The CDC's Johnson wrote the paper that mislead the 5 US Senators who pushed the FDA to begin regulating LDT tests. They will almost certainly go after IgneneX and ALS.
Here is the story of how Johnson left off critical evidence, failed to do a proper contamination analysis and misused irrelevant contamination in a confirmation test or possibly at a third party sequencing lab in Alabama. She implied it was in the actual culture when it was not. Its not the first time the CDC has been dishonest but misleading 5 US Senators deserves they be told.
When the evidence Johnson omitted is incorporated with a proper analysis of the contamination, its clear the culture looks ok. But now that paper has led to an MMWR, Medscape articles, 5 US Senators who used it finally to pressure the FDA to regulate LDTs, especially those for Lyme.
My test results from ALS stated positive growth using polyclonal antibody for Bb.
I now understand that to mean I could have Bb, Bg or Ba.
(Had always assumed I had Bb - never really considered Bg or Ba - and cannot remember if treatment is different).
No mention of monoclonal testing on my sample.
I have to assume patients' samples are not tested monoclonal and polyclonal???
Posted by elara (Member # 41819) on :
Polyclonal can mean any of the three. If monoclonal is positive, its Bb. So you ask for the polyclonal if you think you might have any of the 3 species and ask for the monoclonal for Bb. So if you live in Europe, it probably means Ba or Bg. If you live in the US it probably means Bb unless you traveled to Europe or Asia.
Polyclonal is the best choice if you aren't sure or just want the broadest coverage. It binds to all 3 Bb, Ba and Bg.
Posted by susank (Member # 22150) on :
Thanks and thanks also for posting the paper.
Although I cannot figure out who wrote it.
And it was sent to?
Anyway, that article is about the only thing I have seen past months in regards to the ALS test.
I guess I have been expecting statements from ALS and the CDC.
The info in the article sure appears to say the culture test is valid.