Purpose: To provide a quantitative and qualitative evaluation of the p
redictive value of the laboratory diagnosis of Lyme disease and to use
the resultant data to formulate guidelines for clinical diagnosis. Da
ta Sources: A MEDLINE search of English-language articles or articles
with English-language abstracts published from 1982 to 1996. Data Extr
action: Sensitivity, specificity, and likelihood ratios were calculate
d, and a random-effects model was used to combine the proportions from
the eligible studies. Prespecified criteria were used to determine wh
ich studies were eligible for analysis. Data Synthesis: Laboratory tes
ting in general is not clinically useful if the pretest probability of
Lyme disease is less than 0.20 or greater than 0.80. When the pretest
probability is 0.20 to 0.80, sequential testing with enzyme-linked im
munosorbent assay and Western blot is the most accurate method for rul
ing in or ruling out the possibility of Lyme disease. Conclusions: Lab
oratory testing is recommended only in patients whose pretest probabil
ity of Lyme disease is 0.20 to 0.80. If the pretest probability is les
s than 0.20, testing will result in more false-positive results than t
rue-positive results; a negative test result in this situation effecti
vely rules out the disease.