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GeneProof Neisseria gonorrhoeae PCR Kit

CE IVD

PRODUCT ADVANTAGES

 

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 PREVENTION

  • Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating carryover contamination

 

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

CE IVD CERTIFIED DIAGNOSTIC TEST

Order information

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

EQA Panels

EQA results

; GP_NG_QCMD_05_22_EN_02
pdf, [123.02 kB]
; GP_NG_QCMD_05_22_EN_01
pdf, [121.91 kB]
; GP_NG_QCMD_09_21_EN_02
pdf, [120.21 kB]
; GP_NG_QCMD_09_21_EN_01
pdf, [121.38 kB]
; GP_CTNG_QCMD_09_21_EN_02
pdf, [139.59 kB]
; GP_CTNG_QCMD_09_21_EN_01
pdf, [138.43 kB]
; GP_NG_Instand_06_21_EN
pdf, [901.17 kB]
Choose all

Technical specification

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
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
Rotor-Gene 3000 / 6000 / Q
SLAN® Real-Time PCR System
StepOneTM / StepOnePlusTM Real-Time PCR System
QuantStudio™ 3 / 5 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

Documentation

Instruction for Use

; Declaration of Verification of the kits with medical devices
pdf, [1.6 MB]
; GP_NG_Instruction for Use_EN
pdf, [548.89 kB]

Declaration of Conformity

; GP_EC_Full_Quality_Assurance_Certificate_EN
pdf, [417.58 kB]
; GP_NG_Declaration_of_Conformity_EN
pdf, [576.54 kB]

MSDS

; GP_NG_Safety_Data_Sheet_EN
pdf, [275.52 kB]

Publications

; STI_publications
pdf, [254.48 kB]

PCR Template

; GP_DNA_3CH_2CH_ABI7500
edt, [10.72 kB]
; GP_DNA_3CH_2CH_AriaMx
amxt, [3.61 kB]
; GP_DNA_3CH_2CH_croBEE
fqt, [4.91 kB]
; GP_DNA_3CH_2CH_QS5
edt, [8.14 kB]
; GP_DNA_BioRad
prcl, [1.33 kB]
; GP_Neisseria gonorrhoeae_Mic
micassay, [21.95 kB]
; RG_DNA_2CH_3CH_4CH
ret, [13.83 kB]

Product Leaflet

; GP_NG_Leaflet_EN
pdf, [173.19 kB]
; GP_Poster_EN
pdf, [100.68 kB]

Manual

; AriaMx Real-Time PCR System_EN
pdf, [2.31 MB]
; Bio-Rad CFX 96/Connect/Dx Real-Time PCR Detection System_EN
pdf, [1.43 MB]
; LightCycler 2.0_EN
pdf, [1.8 MB]
; LightCycler 480/480 Instrument II_EN
pdf, [2.18 MB]
; LineGene 9600_9600Plus_K_EN
pdf, [4.6 MB]
; Mic qPCR Cycler_EN
pdf, [2.33 MB]
; QuantStudio 3/5 Real-Time PCR System_EN
pdf, [1.81 MB]
; Rotor-Gene_3000_6000_Q_EN
pdf, [2.22 MB]
; SLAN Real-Time PCR System_EN
pdf, [1.56 MB]
; StepOne/StepOne Plus Real-Time PCR System_EN
pdf, [4.42 MB]
; ThermoFisher ABI 7500/7500 Fast Real-Time PCR System_EN
pdf, [4.2 MB]
Files are available only for registered users.