Introduction

HiPure FFPE Nucleic acid Kit supplies a simple and rapid DNA extraction for Formalin-fixed, paraffin-embedded (FFPE) tissue and sections samples. This kit is based on silica gel column purification technology, no phenol-chloroform extraction or alcohol precipitation. The whole extraction only takes 20 minutes (not including digestion time). DNA can be directly used for downstream applications such as PCR, southern blot and viral DNA detection, etc.

Details

Specifications

Features	Specifications
Main Functions	Isolation total DNA from FFPE tissue samples
Applications	PCR, Southern Blot and viral DNA detection, etc.
Purification method	Mini spin column
Purification technology	Silica technology
Process method	Manual (centrifugation or vacuum)
Sample type	Formalin-fixed, paraffin-embedded (FFPE) tissue and sections samples
Sample amount	<20mg
Elution volume	>15µl
Time per run	≤20 minutes
Liquid carrying volume per column	4ml
Binding yield of column	100μg

Principle

Hipure FFPE Nuclear acid kit adopts silica gel column purification. The sample is deparaffinated by xylene and digested by lysate and protease. After decrosslinked at 90 ℃, DNA/RNA is released into the lysate. Adding ethanol to adjust the binding conditions, the sample is transferred to the column where DNA/RNA is adsorbed on the membrane and protein is removed without adsorption. Protein and other impurities are washed by buffer GW1, and the salt is removed by buffer GW2. Finally, the DNA / RNA is eluted by low salt buffer.

Advantages

• Safety – deparaffinating without contacting with xylene or other toxic solution
• Fast – without overnight incubation and digestion, several samples can be extracted within 2hours
• High efficiency – remove the formaldehyde modification of DNA, greatly enhancing the sensitivity of PCR
• High yield – most optimal process to ensure the highest recovery
• High recovery – silica gel column purification method can recover nucleic acid at the level of PG

Kit Contents

Contents	IVD3126
Purification Times	100 Preps
HiPure DNA Mini Columns I	100
2ml Collection Tubes	100
Buffer DPS	70 ml
Buffer ATL	30 ml
Buffer AL	30 ml
Buffer GW1*	44 ml
Buffer GW2*	20 ml
Proteinase K	50 mg
Protease Dissolve Buffer	6 ml
Buffer AE	20 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 this case buffers should be redissolved before use. Make sure that all buffers are at room temperature when used.

Experiment Data

HiPure FFPE Nucleic acid Kit supplies a simple and rapid DNA extraction for Formalin-fixed, paraffin-embedded (FFPE) tissue and sections samples. This kit is based on silica gel column purification technology, no phenol-chloroform extraction or alcohol precipitation. The whole extraction only takes 20 minutes (not including digestion time). DNA can be directly used for downstream applications such as PCR, southern blot and viral DNA detection, etc.

This test has been authorized by FDA under an EUA for use by authorized laboratories.

Description

The Primerdesign Ltd COVID-19 genesig® Real-Time PCR assay is a real-time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in oropharyngeal swab specimens from patients suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

*FDA clinical study. See Instructions for Use for additional clinical data.

FOR US ONLY
Rapid detection and exclusive to the COVID-19 strain
Does not detect other related coronavirus strains
High priming efficiency
Accurate controls to confirm extraction, and assay validity
Lyophilised components for ambient shipping
Highly specific detection profile
This test has been authorized by FDA under an EUA for use by authorized laboratories.

Overview

• CE-IVDR marked in accordance with the European Commission Regulation (EU) No. 2017/746.
• Input volumes up to 200 µL
• High yield and high quality DNA ready for any application
• Fast and convenient spin column protocol

Norgen’s Blood Genomic DNA Isolation Mini Kit Dx is designed for the rapid preparation of genomic DNA from up to 200 µL of whole blood for subsequent in vitro diagnostic use. Both fresh and frozen anticoagulated blood may be used with this procedure. Purification is based on spin column chromatography as the separation matrix. Norgen’s column binds DNA under optimized salt concentrations and releases the bound DNA under low salt and slightly alkali conditions.

This kit is designed to be used with any downstream application employing enzymatic amplification or other enzymatic modifications of DNA followed by signal detection or amplification. Any diagnostic results generated using the DNA isolated with Norgen’s Blood Genomic DNA Isolation Mini Kit Dx in conjunction with an in vitro diagnostic assay should be interpreted with regard to other clinical or laboratory findings.

To minimize irregularities in diagnostic results, suitable controls for downstream applications should be used.

Norgen’s Blood Genomic DNA Isolation Mini Kit Dx is intended for use by professional users such as technicians, physicians and biologists experienced and trained in molecular biological techniques including experience with whole blood samples and DNA isolation.

Norgen’s Blood Genomic DNA Isolation Mini Kit Dx does not provide a diagnostic result. It is the sole responsibility of the user to use and validate the kit in conjunction with a downstream in vitro diagnostic assay.

Details

Supporting Data

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Kit Specifications
Minimum Blood Input	20 µL
Maximum Blood Input	200 µL
Column Binding Capacity	> 50 µg
Average Yield (200 µL of blood)	4-12 µg*
Time to Complete 10 Purifications	30 minutes

*Yield will vary depending on the type of blood processed

Storage Conditions and Product Stability
All solutions should be kept tightly sealed and stored at room temperature. These reagents should remain stable for at least 2 years in their unopened containers. The kit contains a ready-to-use Proteinase K solution, which is dissolved in a specially prepared storage buffer. The Proteinase K is stable for up to 2 years after delivery when stored at room temperature. To prolong the lifetime of Proteinase K, storage at 2–8°C is recommended.

Component	Cat. Dx46300 (50 preps)
Lysis Solution	20 mL
Wash Solution I	18 mL
Wash Solution II	18 mL
Elution Buffer	12 mL
Proteinase K	1.2 mL
Spin Columns	50
Collection Tubes	50
Elution Tubes	50
Product Insert	1