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

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

This kit is based on a rapid nucleic acid amplification technology at room temperature and constant temperature: at room   temperature and constant temperature (generally 39℃~42℃), reverse transcriptase uses specific primers and template RNA to synthesize cDNA strands, and binds the auxiliary protein and single strand With the help of the protein, the recombinase and the primer form a complex;perform a homology search and bind the target homology domain,at this time a D-loop region is formed at the homology position and strand exchange begins; accompanied by the recombinase from the complex Upon dissociation,the polymerase also binds to the 3′ end of the primer, initiating chain extension. At the same time, relying on the function of exonuclease, adding specific molecular probes designed according to the template, and using fluorescence monitoring equipment can realize real-time monitoring of the amplification process of the target fragment.

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:

Isothermal Nucleic Acid Applications

Suitable for RNA isothermal rapid amplification kit(Fluorescent type)

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

RNA fluorescent 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.

The kit was developed for construction of high quality libraries for next generation sequencing (illumina and MGI Platforms). The kit needs double strand DNA fragments (blunt and/or sticky) as input DNA for NGS library preparation, and is compatible with DNA fragments generated from both enzymatic methods and physical methods (sonication, nebulization etc.). Library multiplexing is possible with different types of indexes.

The kit was optimized for next generation sequencing (NGS) library preparation with different types of samples. Most of DNA library preparation requires the ligation of sheared DNA fragments to library adaptors and the DNA library preparation is closely related to the quality of NGS data. With BioDynami’s unique DNA library preparation technologies, the fast and simple kit allows high quality NGS library preparation to be completed in 1.5 hours with only 10 minutes of hands-on time.

Some genomic regions are very difficult to be covered evenly and usually result in very low coverage rate or gap in these regions.

Typical difficult regions are:
• with high GC contents
• have secondary structures: mainly due to repeat sequences
• the worst cases: have both high GC contents and repeated sequences.

Example: human TERT gene is one of the most difficult regions as shown above. NGS data showed that BioDynami kit has the best performance to cover the extremely difficult human TERT gene region.

Limited GC bias across whole genome

Three index types are available for the illumina platform kits:

Non-index (illumina Cat.# 30009): Libraries do not have index.

Index (illumina Cat.# 30021): A unique barcode sequence with 6 bases has been included in each of the index primers. RNA Sequencing library multiplexing is possible with up to 48 samples. Index information can be downloaded here.

Unique dual index (illumina Cat.# 30023): RNA Sequencing library multiplexing up to 96 samples is possible with the unique dual indexes. We have developed a 4-Base Difference Index System. The system can generate indexes with at least 4 bases different from others in the 8-base indexing region. the unique dual indexing primers identify sequencing errors such as index hopping, mis-assignment, and de-multiplexing errors. Index information can be downloaded here.

Indexes are available for the MGI platform kits (Cat.# 34021).

The kit was developed for construction of high quality libraries for next generation sequencing (illumina and MGI Platforms). The kit needs double strand DNA fragments (blunt and/or sticky) as input DNA for NGS library preparation, and is compatible with DNA fragments generated from both enzymatic methods and physical methods (sonication, nebulization etc.). Library multiplexing is possible with different types of indexes.