It is not FDA approved and therefore not sold in the US, though you can order if from overseas. Not being approved by the FDA is neither good nor bad, just a fact.
But if you read their site, by their own admission, there is up to an 80% false positive rate (seems high to me). Still, do you want to take this test, get a false positive and live under that cloud until you can get it verified by a Western Blot test? Why not just get it done in a clinic where they will verify it BEFORE they scare the shit out of you with a false positive?
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