GeneProof SARS-CoV-2 Screening PCR Kit
Kat.: COV2S/GP/025
A termék CE/IVD minősítéssel rendelkezik és az OGYÉI által nyilvántartásba vett.
A SARS-CoV-2 detektálására alkalmas ‘Ready-to-Use ‘ master mix. 100%-os diagnosztikai és érzékenységi specifitás. A RdRp, N és E géneket célozza. (25 reakció)
Leírás
PRODUCT ADVANTAGES
UNIQUE SPECIFICITY AND SENSITIVITY
- Excellent QCMD panel results
- 100% diagnostic sensitivity and specificity
W.H.O. RECOMMENDED DESIGN
- Three targets (RdRp/E/N genes) in one reaction
- Robust and reliable screening solution for two-channel thermocyclers
- Triple protection against detection failures caused by virus mutations
MADE IN EU
- Developed and manufactured in the Czech Republic, the member of the European Union
EASY-TO-USE CONCEPT
- Single tube Ready-to-Use Master Mix contains all components for PCR amplification
- No additional pipetting of PCR reagents necessary
- Suitable for direct detection without NA extraction
CONTAMINATION PREVENTION
- Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating carryover contamination
Beneficial in Covid-19 • Flu • RSV GPack combination with GeneProof Flu Multiplex PCR Kit.
COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES
CE IVD CERTIFIED DIAGNOSTIC TEST
Technical specification
| 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) | |||
| Validated Specimen | Nasopharyngeal swab (in transport media UTM (Copan), PBS or Physiological saline solution); anterior nasal swab, saliva in Bi-CoV® | |||
| 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 Applied Biosystems 7300 / 7500 Real-Time PCR System AriaMx Real-Time PCR System CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System Mic qPCR Cycler LightCycler® 480 LineGene 9600 Plus Mic qPCR Cycler QuantStudio™ 5 Real-Time PCR System Rotor-Gene 3000 / 6000 / Q SLAN® 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 | |||
