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GeneProof Team
Plasma, serum, whole blood, CSF, urine and tick
Product name | Catalog no. | Technology | Packaging |
GeneProof Borrelia PCR Kit | BOR/GP/025 | real-time PCR | 25 reactions |
GeneProof Borrelia PCR Kit | BOR/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 encoding 16S rRNA |
Analytical Specificity |
Borrelia burgdorferi sensu stricto, B. garinii, B. afzelii, B. andersonii, B. bissettii, B. valaisiana, B. lusitaniae, B. japonica, B. tanukii, B. turdi, B. sinica, B. mayonii, B. spielmanii, B. bavariensis, B. kurtenbachii, B. miyamotoi (Asian genotype), 100 % |
Analytical Sensitivity (LoD with 95% probability) |
0.568 cp/μl (on Amplirun® Borrelia burgdorferi DNA control, Vircell) |
Diagnostic Specificity | 98.15 % (Cl95%: 88.82 % – 99.90 %) |
Diagnostic Sensitivity | 100.00 % (Cl95%: 96.93 % – 100.00 %) |
Positive Predictive Value | 99.35 % (Cl95%: 95.86 % – 99.97 %) |
Negative Predictive Value | 100.00 % (Cl95%: 91.58 % – 100.00 %) |
Extraction / Inhibition Control |
PCR inhibition and DNA extraction efficiency control by Internal Control |
Validated Specimen | CSF, plasma, serum, tick, urine, whole blood (EDTA) |
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/JOE/VIC |
External Quality Assessment | Regularly tested in QCMD and Instand e.V. External Quality Assessment Panels - results at www.geneproof.com |
+420 543 211 679
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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…