Validation of cellular tests for Lyme borreliosis (VICTORY) study
Abstract Background Lyme borreliosis (LB) is a tick-borne disease caused by spirochetes belonging to the Borrelia burgdorferi sensu lato species. Due to a variety of clinical manifestations, diagnosing LB can be challenging, and laboratory work-up is usually required in case of disseminated LB. Howe...
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doaj-885644a690a84bd185b51796af8645002020-11-25T01:59:32ZengBMCBMC Infectious Diseases1471-23342019-08-011911910.1186/s12879-019-4323-6Validation of cellular tests for Lyme borreliosis (VICTORY) studyF. R. van de Schoor0M. E. Baarsma1S. A. Gauw2L. A. B. Joosten3B. J. Kullberg4C. C. van den Wijngaard5J. W. Hovius6Radboudumc, Department of Internal Medicine, Radboud Center for Infectious Diseases (RCI) and Radboud Institute of Health Sciences (RIHS)Amsterdam UMC, University of Amsterdam, Center for Experimental and Molecular Medicine, Amsterdam Institute of Infection and ImmunologyAmsterdam UMC, University of Amsterdam, Center for Experimental and Molecular Medicine, Amsterdam Institute of Infection and ImmunologyRadboudumc, Department of Internal Medicine, Radboud Center for Infectious Diseases (RCI) and Radboud Institute of Health Sciences (RIHS)Radboudumc, Department of Internal Medicine, Radboud Center for Infectious Diseases (RCI) and Radboud Institute of Health Sciences (RIHS)National Institute for Public Health and the Environment (RIVM), Center of Infectious Disease ControlAmsterdam UMC, University of Amsterdam, Center for Experimental and Molecular Medicine, Amsterdam Institute of Infection and ImmunologyAbstract Background Lyme borreliosis (LB) is a tick-borne disease caused by spirochetes belonging to the Borrelia burgdorferi sensu lato species. Due to a variety of clinical manifestations, diagnosing LB can be challenging, and laboratory work-up is usually required in case of disseminated LB. However, the current standard of diagnostics is serology, which comes with several shortcomings. Antibody formation may be absent in the early phase of the disease, and once IgG-seroconversion has occurred, it can be difficult to distinguish between a past (cured or self-cleared) LB and an active infection. It has been postulated that novel cellular tests for LB may have both higher sensitivity earlier in the course of the disease, and may be able to discriminate between a past and active infection. Methods VICTORY is a prospective two-gate case-control study. We strive to include 150 patients who meet the European case definitions for either localized or disseminated LB. In addition, we aim to include 225 healthy controls without current LB and 60 controls with potentially cross-reactive conditions. We will perform four different cellular tests in all of these participants, which will allow us to determine sensitivity and specificity. In LB patients, we will repeat cellular tests at 6 weeks and 12 weeks after start of antibiotic treatment to assess the usefulness as ‘test-of-cure’. Furthermore, we will investigate the performance of the different cellular tests in a cohort of patients with persistent symptoms attributed to LB. Discussion This article describes the background and design of the VICTORY study protocol. The findings of our study will help to better appreciate the utility of cellular tests in the diagnosis of Lyme borreliosis. Trial registration NL7732 (Netherlands Trial Register, trialregister.nl).http://link.springer.com/article/10.1186/s12879-019-4323-6Lyme diseaseBorreliosisErythema MigransBorreliaValidationCellular tests |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
F. R. van de Schoor M. E. Baarsma S. A. Gauw L. A. B. Joosten B. J. Kullberg C. C. van den Wijngaard J. W. Hovius |
spellingShingle |
F. R. van de Schoor M. E. Baarsma S. A. Gauw L. A. B. Joosten B. J. Kullberg C. C. van den Wijngaard J. W. Hovius Validation of cellular tests for Lyme borreliosis (VICTORY) study BMC Infectious Diseases Lyme disease Borreliosis Erythema Migrans Borrelia Validation Cellular tests |
author_facet |
F. R. van de Schoor M. E. Baarsma S. A. Gauw L. A. B. Joosten B. J. Kullberg C. C. van den Wijngaard J. W. Hovius |
author_sort |
F. R. van de Schoor |
title |
Validation of cellular tests for Lyme borreliosis (VICTORY) study |
title_short |
Validation of cellular tests for Lyme borreliosis (VICTORY) study |
title_full |
Validation of cellular tests for Lyme borreliosis (VICTORY) study |
title_fullStr |
Validation of cellular tests for Lyme borreliosis (VICTORY) study |
title_full_unstemmed |
Validation of cellular tests for Lyme borreliosis (VICTORY) study |
title_sort |
validation of cellular tests for lyme borreliosis (victory) study |
publisher |
BMC |
series |
BMC Infectious Diseases |
issn |
1471-2334 |
publishDate |
2019-08-01 |
description |
Abstract Background Lyme borreliosis (LB) is a tick-borne disease caused by spirochetes belonging to the Borrelia burgdorferi sensu lato species. Due to a variety of clinical manifestations, diagnosing LB can be challenging, and laboratory work-up is usually required in case of disseminated LB. However, the current standard of diagnostics is serology, which comes with several shortcomings. Antibody formation may be absent in the early phase of the disease, and once IgG-seroconversion has occurred, it can be difficult to distinguish between a past (cured or self-cleared) LB and an active infection. It has been postulated that novel cellular tests for LB may have both higher sensitivity earlier in the course of the disease, and may be able to discriminate between a past and active infection. Methods VICTORY is a prospective two-gate case-control study. We strive to include 150 patients who meet the European case definitions for either localized or disseminated LB. In addition, we aim to include 225 healthy controls without current LB and 60 controls with potentially cross-reactive conditions. We will perform four different cellular tests in all of these participants, which will allow us to determine sensitivity and specificity. In LB patients, we will repeat cellular tests at 6 weeks and 12 weeks after start of antibiotic treatment to assess the usefulness as ‘test-of-cure’. Furthermore, we will investigate the performance of the different cellular tests in a cohort of patients with persistent symptoms attributed to LB. Discussion This article describes the background and design of the VICTORY study protocol. The findings of our study will help to better appreciate the utility of cellular tests in the diagnosis of Lyme borreliosis. Trial registration NL7732 (Netherlands Trial Register, trialregister.nl). |
topic |
Lyme disease Borreliosis Erythema Migrans Borrelia Validation Cellular tests |
url |
http://link.springer.com/article/10.1186/s12879-019-4323-6 |
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