Borrelia multiplex: a bead-based multiplex assay for the simultaneous detection of Borrelia specific IgG/IgM class antibodies
Abstract Background Lyme borreliosis (LB) is the most common tick-borne infectious disease in the northern hemisphere. The diagnosis of LB is usually made by clinical symptoms and subsequently supported by serology. In Europe, a two-step testing consisting of an enzyme-linked immunosorbent assay (EL...
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| Format: | Article |
| Language: | English |
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BMC
2022-11-01
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| Series: | BMC Infectious Diseases |
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| Online Access: | https://doi.org/10.1186/s12879-022-07863-9 |
| _version_ | 1797983907820339200 |
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| author | Julia Häring Max J. Hassenstein Matthias Becker Julia Ortmann Daniel Junker André Karch Klaus Berger Tatia Tchitchagua Olaf Leschnik Manuela Harries Daniela Gornyk Pilar Hernández Berit Lange Stefanie Castell Gérard Krause Alex Dulovic Monika Strengert Nicole Schneiderhan-Marra |
| author_facet | Julia Häring Max J. Hassenstein Matthias Becker Julia Ortmann Daniel Junker André Karch Klaus Berger Tatia Tchitchagua Olaf Leschnik Manuela Harries Daniela Gornyk Pilar Hernández Berit Lange Stefanie Castell Gérard Krause Alex Dulovic Monika Strengert Nicole Schneiderhan-Marra |
| author_sort | Julia Häring |
| collection | DOAJ |
| description | Abstract Background Lyme borreliosis (LB) is the most common tick-borne infectious disease in the northern hemisphere. The diagnosis of LB is usually made by clinical symptoms and subsequently supported by serology. In Europe, a two-step testing consisting of an enzyme-linked immunosorbent assay (ELISA) and an immunoblot is recommended. However, due to the low sensitivity of the currently available tests, antibody detection is sometimes inaccurate, especially in the early phase of infection, leading to underdiagnoses. Methods To improve upon Borrelia diagnostics, we developed a multiplex Borrelia immunoassay (Borrelia multiplex), which utilizes the new INTELLIFLEX platform, enabling the simultaneous dual detection of IgG and IgM antibodies, saving further time and reducing the biosample material requirement. In order to enable correct classification, the Borrelia multiplex contains eight antigens from the five human pathogenic Borrelia species known in Europe. Six antigens are known to mainly induce an IgG response and two antigens are predominant for an IgM response. Results To validate the assay, we compared the Borrelia multiplex to a commercial bead-based immunoassay resulting in an overall assay sensitivity of 93.7% (95% CI 84.8–97.5%) and a specificity of 96.5% (95%CI 93.5–98.1%). To confirm the calculated sensitivity and specificity, a comparison with a conventional 2-step diagnostics was performed. With this comparison, we obtained a sensitivity of 95.2% (95% CI 84.2–99.2%) and a specificity of 93.0% (95% CI 90.6–94.7%). Conclusion Borrelia multiplex is a highly reproducible cost- and time-effective assay that enables the profiling of antibodies against several individual antigens simultaneously. |
| first_indexed | 2024-04-11T06:53:35Z |
| format | Article |
| id | doaj.art-9215cc648a824afab4bfcc0b5a856702 |
| institution | Directory Open Access Journal |
| issn | 1471-2334 |
| language | English |
| last_indexed | 2024-04-11T06:53:35Z |
| publishDate | 2022-11-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Infectious Diseases |
| spelling | doaj.art-9215cc648a824afab4bfcc0b5a8567022022-12-22T04:39:05ZengBMCBMC Infectious Diseases1471-23342022-11-0122111510.1186/s12879-022-07863-9Borrelia multiplex: a bead-based multiplex assay for the simultaneous detection of Borrelia specific IgG/IgM class antibodiesJulia Häring0Max J. Hassenstein1Matthias Becker2Julia Ortmann3Daniel Junker4André Karch5Klaus Berger6Tatia Tchitchagua7Olaf Leschnik8Manuela Harries9Daniela Gornyk10Pilar Hernández11Berit Lange12Stefanie Castell13Gérard Krause14Alex Dulovic15Monika Strengert16Nicole Schneiderhan-Marra17NMI Natural and Medical Sciences Institute at the University of TübingenDepartment of Epidemiology, Helmholtz Centre for Infection ResearchNMI Natural and Medical Sciences Institute at the University of TübingenDepartment