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 Mic qPCR Cycler QuantStudio™ 5 Real-Time PCR System 2-channel detection |
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 |