Intended use:
The RIDASCREEN® Legionella is an enzyme immunoassay for the qualitative detection of Legionella pneumophila antigens in urine samples.
General information:
Legionnaires’ disease is an acute, respiratory infection which is mainly caused by L. pneumophila. It was first described in 1976 during a congress in Philadelphia, USA, where Legionnaires’ disease was given its Name. The Legionella strain belongs to the Legionellaceae family and is divided into 40 species with more than 70 serogroups. Legionella bacteria are facultative, intracellular gram negative bacteria whose peak infection rate occurs in the summer and early fall. With Legionnaires’ disease, a differentiation is made between externally acquired infections due to travel and nosocomial infections.
Accessories:
Single Components:
| Art. No. | C8001 |
|---|---|
| Test format | Microtiter plate with 96 wells (12 strips with 8 removable wells each) |
| Sample preparation | Urine samples can be used directly without dilution. |
| Incubation time | 105 min |
| Cut-off | Cut-off = extinction rate for the negative control + 0.15 |
| Detection limit | 1.5 ng/mL specific LPS-Antigen of Legionella can be detected |
| Sensitivity | 93.7 % |
| Specificity | 93.8 % |
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.
