External quality control survey for alpha-fetoprotein assay. 1989

G C Zucchelli, and A Pilo, and M Ferdeghini, and M R Chiesa, and A Masini, and A Clerico

Starting from 1984 we organized an interlaboratory quality control (QC) survey for the tumor marker AFP in which 100-150 laboratories have been involved. Seven consecutive QC cycles have been carried out during the period 1984-1988; 15-20 samples have been prepared and sent in each cycle. The 11 kits more used in the survey, which use three different immunological methods (3 kits EIA, 3 kits RIA, and 5 kits IRMA) were evaluated. Since the results of AFP assays were expressed as ng/ml of different local standards of the various kits, the participants were asked to convert their results in UI/ml of the 1st IRP 72/225 distributed by WHO. The total variability of AFP assay resulted approximately constant (19.9-24.7 CV%) during the all QC period. The validity of the consensus mean of AFP determinations obtained in the survey and assumed as reference value has been checked by recovery experiments. Regression analysis indicates that the consensus means found in these samples are in very good agreement with the added AFP. The analytical performance achieved by the most popular methods/kits, observed in the last period, are also reported.

UI MeSH Term Description Entries
D007558 Italy A country in southern Europe, a peninsula extending into the central Mediterranean Sea, northeast of Tunisia. The capital is Rome. Sardinia
D007753 Laboratories Facilities equipped to carry out investigative procedures. Laboratory
D011786 Quality Control A system for verifying and maintaining a desired level of quality in a product or process by careful planning, use of proper equipment, continued inspection, and corrective action as required. (Random House Unabridged Dictionary, 2d ed) Control, Quality,Controls, Quality,Quality Controls
D011933 Reagent Kits, Diagnostic Commercially prepared reagent sets, with accessory devices, containing all of the major components and literature necessary to perform one or more designated diagnostic tests or procedures. They may be for laboratory or personal use. Diagnostic Reagent Kits,Diagnostic Reagents and Test Kits,Diagnostic Test Kits,In Vitro Diagnostic Device,In Vitro Diagnostic Devices,In Vitro Diagnostic Medical Device,In Vitro Diagnostic Medical Devices,Kits, Diagnostic Reagent,Diagnostic Reagent Kit,Diagnostic Test Kit,Kit, Diagnostic Reagent,Kit, Diagnostic Test,Kits, Diagnostic Test,Reagent Kit, Diagnostic,Test Kit, Diagnostic,Test Kits, Diagnostic
D000509 alpha-Fetoproteins The first alpha-globulins to appear in mammalian sera during FETAL DEVELOPMENT and the dominant serum proteins in early embryonic life. alpha-Fetoprotein,alpha Fetoprotein,alpha Fetoproteins

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