In Vitro Diagnostic Industry in China - Blood Typing Instruments and Reagents IV

2.2. Blood Typing Reagents

Blood typing reagents mainly refer to reagents and kits used separately or in combination with blood grouping analyzer, which belong to a segment of in vitro diagnostic (IVD) reagent industry. Blood typing reagents can be mainly divided into forward and reverse blood ABO blood group, Rh (D) blood group test, irregular antibody test, anti-human globulin test, platelet antibody test, and other reagents. In clinical transfusion test, importance of Rh blood group system is only next to ABO blood group system. RhD has the strongest antigenicity in Rh blood group system, which is a main factor that gives rise to adverse reactions in clinical blood transfusion. Hence, screening of Rh blood group is very necessary before blood transfusion. C, c, E, and e antigens are several antigens of significant clinical significance in addition to D antigen of Rh blood group system, which test method’s basically the same to that of RhD antigen test. Anti-human globulin test is the most reliable method for the identification of irregular antibodies, and it is also the “gold standard” for antibody identification and cross-matching of blood at the moment. Surface of platelet contains Human Leukocyfe Antigen (HLA), Human Platelet Antigen (HPA), and other antigens; hence, test of HLA and HPA antigen on the surface of platelet is also of great clinical significance.

Blood typing reagents mainly include ABO test erythrocyte, anti-A (anti-B or anti-D) blood typing reagents, irregular antibody screening erythrocyte, forward and reverse ABO blood grouping card, Rh blood grouping card, anti-human globulin card, and erythrocyte cross matching kit. Both microplate and microcolumn gel card methods need to add specific blood group antibodies (such as anti-A, anti-B and anti-D reagent), erythrocyte, and other reagents to carrier medium. Quality and stability of specific blood group antibodies, erythrocyte, and other reagents will have direct impact on accuracy of test results to a certain extent; hence, blood typing reagents as supporting products of automatic blood grouping analyzer are of great significance to blood typing as well. Microcolumn gel card technique has been extensively used in blood typing; the regent card has been added various blood group antibodies to gel, and it only needs to add samples to realize typing during the test. The technique boasts of high sensitivity, easy standardization, easy observation and retention, and it has become the first choice for clinical ABO and Rh (D) blood typing and cross-matching of blood.

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