Biomaterial Database

External quality control program for inter-laboratory quality control. 2000

N Bewarder, and P Müller

BIOREF GmbH, Dammweg 1, D-63776, Mömbris, Germany.

BACKGROUND The accuracy and precision of tumor marker testing is of high clinical importance requiring the implementation of effective quality control procedures in the diagnostic laboratory. An external quality control program including an inter-laboratory comparison could be of help in improving the quality of test results. METHODS Laboratories using BIOREF reference material sent their routine internal quality control results of each monthly control period to the evaluation center for statistical analysis and inter-laboratory comparison. RESULTS The inter-laboratory comparison showed that the mean values of test results obtained by different laboratories can vary considerably especially when different test kits are used. A comparison of test results of laboratories using the same test kit showed much better correlation but discrepancies of coefficients of variation between these laboratories were still observed. CONCLUSIONS An external quality control program revealed problems in the accuracy and precision of tumor marker test results in the individual laboratory, which could serve as a basis for the improvement of test performance.

UI	MeSH Term	Description	Entries
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
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D014408	Biomarkers, Tumor	Molecular products metabolized and secreted by neoplastic tissue and characterized biochemically in cells or BODY FLUIDS. They are indicators of tumor stage and grade as well as useful for monitoring responses to treatment and predicting recurrence. Many chemical groups are represented including HORMONES; ANTIGENS; amino and NUCLEIC ACIDS; ENZYMES; POLYAMINES; and specific CELL MEMBRANE PROTEINS and LIPIDS.	Biochemical Tumor Marker,Cancer Biomarker,Carcinogen Markers,Markers, Tumor,Metabolite Markers, Neoplasm,Tumor Biomarker,Tumor Marker,Tumor Markers, Biochemical,Tumor Markers, Biological,Biochemical Tumor Markers,Biological Tumor Marker,Biological Tumor Markers,Biomarkers, Cancer,Marker, Biochemical Tumor,Marker, Biologic Tumor,Marker, Biological Tumor,Marker, Neoplasm Metabolite,Marker, Tumor Metabolite,Markers, Biochemical Tumor,Markers, Biological Tumor,Markers, Neoplasm Metabolite,Markers, Tumor Metabolite,Metabolite Markers, Tumor,Neoplasm Metabolite Markers,Tumor Markers, Biologic,Tumor Metabolite Marker,Biologic Tumor Marker,Biologic Tumor Markers,Biomarker, Cancer,Biomarker, Tumor,Cancer Biomarkers,Marker, Tumor,Markers, Biologic Tumor,Markers, Carcinogen,Metabolite Marker, Neoplasm,Metabolite Marker, Tumor,Neoplasm Metabolite Marker,Tumor Biomarkers,Tumor Marker, Biochemical,Tumor Marker, Biologic,Tumor Marker, Biological,Tumor Markers,Tumor Metabolite Markers
D019411	Clinical Laboratory Techniques	Techniques used to carry out clinical investigative procedures in the diagnosis and therapy of disease.	Clinical Laboratory Test,Clinical Laboratory Testing,Clinical Laboratory Diagnoses,Clinical Laboratory Testings,Clinical Laboratory Tests,Diagnoses and Laboratory Examinations,Diagnosis, Laboratory,Laboratory Diagnosis,Laboratory Examinations and Diagnoses,Laboratory Techniques, Clinical,Clinical Laboratory Technique,Diagnose, Clinical Laboratory,Laboratory Diagnoses,Laboratory Technique, Clinical,Laboratory Test, Clinical,Laboratory Testing, Clinical,Technique, Clinical Laboratory,Test, Clinical Laboratory,Testing, Clinical Laboratory