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The new antigen test (nano-trap antigen) test is currently expected to be released this summer according to the manufacturer.
It was reported before that it would be late 2013 or early 2014.
The test has been a moving target. I think it will still be FDA approved upon release, but I'm continuing to get confirmation on that.
An antigen test tests for the presence of active infection rather than an immune response. Antigens are the things on the bacteria. The first release of the test will test for the the ospA antigen.
Posts: 136 | From arlington, VA | Registered: Jun 2010
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Thanks for update. I have been following this closely. Is FDA raising unnecessary issues?
Posts: 360 | From Massachusetts | Registered: Dec 2012
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quote:Originally posted by BobG: Thanks for update. I have been following this closely. Is FDA raising unnecessary issues?
I don't know if the FDA approval is causing the delay. I thought of asking that, but have not. I was told that many parties are involved.
Posts: 136 | From arlington, VA | Registered: Jun 2010
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quote:Originally posted by BobG: PS. Will they be going after co-infections as well with this test?
Co-infection antigens are planned to be added as part of updates to the test. This was originally planned for 2014, but the test is just being released now (summer hopefully) in the first version.
The future versions are supposed to add more antigens for Borrelia other than ospA, as well as test for co-infections Bartonella. I think Babesia was mentioned also.
I have no idea how FDA approval will work for that or the new timeline for that.
It is very upsetting that such a small company had to do this with state funding. There was no help from the federal government to develop antigen tests to bring clarity to this issue.
I can understand that people say not to give antibiotics indefinitely and not cure people for an infection you can't confirm. But, I can't understand the lack of interest to develop tests to get confirmation.
The frustrating part is that we should have all the antigens for all the species of Borrelia as well as coinfections immediately now that we know how to do this. That should be a starting point. I think if there was lots of funding for this it could be done quicker, but I don't know.
If I test positive I would contact the CDC and say we need immediate help because something is very wrong with the old test and the cure we have right now. I don't think I'll test positive because I'm not convinced I have it and also maybe testing is more complicated than we think and may require more antigens which won't be part of the first test release.
Posts: 136 | From arlington, VA | Registered: Jun 2010
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