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:

Product Description

DNA Isothermal Amplification Kit NFO for Room Temperature Amplification

Product Detail

Kit Storage and term of Validity

Storage term: stored at ≤-20℃,keep away from light, avoid heavy weight and repeated freezing and thawing.

Term of Validity: 14 months

Isothermal nucleic acid Principle Summary

The kit is based on room and constant temperature nucleic acid rapid amplification technology, its principle is that at room and constant temperature, the recombinase and primer form a protein/single-stranded nucleotide complex Rec/ssDNA, and invade the double-stranded DNA template with the help of auxiliary proteins and single-stranded binding protein SSB; then form a D-loop region at the invasion point and start to scan the DNA duplex, after finding the target region complementary to the primer and disintegration of the complex Rec/ssDNA, the polymerase also binds to the 3′ end of the primer to start the chain extension. The kit relies on the role of NFO enzyme and adds the designed specific molecular probes according to the template, and get the result by colloidal gold technology (sandwich method).

Isothermal nucleic acid Product Features

1/ High sensitivity and specificity, short reaction time.

2/ The reagent form is freeze-dried, stable and easy to operate.

3/ The reaction can be operated by metal bath and water bath pot without purchasing expensive PCR apparatus.

Technical Parameters:

Parameters	Details
Product Name	DNA Isothermal Amplification Kit NFO
Manufacturer	Amp-future
Storage Temperature	-20°C
Kit Components	Enzymes, Buffers ,Reagents
Packaging	48 Tests/box
Detection Limit	500-1000copies/µL
Shipping	ICE
Test Time	5-20mins

Isothermal nucleic acid Applications

Suitable for DNA isothermal rapid amplification kit(NFO type)

Primer: Require pair of nucleotide primers with the length of 25-35 bp.

DNA basic kit reaction temperature is 39 to 42℃ and time is 5-20 minutes.

Notes

1/ Please avoid nucleic acid contamination and set blank control during reaction due to the high sensitivity of the kit.

2/ Please take out the required quantity of MIRA reaction units for the experiment, and put the rest under storage conditions when performing the experiment.

Introduction

This Kit is designed to purify genomic DNA and total RNA simultaneously from a single biological sample. Lysate is first passed through a DNA spin column to selectively isolate DNA and then through an RNA column to selectively isolate RNA. Pure DNA and RNA are purified from the entire sample, in contrast to other procedures where either the biological sample or the purified total nucleic acids is divided into two before being processed separately. The kit is compatible with small amounts of a wide range of animal cells and tissues.

Details

Specifications

Features	Specifications
Main Functions	Co-isolation DNA and RNA(not include miRNA) from a single sample (cells, soft tissue, plant sample)
Applications	RT-PCR, cDNA synthesis, PCR andsecond-generation sequencing, etc.
Purification method	Mini spin column
Purification technology	Silica technology
Process method	Manual (centrifugation or vacuum)
Sample type	Soft tissue samples (viscera, excluding skin andmuscle), cultured cells and common plant tissues
Sample amount	Soft Tissue: < 30mg, Cell: <1 x 107, Plant: <100mg
Yield	DNA: 1 – 20 μg,  RNA: 3 – 100 μg

Principle

The Kits are designed to purify both genomic DNA and total RNA from the same cellor tissue sample. Samples are first lysed and homogenized. The lysate is passed through a DNA Mini column and bind DNA. Ethanol is added to the flow-through and the sample is applied to an RNA column. DNA/RNA binds to the membrane and contaminants are washed away. High-quality RNA is eluted in as little as 30µl water using the Kit. High-quality DNA is eluted in as little as 50µl water using the Kit.

Advantages

• High quality – high purity total RNA / DNA can be directly used in a variety of downstream applications
• Fast – column method can complete the extraction of several samples in 30 minutes
• Safe – no phenol chloroform extraction required
• Simultaneous extraction- simultaneously isolate DNA and RNA from one sample

Kit Contents

Contents	R511102	R511103
Purification Times	50 Preps	250 Preps
HiPure DNA Mini Columns	50	250
HiPure RNA Mini Columns	50	250
2ml Collection Tubes	100	2 x 250
Buffer RLC	50 ml	200 ml
Buffer DW1	30 ml	150 ml
Buffer RW1	30 ml	150 ml
Buffer RW2*	20 ml	2 x 50  ml
RNase Free Water	10 ml	30 ml
Buffer AE	10 ml	50 ml

Storage and Stability

HiPure DNA/RNA Kit can be stored dry at room temperature (15–25°C) and are stable for at least 18 months under these conditions.

This Kit is designed to purify genomic DNA and total RNA simultaneously from a single biological sample. Lysate is first passed through a DNA spin column to selectively isolate DNA and then through an RNA column to selectively isolate RNA. Pure DNA and RNA are purified from the entire sample, in contrast to other procedures where either the biological sample or the purified total nucleic acids is divided into two before being processed separately. The kit is compatible with small amounts of a wide range of animal cells and tissues.