CLIA Borrelia recombinant IgM

Chemiluminescence kit for the detection of IgM antibodies to Borrelia in human serum or plasma.

New
Catalog Number: CL-BRM100
Size: 100 tests
Regulatory status: CE IVD
Clinical topic: Infectious Diseases
Diagnostic panel: Tick-Borne Infections
CLIA Borrelia recombinant IgM
  • Screening test for the detection of IgG antibodies to Borrelia burgdorferi sensu lato
  • Disease stage specification
  • Intended for human serum, plasma
  • High specificity and sensitivity achieved by a sophisticated combination of recombinant antigens fitting the IgM class antibody response

Lyme disease (Lyme borreliosis, LB) is a tick-borne bacterial disease caused by spirochete Borrelia burgdorferi with polymorphic clinical manifestations (cutaneous, rheumatological, and neurological). Early localized, early disseminated, and late disseminated infection stages of LB are characterized by different clinical symptoms. The later the stage, the more severe clinical manifestation and curing difficulty.

The diagnosis of the disease is based on anamnesis, clinical picture, and results of laboratory tests. At present, all European and North American guidelines (e.g. NICE, EFNS, and CDC) indicate that the laboratory diagnosis is based on a two-tier serology starting with immunoassay screening of specific IgG and IgM class antibodies, and subsequent confirmation of the antibodies to specific antigens by means of immunoblot. Serological diagnosis of borreliosis is difficult regarding the large genetic diversity of the species Borrelia burgdorferi s.l., possible cross-reactivity with unrelated antigens, by different individual serological reactivity, possible slow production of antibodies in the early phase of the disease, and on the other hand very long persistence (even tens of years) of the IgG and IgM antibodies in circulation.

Detection of intrathecal antibody production, necessary for the diagnosis of early and late neuroborreliosis (EFNS guidelines) is a special section of the LB diagnostics.

Technical specifications

Technical data
References
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Technical data

Assay stability (on board)30 days
Sample matrix Serum, Plasma
Sample volume10 µL
Concentration range5 - 100 U/ml
Assay/kit contentReagent Cartridge with specific reagents for the assay, magnetic particles, calibrators
Complementary productsWash buffer, Anchor® Tips, Stackable cuvettes, Trigger solutions

References

References to CLIA Borrelia recombinant IgM

  • Magnarelli LA, Anderson JF, Johnson RC. Cross-reactivity in serological tests for Lyme disease and other spirochetal infections. J Infect Dis. 1987 Jul;156(1):183-8. doi: 10.1093/infdis/156.1.183. PMID: 3298452.
    See more on PubMed
  • Kalish RA, McHugh G, Granquist J, Shea B, Ruthazer R, Steere AC. Persistence of immunoglobulin M or immunoglobulin G antibody responses to Borrelia burgdorferi 10-20 years after active Lyme disease. Clin Infect Dis. 2001 Sep 15;33(6):780-5. doi: 10.1086/322669. Epub 2001 Aug 10. PMID: 11512082.
    See more on PubMed
  • Kodym P, Kurzová Z, Berenová D, Pícha D, Smíšková D, Moravcová L, Malý M. Serological Diagnostics of Lyme Borreliosis: Comparison of Universal and Borrelia Species-Specific Tests Based on Whole-Cell and Recombinant Antigens. J Clin Microbiol. 2018 Oct 25;56(11):e00601-18. doi: 10.1128/JCM.00601-18. PMID: 30185509; PMCID: PMC6204684.
    See more on PubMed
  • Eldin C, Raffetin A, Bouiller K, Hansmann Y, Roblot F, Raoult D, Parola P. Review of European and American guidelines for the diagnosis of Lyme borreliosis. Med Mal Infect. 2019 Mar;49(2):121-132. doi: 10.1016/j.medmal.2018.11.011. Epub 2018 Dec 6. PMID: 30528068.
    See more on PubMed

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