NCT03201042

Lyme Test Indication Combinations (LyTIC) Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 410 (actual)
• Sponsor: Oxford Immunotec · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Accepted

Summary

To establish performance of individual tests and combinations of tests (serological, molecular and cellular tests) in early Lyme infection diagnosis

Detailed description

The present study aims to investigate the performance characteristics of both established and new assays for Borrelia burgdorferi infection and to assess the relative performance of appropriate combinations of these tests. The study will also investigate the effect of the time course of the infection and its treatment on the outcomes for the various tests. Polymerase Chain Reaction(PCR), serology and T cell based tests will be performed. In addition, tests for Babesia, Anaplasma, Ehrlichia and Rickettsia will also be performed as these pathogens can be carried by the same tick that carries Borrelia and may result in coinfection.

Conditions

• Lyme Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	PCR based assay	Whole blood specimens will be tested for the presence of Borrelia DNA by PCR in a two-step test (Imugen). In Cohort 1a and 1b. The first step tests for the presence of any Borrelia DNA. The second step is employed on positive samples and tests for the presence of either B. burgdorferi DNA or B. miyamotoi DNA. Positivity by PCR has a short but early window in the infection cycle for Borrelia burgdorferi and results may enable this window period and diagnosis rates to be better defined. In addition co-infection PCR analysis will be performed for the presence of Babesia, Anaplasma or Ehrlichia DNA (Imugen).
DIAGNOSTIC_TEST	Serology based assay	1. The Imugen Lyme Antibody Analysis which includes immunoglobulin M (IgM),immunoglobulin G (IgG), and immunoglobulin A (IgA) antibody capture immunoassay and IgG and IgM based Western blots. In Cohort 1a and 1b. 2. The Immunetics C6 Lyme ELISA assay. 3. A 2-tier Lyme test performed and interpreted according to Centers for Disease Control (CDC) Guidelines 4. A Rickettsia antibody test will be used to identify Spotted Fever and Typhus fever groups infections. Lyme test methodologies generally indicate a need to run a combination of tests in order to overcome limitations in either sensitivity or specificity of the various individual tests. Performance of all these tests on the same set of samples should enable both individual and combinatorial performance values to be calculated and compared.
DIAGNOSTIC_TEST	Tcell based assay	A research based ELISpot assay will be performed on peripheral blood mononuclear cells (PBMC) extracted from whole blood samples to test for presence of T cells activated against Borrelia antigens. Unlike serology based methods, this signal may not persist over extended periods of time in the absence of Borrelia antigens. The diagnostic window may be different for a test measuring adaptive immune response (i.e. T cells) and thus such test may identify patients with undetectable antibody response and may aid sensitivity of diagnosis.

Timeline

• Start date: 2017-06-08
• Primary completion: 2018-11-30
• Completion: 2018-11-30
• First posted: 2017-06-28
• Last updated: 2018-12-13

Locations

60 sites across 1 country: United States

Regulatory

• FDA-regulated device study