Mycoplasma genitalium/hominis
Kat.: MGH/ISEX/100
A termék CE/IVD minősítéssel rendelkezik és az OGYÉI által nyilvántartásba vett.
A Mycoplasma hominis és Mycoplasma genitalium elkülönítésére (3 csatornás rendszer) és detektálására alkalmas ‘Ready-to-Use ‘ master mix. A 16S rRNS-t (M. genitalium) és a gliceraldehid-3-foszfát-dehidrogenáz (M.hominis) háztartási gap génjét kódoló gén többkópiás szekvenciáját detektálja. (100 reakció)
Leírás
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
COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES
CE IVD CERTIFIED DIAGNOSTIC TEST
Technical specification
| Indication | in vitro diagnostic medical device |
| 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 NA16 Nucleic Acid Extraction System GeneProof PathogenFree DNA Isolation Kit |
| Instruments | croBEE Real-Time PCR System AriaMx Real-Time PCR System CFX Connect™ * / CFX96™/ Dx Real-Time PCR Detection System LineGene 9600 / 9600 Plus Mic qPCR Cycler Rotor-Gene 3000 / 6000 * / Q QuantStudio™ 3 / 5 Real-Time PCR System * StepOne™ / StepOnePlus™ Real-Time PCR System * SLAN® Real-Time PCR System |
| Required Detection Channels | FAM, HEX, Cy5 |
| External Quality Assessment | regularly tested by QCMD External Quality Assessment Panels – results at www.geneproof.com |
| Regulatory Status | CE IVD |
* The kit requires three detection channels. On instruments with two detection channels the kit detects the M. genitalium presence only.
