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GeneProof CT/NG/MG Multiplex PCR Kit

CE 1023 IVD

PRODUCT ADVANTAGES

 

MORE INFORMATION WITH LESS SAMPLES

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


DETECTS porA MUTANT OF N. GONORRHOEAE

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

SWEDISH VARIANT OF C. TRACHOMATIS

  • Dual target detection of 16S rRNA gene and cryptic plasmid

HIGH SENSITIVITY

  • Secured by targeting the multicopy sequence of 16S rRNA for all three detected pathogens

CONTAMINATION ELIMINATION

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

 

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

CE IVD 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_09_20_EN
pdf, [177.19 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]
GP_NG_CNMX_QCMD_2020_EN
pdf, [124.97 kB]
Choose all

Technical specification

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 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)

reaches up to 0.177 cp/μl with the probability of 95 % (on Amplirun® Chlamydia trachomatis DNA control, Vircell)
reaches up to 0.22 cp/μl with the probability of 95 % (on Amplirun® Neisseria gonorrhoeae DNA control, Vircell)
reaches up to 1.129 cp/μl with the probability of 95 % (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%)
Extraction/Inhibition Control

PCR inhibition and DNA extraction efficiency control 

Validated Specimen 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 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

Required Detection Channels FAM, HEX, Cy5, Texas Red
External Quality Assessment Regularly tested by QCMD and INSTAND e.V. External Quality Assessment panels – results at www.geneproof.com
Certification CE1023 IVD 

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.55 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, [91.66 kB]

Declaration of Conformity

GP_CNMX_Declaration of Conformity_EN
pdf, [322.37 kB]
GP_EC_Full_Quality_Assurance_Certificate_EN
pdf, [417.58 kB]

MSDS

GP_CNMX_Safety_Data_Sheet_EN
pdf, [274.67 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, [142.53 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]
croBEE Real-Time PCR System_EN
pdf, [5.9 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.