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With continuous discovery of tumor immune targets and continuous changes in antibody research and development technology, antibody drugs are becoming more and more widely used in clinical practice. However, some targets are not only expressed on tumor cells, but also on red blood cells. Therefore, the clinical application of antibodies against the corresponding targets may interfere with the detection of blood transfusion compatibility, resulting in difficulty in blood matching or delay of blood transfusion. This consensus summarizes the current solutions for the interference of CD38 monoclonal antibody (CD38 mAb) in transfusion compatibility testing. After analyzing the advantages and disadvantages of different methods, polybrene and sulfhydryl reducing agents [dithiothreitol (DTT) or 2-mercaptoethanol (2-Me)], as a solution for CD38 mAb interference in blood compatibility testing, are recommended for Chinese patients, so as to eliminate blood transfusion interference produce by CD38 mAb and further provide a pre-transfusion workflow for clinicians and technicians in Department of Blood Transfusion.
RESUMEN
Objective To explore the implementing process and application effect of risk management in blood transfusion compatibility testing.Methods 16 957 patients receiving transfusion therapy along with blood transfusion compatibility testing at our hospital between July,2013 and June,2015 were selected as the control group,without any risk control in place.19 011 patients receiving such therapy yet with blood transfusion compatibility testing between July, 2015 and June, 2017 were selected as the observation group,and managed by the risk management procedure.The risk incidence and satisfactory rate of doctors,nurses and patients were analyzed between the two groups.Results The risk incidence was zero in the observation group, and 0.09% in the control group, indicating the risk incidence rate in the observation group significantly lower than the control group(P<0.05).The satisfactory rate of doctors, nurses and patients in the observation group(98.33%)was significantly higher than the control group (71.25%)(P <0.05).Conclusions Implementing risk management procedure in blood transfusion compatibility testing may effectively prevent and reduce the risk incidence, enhance the satisfactory rate of doctors,nurses and patients,and ensure the clinical transfusion safety.
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Objective To investigate the testing capabilities of clinical transfusion laboratories in medical institutions in Beijing for the regulatory authorities to formulate administrative policies in this regard.Methods Experts assigned by Beijing Clinical Transfusion Quality Control Center made on-site inspections at the transfusion laboratories in medical institutions using quality control products.They recorded the complete testing process of the operators as well as the instruments,detection reagents in use and the testing results,with statistics and analysis made to the data so collected.Results The pass rate of these on-site inspections was lower than that of the external quality assessment.Some laboratories failed to complete the testing of the quality control products in time and the actual operations in some laboratories were inconsistent to the guidelines.55.9％ of level Ⅰ hospitals and 25.6％ of level Ⅱ hospitals were found with insufficient and inadequate instruments and process layout to meet the needs of clinical blood transfusion.Some of the technicians were found without sufficient trainings in their professional knowledge and basic skills,resulting in their poor competence against emergency cases and weakness in independent problem solving.In addition,the records of detection process and results were found to be substandard.Conclusions Transfusion laboratories in Beijing need to improve their testing capabilities in general.
RESUMEN
Cualquier prueba pretransfusional tiene como objetivo garantizar la normal sobrevida de las células rojas transfundidas (detectando anticuerpos clínicamente significativos en el suero del receptor), minimizar los riesgos para el paciente y contener los costos. Desde su introducción, las pruebas pretransfusionales fueron sometidas a una constante modificación. La cuestión en debate es: ¿Qué constituye hoy, una estrategia segura y costo-efectiva y nos permite en forma rápida disponer de unidades compatibles?. La mayoría de los bancos de sangre testean en sus pruebas pretransfusionales: 1. grupo ABO y RH en dador y receptor. 2. Tamizaje de Ac irregulares en el receptor. 3. Identificación de la especificidad de ese anticuerpo irregular detectado. 4. Prueba de compatibilidad mayor (fase antiglobulínica) con una unidad Antígeno (Ag.) negativa. Bajo este protocolo una unidad compatibilizada es reservada para un paciente en particular por un tiempo de 48-72 horas (dependiendo de la política del servicio) y por lo tanto el stock de sangre disponible se verá reducido. En la política de tamizaje de ACS irregulares con compatibilidad abreviada (type and screen) , cada muestra de un potencial receptor es tipificada para ABO y RH y se realiza un tamizaje de AC inesperados pero clínicamente significativos. Para esto se incuba el suero del paciente con células conocidas (panel de 2 ó 3 tubos) que portan los Ag. de grupos sanguíneos más importantes y representativos, todos preferentemente en estado homocigota; se realiza una lectura a 37°C y una fase antiglobulínica. Si el resultado es negativo, no se reserva sangre compatibilizada. Si se requiere una transfusión, se realiza una compatibilidad abreviada (centrifugación inmediata) para demostrar incompatibilidad ABO y se libera la unidad. Si el resultado del tamizaje es positivo, se identifica el AC y se selecciona una unidad Antígeno negativa para realizar la compatibilidad mayor.
Pretransfusional tests have the object of assuring normal survival of transfused red cells (detecting clinically significant antibodies in the receptor serum), minimizing risks for patients and reducing costs. Since they were first introduced, pretransfusional tests have been subjected to continuous modifications. The issue under discussion is: Which protocol constitutes a safe and cost-effective strategy that allows for a quick availability of compatible units? In pre-transfusion tests, most blood banks test the following: 1. ABO group and RH factor in donor and receptor. 2. Sieving of irregular antibodies in receptor. 3. Identification of specificity of the detected irregular antibodies. 4. Crossmatching test (anti-globulin phase) with a negative Antigenic (Ag.) unit. Under this protocol. a compatible unit is kept for a particular patient for a 48-72-hour period (depending on the service policy) and therefore, the available blood stock will be reduced. In the policy for sieving irregular antibodies with abbreviated match (type and screen), each sample from a potential receptor is typified for ABO and RH, and a sieving of unexpected but clinically significant antibodies is carried out. For this purpose, the patients' serum is incubated with known cells (a 2 or 3-tube panel) which carry the Ag. of more relevant and representative blood groups, all of them preferably in homozygous state. Then an interpretation at 37° C and an anti-globulin phase are performed. If the result is negative, crossmatched blood is not stored. If a transfusion is required, an abbreviated crossmatch is carried out (immediate centrifugation) to demonstrate ABO incompatibility, and the unit is released. If the Sieving result is positive, the antibody is identified, and a negative antigen unit is selected to carry out the majar crossmatch.