CLIA Borrelia recombinant IgG

Description

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 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, Plasma
• Sample volume: 10 μL
• Measuring range: 5 – 700 U/ml
• Complementary products: Anchor® Tips, Stackable Cuvette, KleeYa Trigger Pack, KleeYa Wash buffer
• Note: The kits are CE-IVD certified and intended for professional use.

Specifications

• Catalog Number: CL-BRG100
• Size: 100 tests
• Regulatory status: CE IVD
• Clinical topic: Infectious Diseases
• Diagnostic panel: Tick-Borne Infections
• Producer: TestLine Clinical Diagnostics s.r.o.

References

• 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.
• 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.
• 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.
• 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.

• Reagent Cartridge with specific reagents for the assay
• magnetic particles
• calibrators