Diagnosticgrade – because RUO and IVDR do not fit together

This unique quality seal ensures high quality and performance of raw materials ideally suited for use in development projects for IVD

With the DiagnosticGrade seal, the partners Johner Institut and myPOLS Biotec combine high-quality products, including reliable and reproducible product performance and knowledge on product verification procedures, including documentation to meet the requirements of the IVDR:

• IVD manufacturers can obtain reagents developed and produced by myPOLS Biotec under ISO 13485.
• We offer you the quality and safety that the IVDR requires from suppliers – these are, for example, control of suppliers via quality assurance agreements, information about changes, consent to audits.
• The Johner Institute provides  structured templates for the documentation of your product verification with clear and brief explanations of how to complete them.

Both cooperation partners express with the DiagnosticGrade seal that the reagents meet the relevant requirements and thus ensure the maturity level for diagnostics.

Diagnsoticgrade facilitates the development of new IVD assay products for IVD manufacturers and enables IVDR compliance of existing kits.

Please find more information on www.diagnosticgrade.de (in german) or contact us directly. About the Johner Institut: https://www.johner-institut.de

With the DiagnosticGrade seal, the partners Johner Institut and myPOLS Biotec combine high-quality products, including reliable and reproducible product performance and knowledge on product verification procedures, including documentation to meet the requirements of the IVDR:

Introduction

Magnetic bead nucleic acid purification technology uses nano or micron superparamagnetic material as the matrix, generally black ferric oxide or yellowish brown ferricoxide as the magnetic material. The surface of bead is coated with appropriate functional groups, which can adsorb nucleic acid. Magnetic beads commonly used for nucleic acids, containing carboxyl groups, hydroxyl groups, or silicon groups. Silicon-based magnetic beads are the most common, and its principle of adsorbing nucleic acid is consistent with the classical glass milk purification technology or glass fiber filter membrane purification method. Magpure particle is a kind of polydisperse fast speed silica magnetic beads. The core is ferricoxide, accounting for 50%, and the surface coating is silica, accounting for 50%. The product can be used for plasmid extraction, gel DNA recovery, product purification, genomic DNA and RNA extraction, and viral nucleic acid extraction.

Details

Specifications

Principle

Highsalt mediated binding: in the solution containing 2-4M guanidine isothiocyanate, Magpure particles can selectively recover DNA molecules, and impurities such as protein polysaccharides are not adsorbed.

Alcohol mediated binding: in the solution containing guanidine salt and alcohol (>25%), Magpure particles can selectively recover DNA/RNA molecules, and proteins and other impurities are not adsorbed.

After biological samples are treated with digestive solution or lysis Buffer, DNA/RNA is released from cells, organelles and protein complexes (ribosomes and nucleosomes) into reagents. After Magpure particles and binding solution are added, DNA/RNA is adsorbed to the surface of Magpure particles to form DNA/RNA bead complex. Under the action of the magnetic field, the magnetic beads are separated and collected, and the impurities such as protein are removed with the waste liquid. After two or three steps of further cleaning, the DNA/RNA magnetic bead complex is resuspended in sterilized water or TE buffer, and the DNA/RNA falls off from the surface of the magnetic beads, so as to achieve the purpose of purification.

Ordering information

Purchase Guide

• The MagPure magnetic-particle technology combines the speed and efficiency of silica-based DNA purification with the convenient handling of magnetic particles. DNA binds to the silica surface of the magnetic particles in the presence of a chaotropic salt. DNA bound to the particles is then efficiently washed, considerably improving the purity of DNA. High-quality DNA is eluted. The automated purification procedure completely removes enzymes, nucleotides, and other contaminants and inhibitors. Purified DNA is suitable for direct use in downstream applications, such as sequencing and microarray analysis.

Magnetic bead nucleic acid purification technology uses nano or micron superparamagnetic material as the matrix, generally black ferric oxide or yellowish brown ferricoxide as the magnetic material. The surface of bead is coated with appropriate functional groups, which can adsorb nucleic acid. Magnetic beads commonly used for nucleic acids, containing carboxyl groups, hydroxyl groups, or silicon groups. Silicon-based magnetic beads are the most common, and its principle of adsorbing nucleic acid is consistent with the classical glass milk purification technology or glass fiber filter membrane purification method. Magpure particle is a kind of polydisperse fast speed silica magnetic beads. The core is ferricoxide, accounting for 50%, and the surface coating is silica, accounting for 50%. The product can be used for plasmid extraction, gel DNA recovery, product purification, genomic DNA and RNA extraction, and viral nucleic acid extraction.

Propargyl-PEG8-methane is crosslinker with a propargyl group. It enables the formation of triazole linkage with azide compounds or biomolecules via copper catalyzed Click Chemistry. Reagent grade, for research purpose. Please contact us for GMP-grade inquiries.

Propargyl-PEG8-methane is crosslinker with a propargyl group. It enables the formation of triazole linkage with azide compounds or biomolecules via copper catalyzed Click Chemistry. Reagent grade, for research purpose. Please contact us for GMP-grade inquiries.