There is confusion about FDA approval of Lyme testing. It has been stated (by IDSA experts) that ILADS associated physicians have essentially created their own laboratories which are not FDA approved. And furthermore, these laboratories and physicians use non-peer-reviewed methods to interpret the results.
This is very misleading at the very least.
Laboratories are licensed by state regulatory agencies. Certified laboratories meet strict standards, including proficiency testing.
The FDA is charged with regulating drugs and medical devices. Test kits, commercially prepared for mass distribution are considered medical devices. This is why the FDA licenses these Lyme Western Blot tests. The FDA has licensed more than 70Lyme Western Blot kits made by varying manufactures. There exists no published data validating any one of these kits let alone all 70 or more.
Standard kits report the 13 Western Blot bands specified by the 1994 Dearborn criteria. This standard was created so that various doctors and scientists could communicate with one another reading from the same sheet of music. This surveillance test, never approved for diagnosis, has no peer-reviewed literature supporting its use - especially in light of FDA approval of so many test kits. In fact, a review of the literature shows investigators have used various Band criteria.
Laboratories producing their own testing kits (not for mass distribution) like Stony Brook and IgeneX do not require FDA approval. In fact, these tests cannot be regulated by the FDA. These laboratories must comply with the same regulations and proficiency tests required by all state licensed facilities.
Specialty laboratories likely do a better Lyme Western blot. For example, Stony Brook Lyme lab only does Lyme Western Blots. IgenX has decades of experience. Clongen and MDL are meticulous.
While mass produced Lyme Western Blot kits report 13 bands. Other maligned specialty labs report 28 or even 52 bands.
As stated in the 1994 report the diagnosis of Lyme is(was) largely clinical.
The question then is: How can more be less?