The producer of all EliSpot tests did a study with around 400 samples to figure out whether the additional VlsE and p41i are good parameters for interferon gamma release assay. VlsE is a good marker for serological tests, but it turned out that there is almost no response in interferon gamma testing. p41i is also a good serological marker, but it’s not a specific marker. p41i is also contained in the lysate of the Borrelia burgdorferi Full antigen. There is no scientific evidence for the higher accuracy of the so-called “Elispot 2” compared to the Elispot. In our opinion the higher price is not justified and does not provide any benefit to the patient.
"[…] 409 patients suspected for or with reported tick bite(s) in the past were tested for reactive T-cells after stimulation with Borrelia antigens […]
For the evaluation, positive donors in different disease stages were tested with individual proteins / peptides for published or known epitopes. The amount of T-cells which secrete IFNg after stimulation with VlsE and Bmp is low or practically non-existent. […] Although the Borrelia proteins VlsE, Bmp and p41 are well established and show a good concordance with the clinical picture in serological tests like ELISA or Western Blot, their potential to activate specific T-cells in the EliSpot is relatively low. Based on our studies and collaborations with external diagnostic laboratories, the overall results show that beside the Borrelia lysate the native OspC and the recombinant DbpA used are the most efficient activators for Borrelia specific T-cells."