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On this page you will find order codes, technical specifications and documents for the selected product.
|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 / EC Directive 98/79/EC|
|Type of Analysis||Qualitative|
|Target Sequence||Gene polA encoding DNA polymerase I|
|Analytical Specificity||Treponema pallidum, 100 %|
(LoD with 95% probability)
|0.61 cp/μl (on synthetic DNA ultramer Control Treponema pallidum)|
|Diagnostic Specificity||100,00 % (CI95%: 19.79 % - 100,00 %)|
|Diagnostic Sensitivity||100,00 % (CI95%: 73.24 % - 100,00 %)|
|Positive Predictive Value||100,00 % (CI95%: 73.24 % - 100,00 %)|
|Negative Predictive Value||100,00 % (CI95%: 19.79 % - 100,00 %)|
|Extraction/Inhibition Control||PCR inhibition and DNA extraction efficiency control by Internal Control (IC)|
Swab from genital ulcer (transport medium: UTM® Viral Transport*, COPAN Diagnostics Inc.), urine
(-20 ± 5) °C
|Validated Extraction Methods||croBEE 201A Nucleic Acid Extraction Kit
GeneProof PathogenFree DNA Isolation Kit
croBEE Real-Time PCR System
|Detection Channels||FAM (TP), HEX/JOE/VIC (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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GeneProof merges with American Laboratory Products Company.