Every single blood or plasma donation is a precious lifesaving gift and regular voluntary unpaid donation is essential for building a safe and sustainable blood supply. Access to a secure blood supply based on voluntary unpaid donation is vital for all patients, including many requiring life-long and regular transfusions for conditions such as sickle-cell anaemia and thalassaemia. Voluntary unpaid plasma donations also play an important part in supporting patients with a wide range of long-term conditions such as haemophilia and immune deficiencies.[1]
However, in many countries, blood services face the challenge of making sufficient blood available, while also ensuring its quality and safety [1].
WHO recommends that all blood donations should be screened for infections prior to use. Screening for HIV, hepatitis B, hepatitis C, and syphilis should be mandatory. Blood screening should be performed according to quality system requirements to reduce the risk of transfusion-transmissible infections (TTIs). [2] It is also recommended to test other infections that pose a risk to the safety of the blood supply, such as Trypanosoma cruzi (Chagas disease) and Plasmodium species (malaria). [3]
In the past, whole blood was commonly used for transfusions. However, modern medical practice typically only uses specific components of blood, such as red blood cells, white blood cells, plasma, clotting factors, and platelets.[4] As a result, in certain countries, platelet products are subjected to bacterial infection testing, as they have a higher likelihood of becoming contaminated due to their storage at room temperature.[5] Cytomegalovirus (CMV) testing may also be conducted due to the potential risk it poses to certain immunocompromised recipients, such as those who have undergone organ transplants or have HIV.[6] Besides, microbiological screening of blood is conducted on donations from seemingly healthy and asymptomatic donors to detect the presence of any infections and ensure the blood is safe for transfusion.
Over the past three decades, various types of immunoassays have been developed for use in blood screening. These include enzyme immunoassays (EIAs), Chemiluminescent immunoassays (CLIAs), particle agglutination assays (PA), and rapid tests. Currently, EIAs and CLIAs are the most commonly used assays for screening donated blood for TTIs. CLIAs are particularly well-suited for the screening of large numbers of samples due to their higher sensitivity and specificity compared to particle agglutination assays or rapid tests.[7]
As a world-leading provider of in-vitro diagnostics solutions, Mindray offers high-quality immunoassays, including HIV, HBV, Anti-HCV, and Anti-TP, on its CLIA systems to support blood screening with high sensitivity and specificity.
These immunoassays have obtained the CE list A certification and have also undergone extensive evaluation at German red cross blood donation centers. In addition to immunoassays, Mindray also provides a variety of other IVD solutions for blood transfusion-related screening, such as hematology and microbiology analyzers.
References
[1] WHO:https://www.who.int/southeastasia/news/ events/detail/2023/06/14/south-east-asia-events/
[2] https://biopharmaplasma.ua/en/news/cikavi-fakti- pro-donoriv-krovi-tih-hto-daruye-zhittya
[3] https://www.who.int/news-room/fact-sheets/detail/ blood-safety-and-availability
[4] Blood Transfusion | National Heart, Lung, and Blood Institute (NHLBI)". www.nhlbi.nih.gov. Retrieved
2019-06-16
[5] "Bacterial Detection Testing by Blood and Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion". FDA U.S. Food and Drug Administration.
Retrieved 21 January 2016
[6] Ziemann, Malte; Hennig, Holger (2014-02-01). "Prevention of Transfusion-Transmitted Cytomegalovirus Infections: Which is the Optimal Strategy?". Transfusion Medicine and Hemotherapy.
[7] Laperche S. Antigen-antibody combination assays for blood donor screening: weighing the advantages and costs.
[8] World Health Organization. Screening donated blood for transfusion-transmissible infections: recommendations. 2010; page 52
