Cautions

Serologic tests are recommended for diagnosis of Lyme disease. Polymerase chain reaction (PCR) may play an adjunctive role but may not detect Borrelia burgdorferi DNA from cerebrospinal fluid (CSF) in cases of active or chronic disease. The presence of inhibitory substances may also cause a false-negative result. If clinical features of illness are highly indicative of Lyme neuroborreliosis, serologic testing on CSF is warranted. 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.

Testing of CSF by PCR in patients with suspected Lyme neuroborreliosis should be requested only on patients with positive B burgdorferi antibody in serum confirmed by Western blot assay (LYWB / Lyme Disease Antibody, Immunoblot, Serum) and with abnormal CSF findings (elevated protein and WBC >10 cells/high-power field).

Concurrent infections with multiple tick-borne pathogens, including Ehrlichia muris eauclairensis, Anaplasma phagocytophilum, Babesia microti, and Borrelia miyamotoi (a relapsing fever Borrelia) have been reported in the United States, and consideration should be given to testing for other pathogens, if clinically indicated.

This assay detects most members of the Borrelia burgdorferi sensu lato (Bbsl) complex, including Borrelia andersonii, Borrelia americana, and Borrelia bissettii, which have been rarely detected in humans. Detection of DNA from these organisms would be reported as an atypical result and prompt additional laboratory testing to further identify the DNA present. The sensitivity of this assay for detecting these organisms has not been determined.

This assay also detects some members of the Bbsl complex that are not considered to be human pathogens but may be found in ticks and other animals. Therefore, this assay should not be used to test nonhuman specimens.