recomBead Bordetella pertussis IgG 2.0
recomBead Bordetella pertussis IgA 2.0
Luminex®-based immunoassay (MagPlex®) using recombinant antigens for detection of IgG or IgA antibodies against Bordetella pertussis in human serum or plasma
Bordetella pertussis, which is transmitted by droplet infection, primarily causes the classical clinical presentation of whooping cough with the typical coughing spasms. The clinical symptoms often persist for weeks to months and complications can develop in infants with life-threatening apnoea. Milder progression can be induced by other members of the genus, e.g. Bordetella parapertussis. A preventive vaccine is available.
Along with clinical diagnostics and direct evidence, serology is typically employed about 2–3 weeks after coughing starts. When interpreting the serological results, the immunisation status must always be taken into account because high vaccine induced antibody titres can persist for up to a year. The level of the antibody concentration can contribute to the diagnosis of an acute pertussis infection when considering immunity or an acute infection.
recomBead Bordetella pertussis contains the antigens pertussis toxin (PT) and filamentous haemagglutinin (FHA).
recomBead Bordetella pertussis can be used for clarification/confirmation of screening results or as an initial test for evaluating the infection status using the quantitative anti PT concentration information (IU/ml).
Product advantages
- Meaningful pertussis diagnostics by stating results in international units (IU/ml):
- Quantitative results for IgG and IgA antibodies against pertussis toxin (PT) and filamentous haemagglutinin (FHA)
- Calculation of IU/ml results from the measurements using integrated WHO standard curves
- Option to determine the infection status based on the recommendation of the Robert Koch Institute:
- Easy and safe application:
- Integrated controls in each sample set to check validity criteria (incubation, negative and conjugate controls)
- High and low concentrated controls with target values in IU/ml
- Only one calibrator required per set for recalibration using integrated 4PL WHO standard curves
- High precision and recovery rates when measuring the WHO standard
- Combination of all Mikrogen recomBead 2.0 test systems on one sample plate possible – unique protocol, reagents and test procedure
- Fully automatic processing, software-based analysis and connection to LIMS possible
- Quality guarantee by CE-labelling: the recomBead Bordetella pertussis tests fulfil the high demands of the European Directive 98/79/EC for in vitro diagnostic medical devices.
Evaluation
*For the evaluation, two-fold predetermined samples were used. The reference tests were the corresponding quantitative ELISA tests for anti PT and anti FHA (IU/ml) and the recomLine Bordetella pertussis IgG, IgA.
**WHO International Standard Pertussis Antiserum (Human) 1st IS NIBSC code: 06/140