of Epidemiology, Helmholtz Centre for Infection ResearchNMI Natural and Medical Sciences Institute at the University of TübingenInstitute of Epidemiology and Social Medicine, University of MünsterInstitute of Epidemiology and Social Medicine, University of MünsterDepartment of Neurology, Sächsisches Krankenhaus RodewischDepartment of Neurology, Sächsisches Krankenhaus RodewischDepartment of Epidemiology, Helmholtz Centre for Infection ResearchDepartment of Epidemiology, Helmholtz Centre for Infection ResearchDepartment of Epidemiology, Helmholtz Centre for Infection ResearchDepartment of Epidemiology, Helmholtz Centre for Infection ResearchDepartment of Epidemiology, Helmholtz Centre for Infection ResearchDepartment of Epidemiology, Helmholtz Centre for Infection ResearchNMI Natural and Medical Sciences Institute at the University of TübingenDepartment of Epidemiology, Helmholtz Centre for Infection ResearchNMI Natural and Medical Sciences Institute at the University of TübingenAbstract Background Lyme borreliosis (LB) is the most common tick-borne infectious disease in the northern hemisphere. The diagnosis of LB is usually made by clinical symptoms and subsequently supported by serology. In Europe, a two-step testing consisting of an enzyme-linked immunosorbent assay (ELISA) and an immunoblot is recommended. However, due to the low sensitivity of the currently available tests, antibody detection is sometimes inaccurate, especially in the early phase of infection, leading to underdiagnoses. Methods To improve upon Borrelia diagnostics, we developed a multiplex Borrelia immunoassay (Borrelia multiplex), which utilizes the new INTELLIFLEX platform, enabling the simultaneous dual detection of IgG and IgM antibodies, saving further time and reducing the biosample material requirement. In order to enable correct classification, the Borrelia multiplex contains eight antigens from the five human pathogenic Borrelia species known in Europe. Six antigens are known to mainly induce an IgG response and two antigens are predominant for an IgM response. Results To validate the assay, we compared the Borrelia multiplex to a commercial bead-based immunoassay resulting in an overall assay sensitivity of 93.7% (95% CI 84.8–97.5%) and a specificity of 96.5% (95%CI 93.5–98.1%). To confirm the calculated sensitivity and specificity, a comparison with a conventional 2-step diagnostics was performed. With this comparison, we obtained a sensitivity of 95.2% (95% CI 84.2–99.2%) and a specificity of 93.0% (95% CI 90.6–94.7%). Conclusion Borrelia multiplex is a highly reproducible cost- and time-effective assay that enables the profiling of antibodies against several individual antigens simultaneously.https://doi.org/10.1186/s12879-022-07863-9BorreliaLyme DiseaseLyme borreliosisMultiplexImmunoassaySerology |
| spellingShingle | Julia Häring Max J. Hassenstein Matthias Becker Julia Ortmann Daniel Junker André Karch Klaus Berger Tatia Tchitchagua Olaf Leschnik Manuela Harries Daniela Gornyk Pilar Hernández Berit Lange Stefanie Castell Gérard Krause Alex Dulovic Monika Strengert Nicole Schneiderhan-Marra Borrelia multiplex: a bead-based multiplex assay for the simultaneous detection of Borrelia specific IgG/IgM class antibodies BMC Infectious Diseases Borrelia Lyme Disease Lyme borreliosis Multiplex Immunoassay Serology |
| title | Borrelia multiplex: a bead-based multiplex assay for the simultaneous detection of Borrelia specific IgG/IgM class antibodies |
| title_full | Borrelia multiplex: a bead-based multiplex assay for the simultaneous detection of Borrelia specific IgG/IgM class antibodies |
| title_fullStr | Borrelia multiplex: a bead-based multiplex assay for the simultaneous detection of Borrelia specific IgG/IgM class antibodies |
| title_full_unstemmed | Borrelia multiplex: a bead-based multiplex assay for the simultaneous detection of Borrelia specific IgG/IgM class antibodies |
| title_short | Borrelia multiplex: a bead-based multiplex assay for the simultaneous detection of Borrelia specific IgG/IgM class antibodies |
| title_sort | borrelia multiplex a bead based multiplex assay for the simultaneous detection of borrelia specific igg igm class antibodies |
| topic | Borrelia Lyme Disease Lyme borreliosis Multiplex Immunoassay Serology |
| url | https://doi.org/10.1186/s12879-022-07863-9 |
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