Borrelia Line Immunoblot

Borrelia Line Immunoblot assays are for in vitro diagnostic (IVD) use for the qualitative detection of Borrelia (B.) burgdorferi senu lato specific IgG-respectively IgM-antibodies in human serum. Aside from its use in the serodiagnosis of Lyme borreliosis, the IgG Line Immunoblot is also suited for the diagnosis of neuroborelliosis in CSF. 

The Borrelia Line Immunoblot assays are strip-based methods using an optimized combination of native, highly purified and recombinant B. burgdorferi s.l. antigens applied in well-defined positions to nitrocellulose strips by a micro-dispensing method. 

The presence of specific IgG-respectively IgM antibodies to B. burgdorferi s.l. can be detected within 2,5 hrs.

CE marked
Borrelia Europe IgM LINE Immunoblot

Product number 80826

32 Tests
Borrelia Europe IgG LINE Immunoblot

Product number 80827

32 Tests
Borrelia Europe +TpN17 IgG LINE Immunoblot

Product number 80828

32 Tests
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    About Lyme-Borreliosis

    Lyme-Borreliosis is a systematic disease caused by an infection with the spirochaeta B. burgdorferi.1,2  Transmission of the spirochaete to humans is effected by the bite of an infected tick. In Europe the tick Ixodes ricinus has been identified as main vector.3 The following human pathogenic B. burgdorferi species are currently recognised in Europe: B. burgdorferi sensu stricto, B. garinii, B. afzelii, B.spielmanii and B. bavariensis.4,3,5,5,7,8 They are comprised under the term Borrelia burgdorferi sensu lato (s.l).

    Lyme Borreliosis is a multisystem disease, which takes its course in stages, with a predominantly involvement of skin, joints and nervous system. Due to the wide spectrum of occurring clinical manifestations, the diagnosis of the Lyme-Borreliosis is difficult3. Differential-diagnostically meaningful is above others the limitation compared with different dermatological (e.g. B-cell-lymphom of the skin, Lupus erythematodes), neurological (e.g. multiple sclerosis) and internal (e.g. arthritis, carditis) diseases.9

    The serological diagnostic of the Lyme-Borreliosis is, beside others, complicated by the following factors:

    • negative serology does not exclude Lyme-Borreliosis – especially not in in early stages.10
    • development of IgM-antibodies may fail to appear entirely.
    • IgM-antibodies may persist for months.21,36
    • IgG-antibodies may remain detectable even years after a clinical remission.11,12
    • Cross-reactions to other micro-organisms have been observed.13,14 Bacterial caused diseases like Syphilis as well as Herpes-Virus-Infections (especially EBV) are an important factor here.15 False positive antibody responses may occur also at the presence of autoimmune-antibodies.13

    The challenge of the Lyme-Borreliosis-serology is based on the supportive clarification of a clinical reasonable suspicion.

    Therefore, the Lyme-Borreliosis-serology may give important information about the sero-negativity or confirm the suspicion of presence of an acute- as well as an advanced infection. However, a positive antibody result must absolutely be assessed in connection with the clinical picture.10

    In accordance with MIQ 12/2000 and DIN 58969-44 July 2005, it is recommended to perform Lyme borelliosis serology in two steps.16,17 In the first step the samples are tested with a sensitive screening assay (the MiQ 12/2000 recommends to-use an ELISA as screening assay). Borderline and positive sera are examined with a confirmatory test (Line Immunoblot/Western Blot) afterwards. The analysis with the Line Immunoblot/Western Blot enables the specific analysis of the antibody response that is aimed against single pathogen antigens.
     

    Features & Benefits

    • Optimized combination of native, highly purified and recombinant B. burgdorferi s.l. antigens.
    • Antigen combination of all important human pathogenic genospecies, including B. spielmanii and B. bavariensis.
    • Use of the national Reference Center (NRZ) published B. bavariensis (PBi)-p58 Antigen.
    • DbpA antigen combination of several Borrelia genospecies.
    • VlsE of two genospecies.
    • Exclusion marker for EBV primary infection.
    • Additional exclusion marker for a Syphilis infection on the Borrelia Europe + TpN17 LINE.
    • Easy reading & interpretation, also with the LabImage LA® software.
        

