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Table 1.

Number of studies meeting each quality criteria in QUADAS-2 based on 48 articles from the United States examining the accuracy of diagnostic tests for Lyme disease included in this systematic review.

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Fig 1.

Flow diagram of diagnostic test papers through the systematic review from the scoping review.

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Table 2.

Thirteen studies (78 lines of data) evaluating a two-tier serological test protocol summarized by the stage of Lyme disease tested using a hierarchical logistic regression model in Stata 13 or the range of sensitivity and specificity data presented in the paper when less than four lines of data were available for meta-analysis.

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Table 3.

Twenty three studies (119 lines of data) evaluating different assays (mainly 1st tier tests) by stage of Lyme disease using hierarchical logistic regression models or simply sensitivity and specificity when less than four lines of data were available for meta-analysis.

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Table 4.

Eight studies (33 lines of data) evaluating different immunoblots (2nd tier tests) at all stages of Lyme disease using hierarchical logistic regression models or the sensitivity and specificity data when less than four lines of data were available for meta-analysis.

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Table 5.

Summary of agreement between tests reported in eight studies (10 lines of data) that examined two-tier serology testing compared to a different test or two-tier protocol.

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Table 6.

Summary or range of agreement reported in 14 studies (51 lines of data) evaluating different tests paired against each other and tested on samples meeting the clinical definition of Lyme disease or a test panel.

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Table 7.

Summary of agreement reported in four studies (six lines of data) evaluating culture and/or PCR of biopsy and various blood samples for the identification of Borrelia spp. in early stage1 Lyme disease patients.

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Table 8.

Summary of the sensitivity and specificity of different testing options for early Lyme disease (stage 1) patients.

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