title: Comparison of five diagnostic modalities for direct detection of Borrelia burgdorferi in patients with early Lyme disease.
abstract: Lyme disease, the most commonly reported tick-borne infection in North America, is caused by infection with the spirochete Borrelia burgdorferi. Although an accurate clinical diagnosis can often be made based on the presence of erythema migrans, in research studies microbiologic or molecular microbiologic confirmation of the diagnosis may be required. In this study, we evaluated the sensitivity of 5 direct diagnostic methods (culture and nested polymerase chain reaction [PCR] of a 2-mm skin biopsy specimen, nested PCR and quantitative PCR (qPCR) performed on the same 1-mL aliquot of plasma and a novel qPCR-blood culture method) in 66 untreated adult patients with erythema migrans. Results of one or more of these tests were positive in 93.9% of the patients. Culture was more sensitive than PCR for both skin and blood, but the difference was only statistically significant for blood samples (P<0.005). Blood culture was significantly more likely to be positive in patients with multiple erythema migrans skin lesions compared to those with a single lesion (P=0.001). Positive test results among the 48 patients for whom all 5 assays were performed invariably included either a positive blood or a skin culture. The results of this study demonstrate that direct detection methods such as PCR and culture are highly sensitive in untreated adult patients with erythema migrans. This enabled microbiologic or molecular microbiologic confirmation of the diagnosis of B. burgdorferi infection in all but 4 (6.1%) of the 66 patients evaluated.
authors.affiliation: Department of Microbiology and Immunology, New York Medical College, Valhalla, NY 10595, USA.
authors.forename: Dionysios
authors.initials: D
authors.lastname: Liveris
authors.forename: Ira
authors.initials: I
authors.lastname: Schwartz
authors.forename: Donna
authors.initials: D
authors.lastname: McKenna
authors.forename: John
authors.initials: J
authors.lastname: Nowakowski
authors.forename: Robert
authors.initials: R
authors.lastname: Nadelman
authors.forename: Joseph
authors.initials: J
authors.lastname: Demarco
authors.forename: Radha
authors.initials: R
authors.lastname: Iyer
authors.forename: Susan
authors.initials: S
authors.lastname: Bittker
authors.forename: Denise
authors.initials: D
authors.lastname: Cooper
authors.forename: Diane
authors.initials: D
authors.lastname: Holmgren
authors.forename: Gary P
authors.initials: GP
authors.lastname: Wormser
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001431:Bacteriological Techniques / Q000379:methods*; D025065:Borrelia burgdorferi / Q000235:genetics / Q000254:growth & development / Q000302:isolation & purification*; D042241:Early Diagnosis; D005260:Female; D006801:Humans; D008193:Lyme Disease / Q000175:diagnosis*; D008297:Male; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D012680:Sensitivity and Specificity