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Bordetella Pertussis IgM ELISA Kit

INTENDED USE

Human Bordetella pertussis IgM ELISA kit is designed for detecting in-vitro quantitative concentrations of human IgM antibodies to Bordetella pertussis (Bordetella-IgM) in serum and plasma. This assay has a minimum analytical sensitivity limit of 1.0 U/ml.

BACKGROUND

Pertussis is usually described as an acute infectious disease which can be caused by the bacterium Bordetella pertussis. The bacteria are able to attach to the cilia of the respiratory epithelial cells in order to produce toxins which can paralyse the cilia, this leads to inflammation of the respiratory tract. B. pertussis is a gram-negative, fastidious bacterium which can lead to the production of many biologically active and multiple antigenic products for example agglutinogens, tracheal cytotoxic, filamentous hemagglutinin (FHA), pertussis toxin, pertactin and adenylate cyclase. Pertussis is also a very contagious disease that can only be found in humans and it can be very easily spread from person to person by sneezing, coughing or even sharing breathing space by being near one another.

BORDETELLA 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.

  • Bordetella pertussis antigen coated microtiter strips.
  • Enzyme Conjugate.
  • TMB Substrate.
  • Stop Solution.
  • Sample Diluent.
  • Washing Buffer (10x).
  • Calibrator A (Negative Control).
  • Calibrator B (Cut-Off Standard).
  • Calibrator C (Weak Positive Control).
  • Calibrator D (Positive Control).

SENSITIVITY

The minimum detection sensitivity level of IgM antibodies to Bordetella pertussis (Bordetella-IgM) using current human Bordetella IgM ELISA kit was 0.98 U/ml. The dynamic range for this assay is 1.0 – 75.0 IU/ml.

ASSAY CHARACTERSTICS

– Bordetella pertussis ELISA: IgM
– Intra-Assay-Precision: 6.2 %
– Inter-Assay-Precision: 8.9 %
– Inter-Lot-Precision: 2.0 – 4.9 %
– Analytical Sensitivity: 1.0 U/mL
– Recovery: 107 – 123 %
– Linearity: 102 – 120 %
– Cross-Reactivity: No cross-reactivity to RSV, Adenovirus and Parainfluenza
– 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: 88 %

REFERENCES

  1. High prevalence of antibody titers against Bordetella pertussis in an adult population with prolonged cough. Respir Med. (2008) 102 (11): 1586-91. Kapaskelis A.M., et al.
  2. A Novel IgM-capture enzyme-linked immunosorbent assay using recombinant Vag8 fusion protein for the accurate and early diagnosis of Bordetella pertussis infection. Microbiol Immunol. (2016) 60 (5): 326-33. Otsuka N., et al.
  3. Evaluation of culture, immunofluorescence, and serology for the diagnosis of pertussis. J Clin Microbiol. (1989) 27 (4): 752-7. Halperin S.A., et al.
  4. The IgM and IgG response to Bordetella pertussis vaccination and infection. J Med Microbiol. (1981) 14 (1): 1-7. Macaulay M.E.
  5. Pertussis antibodies in the sera of children exposed to Bordetella pertussis by vaccination or infection. J Hyg (Lond). (1973) 71 (1): 193-207. Dolby J.M. and Stephens S.

ADDITIONAL INFORMATION

  • Full Name: Bordetella Pertussis IgM ELISA Kit
  • Reactivity: Human
  • Sample Type: Plasma, Serum
  • Sensitivity: 1.0 U/ml

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