FDA Clears Marketing for "Modified Two-Tiered" Lyme Disease Tests

[MeSci]

FDA Clears Marketing for "Modified Two-Tiered" Lyme Disease Tests

By Kristin J. Kelley

Edited by
- David G. Fairchild, MD, MPH, and
- Lorenzo Di Francesco, MD, FACP, FHM

The FDA has cleared expanded indications for four Lyme disease tests so that they can be used in a new testing model. The new diagnostic approach eliminates the need to run a Western Blot to confirm the results of an initial enzyme immunoassay (EIA) test. Instead, two EIAs can be run concurrently or sequentially, potentially leading to faster results.

Data reviewed by the FDA demonstrated that the modified two-tiered testing algorithm detected antibodies for exposure to Borrelia burgdorferi as accurately as the current approach. The manufacturer says the algorithm used by the modified test detected "up to 30% more acute Lyme disease cases" than the standard one.

The number of Lyme cases rose 17% from 2016 to 2017, according to the latest published data from the CDC.

Link(s):
FDA news release (Free) http://response.jwatch.org/t?ctl=5EC61:5FF9B588B7CB016CD49283241868B800D2B71D9A95FA21D3&

Manufacturer's news release (Free) http://response.jwatch.org/t?ctl=5EC62:5FF9B588B7CB016CD49283241868B800D2B71D9A95FA21D3&

Manufacturer's explanation of new testing method (Free) http://response.jwatch.org/t?ctl=5EC63:5FF9B588B7CB016CD49283241868B800D2B71D9A95FA21D3&

Background: Physician's First Watch coverage of 2019 Draft Lyme Disease Guidelines (Free) http://response.jwatch.org/t?ctl=5EC64:5FF9B588B7CB016CD49283241868B800D2B71D9A95FA21D3&

 

[duncan]

Still more indirect methods, at the expense, potentially, of the western blot - and knowing about the specifics of your WB can help reduce the chance of a false result. This feels like either an attempt to save $'s, or worse.

Direct testing is desperately needed. Direct testing for both early and late Lyme. Pretty much anything else imo is just a placeholder.

 

[Helen]

I assume the following should have it´s own thread, if there isn´t one already. It could also be interesting to discuss this new test and compare it with the one that you @MeSci links to.

About the test:

" The concept is that we are no longer looking for the bacteria but for its obligatory bacteriophage, which seeks to find the bacteria to survive. The genetic material of the bacteriophage is specific to the bacteria with which it is associated. This means that the different species of bacteria will have different bacteriophages".

https://redlabs.be/phelix-phage-borrelia/

 

[MeSci]

My brain is not working properly at the moment, so I'm not sure if this is directly connected or not:

https://www.cdc.gov/mmwr/volumes/68/wr/mm6832a4.htm

Paul Mead, MD1; Jeannine Petersen, PhD1; Alison Hinckley, PhD1

Summary

What is already known about this topic?

Serologic testing is the principal means of laboratory diagnosis of Lyme disease. Current recommendations include using a sensitive enzyme immunoassay (EIA) or immunofluorescence assay, followed by a western immunoblot assay for specimens yielding positive or equivocal results.

More at link

 

[duncan]

Yes, the CDC is backing this initiative, ostensibly to spare the common physician the complexities of the Western Blot. Also ostensibly, to save money.

One step forward, two steps back.