Intended use:
For in-vitro diagnostic use. The RIDA®UNITY Bordetella test, which can be performed automatically or manually, is a multiplex real-time PCR for the direct qualitative detection of
– Bordetella pertussis DNA
– Bordetella parapertussis DNA
– Bordetella holmesii DNA
from human nasopharyngeal swabs from persons with signs and symptoms of acute whooping cough.
The RIDA®UNITY Bordetella test is intended to support the differential diagnosis of infection with Bordetella pertussis, Bordetella parapertussis and Bordetella holmesii in patients with symptoms of whooping cough in conjunction with other clinical and laboratory findings.
Negative results do not rule out infection with Bordetella (Bordetella pertussis, Bordetella parapertussis and Bordetella holmesii) and should not be used as the sole basis for diagnosis.
The product is intended for professional use.
General information:
Bordetella pertussis is a Gram-negative bacterium that causes an acute respiratory infection known as pertussis or whooping cough. It produces a variety of toxins and virulence factors. B. parapertussis, B. holmesii and B. bronchiseptica (rarely human pathogenic) can also lead to a clinical picture similar to whooping cough, but usually with a shorter and milder course.
Real-time PCR enables rapid, sensitive and specific detection up to 4 weeks after the onset of symptoms of the disease. In
addition, the human pathogenic Bordetella species can be differentiated in a realtime PCR.
Accessories:
| Art. No. | UN2505 |
|---|---|
| Test format | real-time PCR with 96 reactions |
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.
