GeneProof SARS-CoV-2 PCR Kit
Kat.: COV2/GP/100
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. (100 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
- Confirmation in an independent channel
- Reliable detection of all virus variants
- 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
- Simplifies laboratory workflow
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 | ||||||||||||
| 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) | ||||||||||||
| Validated Specimen | nasopharyngeal swab (in transport media UTM (Copan), PBS or Physiological saline solution); anterior nasal swab, saliva in transport medium Bi-CoV® | ||||||||||||
| 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 Applied Biosystems 7500 Real-Time PCR System AriaMx Real-Time PCR System CFX96™/ Dx Real-Time PCR Detection System LightCycler® 480 LineGene 9600 Plus Rotor-Gene 3000 Rotor-Gene Q QuantStudio™ 5 Real-Time PCR System SLAN® 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 |
