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GeneProof Mycoplasma genitalium/hominis PCR Kit

CE IVD

PRODUCT ADVANTAGES

 

MORE INFORMATION WITH LESS SAMPLES

  • Enables to distinguish Mycoplasma hominis from Mycoplasma genitalium using 3-channel system

UNIVERSAL PCR PROFILE

  • Easily combinable with other PCR Kits from the STI group
  • Simplifies laboratory workflow

HIGH SENSITIVITY

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

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 Mycoplasma genitalium/hominis PCR Kit MGH/ISEX/025 real-time PCR 25 reactions
GeneProof Mycoplasma genitalium/hominis PCR Kit MGH/ISEX/050 real-time PCR 50 reactions
GeneProof Mycoplasma genitalium/hominis PCR Kit MGH/ISEX/100 real-time PCR 100 reactions

EQA Panels

EQA results

GP_Instand_06.2020_EN
pdf, [303.08 kB]
GP_MGH_QCMD_2018_EN
pdf, [158.34 kB]
GP_MGH_QCMD_2019_EN
pdf, [181.04 kB]
Choose all

Technical specification

Technology real-time PCR
Type of Analysis qualitative
Target Sequence

a multicopy sequence of the gene encoding the 16S rRNA (M. genitalium) and the housekeeping gap gene for glyceraldehyde-3-phosphate dehydrogenase (M.hominis)

Analytical Specificity

M. genitalium, 100 %
M. hominis, 100 %

Analytical Sensitivity (LoD)

reaches up to 1.256 cp/μl with the probability of 95 % for M. genitalium
reaches up to 1.196 cp/μl with the probability of 95 % for M. hominis

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*
AriaMx Real-Time PCR System
CFX Connect™ ** / CFX96™/ Dx Real-Time PCR Detection System
LineGene 9600 / 9600 Plus
Rotor-Gene 3000 / 6000 ** / Q
SLAN® Real-Time PCR System

Required Detection Channels

FAM, HEX, Cy5

External Quality Assessment regularly tested by QCMD External Quality Assessment Panels - results at www.geneproof.com
Certification CE IVD 

* Validated instruments
** The kit requires three detection channels. On instruments with two detection channels the kit detects the M. genitalium presence only.

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.4 MB]
GP_Declaration of Change_EN_CZ
pdf, [209.66 kB]
GP_MGH_Instruction for Use_CZ
pdf, [549.85 kB]
GP_MGH_Instruction for Use_EN
pdf, [553.2 kB]
GP_MGH_Target Sequence Detection_CZ
pdf, [389.35 kB]

Declaration of Conformity

GP_FQAS EC Certificate_CZ
pdf, [47.46 kB]
GP_MGH_Declaration of Conformity_CZ
pdf, [586.94 kB]
GP_MGH_Declaration of Conformity_EN
pdf, [615.92 kB]

MSDS

GP_Safety Data Sheet_CZ
pdf, [134.4 kB]
GP_Safety Data Sheet_EN
pdf, [148.84 kB]

Manual

AriaMx Real-Time PCR System_CZ
pdf, [2.17 MB]
AriaMx Real-Time PCR System_EN
pdf, [2.14 MB]
CFX 96/Connect/Dx Real-Time PCR Detection System_CZ
pdf, [2.37 MB]
CFX 96/Connect/Dx Real-Time PCR Detection System_EN
pdf, [2.2 MB]
croBEE Real-Time PCR System_CZ
pdf, [6.09 MB]
croBEE Real-Time PCR System_EN
pdf, [5.9 MB]
LineGene 9600_9600Plus_K_CZ
pdf, [4.66 MB]
LineGene 9600_9600Plus_K_EN
pdf, [4.6 MB]
Mic qPCR Cycler_CZ
pdf, [2.7 MB]
Mic qPCR Cycler_EN
pdf, [2.6 MB]
QuantStudio 3/5 Real-Time PCR System_CZ
pdf, [2.31 MB]
QuantStudio 3/5 Real-Time PCR System_EN
pdf, [2.29 MB]
Rotor-Gene_3000_6000_Q_CZ
pdf, [2.25 MB]
Rotor-Gene_3000_6000_Q_EN
pdf, [2.22 MB]
SLAN Real-Time PCR System_CZ
pdf, [1.59 MB]
SLAN Real-Time PCR System_EN
pdf, [1.56 MB]
StepOne/StepOne Plus Real-Time PCR System_CZ
pdf, [4.37 MB]
StepOne/StepOne Plus Real-Time PCR System_EN
pdf, [4.42 MB]

Product Leaflet

GP_MGH_Leaflet_EN
pdf, [135.29 kB]
Files are available only for registered users.