GeneProof Mycoplasma genitalium/hominis PCR Kit

GeneProof Mycoplasma genitalium/hominis PCR Kit

    CE IVD

 

 

PRODUCT DETAIL                                            

The PCR kit is designed for Mycoplasma genitalium and Mycoplasma hominis detection and differentiation by the real-time Polymerase Chain Reaction method (PCR).

The M. genitalium and M. hominis detection and differentiation consist in amplification of a multicopy sequence of the gene encoding the 16S rRNA (M. genitalium) and the housekeeping gap gene for glyceraldehyde-3-phosphate dehydrogenase (M. hominis) and in measurement of fluorescence increase. The M. genitalium presence is indicated by the FAM fluorophore fluorescence growth and the M. hominis presence is indicated by the Cy5 fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR by amplification products. The kit is designed for in vitro diagnostics and provides qualitative detection.
 

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

Validated 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

 

ORDER INFORMATION

Product name Cat. No. Technology Package
GeneProof Mycoplasma genitalium/hominis PCR Kit MGH/ISIN/025 real-time PCR 25 reactions
GeneProof Mycoplasma genitalium/hominis PCR Kit MGH/ISIN/050 real-time PCR 50 reactions
GeneProof Mycoplasma genitalium/hominis PCR Kit MGH/ISIN/100 real-time PCR 100 reactions
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

Comments are closed.