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GeneProof® Mycoplasma genitalium/hominis PCR Kit
| Manufacturer: | GeneProof |
|---|---|
| Country: | Czech Republic |
Specialist consultation
+38 (067) 880 44 83Details
MORE INFORMATION WITH LESS SAMPLES
Enables to distinguish Mycoplasma hominis from Mycoplasma genitalium using 3-channel system
SIMPLE LABORATORY WORKFLOW
Easily combinable with other GeneProof PCR kits in one workflow
HIGH SENSITIVITY
Secured by targeting the multicopy sequence of the 16S rRNA gene of Mycoplasma genitalium
CONTAMINATION PREVENTION
Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating carryover contamination
COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES
CE IVD CERTIFIED DIAGNOSTIC TEST
MGH/GP/025 - 25 tests
MGH/GP/100 - 100 tests
Characteristics
| INDICATION | in vitro diagnostic medical device |
|---|---|
| TECHNOLOGY | Real-time PCR |
| TARGET SEQUENCE | 16S rRNA gene for Mycoplasma genitalium, gap gene for Mycoplasma hominis |
| ANALYTICAL SENSITIVITY (LoD with 95% probability) | ▪ 1.197 cp/μl AmpliRun® Mycoplasma genitalium DNA control, Vircell ▪ 1.406 cp/μl AmpliRun® Mycoplasma hominis DNA control, Vircell |
| DIAGNOSTIC SENSITIVITY | 91.30 % (CI95%: 70.49 % – 98.48 %) |
| NEGATIVE PREDICTIVE VALUE | 99.01 % (CI95%: 96.09 % – 99.83 %) |
| VALIDATED SPECIMEN | DNA extracted from swab (cervical, urethral, vaginal), urine |
| VALIDATED EXTRACTION METHODS | ▪ croBEE 201A Nucleic Acid Extraction Kit ▪ GeneProof PathogenFree DNA Isolation Kit |
| REQUIRED DETECTION CHANNELS | FAM (MG), HEX/JOE/VIC (IC), Cy5 (MH) |
| REGULATORY STATUS | CE 2797 IVD / Regulation (EU) 2017/746 |
|---|---|
| TYPE OF ANALYSIS | Qualitative |
| ANALYTICAL SPECIFICITY | Mycoplasma genitalium (MG), Mycoplasma hominis (MH), 100 % |
| DIAGNOSTIC SPECIFICITY | 98.52 % (CI95%: 95.39 % – 99.62 %) |
| POSITIVE PREDICTIVE VALUE | 87.50 % (CI95%: 66.54 % – 96.71 %) |
| EXTRACTION/INHIBITION CONTROL | PCR inhibition and DNA extraction efficiency control by Internal Control (IC) |
| STORAGE | (-20 ± 5) °C |
| INSTRUMENTS | ▪ croBEE Real-Time PCR System ▪ AMPLilab Real-Time PCR System ▪ Applied Biosystems 7500 Real-Time PCR System ▪ AriaMx Real-Time PCR System ▪ BioQuant-96 Real-Time PCR System ▪ CFX96/ Dx Real-Time PCR Detection System ▪ CFX Opus 96 Real-Time PCR System ▪ Gentier 96E/96R Real-Time PCR System ▪ LightCycler® 480 ▪ LineGene 9600 / 9600 Plus ▪ Mic qPCR Cycler ▪ QuantStudio 5 Real-Time PCR System ▪ Rotor-Gene 3000 / Q ▪ SLAN® Real-Time PCR System ▪ StepOne / StepOne Plus Real-Time PCR System |
| EXTERNAL QUALITY ASSESSMENT | Regularly tested in QCMD and Instand e.V. External Quality Assessment Panels – results at www.geneproof.com |
Service and Warranty
GENEPROOF CALCULATOR
The on-line calculator was developed by GeneProof to simplify the evaluation of GeneProof quantitative PCR kits.
To access the online calculator, click the button below
If you have any questions, please contact our specialists on the CONTACTS page.
We provide premium service and maintenance for every device and consumable:
• Comprehensive maintenance of medical equipment
• Installations, commissioning
• Warranty and post-warranty service
• Instruction, training and consultations for your team
More details on the SERVICE page
| Contact phone | +38 (067) 133 05 52 |
|---|---|
| E-mail: | service@empirica.healthcare |
