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GeneProof Team
| Product name | Catalog no. | Technology | Packaging |
| GeneProof Mycoplasma genitalium/hominis PCR Kit | MGH/ISEX/025 | real-time PCR | 25 reactions |
| GeneProof Mycoplasma genitalium/hominis PCR Kit | MGH/ISEX/100 | real-time PCR | 100 reactions |
| Indication | in vitro diagnostic medical device |
| Regulatory Status | CE IVD |
| Intended User | For professional use in laboratories with trained staff |
| Technology | Real-time PCR |
| Type of Analysis | Qualitative |
| Target Sequence |
A multicopy sequence of the gene encoding the 16S rRNA (M. genitalium) and the housekeeping gap gene for glyceraldehyde-3-phosphate dehydrogenase (M.hominis) |
| Analytical Specificity |
M. genitalium, 100 % |
| Analytical Sensitivity (LoD) |
Reaches up to 1.256 cp/μl with the probability of 95 % for M. genitalium |
| Extraction/Inhibition Control | PCR inhibition and DNA extraction efficiency control |
| Validated Specimen | Swab, urine |
| Storage | -20 ± 5 °C |
| Validated Extraction Methods |
croBEE 201A Nucleic Acid Extraction System |
| Instruments |
croBEE Real-Time PCR System |
| Required Detection Channels |
FAM, HEX, Cy5 |
| External Quality Assessment | Regularly tested in QCMD External Quality Assessment Panels - results at www.geneproof.com |
* The kit requires three detection channels. On instruments with two detection channels the kit detects the M. genitalium presence only.
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