    References

    1. Burgdorfer, W., Barbour, A.G., Hayes S.F. et al. (1982), Lyme disease - a tick -borne pirochetosis? Science 216:1317-19.
    2. Steere, A.C. (1989), Lyme Disease, N. Engl. J. Med. 321:586-96.
    3. Pfister,H-W., Wilske, B. (1994) Lyme borreliosis: basic science and clinical aspects, The Lancet Vol. 343: 1013-1015.
    4. Dressler, F. (1994) Lyme borreliosis in European children and adolescents, Clinical and Experimental Rheumatology 12 (Suppl. 10) :49-54
    5. Dressler, F., Ackermann, R. and Steere, A.C. (1994), Antibody responses to the three genomic groups of Borrelia burgdorferi in European Lyme Borreliosis, J. Infect. Dis. 169: 313-318
    6. Fingerle, V., Schulte-Spechtel, U.C., Ruzic-Sabljic, E., Leonhard, S., Hofmann, H., Weber, K., Pfister, K., Strle, F., Wilske, B. (2007) Epidemiological aspects and molecular characterization of Borrelia burgdorferi s.l. from southern Germany with special respect to the new species Borrelia spielmanii sp. nov. Int J Med Microbiol
    7. Herzberger, P., Siegel, C., Skerka, C., Fingerle, V., Schulte-Spechtel, U., van Dam, A., Wilske, B., Brade, V., Zipfel,P.F., Wallich, R., Kraiczy, P. (2007) Human pathogenic Borrelia spielmanii sp. nov. resist complement-mediated killing by direct binding of immune regulators factor H and FHL-1. Infect Immun
    8. Wang, G., van Dam, A.P., Dankert, J. (1999) Phenotypic and genetic characterization of a novel Borrelia burgdorferi sensu lato isolate from a patient with lyme borreliosis. J Clin Microbiol 37: 3025-3028
    9. Oschmann und Kraiczy, (1998), Lyme-Borreliose und Frühsommer-Meningoenzephalitis“, UNI-MED-Verlag
    10. RKI (1999), Ratgeber Infektionskrankheiten, Lyme-Borreliose, Epidemiologisches Bulletin, überarbeitete Auflage
    11. Craft, J.E., Grodzicki, R.L. and Steere, A.C. (1984), Antibody response in Lyme disease: evaluation of diagnostic tests, J. Inf. Dis. 149:789-95
    12. Craft, J.E., Fischer, D.K., Shimamoto, G.T. and Steere, A.C. (1986), Antigens of Borrelia burgdorferi recognized during Lyme disease. Appearance of a new immunoglobulin M response and expansion of the immunoglobulin G late in the illness.J. Clin. Invest. 78: 934-39
    13. Horst, H. (1997), Einheimische Zeckenborreliose (Lyme-Krankeit) bei Mensch und Tier, 3., überarbeitete Auflage, Spitta Verlag: 128-130
    14. Tewald, F. Braun, R. (1998), Durchführung und Interpretation serologischer Tests bei Verdacht auf Borrelien infektion. Clin. Lab. 44: 897-902
    15. Goosens, H.A.T., Bogaard, van den A.E., Nohlmans, M.K.E., (1999), Epstein-Barr Virus and Cytomegalovirus Infections cause false.positive results in IgM two-test protocol for early Lyme-Borreliosis, Infection 27 No.3: 231
    16. Wilske et al., 12/2000, Qualitätsstandards in der mikrobiologisch-infektiologischen Diagnostik für Lyme-Borreliose, pp. 38ff., Urban&Fischer Verlag
    17. Normenausschuss Medizin (NAMed) im DIN, DIN 58969-44, Medizinische Mikrobiologie-Serologische und molekularbiologische Diagnostik von Infektionskrankheiten -Teil 44: Immunoblot (IB); Spezielle Anforderungen für den Nachweis von Antikörpern gegen Borrelia burgdorferi, Juli 2005, Beuth Verlag GmbH.
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