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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 |
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) |
reaches up to 0.109 cp/µl with the probability of 95% (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 NA16 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 by QCMD and Instand e.V. External Quality Assessment Panels - results at www.geneproof.com |
Certification | CE IVD |
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