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GeneProof Team
myCROBE® line
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 % |
| Analytical Sensitivity (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) |
| Validated Specimen |
Swab from genital ulcer (transport medium: UTM® Viral Transport*, COPAN Diagnostics Inc.), urine |
| Storage Conditions |
(-20 ± 5) °C |
| Validated Extraction Methods | croBEE 201A Nucleic Acid Extraction Kit GeneProof PathogenFree DNA Isolation Kit |
| Applied Instruments |
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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