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GeneProof Team
| Product name | Catalog no. | Technology | Packaging |
| GeneProof Neisseria gonorrhoeae PCR Kit | NG/ISEX/025 | real-time PCR | 25 reactions |
| GeneProof Neisseria gonorrhoeae PCR Kit | NG/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 |
A multi-copy sequence of the gene encoding 16S rRNA and porA preudogene specific for N. gonorrhoeae |
| Analytical Specificity |
N. gonorhoeae, including mutants in porA pseudogene, 100 % |
| Analytical Sensitivity (LoD with 95% probability) |
0.109 cp/µl (on Amplirun® Neisseria gonorrhoeae DNA control, Vircell) |
| Extraction / Inhibition Control |
PCR Inhibition and DNA extraction efficiency control |
| Validated Specimen | Sperm, swab, urine |
| Storage | -20 ± 5 °C |
| Validated Extraction Methods | croBEE 201A Nucleic Acid Extraction System GeneProof PathogenFree DNA Isolation Kit |
| Instruments |
croBEE 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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