LeukoPrint® Molecular Karyotyping Kit

Trade name

LeukoPrint® Molecular Karyotyping Kit

D-SQ-06XZ

B-SQ-06XZ

Reference / catalog number

66761

EUDAMED

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

Genomic alternations especially copy number aberrations (CNAs) are particularly imperative for diagnostic classification and risk stratification in patients with hematopoietic malignancies. The genetic characterization of hematopoietic malignancies has historically been performed by conventional cytogenetic analysis (CCA), mainly referred to as karyotyping, consisting of microscopic observation of chromosome rearrangements and aneuploidies in metaphase stage. Although offering a pan-genomic view of aberrations, this technique comes with several drawbacks, such as a time-consuming and prone-to-failure cell-culturing step, relatively low resolution which is usually unable to detect submicroscopic changes (< 10 Mb), and a visual interpretation that is dependent on cytogeneticists experience and knowledge of the disease. With the advent of sequencing techniques, next-generation sequencing (NGS) based genetic testing has been implemented as a routine protocol for cancer diagnosis, risk stratification, and treatment response evaluation. LeukoPrint® Molecular Karyotyping Kit utilizes genomic DNA isolated from bone marrow collected in EDTA blood collection tubes. Genomic DNA is fragmented to 200-300 bp through sonication by Covaris S220. The DNA fragments undergoes whole-genome library construction, and then analyzes by shallow whole genome sequencing (sWGS). This kit is developed to depict CNAs patterns in hematopoietic malignancies patients without prior knowledge of cytogenetic analysis. This test results can help clinicians make diagnosis and prognostic stratification based on European Leukemia Net (ELN), Revised International Prognostic Scoring System (IPSS-R) or Revised International Staging System (R-ISS) guidelines. Clinicians should make a comprehensive judgment of the test results in combination with other clinical and laboratory test indicators. This kit is only used to construct DNA library.

Additional information URL

No additional information URL provided by the manufacturer.

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

• W01010201ALBUMIN (CC)

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  1. Please read this instruction carefully before experiments, and implement them in strict accordance with the requirements. 2. The results of this kit will be affected by many factors, such as the source of the sample, sample collection, sample quality, sample transportation conditions, sample processing and other factors, as well as the limitations of DNA extraction quality, operating environment and current molecular biology technology, which may lead to false positive or false negative test results. Users must comprehend the potential errors in the test process and the limitation of accuracy. 3. In order to avoid any potential biological hazards in the sample, the test sample shall be regarded as a substance with infectious risk, and corresponding protective measures shall be taken during the operation to avoid contact with skin and mucous membrane. The waste shall be treated according to the biological pollutant treatment procedure. 4. Do not use reagents with damaged package, unclear labels and expiration date. 5. All components of this kit have been strictly prepared. Changing or replacing the components will lead to invalid results. Components of kits with different batch shall not be mixed with each other. 6. Laboratory management shall be carried out in strict accordance with the national management specifications for molecular biology laboratories and clinical gene amplification laboratories. Laboratory personnel must receive professional training. 7. The experimental process shall be carried out in different areas (reagent preparation area, sample preparation area, sample amplification and product analysis area). Special instruments and equipment shall be used in each stage of experimental operation, and supplies in each stage of each area shall not be used interchangeably. 8. This kit is only used for in vitro diagnosis and is not used for other clinical purposes. 9. This kit is only applicable to bone marrow samples and designated device.