GeneProof Neisseria gonorrhoeae PCR Kit
The PCR kit is designed for Neisseria gonorrhoeae detection by the real-time Polymerase Chain Reaction (PCR) method.
The N. gonorrhoeae detection consists in amplification of a multi-copy sequence of the gene encoding 16S rRNA and porA pseudogene specific for N. gonorrhoeae and in measurement of fluorescence increase. The N. gonorrhoeae presence is indicated by the FAM fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR with amplification products.
The kit is designed for in vitro diagnostics and provides qualitative detection.
The kit can sensitively detect porA mutants of N. gonorrhoeae that may go undetected by other kits.
|Type of Analysis||qualitative|
|Target Sequence||a multi-copy sequence of the gene encoding 16S rRNA and porA preudogene specific for N. gonorrhoeae|
|Specificity||N. gonorhoeae, including mutants in porA pseudogene, 100 %|
|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 control (ISIN version)
PCR Inhibition and DNA extraction efficiency control (ISEX version)
|Validated Specimen||sperm, swab, urine|
|Storage||-20 ± 5 °C|
|Validated Extraction Methods||croBEE NA16 Nucleic Acid Extraction System
GeneProof PathogenFree DNA Isolation Kit
|Validated Instruments||croBEE Real-Time PCR System
Applied Biosystems 7300 / 7500 Real-Time PCR System
AriaMx Real-Time PCR System
CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System
LightCycler® 2.0 / 480
LineGene 9600 / 9600 Plus
Mic qPCR Cycler
QuantStudio™ 3 / 5 Real-Time PCR System
Rotor-Gene 3000 / 6000 / Q
SLAN® Real-Time PCR System
StepOne™ / StepOnePlus™ Real-Time PCR SystemRequired Detection ChannelsFAM, HEXQuality Controlquality management system is certified in compliance with the requirements of the standard ISO 13485External Quality Assessmentregularly tested by QCMD and Instand e.V. External Quality Assessment Panels - results at www.geneproof.comCertificationCE IVD for in vitro Diagnostics Use
|Product name||Cat. No.||Technology||Package|
|GeneProof Neisseria gonorrhoeae PCR Kit||NG/ISIN/025||real-time PCR||25 reactions|
|GeneProof Neisseria gonorrhoeae PCR Kit||NG/ISIN/050||real-time PCR||50 reactions|
|GeneProof Neisseria gonorrhoeae PCR Kit||NG/ISIN/100||real-time PCR||100 reactions|
|GeneProof Neisseria gonorrhoeae PCR Kit||NG/ISEX/025||real-time PCR||25 reactions|
|GeneProof Neisseria gonorrhoeae PCR Kit||NG/ISEX/050||real-time PCR||50 reactions|
|GeneProof Neisseria gonorrhoeae PCR Kit||NG/ISEX/100||real-time PCR||100 reactions|