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The GeneProof SARS-CoV-2 Advanced PCR Kit is a new product that offers the next level solution for COVID-19 diagnosis. It has a W.H.O. recommended design, triple protection against detection failures, and an endogenous internal control for the control of the whole diagnostic process. Additionally, it has a faster examination time of less than 1 hour, with direct detection possibility using the unique sampling set Bi-CoV. The kit is easy to use, with a single tube Ready-to-Use Master Mix that eliminates the need for additional pipetting of PCR reagents, and contains Uracil-DNA glycosylase (UNG) and dUTPs for contamination prevention. The SARS-CoV-2 Advanced PCR Kit is made in the European Union and is the ultimate solution for accurate and reliable COVID-19 testing.
Instructions for Use
Declaration of Conformity
MSDS
Publications
PCR Templates
Introducing the GeneProof SARS-CoV-2 Advanced PCR Kit – the next level solution for your diagnostic needs. This kit has a W.H.O. recommended design, targeting three genes (RdRp/E/N) in one reaction, with confirmation in an independent channel (RdRp gene), providing triple protection against detection failures caused by virus mutations.
What sets this kit apart is the addition of an endogenous internal control – the human RNase P gene – which ensures the control of the whole diagnostic process, including proper sampling, simplifying your laboratory workflow. The SARS-CoV-2 Advanced PCR Kit also offers a faster examination with the possibility of direct detection using the unique sampling set Bi-CoV, and a fast PCR profile of less than 1 hour, allowing you to get results quickly and efficiently.
Like its predecessor, the SARS-CoV-2 Advanced PCR Kit features a single tube Ready-to-Use Master Mix that contains all components for PCR amplification, with no additional pipetting of PCR reagents necessary, making it easy to use and simplifying your laboratory workflow. In addition, the Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs, which eliminate carryover contamination, ensuring the accuracy of your results.
Developed and manufactured in Europe, the SARS-CoV-2 Advanced PCR Kit is the ultimate solution for your diagnostic needs. Don’t settle for anything less than the best. Order your kit today and experience the ease and efficiency of our easy-to-use concept.
| 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, UTM) or in Bi-CoV® or in nuclease-free water (NFW) | ||||||||||||||||||||||||||||||||
| Storage | -20 ± 5 °C | ||||||||||||||||||||||||||||||||
| Validated Extraction Methods | croBEE 201A Nucleic Acid Extraction Kit croBEE®max Nucleic Acid Extraction Kit GeneProof PathogenFree RNA Isolation Kit |
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| Instruments | croBEE Real-Time PCR System AMPLilab Real-Time PCR System AriaMX Real-Time PCR System BioQuant-96, Fluorescent Quantitative Detection PCR system CFX96™/ Dx Real-Time PCR Detection system Gentier 96E/96R Real-time PCR system LightCycler® 480 LineGene 9600 Plus Mic qPCR Cycler QuantStudioTM 5 Real-time PCR system Rotor-Gene 3000 / Q 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) |
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