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GeneProof SARS-CoV-2 Screening PCR Kit

CE IVD myCROBE® line

On this page you will find order codes, technical specifications and documents for the selected product.

Order information

Product name Catalog no. Technology Packaging
GeneProof SARS-CoV-2 Screening PCR Kit COV2S/MC/190 real-time PCR 190 qualitative tests

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 reverse transcription real-time polymerase chain reaction (PCR)
Type of Analysis Qualitative
Automated / Manual detection Automated
Target sequence RdRp, E and N genes
Analytical Specificity SARS-CoV-2, 100 %
Analytical Sensitivity (LoD with 95% Probability)

Sample Processing 

Sensitivity Channel Material
myCROBE/croBEE 2.0 Universal Extraction Kit 138,33 cp/mL FAM PBS
Extraction/Inhibition Control

myCROBE Universal Internal Control

Validated Specimen swab, transport medium
Storage -20 ± 5 °C
Validated Extraction Methods myCROBE/croBEE 2.0 Universal Extraction Kit
Instruments

myCROBE® Fully Automated Instrument

Detection Channels FAM (SARS-CoV-2), HEX (IC)
External Quality Assessment Regularly tested in QCMD and INSTAND e.V. External Quality Assessment Panels - results at www.geneproof.com

Documentation

Instruction for Use

MC_COV2S_Instruction for Use_EN
pdf, [483.15 kB]

Declaration of Conformity

GPMC_COV2S_Declaration of Conformity_EN
pdf, [594.77 kB]
Files are available only for registered users.

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