Specimen Collection Manual and Test Catalog

0.5 mL serum; minimum 0.5 mL

Allow to clot. Centrifuge and submit 0.5 mL serum.

Refrigerated (preferred). Room temperature (stable 8 hours) and frozen specimens also acceptable.

Room temperature: 8 hours. 2-8°C: 7 days. Frozen: 6 months.

Specimen stability exceeded; specimen grossly hemolyzed.

Lyme Screen: 
Negative: No detectable antibody; result does not exclude B. burgdorferi infection. An additional sample should be tested within 2-4 weeks if early infection is suspected. 

Indeterminate: Result is preliminary and not diagnostic. Second tier testing will be reflexively performed to confirm preliminary antibody screen result and reported separately. 

Positive: Result is preliminary and not diagnostic. Second tier testing will be reflexively performed to confirm preliminary antibody screen result and reported separately. 

Confirmation: 
IgG/IgM negative: Antibodies detected by the first-tier test were not confirmed. Negative results may occur in recently infected (= 14 days) patients. If recent infection is suspected, repeat testing in 7-14 days is recommended. Testing may not be necessary when a clinical diagnosis can be made based on presentation (e.g. presence of erythema migrans). 

IgG Negative; IgM Positive/Indeterminate: Results are consistent with acute or recent infection with B. burgdorferi (Lyme disease). IgM immunoassay results should only be considered as indicative of recent infections in patients presenting within 30 days of symptom onset. Consideration of IgM results in patients with symptoms lasting >30 days is discouraged due to the risk of false positive IgM results or prolonged IgM seropositivity following disease resolution. Testing of a new specimen collected in 7–14 days to demonstrate IgG seroconversion may be considered to confirm infection. 

IgG Positive/Indeterminate, regardless of IgM result: Results are consistent with B. burgdorferi infection (Lyme disease) in the recent or remote past. IgG-class antibodies may remain detectable for months to years following resolution of infection. Results should not be used to monitor or establish adequate response to therapy. Response to therapy is confirmed through resolution of clinical symptoms; additional laboratory testing should not be performed.

Test progresses to Confirmation at an additional charge if patient screening result is positive or indeterminate. Reference: APHL Suggested Reporting Language, Interpretation and Guidance Regarding Lyme Disease Serologic Test Results. Association of Public Health Laboratories. May 2021.

Qualitative determination of IgM/IgG antibodies by screen with reflex to Lyme Confirmation if screen is positive or indeterminate.

Borrelia Burgdorferi Antibody IgG/IgM; Lyme Screen; Lyme Progressive; Lyme Titer, LYMPRO

Lyme disease is caused by a bacterium, Borrelia burgdorferi, that is transmitted by the ticks of the genus Ixodes. Patients with early infection produce IgM antibodies during the first few weeks and produce IgG antibodies more slowly. IgG antibodies can remain detectable for years. CDC recommends that equivocal or positive results be supplemented with a confirmatory test.