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GeneProof Team
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 |
Regulatory Status | CE IVD |
Intended User | For professional use in laboratories with trained staff |
Technology | Real-time PCR |
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) |
Extraction/Inhibition Control |
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 201A Nucleic Acid Extraction System GeneProof PathogenFree DNA Isolation Kit |
Instruments |
croBEE Real-Time PCR System |
Required Detection Channels | FAM, HEX |
External Quality Assessment | Regularly tested in QCMD and INSTAND e.V. External Quality Assessment panels – results at www.geneproof.com |
* UTM® Viral Transport is validated only in combination with croBEE 201A Nucleic Acid Extraction System
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GeneProof offers a unique PCR testing solution that provides differential diagnostics of many pathogens
Our products’ quality, safety, and performance are fully compliant with the new rules for in vitro…