Lyme Disease, Molecular Detection, PCR, Blood
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.
New York Approved
Methodology
PCR-based (Real-Time PCR)
Biomarkers
LOINC Codes
- 90892-1
- 94247-4
- 94248-2
- 94249-0
- 59464-8
Result Turnaround Time
1-4 days
Related Documents
For more information, please review the documents below
Specimen
Whole Blood
Volume
1 mL
Minimum Volume
0.3 mL
Container
Lavender top (EDTA)
Collection Instructions
Send whole blood specimen in original tube. Do not aliquot.
Causes for Rejection
Gross hemolysis
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 7 days |
| Frozen | 7 days |