Lyme Disease, Molecular Detection, PCR, Blood

Casandra

Casandra Test Code MC49607Version 1 (DRAFT)

Performing Lab

Lab Mayo Clinic LabLab Test ID PBORBCPT Codes 87476, 87798, 87801

Lyme Disease, Molecular Detection, PCR, Blood

Clinical Use

Use

This test supports the diagnosis of Lyme disease in conjunction with serologic testing. Lyme disease is a multisystem and multistage tick-transmitted infection caused by spirochetal bacteria in the Borrelia burgdorferi sensu lato complex. It is the most commonly reported tick-borne infection in Europe and North America.

Special Instructions

This test should not be used to screen asymptomatic patients. Lyme PCR should be performed in conjunction with FDA-approved serologic tests, and results should be correlated with clinical presentation and epidemiologic data.

Limitations

PCR may not detect Borrelia burgdorferi DNA from blood in cases of active or chronic disease due to the presence of inhibitory substances, leading to false-negative results. The assay detects most Borrelia species but cannot differentiate between B. afzelii and B. garinii. Additionally, the test has not been cleared or approved by the FDA.

Test Details

New York Approved