SRM 2921 证书.pdf

National Institute of Standards Technology Certificate of Analysis Standard Reference Material 2921 Human Cardiac Troponin Complex This Standard Reference Material (SRM) is primarily intended for use in calibrating procedures and devices for the determination of cardiac troponin I (cTnI) in human serum. It can also be used for value-assignment of calibrators and control materials. A unit of SRM 2921 consists of five vials, each containing approximately 115 μLof a dilute solution of human cardiac troponin complex. The troponin complex was purified from human heart tissue and consists of three subunits: troponin T (cTnT), troponin I (cTnI), and troponin C (cTnC). The choice of a human cardiac troponin complex was made with the assistance of the Cardiac Troponin I Standardization Subcommittee of the American Association for Clinical Chemistry (AACC). Through two interlaboratory comparison studies, various troponin preparations, including recombinant and native troponin complexes of the troponin T, troponin I, and troponin C subunits, recombinant troponin I/troponin C complex, and recombinant and native cTnI, were evaluated using fifteen commercial cTnI assays [1]. Based on the results of these interlaboratory comparison studies, the human cardiac troponin complex was chosen for its ability to harmonize clinical assays and for its commutability. Certified Human Cardiac Troponin Concentration: The certified concentration value of human cTnI was determined through a combination of amino acid analysis and liquid chromatography (LC). The amino acid analysis used SRM 2389 Amino Acids in 0.1 mol/L Hydrochloric Ac