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Clinical Chemistry 45: 869-881, 1999;
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(Clinical Chemistry. 1999;45:869-881.)
© 1999 American Association for Clinical Chemistry, Inc.

Articles

A New Approach for Clinical Biological Assay Comparison and Standardization: Application of Principal Component Analysis to a Multicenter Study of Twenty-One Carcinoembryonic Antigen Immunoassay Kits

Jean-Claude Rymer1, Robert Sabatier2, Alain Daver3, Jacques Bourleaud4, Marcel Assicot5, Jacqueline Bremond6, Jacqueline Rapin7, Sharon Lynn Salhi8, Bruno Thirion9, Anne Vassault10, Jacques Ingrand11, Bernard Pau2,12,a and for the joint group convened by the Société Française de Biologie Clinique (SFBC), the Commission de Radioanalyse et Techniques Associées (CORATA), the Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC), and the Syndicat de L'Industrie du Diagnostic In Vitro (SIDV)

1 Laboratoire de Biochimie, CHU Henri Mondor, Avenue De Lattre de Tassigny, 94000 Créteil, France.

2 CNRS UMR 9921, Faculté de Pharmacie, Avenue Charles Flahault, 34060 Montpellier Cedex 2, France.

3 Centre Paul Papin, Laboratoire de Radio-Immunologie, 2 Rue Moll, 49036 Angers Cedex, France.

4 Agence Française de Sécurité Sanitaire des Produits de Santé, Site de Montpellier-Vendargues, 13 Rue de la Garenne, 34740 Vendargues, France.

5 Département de Biologie Clinique, Institut Gustave Roussy, 94805 Villejuif, France.

6 Laboratoires Abbott, 12 Rue de la Couture Silic 203, 94518 Rungis Cedex, France.

7 Syndicat de l'Industrie du Diagnostic in Vitro, 6 Rue de la Trémoille, 75008 Paris, France.

8 Laboratoire d'Immunologie et Biotechnologie, Faculté de Pharmacie, Avenue Charles Flahault, 34060 Montpellier Cedex 2, France.

9 Cis Bio International, BP 21, 91192 Gif sur Yvette Cedex, France.

10 Biochimie A, Hôpital Necker, 149 Rue de Sèvres, 75743 Paris Cedex 15, France.

11 Laboratoire de Radioanalyse, Hôpital Cochin, 27 Rue du Faubourg St. Jacques, 75674 Paris Cedex 14, France.

12 Comitee of Immunoanalysis IFCC, Faculté de Pharmacie, Avenue Charles Flahault, 34060 Montpellier Cedex 2, France.
a Author for correspondence. Fax 33 (0)4 67 54 86 10; e-mail sumr9921{at}pharma.univ-montp1.fr

Background: Principal component analysis (PCA) is a powerful mathematical method able to analyze data sets containing a large number of variables. To our knowledge, this method is applied here for the first time in the field of medical laboratory analysis.

Methods: PCA was used to evaluate the results of a blind comparative study of 21 carcinoembryonic antigen (CEA) reagent kits used to determine CEA concentration in a panel of sera from 80 patients.

Results: The mathematical technique first eliminated the variations attributable to the use of different calibrators. The PCA representation then gave a global view of the dispersion of the kits and allowed the identification of a main homogeneous group and of some discrepant kits.

Conclusions: PCA applied to the in vitro diagnostic reagent field could contribute to the standardization process and improve the quality of medical laboratory analyses. A standardization method using a panel of patient sera is proposed.© 1999 American Association for Clinical Chemistry




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[Abstract] [Full Text] [PDF]


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