User Manual Summary for the iHealth COVID-19 Antigen Rapid Test
The iHealth COVID-19 Antigen Rapid Test is an in vitro diagnostic medical device designed for rapid detection of SARS-CoV-2 viral proteins in nasal swab specimens. The test is tailored for non-prescription home use for individuals aged 15 years or older and is also suitable for adult-supervised testing of individuals aged 2 years or older. The manual provides step-by-step instructions for use.
Key Components and Test Preparation
Test kits may come in two sets with varied contents. Set 1 includes a pre-filled tube with extraction solution, while Set 2 has an empty tube and separate sealed solution. Regardless of the test set, a COVID-19 Test Card and swab are included.
Prior to testing, users must download the “iHealth COVID-19 Antigen Rapid Test” app for iOS or Android, which offers instructional videos and a platform to report results.
Specimen Collection and Processing
Users should perform a nasal swab by brushing the insides of both nostrils with the provided swab. The sample is then mixed with the extraction solution, and three drops of the mixed sample are added to the test card.
The test requires a 15-minute wait period after sample application before results can be interpreted. It is cautioned not to read results prior to 15 minutes or post 30 minutes to avoid incorrect outcomes.
Result Interpretation and Reporting
Positive results, indicated by visible test and control lines, imply a current COVID-19 infection and necessitate immediate contact with healthcare providers and adherence to local guidelines. Negative results, indicated by a visible control line without a test line, suggest non-detection of the virus but are not definitive; repeat testing and medical consultation are advised.
Invalid results require re-testing with a new kit. All results, positive or negative, should be reported according to the app instructions or to healthcare providers.
LIMITATIONS and Intended Use
The manual explains that antigen tests have a higher chance of a false negative compared to PCR tests and details circumstances where molecular testing may be necessary. The test’s performance was established with certain clinical specimens and may vary with different viral strains.
It is crucial for users to follow all instructions provided in the manual to ensure accurate test performance. The manual also highlights the operational requirements for the test, including appropriate storage conditions, and provides guidance on safe disposal of the test materials.
For further assistance, the manual advises contacting iHealth Labs through their website or customer service hotline.
Safety and Regulations
This product is authorized by the FDA under an Emergency Use Authorization (EUA) and is only for the detection of proteins from SARS-CoV-2. The manual emphasizes the importance of not using the test past its expiration date and not to rely solely on this test to manage health.
It also alerts to possible discomfort during sample collection and potential incorrect results. Users must be aware of the risks of handling the kit components, with specific details on chemical ingredients and safety precautions related to them.
Overall, the iHealth COVID-19 Antigen Rapid Test is positioned as a convenient and effective tool for early detection of COVID-19, providing critical information for managing personal and public health during the pandemic.
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