GeneProof Treponema pallidum MC PCR Kit

myCROBE® line

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Order information

Product name	Catalog no.	Technology	Packaging
GeneProof Treponema pallidum MC PCR Kit	TP/MC/190	PCR	for 180 quantitative tests

Indication	in vitro diagnostic medical device
Regulatory Status	CE IVD
Intended User	For professional use in laboratories with trained staff
Type of Analysis	Qualitative
Target Sequence	Gene polA encoding DNA polymerase I
Analytical Specificity	Treponema pallidum, 100 %
Analytical Sensitivity (LoD with 95% probability)	1.73 cp/µl (performed on Amplirun® Treponema pallidum DNA control, Vircell)
Extraction/Inhibition Control	Internal control by myCROBE Universal Internal Control
Validated Specimen	Swab, urine
Storage Conditions	(-20 ± 5) °C
Validated Extraction Methods	myCROBE/croBEE 2.0 Universal Extraction Kit
Applied Instruments	myCROBE® Fully Automated Instrument
Detection Channels	FAM (TP), HEX (IC)
External Quality Assessment	Regularly tested in QCMD and INSTAND e.V. External Quality Assessment Panels - results at www.geneproof.com

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