Clinical Chemistry, Vol 7, 185-191, Copyright © 1961 by the American Association for Clinical Chemistry

Commercial Control Sera in the Clinical Chemistry Laboratory

¹ U. S. Army Chemical Corps Biological Laboratories, Fort Detrick, Md.
² Temple University School of Medicine, 3400 N. Broad St., Philadelphia 40, Pa.

1. The control of precision and accuracy in a clinical chemistry laboratory can be achieved only by knowledgeable and careful use of "concurrent standardization" together with the use of control sera in routine analysis. That is, within each series of analyses, both reference standards and control sera should be included as the only means by which the ultimate in reliability can be achieved.

2. The use of standard curves or calibration factors can be tolerated only when the pure reference standard is difficult to obtain, prepare, or maintain. In such cases, however, the curves or factors should be rechecked frequently and a control serum analyzed concurrently with the unknown.

3. The manufacturer or supplier should refrain from advertising his product as simultaneously a standard and a control. Secondly, he should ascertain the shelf-life of his product under the most rigorous conditions likely to be encountered and indicate this information on the label of the individual bottle or on the container of that lot of control sera. Finally, he should make every effort to reduce the cost of his product in order to make it practical for the clinical chemistry laboratory to establish and maintain an adequate control system.

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