adding it to the extraction reagent tube, and then applying 3 drops of the sample to the COVID-19 Test Card. The result is ready in 15-30 minutes.
Important: Results should not be read before 15 minutes or after 30 minutes, as this may lead to false positive, false negative, or invalid results.
Test Interpretation
A positive test result indicates the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions.
Manual:
Download: iHealth COVID-19 Antigen Rapid Test Pro Instructions for Use
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