Intended use
Clinical information:
RealLine Ureaplasma urealyticum / Ureaplasma parvum assay kit is intended for the differential detection of Ureaplasma urealyticum and Ureaplasma parvum DNA in clinical specimens (urogenital and cervical swabs, semen, prostate fluid, urine) using the method of real-time polymerase chain reaction (PCR) with fluorescence detection of amplified product.
The extraction of DNA from clinical materials can be performed using the extraction kits:
- RealLine DNA-Express (REF VBC8899-R)
- RealLine Extraction 100 (REF VBC8896-R)
- INSTANT Virus RNA/DNA Kit – IPC16 (Roboscreen GmbH, Germany)
- INSTANT Virus RNA/DNA Kit – FX (Roboscreen GmbH, Germany)
- VeriLab UMag (Laboveritas SIA)
When using NA extraction kits of other manufacturers, it is highly recommended to use Internal Control sample (IC, VBC8881), which can be ordered additionally. Please note that full and valid result interpretation is not possible without IC.
The results of PCR analysis are taken into account in complex diagnostics of disease.
The kit is intended to use with block cyclers: iQ™5 iCycler, CFX™96 (Bio-Rad, USA), DT-96 (DNATechnology, Russia) and RealLine Cycler (BIORON Diagnostics GmbH).
The use of:
! Extraction Kits for nucleic acids from clinical specimen from other supplier
! other real-time PCR devices
! appropriate reaction volumes, other than 50 µl
has to be validated in the lab by the user. The special notes regarding the internal control IC have to be strongly followed.
Status
CE IVD
Validated extraction kits
RealLine DNA-Express (REF VBC8899-R)
RealLine Extraction 100 (REF VBC8896-R)
INSTANT Virus RNA/DNA Kit – IPC16 (Roboscreen GmbH, Germany)
INSTANT Virus RNA/DNA Kit – FX (Roboscreen GmbH, Germany)
VeriLab UMag (Laboveritas SIA)
Validated real-time PCR platforms
The kit is intended to use with block cyclers: iQ™5 iCycler, CFX™96 (Bio-Rad, USA), DT-96 (DNATechnology, Russia) and RealLine Cycler (BIORON Diagnostics GmbH).
Specifications
Sensitivity
Sensitivity of the detection of Ureaplasma urealyticum DNA is determined on five samples prepared from Ureaplasma urealyticum DNA SRS (Standard Reference Sample), containing 100 copies of Ureaplasma urealyticum DNA per sample. Sensitivity equals 100%.
Sensitivity of Ureaplasma parvum DNA detection is determined on five samples prepared from Ureaplasma parvum DNA SRS, containing 100 copies of Ureaplasma parvum DNA per sample.
Sensitivity equals 100%.
Specificity
Specificity of Ureaplasma urealyticum DNA detection equals 100 %. It is determined on five samples prepared from Ureaplasma parvum DNA SRS, containing 100 copies of Ureaplasma parvum DNA per sample.
Specificity of Ureaplasma parvum DNA detection equals 100 %. It is determined on five samples prepared from Ureaplasma urealyticum DNA SRS, containing 100 copies of Ureaplasma urealyticum DNA per sample.
Diagnostic sensitivity
Diagnostic sensitivity of Ureaplasma urealyticum DNA detection: clinical trials conducted on 47 positive samples showed 100 % sensitivity (interval 93.8 % -100 %, with a confidence level of 90 %);
Diagnostic sensitivity of Ureaplasma parvum DNA detection: clinical trials conducted on 75 positive samples showed 100% sensitivity (interval 96.1 % -100 %, with a confidence level of 90 %);
Diagnostic specificity
Diagnostic specificity of Ureaplasma urealyticum DNA detection: clinical trials conducted on 130 negative samples showed 100 % specificity (97.7 % -100 % interval, with a 90 % confidence level).
Diagnostic specificity of Ureaplasma parvum DNA detection: clinical trials conducted on 113 negative samples showed 100% specificity (interval 97.4 % -100 %, with a confidence level of 90 %).
Analysis by the CE-marked reference kit showed full match of results.
Order information
| Item number | Kit size | |
| VBD2294 | 96 reactions | |
| RealLine Internal Control | Kit size | |
| VBC8881 | 250 reactions |