[Development of a validation method for readers of ELISA microplates]. 1995

F Durand, and B Genetet
Centre Régional de Transfusion Sanguine de Rennes.

The results, either positive or negative, of the ELISA tests performed on blood donors to detect viral markers, are always validated by reading microplates on photometers. In Rennes, these microplates can be read on MR 7000 (Dynatech) or IEMS (Labsystems) photometers. This step, the last one in the technical sequence, conditions the results. Regular checking of the photometers therefore may enhance the quality of the testing sequence. To check the quality of the photometers, we use a 96-well microplate, the "Universal Calibration Test Plate" marketed by BIO-TEK Instruments USA. The plate includes 8 blank wells, 6 wells equipped with glass filters (3 stained and 3 unstained). This plate comes with a table showing the optical density in relation to the wavelength. We first verify the repeatability of each photometer, and secondly, verify accuracy. The plate also permits verifying the linearity of each photometer. In view of the results, we were able to state that both photometers were accurate, since the results obtained were compatible with an optical density of +/- 0.024 +/- 1%. Do. The tests are repeatable, with a variation coefficient below 0.5%, linearity was verified (r: 0.999 for both photometers). Reading the plate only takes a few minutes and permits daily control of the photometers. It only requires that the test results be reported on a control card to follow-up possible deviations, and technical maintenance can thus be carried out immediately.

UI MeSH Term Description Entries
D010783 Photometry Measurement of the various properties of light. Photometries
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
D002138 Calibration Determination, by measurement or comparison with a standard, of the correct value of each scale reading on a meter or other measuring instrument; or determination of the settings of a control device that correspond to particular values of voltage, current, frequency or other output. Calibrations
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
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D015203 Reproducibility of Results The statistical reproducibility of measurements (often in a clinical context), including the testing of instrumentation or techniques to obtain reproducible results. The concept includes reproducibility of physiological measurements, which may be used to develop rules to assess probability or prognosis, or response to a stimulus; reproducibility of occurrence of a condition; and reproducibility of experimental results. Reliability and Validity,Reliability of Result,Reproducibility Of Result,Reproducibility of Finding,Validity of Result,Validity of Results,Face Validity,Reliability (Epidemiology),Reliability of Results,Reproducibility of Findings,Test-Retest Reliability,Validity (Epidemiology),Finding Reproducibilities,Finding Reproducibility,Of Result, Reproducibility,Of Results, Reproducibility,Reliabilities, Test-Retest,Reliability, Test-Retest,Result Reliabilities,Result Reliability,Result Validities,Result Validity,Result, Reproducibility Of,Results, Reproducibility Of,Test Retest Reliability,Validity and Reliability,Validity, Face
D016014 Linear Models Statistical models in which the value of a parameter for a given value of a factor is assumed to be equal to a + bx, where a and b are constants. The models predict a linear regression. Linear Regression,Log-Linear Models,Models, Linear,Linear Model,Linear Regressions,Log Linear Models,Log-Linear Model,Model, Linear,Model, Log-Linear,Models, Log-Linear,Regression, Linear,Regressions, Linear

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