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Test ID SLYME Lyme Antibody Modified 2-Tier with Reflex, Serum


Specimen Required


Supplies: Aliquot Tube, 5 mL (T465)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: 5-mL aliquot tube

Specimen Volume: 0.6 mL


Useful For

Diagnosis of Lyme disease

 

This test should not be used as a screening procedure for the general population.

Testing Algorithm

If the Lyme antibody result is positive or equivocal, then confirmation by whole cell sonicate will be performed at an additional charge.

 

See Acute Tick-Borne Disease Testing Algorithm in Special Instructions.

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Reporting Name

Lyme Ab Modified 2-Tier w/Reflex, S

Specimen Type

Serum

Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 10 days
  Frozen  30 days

Clinical Information

Lyme disease (LD) is caused by infection with a member of the Borrelia burgdorferi sensu lato complex, which includes B burgdorferi sensu stricto (herein referred to as B burgdorferi), Borrelia afzelii, and Borrelia garinii. Among these species, B burgdorferi is the most frequent cause of LD in North America. These tick-borne spirochetes are transmitted to humans through the bite of Ixodes species ticks. Endemic areas for LD in the United States correspond with the distribution of 2 tick species, Ixodes scapularis (Northeastern and Upper Midwestern US) and Ixodes pacificus (West Coast US).

 

Transmission of LD-associated Borrelia requires at least 36 hours of tick attachment. Approximately 80% of infected individuals will develop a unique expanding skin lesion with a central zone of clearing, referred to as erythema migrans (EM; stage 1). In the absence of treatment, patients may progress to early disseminated disease (stage 2), which is characterized by neurologic manifestations (eg, meningitis, cranial neuropathy, radiculoneuropathy) and is often associated with B garinii infection. Patients with late LD often present with intermittent or persistent arthralgia, most often associated with B burgdorferi infection, or with acrodermatitis chronica atrophicans (ACA), typically due to infection with B afzelii.

 

Diagnosis of LD is currently based on either the standard or modified 2-tiered serologic testing algorithm (STTTA or MTTTA, respectively). For the STTTA, see LYME/ Lyme Disease Serology, Serum.

 

The MTTTA starts with an initial enzyme immunoassay (EIA) screen for detection of total antibodies against the Borrelia Vlse/pepC10 proteins. Samples that are screen positive or equivocal by this first tier EIA are subsequently reflexed for supplemental assessment using 2 separate EIAs for detection of IgM and IgG antibodies against B burgdorferi whole cell sonicate material. 

 

Importantly, while serologic assessment for LD may be negative in the early weeks following infection, over 90% of patients with later stages of infection are seropositive by serology, which remains the diagnostic method of choice for this disease.

Reference Values

Negative

Reference values apply to all ages.

Interpretation

Negative:

Negative for antibodies to the Borrelia (Borreliella) species causing Lyme disease. Negative results may occur in patients who have been recently infected (≤14 days).  If recent infection is suspected, repeat testing on a new sample collected in 7 to 14 days is recommended.

 

Equivocal: 

Not diagnostic. Supplemental testing in accordance with the modified 2-tiered testing algorithm for Lyme disease has been ordered by reflex.

 

Positive: 

Not diagnostic. Supplemental testing in accordance with the modified 2-tiered testing algorithm for Lyme disease has been ordered by reflex.

Clinical Reference

1. Theel ES: The past, present and (possible) future of serologic testing for Lyme disease. J Clin Microbiol. 2016;54(5):1191-1196. doi: 10.1128/JCM.03394-15. 

2. Dattwyler RJ: Lyme borreliosis: an overview of clinical manifestations. Lab Med. 1990;21:290-292

3. Schwan TG, Burgdorfer W, Rosa PA: Borrelia. In: Murray PR, ed. Manual of Clinical Microbiology. 7th ed. ASM Press; 1999:746-758

4. CDC: Recommendation for test performance and interpretation from second national conference on serological diagnosis of lyme disease. MMWR Morb Mortal Wkly Rep. 1996;45:481-484

Day(s) Performed

Monday through Friday

Report Available

Same day/1 to 4 days

Test Classification

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

86618

86617 x 2-Lyme IgM/IgG, WCS, EIA S (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
SLYME Lyme Ab Modified 2-Tier w/Reflex, S 83081-0

 

Result ID Test Result Name Result LOINC Value
SLYME Lyme Ab Modified 2-Tier w/Reflex, S 83081-0

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
TLYME Lyme IgM/IgG, WCS, EIA, S Yes No