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:

Overview

• Simultaneous concentration, desalting and buffer exchange of total urinary proteins
• No molecular weight cutoff allows for isolation of all sizes of proteins and peptides
• Purification is based on spin column chromatography that uses Norgen’s resin separation matrix

These kits concentrate urine proteins while simultaneously removing salts, urea, and other urine contaminants. There is no molecular weight cut-off and therefore the columns capture total urinary proteins and peptides of all sizes making them ideal for biomarker discovery work, differential expression of proteins in various diseases, or other diagnostic research. The columns are convenient, rapid and easy to use and thus offer significant time savings over classic dialysis protocols. The resulting high-quality protein sample is concentrated and free from the original sample salts, thus preparing the sample conveniently for downstream proteomic applications including SDS-PAGE, 2D Gels, MALDI-TOF, LC/MS, LC/MS/MS, whole protein mass spectrometry, western blotting, protein microarrays, and more.

ProteoSpin™ Urine Protein Concentration Micro Kit

Each spin column is able to concentrate and desalt up to 200 μg of urine proteins. Twelve samples can be processed in 20 minutes.

ProteoSpin™ Urine Protein Concentration Midi Kit

The ProteoSpin™ Urine Protein Concentration Midi Kit provides a fast and simple procedure for concentrating dilute solutions of urine proteins from 1 to 5 mL inputs of urine. Each mini spin column is able to concentrate and desalt up to 3 mg of urine proteins in 30 minutes.

ProteoSpin™ Urine Protein Concentration Maxi Kit

The ProteoSpin™ Urine Protein Concentration Maxi Kit provides a fast and simple procedure for concentrating dilute solutions of urine proteins from 2 to 20 mL inputs of urine. Each maxi spin column is able to concentrate and desalt up to 4 mg of urine proteins in 45 minutes.

Details

Supporting Data

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Kit Specifications
Maximum Urine Input Volume	20 mL
Maximum Recovered Protein	4 mg
Minimum Elution Volume	2 mL
Time to Process 4 Samples	45 minutes

Storage Conditions
All solutions should be kept tightly sealed and stored at room temperature. Once opened, the solution should be stored at 4°C. This kit is stable for 2 years after the date of shipment.

Component	Cat. 17400 (25 preps)	Cat. 52300 (10 preps)	Cat. 21600 (4 preps)
Wash Solution C	60 mL	60 mL	130 mL
Binding Buffer A	4 mL	4 mL	8 mL
Elution Buffer C	8 mL	30 mL	30 mL
Protein Neutralizer	4 mL	4 mL	4 mL
Micro Spin Columns	25	–	–
Midi Spin Columns (assembled with collection tubes)	–	10	–
Maxi Spin Columns (assembled with collection tubes)	–	–	4
Collection Tubes	25	–	–
Elution Tubes (1.7 mL)	25	–	–
Midi Elution Tubes	–	10	–
Elution Tubes (50 mL)	–	–	4
Product Insert	1	1

Introduction

HiPure Insect DNA Kits provides a simple and rapid solution for total DNA extraction of insect tissue samples. This kit is based on silica gel column purification technology without toxic phenol chloroform extraction and time-consuming alcohol precipitation. The whole extraction process only takes 30 minutes. HiPure Insect DNA Kit can process tissue samples less than 10mg at a time. Hipure Insect DNA 96 kit can process 96 insect tissue samples at a high throughput. The obtained DNA can be directly used in PCR, Southern blot, viral DNA detection and other experiments.

Details

Specifications

Features	Specifications
Main Functions	Isolation total DNA from <10 mg insect tissue
Applications	PCR, southern bolt and virus detection, etc
Purification method	Midi spin column
Purification technology	Silica technology
Process method	Manual (centrifugation or vacuum)
Sample type	Insect tissue samples
Sample amount	<10 mg
Elution volume	≥15μl
Time per run	≤30 minutes
Liquid carrying volume per column	800μl
Binding yield of column	100μg

Principles

This product is based on silica column purification. The sample is lysed and digested with lysate and protease, DNA is released into the lysate. Transfer to an adsorption column. Nucleic acid is adsorbed on the membrane, while protein is not adsorbed and is removed with filtration. After washing proteins and other impurities, Nucleic acid was finally eluted with low-salt buffer (10mm Tris, pH9.0, 0.5mm EDTA).

Advantages

• High purity DNA – can be used in sensitive downstream applications such as multiplex and quantitative pcr
• Fast – several samples can be extracted in less than 30 minutes
• Good repeatability – suitable for extracting high-yield DNA from insect tissue samples
• Safe – without phenol chloroform extraction and alcohol precipitation

Kit Contents

Contents	D312902	D312903
Purification Times	50	250
HiPure DNA Mini Columns I	50	250
2ml Collection Tubes	50	250
Buffer ITL	30 ml	120 ml
Buffer IL*	30 ml	120 ml
Buffer GW1*	22 ml	110 ml
Buffer GW2*	20 ml	2 x 50 ml
Proteinase K	24 mg	120 mg
Protease Dissolve Buffer	1.8 ml	15 ml
Buffer AE	15 ml	60 ml

Storage and Stability

Proteinase K should be stored at 2-8°C upon arrival. However, short-term storage (up to 12 weeks) at room temperature (15-25°C) does not affect their performance. The remaining kit components can be stored at room temperature (15-25°C) and are stable for at least 18 months under these conditions. The entire kit can be stored at 2–8°C, but in thiscase buffers should be redissolved before use. Make sure that all buffers areat room temperature when used.

HiPure Insect DNA Kits provides a simple and rapid solution for total DNA extraction of insect tissue samples. This kit is based on silica gel column purification technology without toxic phenol chloroform extraction and time-consuming alcohol precipitation. The whole extraction process only takes 30 minutes. HiPure Insect DNA Kit can process tissue samples less than 10mg at a time. Hipure Insect DNA 96 kit can process 96 insect tissue samples at a high throughput. The obtained DNA can be directly used in PCR, Southern blot, viral DNA detection and other experiments.