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GeneProof Team
| Product name | Catalog no. | Technology | Packaging |
| GeneProof Legionella pneumophila PCR Kit | LP/ISEX/025 | real-time PCR | 25 reactions |
| GeneProof Legionella pneumophila PCR Kit | LP/ISEX/100 | real-time PCR | 100 reactions |
| Indication | in vitro diagnostic medical device |
| Regulatory Status | CE IVD |
| Intended User | For professional use in laboratories with trained staff |
| Technology | Real-time PCR |
| Type of Analysis | Qualitative |
| Target Sequence | The gene encoding 16S rRNA specific for L. pneumophila |
| Analytical Specificity |
L. pneumophila, 100 % |
| Analytical Sensitivity (LoD) |
Reaches up to 0.578 cp/μl with the probability of 95% (on Amplirun® Legionella pneumophila DNA control, Vircell) |
| Extraction/Inhibition Controls |
PCR Inhibition and DNA extraction efficiency control |
| Validated specimen | BAL, sputum, swab |
| Storage | -20 ± 5 °C |
| Validated Extraction Methods | croBEE 201A Nucleic Acid Extraction System GeneProof PathogenFree DNA Isolation Kit |
| Instruments |
ccroBEE Real-Time PCR System |
| Required Detection Channels | FAM, HEX |
| External Quality Assessment | Regularly tested in QCMD and Instand e.V. External Quality Assessment Panels - results at www.geneproof.com |
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