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Journal of Clinical Microbiology, March 1999, p. 848-851, Vol. 37, No. 3
0095-1137/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.

Quality Control in Nucleic Acid Amplification Methods: Use of Elementary Probability Theory

Daniel S. Shapiro*

Department of Medicine and Department of Pathology and Laboratory Medicine, Boston University School of Medicine and Boston Medical Center, Boston, Massachusetts

Received 7 May 1998/Returned for modification 17 November 1998/Accepted 25 November 1998

Since it is not possible to state with certainty that contamination has occurred during a nucleic acid amplification assay in the absence of a positive result for a negative control, methods of elementary probability theory are used to illustrate how to identify those runs in which the possibility of contamination should be considered. The use of binomial and Poisson distributions and an analysis of clusters are presented with illustrative examples to demonstrate their use.

* Mailing address: Clinical Microbiology and Molecular Diagnostics Laboratories, ENC H-406, Boston Medical Center, 88 East Newton St., Boston, MA 02118. Phone: (617) 638-8705. Fax: (617) 638-7878. E-mail: dshapiro{at}bu.edu.

Journal of Clinical Microbiology, March 1999, p. 848-851, Vol. 37, No. 3
0095-1137/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.


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