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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 Screening PCR Kit | COV2S/GP/025 | real-time PCR | 25 reactions |
GeneProof SARS-CoV-2 Screening PCR Kit | COV2S/GP/100 | real-time PCR | 100 reactions |
GeneProof SARS-CoV-2 Screening PCR Kit | COV2S/MC/190 | real-time PCR | 180 tests |
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 | |||
Test Principle | Real-time polymerase chain reaction (PCR) | |||
Type of Analysis | Qualitative | |||
Target sequence | RdRp, E and N genes | |||
Analytical Specificity | SARS-CoV-2, 100 % | |||
Analytical Sensitivity (LoD with 95% Probability) |
Sample Processing |
Sensitivity | Material | |
GeneProof PathogenFree RNA Isolation Kit | 86.96 IU/ml | PBS | ||
croBEE 201A Nucleic Acid Extraction Kit | 183.79 IU/ml | PBS | ||
Direct detection (Bi-CoV®) | 417.97 IU/ml | anterior nasal swab in Bi-CoV® | ||
croBEE®max Nucleic Acid Extraction Kit | 450.51 IU/ml | PBS | ||
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%) | |||
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 | croBEE 201A Nucleic Acid Extraction Kit GeneProof PathogenFree RNA Isolation Kit croBEE®max Nucleic Acid Extraction Kit |
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Instruments |
croBEE Real-Time PCR System |
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Required Detection Channels | FAM (RdRp/N/E), HEX/JOE/VIC (IC) | |||
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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