Intended use
Clinical information:
Trichomonas vaginalis - a flagellate - causes trichomoniasis, a disease that causes vaginal infections in women and urethritis in men. The transmission of trichomoniasis runs through sexual intercourse and is one of the most common sexually transmitted diseases.
Gardnerella vaginalis is a facultatively anaerobic Gram-variable rod that can cause bacterial vaginosis in some women as a result of a disruption in the normal vaginal microflora.
RealLine Trichomonas vaginalis / Gardnerella vaginalis (Str-format) assay kit is intended for the detection of Trichomonas vaginalis and Gardnerella gonorrhoeae 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 DNA extraction kits of other manufacturers, it is highly recommended to use Internal Control sample (IC) (VBC8881, BIORON Diagnostics GmbH).
The results of PCR analysis are taken into account in complex diagnostics of disease.
The Str-Format Kit contains 96 tubes (0.2 ml) in strips with lyophilized Mastermix. 50 μl of extracted DNA have to be pipetted into the tube and the ready Mastermix is diluted. The kit contains reagents required for 96 tests, including control samples and the positive control sample.
The kit is intended to use with block type cyclers: iQ™5 iCycler, CFX™96 (Bio-Rad, USA), DT-96 (DNA-Technology, 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 type cyclers: iQ™5 iCycler, CFX™96 (Bio-Rad, USA), DT-96 (DNA-Technology, Russia) and RealLine Cycler (BIORON Diagnostics GmbH).
Specifications
Sensitivity – the detection of 100 Trichomonas vaginalis DNA copies and 100 Gardnerella vaginalis DNA copies in Standard Reference Samples — 100%.
Specificity of Trichomonas vaginalis and Gardnerella vaginalis DNA detection using the Standard Reference Panel of negative samples is 100 %.
Analysis by the CE-marked reference kit showed full match of results.
Order information
| Item number | Kit size | |
| VBD0477 | 96 reactions | |
| RealLine Internal Control | Kit size | |
| VBC8881 | 250 reactions |