Intended use
Clinical information:
Mycoplasma hominis and Mycoplasma genitalium are bacteria which cause sexually transferred diseases. Mycoplasma genitalium is known to cause the so-called non-gonococcal urethritis and Mycoplasma hominis can be associated with post-abortal and post-partum fever.
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)
RealLine Mycoplasma hominis / M. genitalium (Str-format) kit is designed for the analysis of clinical materials: urogenital and cervical swabs, epithelial cells, semen, prostatic fluid, urine.
The results of PCR analysis are taken into account in complex diagnostics of disease.
The assay is based on real-time polymerase chain reaction (PCR) method with fluorescent detection of amplified product.
The Str-Format Kit contains 96 tubes (0.2ml) 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 for use with block-type PCR cyclers: iQ5 iCycler (Bio-Rad, USA), CFX96 (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 for use with block-type PCR cyclers: iQ5 iCycler (Bio-Rad, USA), CFX96 (Bio-Rad, USA), DT-96 (DNA-Technology, Russia) and RealLine Cycler (BIORON Diagnostics GmbH).
Specifications
Sensitivity
Sensitivity control was performed on 5 samples containing 100 Mycoplasma hominis DNA copies per sample, prepared from SRS (Standard Reference Sample containing Mycoplasma hominis DNA), and 100 Mycoplasma genitalium DNA copies per sample, prepared from SRS (Standard Reference Sample containing Mycoplasma genitalium DNA).
The sensitivity equals 100%.
Specificity
Specificity of Mycoplasma hominis and Mycoplasma genitalium DNA detection was determined using negative DNA-extracts of the Standard Reference Panel, consisting of samples containing IC DNA and not containing DNA of STD agents. Specificity of Mycoplasma hominis and Mycoplasma genitalium DNA detection equals 100%.
Diagnostic sensitivity of Mycoplasma hominis detection: clinical trials conducted on 75 positive samples showed 100% sensitivity (interval 96.1% -100%, with a confidence level of 90%).
Diagnostic sensitivity of Mycoplasma genitalium detection: clinical trials conducted on 48 positive samples showed 100% sensitivity (interval 94% -100%, with a confidence level of 90%).
Diagnostic specificity of Mycoplasma hominis detection: clinical trials conducted on 112 negative samples showed 100% specificity (interval 97.4% -100%, with a confidence level of 90%).
Diagnostic specificity of Mycoplasma genitalium detection: clinical trials conducted on 139 negative samples showed 100% specificity (interval 97.9% -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 | |
| VBD0494 | 96 reactions | |
| RealLine Internal Control | Kit size | |
| VBC8881 | 250 reactions |