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Clinical Chemistry 45: 1414-1423, 1999;
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(Clinical Chemistry. 1999;45:1414-1423.)
© 1999 American Association for Clinical Chemistry, Inc.

Articles

Standardization of Creatine Kinase-MB (CK-MB) Mass Assays: The Use of Recombinant CK-MB as a Reference Material

Robert H. Christenson1,2,1,a, Hemant Vaidya3,1,2, Yvonne Landt4,1, Roger S. Bauer5,1, Sol F. Green6, Fred A. Apple7,1, Ann Jacob8,1, Gerald R. Magneson9, Sumitra Nag9, Alan H.B. Wu10,1 and Hassan M.E. Azzazy2

Departments of
1 Pathology and
2 Medical and Research Technology, University of Maryland School of Medicine, Baltimore, MD 21201.
3 Dade Behring, West Sacramento, CA 95691.

4 Department of Pathology, Washington University School of Medicine, St. Louis, MO 63110.

5 Dade Behring, Glasgow, DE 19714.

6 Becton Dickinson Vacutainer Systems, Franklin Lakes, NJ 07417.

7 Department of Laboratory Medicine and Pathology, Hennepin County Medical Center, Minneapolis, MN 55415.

8 Chiron Diagnostics, Inc., East Walpole, MA 02032.

9 Genzyme Diagnostics, Cambridge, MA 02139.

10 Department of Pathology and Laboratory Medicine, Hartford Hospital, Hartford, CT 06102.
a Address correspondence to this author at: Clinical Pathology, University of Maryland School of Medicine, 22 S. Greene St., Baltimore, MD 21201. Fax 410-328-5880; e-mail rchriste{at}umaryland.edu

Background: The AACC assembled a committee to identify and validate a standard creatine kinase MB isoenzyme (CK-MB) material to improve the comparability of CK-MB mass assays.

Methods: Three protocols were used. In protocol I, various CK-MB materials prepared in different matrices were screened as candidate standards. In protocol II, participating manufacturers calibrated their systems with concentrates of human heart CK-MB and then tested 20 patient samples to evaluate calibration bias. In protocol III, participating manufacturers calibrated their immunoassay systems using recombinant CK-MB2 (rCK-MB2) diluted into their respective sample diluents and measured 50 samples.

Results: Candidate materials showed high recovery in stripped human serum, but bias improved only from 59% to 38%. These data led to the use of human heart CK-MB diluted in each manufacturer's sample diluent. This strategy reduced bias from 31% to 15%. Because human heart CK-MB is difficult to provide, a lyophilized source of CK-MB2 was identified. rCK-MB2 was shown by sodium dodecyl sulfate-polyacrylamide gel electrophoresis, reversed-phase HPLC, intrinsic protein fluorescence, circular dichroism, agarose gel electrophoresis, immunoreactivity studies, high and low temperature stability, and reconstituted stability to be equivalent to human heart CK-MB. Calibration of immunoassay systems with rCK-MB2 added into each respective manufacturer's sample diluent showed a 13% between-manufacturer bias.

Conclusion: Lyophilized rCK-MB2 was determined suitable for use as a reference material for CK-MB mass assays.




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