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GeneProof® Gardnerella vaginalis PCR Kit
| Manufacturer: | GeneProof |
|---|---|
| Country: | Czech Republic |
Specialist consultation
+38 (067) 880 44 83Details
COMPLETE SOLUTION FOR STI
As a part of STI Panel enables a comprehensive solution for symptomatic STI diagnostics
Suitable especial for differential diagnostics of non-candidal vulvovaginitis
SIMPLE LABORATORY WORKFLOW
Easily combinable with other PCR kits from the STI Panel in one workflow
EASY-TO-USE CONCEPT
Single tube Ready-to-Use Master Mix contains all components for PCR amplification
No additional PCR reagents pipetting necessary
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
TP/GP/025 - 25 tests
TP/GP/100 - 100 tests
Characteristics
| INDICATION | in vitro diagnostic medical device |
|---|---|
| TECHNOLOGY | Real-time PCR |
| TARGET SEQUENCE | tuf gene for transcription elongation factor |
| ANALYTICAL SENSITIVITY (LoD with 95% probability) | 0.82 cp/μl (performed on AmpliRun® GVA DNA control, Vircell) |
| VALIDATED SPECIMEN | Swab, urine |
| VALIDATED EXTRACTION METHODS | ▪ croBEE 201A Nucleic Acid Extraction Kit ▪ GeneProof PathogenFree DNA Isolation Kit |
| REQUIRED DETECTION CHANNELS | FAM, HEX/JOE |
| REGULATORY STATUS | CE IVD |
|---|---|
| TYPE OF ANALYSIS | Qualitative |
| ANALYTICAL SPECIFICITY | Gardnerella vaginalis, 100 % |
| EXTRACTION/INHIBITION CONTROL | PCR inhibition and DNA extraction efficiency control |
| STORAGE | (-20 ± 5) °C |
| INSTRUMENTS | ▪ croBEE Real-Time PCR System ▪ Applied Biosystems 7300 / 7500 Real-Time PCR System ▪ AMPLilab Real-Time PCR System ▪ AriaMx Real-Time PCR System ▪ BioQuant-96 real-time PCR detection system ▪ CFX Connect / CFX96/ Dx Real-Time PCR Detection System ▪ Gentier 96E/96R Real-Time PCR System ▪ LightCycler® 480 ▪ Line Gene 9600 Plus ▪ Rotor-Gene 3000 / 6000 / Q |
| EXTERNAL QUALITY ASSESSEMENT | 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 |
