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Bloodstream invasion in early Lyme disease: results from a prospective, controlled, blinded study using the polymerase chain reaction.

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Abstract

PURPOSE:

The purposes of this study were to determine (1) the optimal techniques for and potential diagnostic usefulness of the polymerase chain reaction (PCR) in early
Lyme disease, and (2) the true frequency and clinical correlates of PCR-documented blood-borne infection in the dissemination of
Lyme disease.

PATIENTS AND METHODS:

We performed a prospective, controlled, blinded study of PCR, culture, and serology on fractionated blood samples from 105 patients; 76 with physician-diagnosed erythema migrans and 29 controls. Clinical characteristics of the patients were obtained with a standardized data entry form and correlated with results of the laboratory studies.

RESULTS:

Only 4 of the 76 (5.3%) patients with erythema migrans were culture positive; however, 14 of 76 (18.4%) had spirochetemia documented by PCR of their plasma. None of 29 controls were PCR or culture positive (P = 0.007, versus patients). PCR-documented spirochetemia correlated with clinical evidence of disseminated
disease; 10 of 33 patients (30.3%) with systemic symptom(s) were PCR positive compared to 4 of 43 (9.3%) without such evidence (P = 0.02). PCR positivity was more frequent among patients with each of four specific symptoms: fever, arthralgia, myalgia, and headache (all P < 0.05). A higher total number of symptoms (median 2.5 in PCR-positive patients versus 0 in PCR-negative controls; P < 0.01) and the presence of multiple skin lesions (37.5% of patients with multiple, versus 13.3% of patients with single lesions [P = 0.04] were also correlated with PCR positivity. Patients with both systemic symptoms and multiple skin lesions had a 40% PCR-positivity rate; however, 4 of 42 (9.5%) asympatomatic patients with only single erythema migrans lesions were also PCR positive. In multivariate analysis using logistic regression, the number of systemic symptoms was the strongest independent predictor of PCR positivity (P = 0.004).

CONCLUSIONS:

PCR detection of Borrelia burgdorferi is at least three times more sensitive than culture for identifying spirochetemia in early
Lyme disease and may be useful in rapid diagnosis. PCR positivity significantly correlates with clinical evidence of
disease dissemination. Bloodstream invasion is an important and common mechanism for the dissemination of the
Lyme disease spirochete.

Am J Med. 1995 Jul;99(1):6-12. Clinical Trial; Randomized Controlled Trial; Research Support, U.S. Gov’t, P.H.S.

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