My recommendations for Lyme testing have not changed.
Some new tests have been introduced, unfortunately there are no published studies demonstating their validity. One test is called an immune tolerance test. It measures T cell proliferation after exposure to select Lyme antigens. There exist very few studies regarding such lymphocyte proliferation tests for diagnosing Lyme. Oddly, the background paper published by the manufacturer, describing the underpinnings of this technology, cites an old Wormser study in the foot notes. The Wormser study using somewhat different methods concluded the test was insensitive but specific.
A second test measures an array of cytokines levels in response to antigenic stimulation. This test is also offered without any validation.
I suspect the problem may relate to the way the immune system responds to Lyme infection. The early immune response to Lyme infection, the cell mediated response, is measured here. Lyme bacteria are known to be very immungenic. Early Lyme infections are associated with dramatic immune responses. This is why for example, early EM rashes frequently show marked inflammation. It is also why early Lyme may be associated with fever and a flu like illness(mini-cytokine storm).
I think the concept of a cell mediated immune assay for the diagnosis of Lyme is right.
Such a test has been developed for tuberculosis. It measures a direct cytokine response to antigen presentation.
A new test for Lyme is sorely needed. Current tests remain clearly inadequate.
When I test my patients I continue to skip the ELISA and go right to the Western Blot. Although there are some patient who are ELISA positive and WB negative, these patients generally show some reactivity on WB assays.
Various labs seem to offer complete Lyme Western Blots. These include: IgeneX, Clongen, MDL, and SUNY. The SUNY Lyme lab presents some bands not seen from the other laboratories. Western Blot testing may also be available through the Mayo Clinic I have been informed. (I only have direct experience with IgeneX and Clongen although I have seen reports from other labs)
I like the C6 peptide test. This is a very specific ELISA test. It has a lot of false negatives because the antigen tested can easily change its epitope. Any value greater than 0.1 needs to be considered. With values of 0.4 and greater, I am fairly comfortable suggesting the patient has had prior exposure to Bb even in the face of a negative WB.
Co-infection testing is indispensible. Any positive results significantly increase the likelihood that a co-infection (here Borrelia) is also present.
The best test still remains a careful history and physical examination of the patient.