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Complete Blood Count (CBC) - in vitro Assay

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The complete blood count (CBC) is used to quickly and accurately enumerate the concentrations of cell populations in blood. This includes cell counts of platelets or thrombocytes, white blood cells (WBC) or leukocytes and red blood cells (RBC) or erythrocytes.

The CBC test is performed in accordance with the ISO guidelines 10993-11, 10993-42 and 10993-123 or ASTM F619-204 and ASTM F2888 − 195 at Eurofins BioPharma Product Testing Munich GmbH.

The analysis of CBC before and after direct blood contact with a test device provides basic information on the impact of the device interaction with formed blood elements. Counts of platelets and WBC pre- and post-exposure to a device are valuable in deducing the loss of activated platelets and WBC taken up in clot formation by thrombogenic surfaces. Therefore, the CBC provides an estimate of the thrombogenic potential of a device.

Due to the key role of platelets in preventing bleeding it is important to determine the platelet count. A significant drop in platelet count of blood exposed to a device can be caused by platelet adhesion, platelet aggregation, platelet sequestration or blood coagulation on materials. A reduction on platelet count during use of an implanted device may also be caused by accelerated destruction or removal of platelets from the circulation.

Leucocytes are integral parts of the immune system and mediate the response of an organism against infections and foreign particles. A reduction (leucopenie) or increase (leukocytosis) of white blood cells can occur in the scope of the CBC assessment.

RBCs are the major cellular component in blood. RBC count is important since a decrease in RBCs as occurring in anaemia results in a decreased oxygen transport capacity from blood to other tissues. In addition, a decrease in RBC count can be indicative of RBC lysis (haemolysis).

Procedure

Human whole blood is incubated with the test item. Afterwards, blood cell counts are determined via flow cytometry using surface markers and cell size. The resulting numbers are compared to untreated whole blood.

Historical Data for Platelets

Historical Data for RBC count

Historical data for WBC count

ISO vs. ASTM Guideline

References

  1. ISO 10993-1: “Evaluation and testing within a risk management process”
  2. ISO 10993-4: “Selection of tests for interactions with blood”
  3. ISO 10993-12: “Sample preparation and reference materials”
  4. ASTM F 619 – 20: “Standard Practice for Extraction of Materials used in Medical Devices”
  5. ASTM F2888 – 19: Standard Practice for Platelet Leukocyte Count—An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials
  6. Holinstat M. Normal platelet function. Cancer Metastasis Rev. 2017 Jun;36(2):195-198. doi: 10.1007/s10555-017-9677-x. PMID: 28667366; PMCID: PMC5709181.
  7. Weber M, Steinle H, Golombek S, Hann L, Schlensak C, Wendel HP, Avci-Adali M. Blood-Contacting Biomaterials: In Vitro Evaluation of the Hemocompatibility. Front Bioeng Biotechnol. 2018 Jul 16;6:99. doi: 10.3389/fbioe.2018.00099. PMID: 30062094; PMCID: PMC6054932.