CLIA Borrelia CSF IgM
The chemiluminescence kit is used for the diagnosis and monitoring of Borrelia burgdorferi sensu lato infection by determining IgM antibodies in human cerebrospinal fluid, serum or plasma in the general population.
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This kit in detail
Description
Lyme borreliosis (LB) is a multisystem infectious disease caused by the spirochete Borrelia burgdorferi . It is transmitted by ticks of the Ixodes genus.
The clinical symptoms of LB are classified into early and late stages. Approximately 10%–15% of patients with untreated Lyme borreliosis may develop neurological manifestations.
The bacteria can cross the blood-brain barrier and cause inflammation in the brain or spinal cord, leading to various neurological symptoms such as meningitis, encephalitis, and even peripheral neuropathy. Additionally, Lyme borreliosis can disrupt neurotransmitter function, affecting pain perception, mood regulation, and cognitive processes.
The detection of antibody levels in serum or plasma alone is insufficient for diagnosing neuroborreliosis. Therefore, cerebrospinal fluid (CSF) examination is crucial, as specific anti-Borrelia antibodies are produced intrathecally.
To confirm intrathecal antibody production, the determination of the specific antibody index (AI) is used, in accordance with international EFNS guidelines. This index is essential for diagnosing both early and late-stage neuroborreliosis.
Technical data
- Assay time: 30 min
- Assay stability: 30 days on board stability / In use stability until the expiration date at storage temperature 2-8 °C
- Sample matrix: Serum, Cerebrospinal fluid, Plasma
- Sample volume: 10 μL
- Measuring range: 0,00–100,00 U/ml
- Complementary products: CLIA Dilution Cartridge 3 (catalog number: CL-DIC3) , Anchor® Tips, Stackable Cuvette, KleeYa Trigger Pack, KleeYa Wash buffer
- Note: The dilution cartridge CLIA Dilution Cartridge 3 (catalog number: CL-DIC3) is required only for the determination of the antibody index The kits are CE-IVD certified and intended for professional use.
Specifications
- Catalog Number: CL-BCSFM50
- Size: 50 tests
- Regulatory status: CE IVD
- Clinical topic: Infectious Diseases
- Diagnostic panel: Tick-Borne Infections
- Producer: TestLine Clinical Diagnostics s.r.o.
References
- Embers ME, Hasenkampf NR, Barnes MB, Didier ES, Philipp MT, Tardo AC. Five- Antigen Fluorescent Bead-Based Assay for Diagnosis of Lyme Disease. Clin Vaccine Immunol. 2016 Apr 4;23(4):294-303. doi: 10.1128/CVI.00685-15. PMID: 26843487; PMCID: PMC4820514.
- 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.
- 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.
- Marques AR. Laboratory diagnosis of Lyme disease: advances and challenges. Infect Dis Clin North Am. 2015 Jun;29(2):295-307. doi: 10.1016/j.idc.2015.02.005. PMID: 25999225; PMCID: PMC4441761.
- Rauer S, Kastenbauer S, Hofmann H, Fingerle V, Huppertz HI, Hunfeld KP, Krause A, Ruf B, Dersch R; Consensus group. Guidelines for diagnosis and treatment in neurology – Lyme neuroborreliosis. Ger Med Sci. 2020 Feb 27;18:Doc03. doi: 10.3205/000279. PMID: 32341686; PMCID: PMC7174852.
- Reiber H, Lange P. Quantification of virus-specific antibodies in cerebrospinal fluid and serum: sensitive and specific detection of antibody synthesis in brain. Clin Chem. 1991 Jul;37(7):1153-60. PMID: 1855284.
- Stanek G, Fingerle V, Hunfeld KP, Jaulhac B, Kaiser R, Krause A, Kristoferitsch W, O’Connell S, Ornstein K, Strle F, Gray J. Lyme borreliosis: clinical case definitions for diagnosis and management in Europe. Clin Microbiol Infect. 2011 Jan;17(1):69-79. doi: 10.1111/j.1469-0691.2010.03175.x. PMID: 20132258.
- Steere AC. Lyme disease. N Engl J Med. 2001 Jul 12;345(2):115-25. doi: 10.1056/NEJM200107123450207. PMID: 11450660.
- Trevejo RT, Krause PJ, Sikand VK, Schriefer ME, Ryan R, Lepore T, Porter W, Dennis DT. Evaluation of two-test serodiagnostic method for early Lyme disease in clinical practice. J Infect Dis. 1999 Apr;179(4):931-8. doi: 10.1086/314663. PMID: 10068589.
- van Dam AP, Kuiper H, Vos K, Widjojokusumo A, de Jongh BM, Spanjaard L, Ramselaar AC, Kramer MD, Dankert J. Different genospecies of Borrelia burgdorferi are associated with distinct clinical manifestations of Lyme borreliosis. Clin Infect Dis. 1993 Oct;17(4):708-17. doi: 10.1093/clinids/17.4.708. PMID: 7903558.
- Zhang JR, Hardham JM, Barbour AG, Norris SJ. Antigenic variation in Lyme disease borreliae by promiscuous recombination of VMP-like sequence cassettes. Cell. 1997 Apr 18;89(2):275-85. doi: 10.1016/s0092-8674(00)80206-8. Erratum in: Cell 1999 Feb 5;96(3):447. PMID: 9108482.
- Reagent Cartridge with specific reagents for the assay
- magnetic beads
- calibrators
Datasheets and regulatory documentation
Everything your quality team needs for evaluation and procurement.
Safety information
Product brochure
Declaration of conformity
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