Welcome to GeneProof website!

It is great to see you here. To see all contents of the website, please register or restore your access.
We believe you will come back gladly.

GeneProof Team

 

User account
Forgot your password?
Searching

GeneProof MH/UU/UP Multiplex PCR Kit

CE IVD

PRODUCT ADVANTAGES

 

MORE INFORMATION FROM ONE REACTION

  • PCR Kit detects and distinguishes the important STI pathogens in a single reaction tube:
    Mycoplasma hominis
    Ureaplasma urealyticum
    Ureaplasma parvum

SIMPLE LABORATORY WORKFLOW

  • Easily combinable with other GeneProof PCR kits in one workflow

CONTAMINATION PREVENTION

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

EASY-TO-USE CONCEPT

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

 

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

CE IVD CERTIFIED DIAGNOSTIC TEST

Order information

Product name Catalog no. Technology Packaging
GeneProof MH/UU/UP Multiplex PCR Kit MUPX/GP/025 real-time PCR 25 reactions
GeneProof MH/UU/UP Multiplex PCR Kit MUPX/GP/100 real-time PCR 100 reactions

Product Leaflet

Product Leaflet

; GP_STI_Panel_Leaflet_EN
pdf, [1.42 MB]
; GP_MUPX_Leaflet_EN
pdf, [121.74 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_MUPX_QCMD_09_20_EN
pdf, [177.19 kB]
; GP_MUPX_Instand_06_21_EN
pdf, [901.27 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 gap gene (M. hominis)
UreD gene (U. urealyticum, U. parvum)
Analytical Specificity Mycoplasma hominis, Ureaplasma urealyticum, Ureaplasma parvum, 100 %
Analytical Sensitivity (LoD with 95% probability)

0.84 cp/μl (on Amplirun® Mycoplasma hominis DNA control, Vircell)
1.48 cp/μl (on Amplirun® Ureaplasma urealyticum DNA control, Vircell) 
0.73 cp/μl (on synthetic DNA ultramer control Ureaplasma parvum)

Diagnostic Specificity 96.00 % (CI95%: 87.97 % - 98.96 %) Mycoplasma hominis
98.67 % (CI95%: 91.79 % - 99.93 %) Ureaplasma urealyticum
100.00 % (CI95 %: 92.13% - 100.00 %) Ureaplasma parvum
Diagnostic Sensitivity  87.50 % (CI95 %: 60.41% - 97.80 %) Mycoplasma hominis
93.75 % (CI95 %: 67.71% - 99.67 %) Ureaplasma urealyticum
100.00 % (CI95 %: 87.36% - 100.00 %) Ureaplasma parvum
Positive Predictive Value  82.35 % (CI95%: 55.80 % - 95.33 %) Mycoplasma hominis
93.75 % (CI95%: 67.71 % - 99.67 %) Ureaplasma urealyticum
100.00 % (CI95%: 87.36 % - 100.00 %) Ureaplasma parvum
Negative Predictive Value  97.30 % (CI95%: 89.69 % - 99.53 %) Mycoplasma hominis
98.67 % (CI95%: 91.79 % - 99.93 %) Ureaplasma urealyticum
100.00 % (CI95%: 92.13 % - 100.00 %) Ureaplasma parvum
Extraction/Inhibition Control

PCR inhibition and DNA extraction efficiency control 

Validated Specimen Swab, urine, transport medium: UTM® Viral Transport (COPAN Diagnostics Inc.)
Storage -20 ± 5 °C
Validated Extraction Methods croBEE 201A Nucleic Acid Extraction Kit
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
Gentier 96E/96R Real-Time PCR System
LineGene 9600 Plus
Mic qPCR Cycler
QuantStudio™ 5 Real-Time PCR System

Required 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

 

Instructions for Use

; Declaration of Verification of the kits with medical devices
pdf, [1.61 MB]
; GP_MUPX_Advisory_Notice_EN
pdf, [867.95 kB]
; GP_MUPX_Instruction for Use_EN
pdf, [285.81 kB]
; GP_MUPX_Instructions_for_Use_IT
pdf, [176.75 kB]
; GP_MUPX_Instruction_for_Use_ FR
pdf, [275.19 kB]

Declaration of Conformity

; GP_MUPX_Declaration_of_Conformity_EN
pdf, [599.29 kB]

MSDS

; GP_MUPX_Safety_Data_Sheet_EN
pdf, [274.79 kB]

PCR Template

; 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]
; GP_MH_UU_UP_Mic
micassay, [30.87 kB]

Manual

; 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]
; 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.