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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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GeneProof offers a unique PCR testing solution that provides differential diagnostics of many pathogens
Our products’ quality, safety, and performance are fully compliant with the new rules for in vitro…