GeneProof MH/UU/UP Multiplex PCR Kit
Kat.: MUPX/GP/025
A termék CE/IVD minősítéssel rendelkezik és az OGYÉI által nyilvántartásba vett.
A Mycoplasma hominis, Ureaplasma urealyticum és a Ureaplasma parvum egyetlen reakciócsőben történő elkülönítésére és detektálására alkalmas ‘Ready-to-Use ‘ master mix. A detektált szekvenciák: gap gén (M. hominis); UreD gén (U. urealyticum, U. parvum). (25 reakció)
Leírás
PRODUCT ADVANTAGES
MORE INFORMATION FROM ONE REACTION
- PCR Kit detects and distinguishes the important STI pathogens in a single reaction tube:
Mycoplasma hominis
Ureaplasma urealyticum
Ureaplasma parvum
PART OF STI PANEL
- Easily combinable with other PCR kits from the STI Panel in one workflow
- Simplifies laboratory workflow
CONTAMINATION PREVENTION
- Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating carryover contamination
EASY-TO-USE CONCEPT
- Single tube ready-to-use Master Mix contains all components for PCR amplification
- No additional PCR reagents pipetting necessary
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 | gap gene (M. hominis) UreD gene (U. urealyticum, U. parvum) |
| Analytical Specificity | Mycoplasma hominis, Ureaplasma urealyticum, Ureaplasma parvum, 100 % |
| Analytical Sensitivity (LoD) | reaches up to 0.84 cp/μl with the probability of 95 % (on Amplirun® Mycoplasma hominis DNA control, Vircell) reaches up to 1.48 cp/μl with the probability of 95 % (on Amplirun® Ureaplasma urealyticum DNA control, Vircell) reaches up to 0.73 cp/μl with the probability of 95 % (on synthetic DNA ultramer control Ureaplasma parvum)) |
| Diagnostic Specificity | 96.00 % (CI95%: 87.97 % – 98.96 %) Mycoplasma hominis 98.67 % (CI95%: 91.79 % – 99.93 %) Ureaplasma urealyticum 100.00 % (CI95 %: 92.13% – 100.00 %) Ureaplasma parvum |
| Diagnostic Sensitivity | 87.50 % (CI95 %: 60.41% – 97.80 %) Mycoplasma hominis 93.75 % (CI95 %: 67.71% – 99.67 %) Ureaplasma urealyticum 100.00 % (CI95 %: 87.36% – 100.00 %) Ureaplasma parvum |
| Positive Predictive Value | 82.35 % (CI95%: 55.80 % – 95.33 %) Mycoplasma hominis 93.75 % (CI95%: 67.71 % – 99.67 %) Ureaplasma urealyticum 100.00 % (CI95%: 87.36 % – 100.00 %) Ureaplasma parvum |
| Negative Predictive Value | 97.30 % (CI95%: 89.69 % – 99.53 %) Mycoplasma hominis 98.67 % (CI95%: 91.79 % – 99.93 %) Ureaplasma urealyticum 100.00 % (CI95%: 92.13 % – 100.00 %) Ureaplasma parvum |
| Extraction/Inhibition Control | PCR inhibition and DNA extraction efficiency control |
| Validated Specimen | swab, urine, transport medium: UTM® Viral Transport (COPAN Diagnostics Inc.) |
| Storage | -20 ± 5 °C |
| Validated Extraction Methods | croBEE 201A Nucleic Acid Extraction Kit GeneProof PathogenFree DNA Isolation Kit |
| Instruments | croBEE Real-Time PCR System Applied Biosystems 7500 Real-Time PCR System CFX96™/ Dx Real-Time PCR Detection System LineGene 9600 Plus Mic qPCR Cycler QuantStudio™ 5 Real-Time PCR System |
| Required Detection Channels | FAM, HEX, Cy5, Texas Red |
| External Quality Assessment | Regularly tested by QCMD and INSTAND e.V. External Quality Assessment panels – results at www.geneproof.com |
| Regulatory Status | CE IVD |
