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|Product name||Catalog no.||Technology||Packaging|
|GeneProof Neisseria gonorrhoeae PCR Kit||NG/ISEX/025||real-time PCR||25 reactions|
|GeneProof Neisseria gonorrhoeae PCR Kit||NG/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 multi-copy sequence of the gene encoding 16S rRNA and porA preudogene specific for N. gonorrhoeae
N. gonorhoeae, including mutants in porA pseudogene, 100 %
|Analytical Sensitivity (LoD)||
reaches up to 0.109 cp/µl with the probability of 95% (on Amplirun® Neisseria gonorrhoeae DNA control, Vircell)
|Extraction / Inhibition Control||
PCR Inhibition and DNA extraction efficiency control
|Validated Specimen||sperm, swab, urine|
|Storage||-20 ± 5 °C|
|Validated Extraction Methods||croBEE NA16 Nucleic Acid Extraction System
GeneProof PathogenFree DNA Isolation Kit
croBEE Real-Time PCR System
|Required Detection Channels||FAM, HEX|
|External Quality Assessment||Regularly tested by QCMD and Instand e.V. External Quality Assessment Panels - results at www.geneproof.com|
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GeneProof merges with American Laboratory Products Company.