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GeneProof CT/NG/MG Multiplex PCR Kit

CE 1023 IVD

PRODUCT ADVANTAGES

 

MORE INFORMATION FROM ONE REACTION

  • PCR Kit detects and distinguishes the most important STI pathogens in a single reaction tube:
    Chlamydia trachomatis
    Neisseria gonorrhoeae
    Mycoplasma genitalium

SIMPLE LABORATORY WORKFLOW

  • Easily combinable with other PCR kits from the STI Panel in one workflow

EASY-TO-USE CONCEPT

  • Single tube Ready-to-Use Master Mix contains all components for PCR amplification
  • No additional PCR reagents pipetting necessary

HIGH SENSITIVITY

  • Detects porA mutant of Neisseria gonorrhoeae and Swedish variant of Chlamydia trachomatis
  • Secured by targeting the multicopy sequence of 16S rRNA for all three detected pathogens

CONTAMINATION PREVENTION

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

 

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

CE1023IVD CERTIFIED DIAGNOSTIC TEST

Order information

Product name Catalog no. Technology Packaging
GeneProof CT/NG/MG Multiplex PCR Kit CNMX/ISEX/025 real-time PCR 25 reactions
GeneProof CT/NG/MG Multiplex PCR Kit CNMX/ISEX/100 real-time PCR 100 reactions

EQA Panels

EQA results

; GP_CNMX_QCMD_05_22_EN_04
pdf, [124.39 kB]
; GP_CNMX_QCMD_05_22_EN_03
pdf, [126.99 kB]
; GP_CNMX_QCMD_05_22_EN_02
pdf, [131.63 kB]
; GP_CNMX_QCMD_05_22_EN_01
pdf, [129.19 kB]
; GP_NG_QCMD_09_21_EN_02
pdf, [125.32 kB]
; GP_NG_QCMD_09_21_EN_01
pdf, [122.7 kB]
; GP_MG_QCMD_09_21_EN
pdf, [183.1 kB]
; GP_CHT_QCMD_09_21_EN_02
pdf, [138.45 kB]
; GP_CHT_QCMD_09_21_EN_01
pdf, [136.05 kB]
; GP_CTNG_QCMD_09_21_EN_04
pdf, [140 kB]
; GP_CTNG_QCMD_09_21_EN_03
pdf, [139.96 kB]
; GP_CTNG_QCMD_09_21_EN_01
pdf, [140.79 kB]
; GP_NG_Instand_06_21_EN
pdf, [901.17 kB]
Choose all

Technical specification

Indication in vitro diagnostic medical device
Regulatory Status CE1023IVD
Intended User For professional use in laboratories with trained staff
Technology Real-time PCR
Type of Analysis Qualitative
Target sequence The cryptic plasmid sequence and the 16S rRNA gene for Chlamydia trachomatis
The 16S rRNA gene and porA pseudogene for Neisseria gonorrhoeae
The 16S rRNA gene for Mycoplasma genitalium
Analytical Specificity Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium, 100 %
Analytical Sensitivity (LoD with 95% probability)

0.177 cp/μl (on Amplirun® Chlamydia trachomatis DNA control, Vircell)
0.22 cp/μl (on Amplirun® Neisseria gonorrhoeae DNA control, Vircell)
1.129 cp/μl (on Amplirun® Mycoplasma genitalium DNA control, Vircell)

Diagnostic specificity 96.89% (CI95%: 93.04% – 98.73%)
Diagnostic sensitivity 97.67 % (CI95%: 86.20% – 99.88%)
Validated Specimen 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
AMPLilab Real-Time PCR System
Applied Biosystems 7500 Real-Time PCR System
CFX96™/ Dx Real-Time PCR Detection System
Mic qPCR Cycler
QuantStudio™ 5 Real-Time PCR System
AriaMx Real-Time PCR System
LineGene 9600 Plus
Rotor-Gene 3000 / Q

Detection Channels FAM, HEX, Cy5, Texas Red
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, [1.61 MB]
; GP_CNMX_Advisory Notice_EN_CZ
pdf, [265.33 kB]
; GP_CNMX_Advisory_Notice_05_22_EN
pdf, [440.49 kB]
; GP_CNMX_Instruction_for_Use_EN
pdf, [209.18 kB]
; GP_CNMX_Instruction_for_Use_ES
pdf, [234.4 kB]
; GP_CNMX_Instruction_for_Use_FR
pdf, [233.1 kB]

Declaration of Conformity

; GP_CNMX_Declaration_of_Conformity_EN
pdf, [618.12 kB]
; GP_EC_Full_Quality_Assurance_Certificate_EN
pdf, [417.58 kB]

MSDS

; GP_CNMX_Safety_Data_Sheet_EN
pdf, [273.93 kB]

PCR Template

; GP_CNMX_Mic
micassay, [19.87 kB]
; GP_CNMX_template_AmpliLAB
tlpi, [3.53 kB]
; GP_DNA_4CH_ABI7500
edt, [10.36 kB]
; GP_DNA_4CH_AriaMx
amxt, [3.72 kB]
; GP_DNA_4CH_croBee
fqt, [4.94 kB]
; GP_DNA_4CH_QS5
edt, [8.21 kB]
; GP_DNA_BioRad
prcl, [1.33 kB]
; RG_DNA_2CH_3CH_4CH
ret, [13.83 kB]

Product Leaflet

; GP_CNMX_Leaflet_EN
pdf, [130.86 kB]
; GP_CNMX_Poster_EN
pdf, [101.38 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]
; 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]
; ThermoFisher ABI 7500/7500 Fast Real-Time PCR System_EN
pdf, [4.2 MB]
Files are available only for registered users.