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Evaluation of Modified 2-Tiered Serodiagnostic Testing Algorithms for Early Lyme Disease.

Publication ,  Journal Article
Branda, JA; Strle, K; Nigrovic, LE; Lantos, PM; Lepore, TJ; Damle, NS; Ferraro, MJ; Steere, AC
Published in: Clin Infect Dis
April 15, 2017

BACKGROUND: The conventional 2-tiered serologic testing protocol for Lyme disease (LD), an enzyme immunoassay (EIA) followed by immunoglobulin M and immunoglobulin G Western blots, performs well in late-stage LD but is insensitive in patients with erythema migrans (EM), the most common manifestation of the illness. Western blots are also complex, difficult to interpret, and relatively expensive. In an effort to improve test performance and simplify testing in early LD, we evaluated several modified 2-tiered testing (MTTT) protocols, which use 2 assays designed as first-tier tests sequentially, without the need of Western blots. METHODS: The MTTT protocols included (1) a whole-cell sonicate (WCS) EIA followed by a C6 EIA; (2) a WCS EIA followed by a VlsE chemiluminescence immunoassay (CLIA); and (3) a variable major protein-like sequence, expressed (VlsE) CLIA followed by a C6 EIA. Sensitivity was determined using serum from 55 patients with erythema migrans; specificity was determined using serum from 50 patients with other illnesses and 1227 healthy subjects. RESULTS: Sensitivity of the various MTTT protocols in patients with acute erythema migrans ranged from 36% (95% confidence interval [CI], 25%-50%) to 54% (95% CI, 42%-67%), compared with 25% (95% CI, 16%-38%) using the conventional protocol (P = .003-0.3). Among control subjects, the 3 MTTT protocols were similarly specific (99.3%-99.5%) compared with conventional 2-tiered testing (99.5% specificity; P = .6-1.0). CONCLUSIONS: Although there were minor differences in sensitivity and specificity among MTTT protocols, each provides comparable or greater sensitivity in acute EM, and similar specificity compared with conventional 2-tiered testing, obviating the need for Western blots.

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Published In

Clin Infect Dis

DOI

EISSN

1537-6591

Publication Date

April 15, 2017

Volume

64

Issue

8

Start / End Page

1074 / 1080

Location

United States

Related Subject Headings

  • Serologic Tests
  • Sensitivity and Specificity
  • Microbiology
  • Lyme Disease
  • Immunoassay
  • Humans
  • Early Diagnosis
  • Algorithms
  • 3202 Clinical sciences
  • 11 Medical and Health Sciences
 

Citation

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Branda, J. A., Strle, K., Nigrovic, L. E., Lantos, P. M., Lepore, T. J., Damle, N. S., … Steere, A. C. (2017). Evaluation of Modified 2-Tiered Serodiagnostic Testing Algorithms for Early Lyme Disease. Clin Infect Dis, 64(8), 1074–1080. https://doi.org/10.1093/cid/cix043
Branda, John A., Klemen Strle, Lise E. Nigrovic, Paul M. Lantos, Timothy J. Lepore, Nitin S. Damle, Mary Jane Ferraro, and Allen C. Steere. “Evaluation of Modified 2-Tiered Serodiagnostic Testing Algorithms for Early Lyme Disease.Clin Infect Dis 64, no. 8 (April 15, 2017): 1074–80. https://doi.org/10.1093/cid/cix043.
Branda JA, Strle K, Nigrovic LE, Lantos PM, Lepore TJ, Damle NS, et al. Evaluation of Modified 2-Tiered Serodiagnostic Testing Algorithms for Early Lyme Disease. Clin Infect Dis. 2017 Apr 15;64(8):1074–80.
Branda, John A., et al. “Evaluation of Modified 2-Tiered Serodiagnostic Testing Algorithms for Early Lyme Disease.Clin Infect Dis, vol. 64, no. 8, Apr. 2017, pp. 1074–80. Pubmed, doi:10.1093/cid/cix043.
Branda JA, Strle K, Nigrovic LE, Lantos PM, Lepore TJ, Damle NS, Ferraro MJ, Steere AC. Evaluation of Modified 2-Tiered Serodiagnostic Testing Algorithms for Early Lyme Disease. Clin Infect Dis. 2017 Apr 15;64(8):1074–1080.
Journal cover image

Published In

Clin Infect Dis

DOI

EISSN

1537-6591

Publication Date

April 15, 2017

Volume

64

Issue

8

Start / End Page

1074 / 1080

Location

United States

Related Subject Headings

  • Serologic Tests
  • Sensitivity and Specificity
  • Microbiology
  • Lyme Disease
  • Immunoassay
  • Humans
  • Early Diagnosis
  • Algorithms
  • 3202 Clinical sciences
  • 11 Medical and Health Sciences