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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

SIMPLE LABORATORY WORKFLOW

  • Easily combinable with other GeneProof PCR kits in one workflow

HIGH SENSITIVITY

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

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

Product Leaflet

Product Leaflet

; GP_STI_Panel_Leaflet_EN
pdf, [1.42 MB]
; GP_MGH_Leaflet_EN
pdf, [126.9 kB]
Choose all

EQA Panels

EQA results

; GP_STI_I_QCMD_croBEE_11_2022_EN
pdf, [246.42 kB]
; GP_STI I_QCMD_11_2022_EN
pdf, [261.07 kB]
; GP_MG_QCMD_09_21_EN_02
pdf, [182.21 kB]
; GP_MG_QCMD_09_21_EN_01
pdf, [184.16 kB]
; GP_MG_Instand_06_21_EN
pdf, [901.27 kB]
; GP_MGH_croBEE_QCMD_11_2020_EN
pdf, [182.89 kB]
; GP_MGH_QCMD_11_2020_EN
pdf, [180.92 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 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 201A Nucleic Acid Extraction System
GeneProof PathogenFree DNA Isolation Kit

Instruments

croBEE Real-Time PCR System
AMPLilab Real-Time PCR System
AriaMx Real-Time PCR System
BioQuant-96 Real-Time PCR System
CFX Connect™ Real-Time PCR Detection System *
CFX96™ / Dx Real-Time PCR Detection System
Gentier 96E/96R Real-Time PCR System
LightCycler® 480
LineGene 9600 / 9600 Plus
Mic qPCR Cycler
QuantStudioTM 3 Real-Time PCR System *
QuantStudioTM 5 Real-Time PCR System
Rotor-Gene 3000 / Q
Rotor-Gene 6000 *
SLAN® Real-Time PCR System
StepOneTM / StepOne PlusTM Real-Time PCR System *

Required Detection Channels

FAM, HEX, Cy5

External Quality Assessment Regularly tested in QCMD External Quality Assessment Panels - results at www.geneproof.com

* The device allows detection of M. genitalium only.

Instructions for Use

; Declaration of Verification of the kits with medical devices
pdf, [1.61 MB]
; GP_MGH_Advisory_Notice_11_22_EN
pdf, [816.45 kB]
; GP_MGH_Advisory_Notice_1_23_EN
pdf, [415.07 kB]
; GP_MGH_Instruction_for_Use_EN
pdf, [110.75 kB]
; GP_MGH_Instruction_for_Use_IT
pdf, [144.12 kB]

Declaration of Conformity

; GP_MGH_Declaration_of_Conformity_EN
pdf, [571.56 kB]

MSDS

; GP_MGH_Safety_Data_Sheet_EN
pdf, [303.09 kB]

Publications

; GP_STI_publications_08_22_EN
pdf, [204.33 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_Mycoplasma genitalium_hominis_Mic
micassay, [26.61 kB]
; RG_DNA_2CH_3CH_4CH
ret, [13.83 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]
; SLAN Real-Time PCR System_EN
pdf, [1.56 MB]
; StepOne/StepOne Plus Real-Time PCR System_EN
pdf, [4.42 MB]
Files are available only for registered users.