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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 |
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 NA16 Nucleic Acid Extraction System |
Instruments |
croBEE Real-Time PCR System |
Required Detection Channels |
FAM, HEX, Cy5 |
External Quality Assessment | regularly tested by QCMD External Quality Assessment Panels - results at www.geneproof.com |
Regulatory Status | CE IVD |
* The kit requires three detection channels. On instruments with two detection channels the kit detects the M. genitalium presence only.
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