GeneProof Neisseria gonorrhoeae PCR Kit

CE IVD

PRODUCT DETAIL

Learn about a clinical evaluation of GeneProof Neisseria gonorrhoeae PCR Kit to our competitors.

DUAL TARGET DETECTION

  • Dual target detection of the 16S rRNA gene and the porA pseudogene

HIGH SENSITIVITY

  • Secured by targeting the multicopy sequence of the 16S rRNA gene

RELIABLE DETECTION OF porA MUTANT

  • Elimination of false-negative results caused by a sequence variation in the porA pseudogene

CONTAMINATION ELIMINATION

  • Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating contamination with amplification products

 

TECHNICAL SPECIFICATION 

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

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
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 System

Required Detection Channels FAM, HEX
Quality Control quality management system is certified in compliance with the requirements of the standard ISO 13485
External Quality Assessment regularly tested by QCMD and Instand e.V. External Quality Assessment Panels results at www.geneproof.com
Certification CE IVD for in vitro Diagnostics Use

*Validated Instruments

ORDER INFORMATION

Product name

Cat. No. Technology Package
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