Supportive Data

The following validation data supports the use of this assay for clinical testing.

Analytical Sensitivity/Limit of Detection:

The lower limit of detection (LOD) is approximately 300 to 1000 genomic copies/mL in cerebrospinal fluid (CSF), tissue, blood, and synovial fluid.

Accuracy/Diagnostic Sensitivity and Specificity:

Spiking studies of whole organism in fresh tissue, synovial fluid, and CSF (spiked near the approximate LOD) showed 100% recovery.

Analytical Specificity:

No polymerase chain reaction signal was obtained from the extracts of 22 bacterial, viral, parasitic, and fungal isolates that can cause symptoms similar to Lyme disease, including Rickettsia rickettsii, Rickettsia typhi, Ehrlichia canis, Babesia microti, Plasmodium falciparum, Plasmodium vivax, Bartonella henselae, Bartonella quintana, herpes simplex virus, and Toxoplasma gondii. Relapsing fever borreliae (including Borrelia miyamotoi) are also not detected with this assay.

Precision:

Interassay precision was 100%, and intra-assay precision was 100%.

Reference Range:

The reference range for this assay is negative. This assay is only to be used for patients with a clinical history and symptoms consistent with Lyme disease and must be interpreted in the context of serologic tests, which are the gold standard for diagnosis of Lyme disease.

Reportable Range:

This is a qualitative assay, and the results are reported as negative or positive for targeted Borrelia burgdorferi, Borrelia afzelii, Borrelia garinii, or Borrelia mayonii.