Internal quality control and external quality management of data in practice. 2009


In this chapter, the use of control charts to both continuously evaluate testing in individual laboratories as well as provide data for external monitoring is examined in detail. The data is based on the publication by D. E. Rebeski' et al., "Charting methods to monitor the operational performance of ELISA method for the detection of antibodies against trypanosomes" in Veterinary Parasitology, 2001, 96, 11-50, and is a detailed example of the investigation of the performance of four indirect ELISAs for the detection of antibodies against trypanosomes using Trypanosoma congolense and T. vivax antigen-precoated plates in 15 veterinary diagnostic laboratories in Africa and Europe. The study shows the practical use of charting methods with respect to assessing the operational performance of each ELISA. Data from standardized internal quality control (IQC) samples were used to assess ELISA performance indicators with reference to expected upper and lower control limits, as determined from studies by the kit producer (tentative values). Based on unprocessed (optical density) and normalized absorbance values (calculated as a percentage positivity of a control), dispersion of values from the expected data range were estimated though plotting the location and deviation of the values. In addition, assay precision was estimated by plotting the distribution of coefficients of variation <10% of the IQCs. Binding ratios of various controls were calculated to estimate the assay proficiency with respect to the accuracy of assessing whether the IQC samples tested positive or negative in the test proper. The graphical analysis of dispersion of absorbance values in combination with assay precision and proficiency criteria were considered satisfactory to allow the evaluation of the operational performances of the ELISAs, and provide useful decision-making criteria for plate acceptance and rejection. The establishment of standardized and transparent IQC data charting methods for the indirect ELISAs provided an increased measure of confidence to national laboratories with respect to their reports on disease occurrence. Moreover, the relative assay performances among all laboratories were examined, using summary data charts, with reference to the performance criteria described. The IQC data were also examined using modified Youden plot analysis, demonstrating that indirect ELISA methods can be successfully applied at diagnostic laboratories in the tropics for monitoring trypanosomosis control programs.

UI MeSH Term Description Entries
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
D012015 Reference Standards A basis of value established for the measure of quantity, weight, extent or quality, e.g. weight standards, standard solutions, methods, techniques, and procedures used in diagnosis and therapy. Standard Preparations,Standards, Reference,Preparations, Standard,Standardization,Standards,Preparation, Standard,Reference Standard,Standard Preparation,Standard, Reference
D004797 Enzyme-Linked Immunosorbent Assay An immunoassay utilizing an antibody labeled with an enzyme marker such as horseradish peroxidase. While either the enzyme or the antibody is bound to an immunosorbent substrate, they both retain their biologic activity; the change in enzyme activity as a result of the enzyme-antibody-antigen reaction is proportional to the concentration of the antigen and can be measured spectrophotometrically or with the naked eye. Many variations of the method have been developed. ELISA,Assay, Enzyme-Linked Immunosorbent,Assays, Enzyme-Linked Immunosorbent,Enzyme Linked Immunosorbent Assay,Enzyme-Linked Immunosorbent Assays,Immunosorbent Assay, Enzyme-Linked,Immunosorbent Assays, Enzyme-Linked
D005060 Europe The continent north of AFRICA, west of ASIA and east of the ATLANTIC OCEAN. Northern Europe,Southern Europe,Western Europe
D000349 Africa The continent south of EUROPE, east of the ATLANTIC OCEAN and west of the INDIAN OCEAN.
D000818 Animals Unicellular or multicellular, heterotrophic organisms, that have sensation and the power of voluntary movement. Under the older five kingdom paradigm, Animalia was one of the kingdoms. Under the modern three domain model, Animalia represents one of the many groups in the domain EUKARYOTA. Animal,Metazoa,Animalia
D000913 Antibodies, Protozoan Immunoglobulins produced in a response to PROTOZOAN ANTIGENS. Protozoan Antibodies
D000953 Antigens, Protozoan Any part or derivative of any protozoan that elicits immunity; malaria (Plasmodium) and trypanosome antigens are presently the most frequently encountered. Protozoan Antigens

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