Intended use:
The SeraSpot® Anti-Borrelia-10 IgG / SeraSpot® Anti-Borrelia-10 IgM test is an in vitro diagnostic device (spotimmunoassay, SIA) for the detection of Borrelia-specific IgG or IgM antibodies in human serum or plasma samples.
General information:
Lyme borreliosis is a systemic infectious disease with various clinical manifestations. The disease can be divided into 3 stages involving different organ systems. Cardinal symptoms of the first stage (4 to 8 weeks p. i.) are the erythema chronicum migrans and local or general lymphadenopathies (lymphadenosis cutis benigna). The clinical manifestations of the second stage (1 to 12 months p. i.) range from meningitis, meningopolyneuritis, encephalitis up to hemiparesis, myoneuralgia and arthralgia, especially knee joint arthritis. The third stage (months to years p. i.) is characterized by chronic infection of the nervous system (neuroborreliosis, progressive encephalomyelitis), the skin (acrodermatitis chronica atrophicans) and the joints (chronic erosive arthritis). Especially late manifestations of Lyme borreliosis can reduce quality of life and antibiotic treatment is difficult. Therefore an early diagnosis of borrelia infections is of great importance.
Test principle:
The SeraSpot® Anti-Borrelia-10 IgG / SeraSpot® Anti-Borrelia-10 IgM test is a solid phase immunoassay based on the use of recombinant Borrelia proteins as capture antigens printed in array arrangement (spot array) on the bottom of the wells of 96 well-microtiter plates. The recombinant antigens serve as capture molecules for antibodies against Borrelia antigens. Bound antibodies are detected by horseradish peroxidase-(HRP)-labeled antibodies against human antibodies of IgG- or IgM-type by substrate reaction with hydrogen peroxide and 3,3’,5,5’-tetramethylbenzidine (TMB). At the site of formed immune complexes blue spots are developed by precipitated product from colorless substrate solution. Color intensity is correlated to the antibody concentration. Pale blue to dark blue spots are visible by eye.
Art. No.:
- SP-006-10 G-S12 (1×96)
- SP-006-10 M-S12 (1×96)
- SP-006-10 G-S120 (10×96)
- SP-006-10 M-S120 (10×96)
Please also pay attention to our ELISA for screening (Art. No. K3221 and K3231) for antibody detection against Borrelia IgG or IgM.
| Art. No. | SP-006-10 **** |
|---|---|
| Test format | Microspot array |
| Incubation time | 1.5 h |
Dear customers,
we have started to provide the documents for our products in an electronic format. These are the Instructions for Use (IFU), the Safety Data Sheets (SDS) and the Certificate of Analysis (CoA). For batches placed on the market after 01 January 2023, you can find our documents on the eIFU portal eifu.r-biopharm.com/clinic.
