Borrelia Burgdorferi IgM ELISA Kit
INTENDED USE
Human Borrelia burgdorferi IgM ELISA kit can be used for measuring in-vitro quantitative amounts of human IgM antibodies against Borrelia burgdorferi (Borrelia IgM) in samples of serum and plasma. This assay has a minimum analytical sensitivity limit of 0.99 U/ml.
BACKGROUND
Borrelia burgdorferi is responsible for causing Lyme disease and it is a member of the spirochete group of bacterium, this is due to their unique corkscrew shape and twisting propulsion. There are about 20 different species which have been associated with relapsing fevers, majority of these are transmitted by soft tick and some by lice (Borrelia recurrentis). Borrelia species are not Gram-positive or negative but known as diderm (double membrane). Majority of cases for B. burgdorferi are found either in North America or in Europe.
BORRELIA IGM ELISA KIT CONTENT
All reagents supplied need to be stored at 2 °C – 8 °C, unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date.
- Borrelia burgdorferi antigen coated microtiter strips.
- Calibrator D (Positive Control).
- Calibrator C (Weak Positive Control).
- Calibrator B (Cut-Off Standard).
- Calibrator A (Negative Control).
- Sample Diluent.
- Enzyme Conjugate.
- TMB Substrate.
- Washing Buffer (10x).
- Stop Solution.
SENSITIVITY
The minimum detection sensitivity level of IgM antibodies against Borrelia burgdorferi (Borrelia-IgM) using current human borrelia IgM ELISA kit was 0.99 U/ml. The dynamic range for this assay is 10.0 – 150.0 IU/ml.
ASSAY CHARACTERSTICS
– Borrelia burgdorferi ELISA: IgM
– Intra-Assay-Precision: 5.0 %
– Inter-Assay- Precision: 9.0 %
– Inter-Lot- Precision: 4.8 – 10.3 %
– Analytical Sensitivity: 0.99 U/mL
– Recovery: 110 – 111 %
– Linearity: 77 – 120 %
– Cross-Reactivity: No cross-reactivity to TBEV (FSME)
– Interferences: No interferences to bilirubin up to 0.3 mg/mL, hemoglobin up to 8.0 mg/mL and triglycerides up to 5.0 mg/mL.
– Clinical Specificity: 100 %
– Clinical Sensitivity: 100 %
REFERENCES
- Multiplex assay (Mikrogen recomBead) for detection of serum IgG and IgM antibodies to 13 recombinant antigens of Borrelia burgdorferi sensu lato in patients with neuroborreliosis: the more the better? J Med Microbiol. (2015) 64 (Pt 3): 224-31. Dessau R.B., et al.
- High frequency of false positive IgM immunoblots for Borrelia burgdorferi in clinical practice. Clin Microbiol Infect. (2012) 18 (12): 1236-40. Seriburi V., et al.
- Intrathecal synthesis of anti-Borrelia burgdorferi antibodies in neuroborreliosis: a study with special emphasis on oligoclonal IgM antibody bands. Scand J Immunol. (1993) 37 (3): 369-76. Wang Z.Y., et al.
- False-positive IgM antibodies to Borrelia burgdorferi in indirect ELISA as a result of IgM rheumatoid factor. J Infect Dis. (1990) 161 (6): 1312. Barka N.E., et al.
ADDITIONAL INFORMATION
- Full Name: Borrelia Burgdorferi IgM ELISA Kit
- Reactivity: Human
- Sample Type: Serum, Plasma
- Sensitivity: 0.99 U/ml
