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|Product name||Catalog no.||Technology||Packaging|
|GeneProof Mycobacterium tuberculosis PCR Kit||MT/ISEX/025||real-time PCR||25 reactions|
|GeneProof Mycobacterium tuberculosis PCR Kit||MT/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|
|Target Sequence||specific multi-copy insertion sequence IS6110|
Mycobacterium tuberculosis complex (M. tuberculosis, M. bovis, M. africanum, M. microti, M. caprae, M. canetti and vaccine strain BCG), 100%
|Analytical Sensitivity (LoD)||
reaches up to 0.191 cp/µl with the probability 95 % (on Amplirun® Mycobacterium tuberculosis DNA control, Vircell)
|Extraction / Inhibition Control||
PCR inhibition control (ISIN version)
PCR inhibition and DNA extraction efficiency control (ISEX version)
BAL, CSF, sputum, stool, swab, urine
-20 ± 5 °C
|Validated Extraction Methods||
croBEE NA16 Nucleic Acid Extraction System
croBEE Real-Time PCR System*
|Required Detection Channels||FAM, HEX|
|External Quality Control||regularly tested by the QCMD and Instand e. V. External Quality Assessment Panels - results at www.geneproof.com|
Association between acute, severe hepatitis in small children and Adenovirus infection is currently under…
GeneProof merges with American Laboratory Products Company.