ELISA tests are performed in an automated fashion which means that processing times and the expense of testing are kept relatively low. A large number of commercial ELISA tests for Lyme disease are available and, theoretically, the automation of the process means that results will be standardized across different laboratories. In practice however, some researchers have found that different results are given at different laboratories, and even at a single laboratory for the same sample (Bakken, et al, 1997). More recent reviews of the various commercially available ELISA tests demonstrate comparable sensitivity and specificity between the tests but less than the required 95% sensitivity for screening of Lyme disease. False negatives appeared to be quite common, with a 56% rate found in some commercial kits by Luger and Krauss (1990). A false-negative rate of 70% was found in early Lyme disease cases using the ELISA test in one study, with 4-46% false-negative rates in later stage Lyme disease (Golightly, et al, 1990).
Should ELISA be the Primary Test for Lyme Disease?
Wojciechowska-Koszko (et al, 2011) also question the practice of using an ELISA test as the primary screening tool for Lyme disease. In their recent study these researchers found that indirect immunofluorescence assay (IIFA) and immunoblot (Western blot) tests produced positive results for both IgG and IgM antibodies but the ELISA tests only returned positive or borderline results in 53.3% of the patients with suspected Lyme disease. Using an initial IIFA screening test followed by an immunoblot in positive cases appeared to be the best course of action according to these findings, rather than using the ELISA test as currently recommended.
However, recent advances in ELISA testing may help improve accuracy and lead to better diagnosis of Lyme disease. A study by van Burgel (2011) found that the C6-peptide ELISA testing cerebrospinal fluid of patients with or without Lyme neuroborreliosis had a 95% sensitivity and 83% specificity in the Lyme non-neuroborreliosis patients and a 96% sensitivity and 97% specificity in the neurological controls. Serum tests using the C6-peptide ELISA do not appear to be as sensitive or specific as when testing CSF, with Skarpaas (et al, 2007) finding a 61% specificity compared to 88% specificity between serum and CSF testing for Lyme neuroborreliosis.
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Luger SW, Krauss E. Serologic tests for Lyme disease: interlaboratory variability. Arch Intern Med 1990; 15: 761-763.
Bakken LL, Callister SM, Wand PJ, Schell RF. Interlaboratory comparison of test results for detection of Lyme disease by 516 participants in the Wisconsin State laboratory of hygiene/College of American Pathologists proficiency testing program. J Clin Microbiol 1997; 35: 537-543.
Skarpaas T, Ljøstad U, Søbye M, Mygland A. Sensitivity and specificity of a commercial C6 peptide enzyme immuno assay in diagnosis of acute Lyme neuroborreliosis. Eur J Clin Microbiol Infect Dis. 2007 Sep;26(9):675-7.
Wojciechowska-Koszko I, Mączyńska I, Szych Z, Giedrys-Kalemba S. Serodiagnosis of borreliosis: indirect immunofluorescence assay, enzyme-linked immunosorbent assay and immunoblotting. Arch Immunol Ther Exp (Warsz). 2011 Feb;59(1):69-77. Epub 2011 Jan 22.
van Burgel ND, Brandenburg A, Gerritsen HJ, Kroes AC, van Dam AP. High sensitivity and specificity of the C6-peptide ELISA on cerebrospinal fluid in Lyme neuroborreliosis patients. Clin Microbiol Infect. 2011 Jan 17. doi: 10.1111/j.1469-0691.2011.03459.x. [Epub ahead of print]
Golightly MG, Thomas JA, Viciana AL. The laboratory diagnosis of Lyme Borreliosis. Lab Med 1990; 21: 299-304.