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GeneProof Team
Product name | Catalog no. | Technology | Packaging |
GeneProof Gardnerella vaginalis PCR Kit | GV/GP/025 | real-time PCR | 25 reactions |
GeneProof Gardnerella vaginalis PCR Kit | GV/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 |
tuf gene for transcription elongation factor |
Analytical Specificity |
Gardnerella vaginalis, 100 % |
Analytical Sensitivity (LoD) |
0,82 cp/µl (performed on AmpliRun® GVA DNA control, Vircell) |
Diagnostic Specificity | 93.33 % (CI95%: 86.28 % - 97.05 %) |
Diagnostic Sensitivity | 100.00 % (CI95%: 91.73 % - 100.00 %) |
Positive Predictive Value | 88.52 % (CI95%: 77.17% - 94.88 %) |
Negative Predictive Value | 100.00 % (CI95%: 95.30 % - 100.00 %) |
Extraction/Inhibition Control | PCR inhibition and DNA extraction efficiency control by Internal Control |
Validated Specimen | swab, urine |
Storage | -20 ± 5 °C |
Validated Extraction Methods |
croBEE NA16 Nucleic Acid Extraction System |
Instruments |
croBEE Real-Time PCR System |
Required Detection Channels |
FAM, HEX/JOE |
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…