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Product Description BactoReal® Kit Bordetella Multiplex (IVD) Download PDF
Product Manual BactoReal® Kit Bordetella Multiplex (IVD) Download PDF
Material Safety Data Sheet BactoReal® Kit Bordetella Multiplex (IVD) Download PDF
Declaration of Conformity BactoReal® Kit Bordetella Multiplex (IVD) Download PDF
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Background:  Bordetella pertussis is a gram-negative bacterium of the genus Bordetella and the causative agent of pertussis, an acute respiratory disease. Transmission occurs by droplet infection. Bordetella parapertussis, Bordetella holmesii and Bordetella bronchiseptica can cause a whooping cough-like illness with a milder clinical course. While Bordetella pertussis and Bordetella parapertussis only infect humans, Bordetella bronchiseptica occurs mainly in animals and is occasionally isolated from humans.

Description: 

BactoReal® Kit Bordetella Multiplex is a non-automated IVD test, based on real-time PCR, for the qualitative detection of DNA of Bordetella pertussis, Bordetella parapertussis, Bordetella holmesii and some strains of Bordetella bronchiseptica. This test detects the insertion sequence IS481 of B. pertussis, B. holmesii and B. bronchiseptica as well as the insertion sequence IS1001 of B. parapertussis, B. bronchiseptica and B. holmesii. IS481 or IS1001 may be present in B. bronchiseptica in rare cases. Proper specimens are DNA extracts of samples from the human respiratory tract (sputum, BAL, nasal swabs, throat swabs, bronchial secretion, tracheal secretion). This test is suitable for patients of all ages with suspected respiratory infection with Bordetella (causative agent of whooping cough and whooping cough-like infections) and is intended as an aid in the diagnosis of infection with this pathogen in combination with patient history and additional clinical information. The test is for professional use only and the use is limited to qualified personnel instructed in real-time PCR and in vitro diagnostic procedures. A probe-specific amplification-curve in the FAM channel (530 nm) and/or VIC channel (554 nm) indicates the amplification of Bordetella specific DNA. An internal DNA positive control (DNA IPC) is detected in Cy5 channel and is used as DNA extraction as well as real-time PCR inhibition control. The target for the DNA IPC (artificial target DNA) is extracted with the sample.

BactoReal® Kit Bordetella Multiplex (IVD)
Order Number Reactions Channel Pathogen Channel IPC Target
DHUB00453 50 FAM, VIC Cy5
Shipping Temperature: -20 °C to +4 °C
Product Features:
  • Amplification and detection: Insertion sequence IS481 of B. pertussis, B. holmesii and B. bronchiseptica as well as the insertion sequence IS1001 of B. parapertussis, B. bronchiseptica and B. holmesii.
  • Real-time PCR with rapid hot-start Taq DNA polymerase
  • ROX™ dye as passive reference
  • Internal Positive Control System to exclude false-negative results
  • Optimized to handle PCR inhibitors
  • PCR- platforms: runs on all established standard real-time PCR- platforms
  • Harmonized thermal profiles to run RNA and DNA samples simultaneously

PCR platforms: This test has been validated with the ABI® 7500 Fast Real-Time PCR System (fast cycle parameters are not supported, Thermo Fisher Scientific) and was also tested with a LightCycler® 480 II (Roche Diagnostics), QuantStudio™ 7 real-time PCR system (Thermo Fisher Scientific) and Mic instrument (bio molecular systems).
It is also compatible with other real-time PCR instruments which detect and differentiate fluorescence in FAM, VIC and Cy5 channel (e.g., QuantStudio™ 5 real-time PCR system (Thermo Fisher Scientific), qTOWER3G (Analytik Jena), cobas z 480 Analyzer (Roche), CFX Opus Real-time PCR System (Bio-Rad), CFX Dx (Bio-Rad) and T-COR 8 (Tetracore)).
When using PCR-platforms not tested by ingenetix, an evaluation of the multiplex-PCR shall be done. Keep in mind that some PCR-platforms first must be calibrated with the corresponding dye before performing multiplex-PCR.

BactoReal® , MycoReal® , ParoReal ® and ViroReal® Kits run with the same thermal cycling conditions.