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|Product name||Catalog no.||Technology||Packaging|
|GeneProof Treponema pallidum PCR Kit||TP/GP/025||real-time PCR||25 reactions|
|GeneProof Treponema pallidum PCR Kit||TP/GP/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||gene polA encoding DNA polymerase I|
|Analytical Specificity||Treponema pallidum, 100 %|
|Analytical Sensitivity (LoD)||
reaches up to 0.61 cp/μl with the probability of 95 % (on synthetic DNA ultramer Control Treponema pallidum)
PCR inhibition and DNA extraction efficiency control
|Validated Specimen||swab from genital ulcer, urine, transport medium: UTM® Viral Transport* (COPAN Diagnostics Inc.)|
|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|
* UTM® Viral Transport is validated only in combination with croBEE NA16 Nucleic Acid Extraction System
** Validated Instrument
Association between acute, severe hepatitis in small children and Adenovirus infection is currently under…
GeneProof merges with American Laboratory Products Company.