Establishment and performance assessment of preparation technology of internal quality control products for blood transfusion compatibility testing

Abstract

The aim of this study was to establish and to optimize the preparation technology of whole blood internal quality control (IQC) products for blood transfusion compatibility testing. Several B-type RhD-negative blood samples collected from healthy donors were mixed. Two groups of whole blood IQC products, namely, the preservative solution group (PS group) and the saline group, were prepared. The agglutination intensity of IQC sample red cells and anti-B antibody, IgM anti-A antibody and reverse-typing A cell, IgG anti-D and O-type RhD-positive red cells, as well as free hemoglobin concentration in the supernatant of the two groups were detected. The erythrocytes in both groups were damaged to a certain extent during storage, but no evident (above moderate) hemolysis was observed in the stored sample within 42 days. The red cells remained structurally complete and the reaction activity of IgG anti-D reagent remained generally unchanged (P>0.05). Although the reaction activity oscillation of IgM anti-A reagent was observed, the agglutination intensity varied within an acceptable range of 1+. No difference was observed between the preparation methods of the samples, i.e., between the erythrocyte washed with saline and the one washed with red cell preservative solution (P>0.05). The long shelf life, low variance between tubes and stable antigen-antibody reaction activity of the whole blood IQC products prepared using the proposed method can meet the requirements of blood transfusion compatibility testing.

Internal quality control of blood products: An experience from a tertiary care hospital blood bank from Southern Pakistan

“…Internal quality control (IQC) is the backbone of the quality management program in the blood bank. [ 2 3 ] In the modern blood banking, quality controls of blood products ensure the timely availability of a blood component of high-quality yield with maximum efficacy and minimal risk to potential recipients. [ 4 ] Processes and manuals are need to be highly focused on generating quality blood components that are more efficacious and safe.…”

Performance Assessment of Internal Quality Control (IQC) Products in Blood Transfusion Compatibility Testing in China

“…Hence, IQC products are indispensable in transfusion compatibility laboratories, as demanded by many organizations, such as the AABB, the British Committee for Standards in Hematology (BCSH), and the Ministry of Health (MOH) of the People's Republic of China [ 16 – 18 ]. However, due to the lack of uniform methods and standards for IQCs and cost-saving concerns, most transfusion compatibility laboratories in China have not yet developed methods for IQC [ 19 ].…”

“…When the difference between the value of the agglutination intensity of the IQC testing results and the reference value was no higher than 1, and no false-positive results were found, the test was defined as “under control”. Otherwise, it was defined as “out of control” [ 19 ]. Sensitivity, specificity, and reliability were used to evaluate the results of the IQC products [ 16 , 24 ].…”

“…However, pre-transfusion compatibility testing is a qualitative or semi-quantitative assay, and its results are mainly obtained by evaluating the intensity of RBC agglutination or comparing the results with standard images using the naked eye. Furthermore, the results of pre-transfusion compatibility testing do not show a Gaussian distribution, which means that the cut-off value used in traditional immunological tests is incapable of determining negative or positive results [ 19 ]. Therefore, special IQC products and methods need to be developed.…”

“…At present, most studies focus on external quality assessment in transfusion laboratories; studies on the IQC of pre-transfusion compatibility testing in laboratories remains rare [ 20 – 22 ]. Uniform and standardized IQC products and methods have not yet been developed for pre-transfusion compatibility testing in China [ 19 , 23 ]. In this paper, we present the IQC tests that were conducted in our laboratory from 2012 to 2014, and we analyze the sensitivity, specificity, and confidence levels of these products.…”