GeneProof SARS-CoV-2 Advanced PCR Kit
Kat.: COV2A/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. A RdRp, N és E géneket célozza. (25 reakció)
Leírás
PRODUCT ADVANTAGES
W.H.O. RECOMMENDED DESIGN
- Three targets (RdRp/E/N genes) in one reaction
- Confirmation in an independent channel (RdRp gene)
- Triple protection against detection failures caused by virus mutations
ENDOGENOUS INTERNAL CONTROL
- Human RNase P gene for the control of the whole diagnostic process including of proper sampling
- Simplifies laboratory workflow
FASTER EXAMINATION
- Direct detection possibility with unique sampling set Bi-CoVTM
- Fast PCR profile – less than 1 hour
EASY-TO-USE CONCEPT
- Single tube Ready-to-Use Master Mix contains all components for PCR amplification
- No additional pipetting of PCR reagents necessary
CONTAMINATION PREVENTION
- Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating carryover contamination
MADE IN EUROPEAN UNION
- Developed and manufactured in the Czech Republic, the member of EU
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, N and E genes | ||||||||||||||||||||||||||||||||
| Analytical Specificity | SARS-CoV-2, 100 % | ||||||||||||||||||||||||||||||||
| Analytical Sensitivity (LoD with 95% probability) |
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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 and UTM) or in Bi-CoV® | ||||||||||||||||||||||||||||||||
| Storage | -20 ± 5 °C | ||||||||||||||||||||||||||||||||
| Validated Extraction Methods | croBEE 201A Nucleic Acid Extraction Kit croBEE® max Universal Extraction Kit GeneProof PathogenFree RNA Isolation Kit |
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| Instruments | croBEE 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 AMPLilab SystemBioQuant-96, Fluorescent Quantitative Detection PCR system SLAN® 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) |
Nucleic Acid Purification
| Medium | GeneProof PathogenFree RNA Isolation Kit | croBEE 201A Nucleic Acid Extraction Kit | Direct detection |
| UTM (Copan) | YES | YES | – |
| PBS | YES | YES | – |
| Physiological Saline Solution | YES | YES | – |
| Bi-CoVTM set (Bioinova) | – | – | YES |
