Question 1

How is it no one has asked the key question: what are verified rates of false-negatives or false-positives?

Accepted Answer

They do report in small print having 94.3% sensitivity (correctly identified positive cases) but this was calculated based on comparison of their results to results from an unspecified PCR test of only 35 individuals.  Not much of a sample size and it is unlikely that it included people who have Omicron variant as the package insert was dated 11/2021.  The specificity (correctly identified negative samples) was 98.1% per their literature, again the sample size was low, only 108 individuals if I remember correctly.   It did not say when or where the testing was done.  I suspect it was done in China as that is where this product is manufactured.  Most independent sources are estimating at home antigen testing kits to have a wide range of sensitivity from the upper 50s%  to very low 90s% range; none are as accurate as PCR tests.  The devil is in the details.

Question 2

Is there an expiration date?

Accepted Answer

On Mar 29, 2022, the FDA granted a three-month shelf-life extension for the iHealth COVID-19 Antigen Rapid Test, which extended the shelf-life of all iHealth tests with expiration dates on or before 2022-09-29 (YYYY-MM-DD) from 6 months to 9 months. For example, if the expiration date printed on your box says 2022-05-21 (YYYY-MM-DD), the updated expiration date is 2022-08-21 (YYYY-MM-DD). We will continue to apply to FDA for shelf-life extensions every three months based on our stability studies, and the new shelf-lives for our tests will apply to tests already produced as well as future production.

Question 3

Will this test satisfy US governmental requirements for airplane travel?

Accepted Answer

We just used it to return to the US while abroad. We paid the $20 fee to have the verified Test Service. Our first connection wasn't very good and even though I was using Chrome, had updated and refreshed the browser and restarted my computer before taking the test... it didn't initially open to a proctor. I retried several times. But after taking a 10 min break I was able to get in contact with a proctor and the rest was seamless. The other three members in my family did not have any trouble making the connection. Overall, it was much cheaper and way more convenient than finding a local testing location and waiting on results. We had the paperwork needed for our flights within 30 min of starting the whole process.

Question 4

What is the shelf life of the kits after shipment? (NOT after manufacture -- they don't do much good if they expire waiting to be shipped.)

Accepted Answer

On Mar 29, 2022, the FDA granted a three-month shelf-life extension for the iHealth COVID-19 Antigen Rapid Test, which extended the shelf-life of all iHealth tests with expiration dates on or before 2022-09-29 (YYYY-MM-DD) from 6 months to 9 months. For example, if the expiration date printed on your box says 2022-05-21 (YYYY-MM-DD), the updated expiration date is 2022-08-21 (YYYY-MM-DD). We will continue to apply to FDA for shelf-life extensions every three months based on our stability studies, and the new shelf-lives for our tests will apply to tests already produced as well as future production.

FDA extension letter could be found from here: 
https://www.fda.gov/media/157340/download

ASIN	B09KZ6TBNY
Best Sellers Rank	#163 in Industrial & Scientific ( See Top 100 in Industrial & Scientific ) #5 in Clinical Diagnostic Test Kits
Customer Reviews	4.5 4.5 out of 5 stars (212,904)
Date First Available	November 4, 2021
Item Weight	0.1 ounces
Item model number	ICO-3000
Manufacturer	Andon Medical Co., Ltd.
Product Dimensions	3.46 x 0.71 x 0.16 inches

iHealth COVID-19 Antigen Rapid Home Test, 2 Tests, FDA 510(k) Cleared OTC

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