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|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|
|Type of Analysis||qualitative|
a multicopy sequence of the gene encoding the 16S rRNA (M. genitalium) and the housekeeping gap gene for glyceraldehyde-3-phosphate dehydrogenase (M.hominis)
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
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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GeneProof merges with American Laboratory Products Company.