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GeneProof Team
Beneficial in Covid-19 • Flu • RSV GPack combination with GeneProof Flu Multiplex PCR Kit.
Product name | Catalog no. | Technology | Packaging |
GeneProof SARS-CoV-2 PCR Kit | COV2/GP/100 | real-time PCR | 100 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 gene, E gene and N gene | ||||||||||||
Analytical Specificity | SARS-CoV-2, 100 % | ||||||||||||
Analytical Sensitivity (LoD with 95% Probability) |
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Diagnostic specificity | 100% (CI95%: 95.68% - 100%) | ||||||||||||
Diagnostic sensitivity | 100% (CI95%: 91.58% - 100%) | ||||||||||||
Positive predictive value | 100% (CI95%: 91.58% - 100%) | ||||||||||||
Negative predictive value | 100% (CI95%: 95.68% - 100%) | ||||||||||||
Reporting Units | IU/ml | ||||||||||||
Metrological Traceability | 1st WHO International Standard for SARS-CoV-2 RNA (NIBSC code: 20/146) | ||||||||||||
Extraction/Inhibition Control |
PCR inhibition and RNA extraction efficiency control by Internal Control (IC) |
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Validated Specimen | Nasopharyngeal swab in transport media UTM (Copan), PBS or physiological saline solution Anterior nasal swab, saliva in Bi-CoV® Anterior nasal swab in nuclease-free water (NFW) |
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Storage | -20 ± 5 °C | ||||||||||||
Validated Extraction Methods | ccroBEE 201A Nucleic Acid Extraction Kit GeneProof PathogenFree RNA Isolation Kit |
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Instruments |
croBEE Real-Time PCR System |
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Required Detection Channels | FAM, HEX/JOE/VIC, Cy5 | ||||||||||||
External Quality Assessment | Regularly tested in QCMD and INSTAND e.V. External Quality Assessment Panels – results at www.geneproof.com |
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