Test Code LYMIB 
Methodology Immunoblot 
Description Useful for the diagnosis of Lyme disease by detection of serum antibodies (IgM and IgG) to Borrelia burgdorferi.

The Interpretation is based on the 1995 CDC criteria. 

Specimen Draw blood in either a plain, red-top or serum gel tube. Spin down and send 1.0 mL (minimum 0.5 mL) of serum refrigerated. 
Reference Values IgG: Negative, IgM: Negative

1. This assay should be used to test human serum specimens which have been found to be positive or equivocal using an EIA or IFA test procedure. It should not be performed as a primary screening test.
2. A negative result does not completely exclude the possibility of an infection. The sample may have been taken before the appearance of IgM antibodies, or the antibody titer exists below the detection limit of the test.
3. The treatment of the patients with antibiotics during the early stage of the disease may lead to a suppression of the immune response, so that no specific antibodies may be detected.
4. The diagnosis of Lyme disease must include careful clinical evaluation and should not be based only on detection of antibodies to B. burgdorferi.
5. A positive IgM test result indicates recent or past exposure and does not necessarily indicate a current infection with B. burgdorferi.
6. The continued presence or absence of antibodies to B. burgdorferi cannot be used to determine the success or failure of therapy.

Interpretation: IgM
Positive: A sample is considered anti-B. burgdorferi IgM positive if two or more of the following three bands are present: 23 kDa (OspC), 39 kDa (BmpA), and 41 kDa (Fla).
Interpretation: IgG
Positive: A sample is considered anti-B. burgdorferi IgG positive if five or more of the following 10 bands are present: 18 kDa, 23 kDa (OspC), 28 kDa, 30 kDa, 39 kDa (BmpA), 41 kDa (Fla), 45 kDa, 58 kDa (OppA-2), 66 kDa and 93 kDa.

CDC criteria (mmwrq@cdc.gov, 1995) require >=5 bands for IgG or >=2 bands for IgM for the Western blot to be considered positive. Bands (e.g.,p41) may be detected in patients without Lyme disease, and patterns not meeting the CDC criteria should be interpreted with caution.
European criteria (based on German guidelines www.lgl.bayern.de, 2014) require >=1 band for Ig M and at least 2 of the following bands (p23, p30, p39 or p58) for IgG for the western blot to be considered positive. These criteria should be applied only if there is a suspicion that the patient could have been in contact with ticks or Borrelia spp of European origin. 

Analytic Time 1 Day; Maximum Laboratory Time - 5 Days 
Day(s) Test Set Up Monday and Thursday 
CPT Code(s) 86617 2  Immunoblot