Vazyme Target Capture Hybridization and Wash Kit

Trade name

Vazyme Target Capture Hybridization and Wash Kit

UDI-DI code

06973315739344

Basic UDI-DI

6973315739344B2

Reference / catalog number

NC403ME-C1

Issuing entity

GS1

Risk category

IVDR Class A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The Vazyme Comprehensive Exome Dx Panel includes capture probes used for the preparation of sequencing libraries from high-quality genomic DNA (gDNA) isolated from human cells, such as whole blood, to produce target enriched libraries compatible with Illumina sequencing platform. It includes following steps: DNA Fragmentation, End Repair, and dA-tailing: A minimum of 50 ng purified gDNA is enzymatically fragmented. During the same reaction, DNA ends are blunted and A-tailed to prepare libraries for ligation. Ligate Universal Adapters and Purify: Adapters are added to allow for unbiased amplification of the fragmented libraries and cleaned up with bead-based purification. PCR Amplify Using Primers, Purify, and Perform QC: Fragmented libraries are PCR-amplified. Primers required for cluster generation during sequencing are added during this step. Libraries are cleaned up with bead-based purification and evaluated for yield and size. Prepare Libraries for Hybridization: Different libraries are combined, if necessary, each barcoded with distinct Indexs, into one pool to simplify the complexity of downstream steps. Using concentration method, sample DNA is reconstituted in a hybrid capture-compatible buffer. Hybridize Capture Probes With Pools: Probes in the Panel are hybridized to targets in the pooled and prepared libraries. Bind Hybridized Targets to Streptavidin Beads: Hybridized targets of interest, hybridized to biotinylated probes, are enriched by binding them to streptavidin-coated magnetic beads. Post-Capture PCR Amplify, Purify, and Perform QC: Enriched libraries are amplified and cleaned up with bead-based purification. The final library pool is evaluated for yield and size. Sequencing: Enriched libraries are ready for sequencing on an Illumina instrument.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W010699GENETIC TESTS - OTHER

No certificate specifically references this device's Basic UDI-DI.