A negative result does not rule out Lyme disease, since inhibitory substances may be present in the specimen and the assay has limited diagnostic sensitivity when testing certain types of specimens. If clinical features of illness are highly indicative of Lyme neuroborreliosis, serologic testing on CSF is warranted.
Patients with active infection due to Borrelia afzelii, or Borrelia garinii may have positive results from this PCR test, which can distinguish Borrelia burgdorferi infection from those of Borrelia afzelii and Borrelia garinii. However, the later 2 infections are indistinguishable from one another by this PCR assay. Specimens with detectable DNA from either of these two sprirochetes in this assay will be reported as “positive” for Borrelia afzelii/Borrelia garini”.
PCR test results should be used as an aid in diagnosis and not considered diagnostic by themselves. These results should be correlated with serologic and epidemiologic data and clinical presentation of the patient.
Coinfection with Erhlichia chaffeensis/Anaplasma phagocytophilum and/or Babesia microti have been reported in the United States.