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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 |
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) |
reaches up to 0.61 cp/μl with the probability of 95 % (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 NA16 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 by QCMD and INSTAND e.V. External Quality Assessment panels – results at www.geneproof.com |
Certification | CE IVD |
* UTM® Viral Transport is validated only in combination with croBEE NA16 Nucleic Acid Extraction System
** Validated Instrument
+420 543 211 679
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