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

1. Overview

Blood typing has become a routine test item of clinical blood transfusion department and clinical laboratory, which includes ABO blood group, Rh blood group, and cross-matching of blood test. At present, tests are mainly conducted against ABO and Rh blood group system of the greatest clinical significance, Kell, Duffy, Kidd, MNS, P, and Lewis blood group system of certain clinical significance and irregular antibodies, that is, detect unknown antibodies with known antigens or detect unknown antigens with known antibodies through immunological techniques, and identify blood group based on agglutination. Genetic detection techniques directly targeting on carrier of genetic information—base sequence of DNA or RNA—are still subject to certain limitations, and not extensively used in clinical blood grouping tests.

Blood typing technique has experienced development from glass way (include ceramic plate test and paper method), tube method to microcolumn gel method (henceforth referred to as MGT). In 1985, Dr. Yves Lappierre in Lyons, France, developed MGT who attempted to capture agglutinator at precipitation and centrifugation step through study on gelatin, acrylamide gel, and glass bead. He cooperated with Switzerland-based DiaMed A.G. in 1988 for commercialized production of blood group gel cards; MGT boasts of high sensitivity, high specificity, excellent test repeatability, and easy standardization. At present, most clinical blood transfusion departments take gel technique as blood typing and cross-matching of blood method.

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