Manual of Reference Material and Third Party Run controls


  • The products contain the following series:
  • Nucleic acid Run controls
  • Immunodiagnostic Run controls
  • Clinical biochemical Run controls


Gen Blood Derived Screening (GBDS) is a lab owned by The Gen Molecular Institute Belgium, Eu of the KULeuven University, and GBDS is a specialized innovative high-tech enterprise integrating the research, development, production and marketing of bio-diagnostic reagent third party quality Run control materials and reference materials in the fields of molecular diagnosis, immunity and clinical biochemical laboratory test; GBDSis a specialized innovative high-tech company that undertakes reagent sales, technical services and contract development, and it is also a leading company in the field of domestic biometric reference materials.


Relying on the leading position in the field of domestic molecular diagnosis of Gen Institute Belgium, Eu of KULeuven University, GBDS carries out transverse and longitudinal cooperation and coordination with the relevant domestic clinical units, medical management institutions, midiagnosics reagent industrial standard management department, establishes PCR quality Run control material R&D system, and forms the scale POCT and NAT Run controls.


Additionally, it gradually carries out the standardized studies on series reference materials and applies for European IVDR and ISO13485 reference material registration according to the standard material management regulations of General Administration of Quality Supervision.


Currently, GBDS has obtained approval of over 40 national second reference materials and possesses the domestically earliest nucleic acid reference materials with most varieties, and among them, the series reference materials such as EBV DNA, HCMV DNA, HPV16 DNA, HPV18 DNA and HIV1 RNA are original domestically.