Diagnosticgrade – because RUO and IVDR do not fit together
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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:
Detail
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.
This kit provides a simple and fast solution for the extraction of circulating nuclear acid from serum, plasma, and other cell-free liquid samples. Circulating nucleic acid refers to the free extracellular nucleic acid produced by cell apoptosis, of which fragments are generally below 1KB. The kit is based on silica gel column purification technology, which is no need for toxic phenol chloroform extraction and time-consuming alcohol precipitation during the extraction. The obtained Circulating Nucleic Acid can be directly used for quantitative PCR, liquid or solid phase chip analysis, hybridization, and SNP detection. HiPure Circulating DNA/RNA Kit adopts a unique solution system and multiple layers of filter membranes with different pore sizes, which can efficiently process large volumes of serum and plasma samples and capture extremely small amounts of free nucleic acids.
Details
Specifications
Features
Specifications
Main Functions
Isolation both Circulating DNA/RNA (include miRNA) from 1-5 ml serum and plasma
Applications
qPCR / RT-PCR, liquid or solid-phasechip analysis, hybridization and SNP detection
Purification method
Midi spin column
Purification technology
Silica technology, DNA filtration technology
Process method
Manual (centrifugation or vacuum)
Sample type
serum, plasma, and other cell-free liquid samples
Sample amount
1-5 ml
Elution volume
≥20μl
Time per run
≤100 minutes
Liquid carrying volume per column
4 ml
Binding yield of column
1 mg
Principle
This kit is based on silica gel column technology. Serum or other liquid samples are lysed and digested in buffer CFL. After adding buffer CFP, the protein is removed by centrifugation to obtain the supernatant. Isopropanol is added to precipitate the total nucleic acid and transferred to the column for filtration. DNA / RNA is adsorbed on the membrane of the column, while the protein is not adsorbed and removed with the filtrate.The column is washed with buffer MGW1 to remove protein and other impurities, and then washed with buffer RW2 to remove salt. Finally, DNA / RNA is eluted by low salt buffer. The eluted DNA / RNA can be directly used for quantitative PCR/ RT-PCR, liquid or solid-phase chip analysis, hybridization and SNP detection.
Advantages
High yield – most optimized process to obtain maximum free RNA and small RNA
High concentration – low elution volume (>20μl) to ensure nucleic acid concentration
High purity – low alcohol combination, completely remove inhibitor and protein pollution
High recovery – silica gel column technology can recover nucleic acid molecules at the level of PG
Large volume – 1-2ml serum and plasma samples can be processed at one time
Kit Contents
Contents
R431602
D431603
Purification Times
50 Preps
250 Preps
HiPure RNA Micro Columns
50
5 x 50
HiPure Viral Midi Columns
50
5 x 50
15 ml Collection Tubes
50
5 x 50
2ml Collection Tubes
50
5 x 50
Buffer CFL
150 ml
2 x 375 ml
Buffer CFP
30 ml
150 ml
Buffer MGW1*
100 ml
2 x 250 ml
Buffer RW2*
2 x 50 ml
5 x 100 ml
RNase Free Water
10 ml
50 ml
Storage and Stability
The kit components can be stored at room temperature (15–25°C) and are stable for at least 18 months under these conditions.
Document
This kit provides a simple and fast solution for the extraction of circulating nuclear acid from serum, plasma, and other cell-free liquid samples. Circulating nucleic acid refers to the free extracellular nucleic acid produced by cell apoptosis, of which fragments are generally below 1KB. The kit is based on silica gel column purification technology, which is no need for toxic phenol chloroform extraction and time-consuming alcohol precipitation during the extraction. The obtained Circulating Nucleic Acid can be directly used for quantitative PCR, liquid or solid phase chip analysis, hybridization, and SNP detection. HiPure Circulating DNA/RNA Kit adopts a unique solution system and multiple layers of filter membranes with different pore sizes, which can efficiently process large volumes of serum and plasma samples and capture extremely small amounts of free nucleic acids.
This ELISA kit is for the quantitative detection of IgG antibodies against parasites of Anisakidae family in human serum. Serology is an aid for diagnosis and cannot be used as the sole method of diagnosis.
This product is manufactured by Bordier Affinity Products in Switzerland and distributed in Germany exclusively by Milenia Biotec.
Method/Platform
ELISA in microplate format
Range/Assay Sensivity
97%
Test Principle
Specific antibodies in the sample bind to Anisakidae excreted/secreted larval antigens sensitized on microtiter plates. The presence of parasite specific antibodies is detected with a Protein A alkaline phosphatase conjugate.
12 x 8 strips (96 tests) This ELISA kit is for the quantitative detection of IgG antibodies against parasites of Anisakidae family in human serum. Serology is an aid for diagnosis and cannot be used as the sole method of diagnosis.
This product is manufactured by Bordier Affinity Products in Switzerland and distributed in Germany exclusively by Milenia Biotec.
This H14 filter is a replacement for use with the OT-2 HEPA Module GEN1. The HEPA Module enables you to run sensitive contamination-prone applications on the OT-2.
Document
This H14 filter is a replacement for use with the OT-2 HEPA Module GEN1. The HEPA Module enables you to run sensitive contamination-prone applications on the OT-2.
