SeekInCare® Cancer DetectionKit

Dénomination commerciale

SeekInCare® Cancer DetectionKit

Code d'IUD-ID

06979082370032

IUD-ID de base

B-06979082370032

Numéro de référence/catalogue

64110

Entité d'attribution

GS1

Catégorie de risque

IVDD — Général

Législation applicable

IVDD [Directive 98/79/CE relative aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

This kit assesses the performance of a newly developed blood-based assay that utilized genomic features for the early detection of pan-cancer. This kit utilizes circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood (about 10 ml) of clients collected in streck cfDNA blood collection tubes. Extracted cfDNA undergoes whole-genome library construction, and then analyzes by shallow whole genome sequencing. A cancer-associated hallmark, copy-number aberrations (CNA), utilizes to differentiate cancer patients from healthy subjects. 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 cfDNA library.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• W01010201ALBUMIN (CC)

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• 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 blood samples and designated device.

Aucun certificat ne référence l'IUD-ID de base de ce dispositif.