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Introducing the GeneProof SARS-CoV-2 PCR Kit – developed and manufactured in Europe with excellent QCMD panel results, providing unique specificity and sensitivity. The WHO recommended design targets three genes in one reaction, with confirmation in an independent channel, providing triple protection against detection failures. Its easy-to-use concept simplifies laboratory workflow, with no additional pipetting necessary, and contamination prevention. The kit has a 100% diagnostic sensitivity and specificity.
Instructions for Use
Declaration of Conformity
MSDS
Publications
Manual
PCR Templates
Introducing the GeneProof SARS-CoV-2 PCR Kit – the perfect solution for your diagnostic needs. Developed and manufactured in Europe, this kit provides unique specificity and sensitivity, with excellent QCMD panel results, ensuring reliable detection of all virus variants. With the W.H.O. recommended design, this kit targets three genes (RdRp/E/N) in one reaction, with confirmation in an independent channel, providing triple protection against detection failures caused by virus mutations.
This kit has 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. Additionally, the Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs, which eliminate carryover contamination, ensuring contamination prevention.
With 100% diagnostic sensitivity and specificity, the SARS-CoV-2 PCR Kit is the perfect solution for accurate and reliable COVID-19 testing.
| 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 Bi-CoV® Anterior nasal swab in nuclease-free water (NFW) |
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| 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 AMPLilab Real-Time PCR System AriaMx Real-Time PCR System CFX96™/ Dx Real-Time PCR Detection System Gentier 96E/96R Real-Time PCR 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 |
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