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

 

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)

Specificity

M. genitalium, 100 %

M. hominis, 100 %

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 control (ISIN version)
PCR inhibition and DNA e0xtraction efficiency control (ISEX version)
Validated Specimen swab, urine
Storage -20 ± 5 °C
Validated Extraction Methods

croBEE NA16 Nucleic Acid Extraction System

GeneProof PathogenFree DNA Isolation Kit

Instruments

3-channel detection
croBEE Real-Time PCR System*
AriaMx Real-Time PCR System
CFX96™ / Dx Real-Time PCR Detection System
LineGene 9600 / 9600 Plus

Mic qPCR Cycler

QuantStudio™ 5 Real-Time PCR System
Rotor-Gene 3000 / Q
SLAN® Real-Time PCR System
StepOne™ / StepOnePlus™ Real-Time PCR System

 

2-channel detection
CFX Connect™ Real-Time PCR System
QuantStudio™ 3 Real-Time PCR System
Rotor-Gene 6000

Required Detection Channels

3-channel detection: FAM, HEX, Cy5

2-channel detection: FAM, HEX

if a 2-channel system is used, only the presence of M. genitalium is detected in the FAM channel

Quality Control quality management system is certified in compliance with the requirements of the standard ISO 13485
External Quality Assessment regularly tested by QCMD External Quality Assessment Panels - results at www.geneproof.com
Certification CE IVD for in vitro Diagnostics Use

*Validated Instruments
 

ORDER INFORMATION

Product name

Cat. No. Technology Package
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