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GeneProof Team
Product name | Catalog no. | Technology | Packaging |
GeneProof SARS-CoV-2 Advanced PCR Kit | COV2A/GP/100 | real-time PCR | 100 reactions |
GeneProof SARS-CoV-2 Advanced PCR Kit | COV2A/GP/025 | real-time PCR | 25 reactions |
Indication | in vitro diagnostic medical device | ||||||||||||||||||||||||||||||||
Regulatory Status | CE IVD / EC Directive 98/79/EC | ||||||||||||||||||||||||||||||||
Intended User | For professional use in laboratories with trained staff | ||||||||||||||||||||||||||||||||
Technology | real-time PCR | ||||||||||||||||||||||||||||||||
Type of Analysis | Qualitative | ||||||||||||||||||||||||||||||||
Target Sequence | RdRp, N and E genes | ||||||||||||||||||||||||||||||||
Analytical Specificity | SARS-CoV-2, 100 % | ||||||||||||||||||||||||||||||||
Analytical Sensitivity |
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Diagnostic Specificity | 100 % (CI95%: 99.16 % – 100 %) | ||||||||||||||||||||||||||||||||
Diagnostic Sensitivity | 100 % (CI95%: 97.10 % – 100 %) | ||||||||||||||||||||||||||||||||
Positive Predictive Value | 100 % (CI95%: 97.10 % – 100 %) | ||||||||||||||||||||||||||||||||
Negative Predictive Value | 100 % (CI95%: 99.16 % – 100 %) | ||||||||||||||||||||||||||||||||
Reporting Units | IU/ml | ||||||||||||||||||||||||||||||||
Metrological Traceability | 1st WHO International Standard for SARS-CoV-2 RNA (NIBSC code: 20/146) | ||||||||||||||||||||||||||||||||
Inhibition / Extraction Control | Proper sampling, RNA extraction efficiency, reverse transcription and PCR inhibition control by endogenous Internal control (RNase P gene) | ||||||||||||||||||||||||||||||||
Validated Specimen | Swab in transport medium (PBS, physiological saline solution, UTM) or in Bi-CoV® or in nuclease-free water (NFW) | ||||||||||||||||||||||||||||||||
Storage | -20 ± 5 °C | ||||||||||||||||||||||||||||||||
Validated Extraction Methods | croBEE 201A Nucleic Acid Extraction Kit croBEE®max Nucleic Acid Extraction Kit GeneProof PathogenFree RNA Isolation Kit |
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Instruments |
croBEE Real-Time PCR System |
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External Quality Assessment |
Regularly tested in QCMD and INSTAND e.V. External Quality Assessment Panels – results at www.geneproof.com | ||||||||||||||||||||||||||||||||
Required Detection Channels | FAM (RdRp), Cy5 (E/N), HEX/VIC (RNase P) |
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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…