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Validation of the analytical methodsValidation here means the testing of theperformance capacity of a given analyticalmethod. The characteristic data of the methodobtained in our development laboratories –measuring range, limit of detection, accuracy,selectivity, sensitivity, calibration function, androbustness of the method – are all documented.These data are quality characteristics andform the basis for quality assurance in routineanalysis.Certificate for the suitability ofSpectroquant ® test kits for self-monitoringThe characteristic method data for each testkit, determined according to standardizedprocedures, are summarized in a quality certificate.This certificate guarantees the consistentquality of all batches that have been suppliedto customers so far. Both the quality certificatesas well as batch certificates for eachSpectroquant ® test kit can be accessed on theweb at http://photometry.merck.de.Quality of the Spectroquant ® photometersMeasuring rangeWorking range within which the methodyields reliable results.The same principles also apply to the productionof the photometers. Each instrument is accompaniedby a test report that not only documentsthe optical tests (photometric accuracy, linearity,reproducibility, wavelength accuracy), but alsoconfirms the electrical safety.Sensitivityindicates the degree to which a resultchanges relative to the signal of themeasurement system. This can be shownin quantitative terms by the gradient ofthe calibration curve.Lower Limit of Detection (LLD)the smallest content of an analyte,the result for which may be taken asindicating the presence of the analytewith a sufficient statistical probability.Method Detection Limit (MDL)is that content of an analyte, the resultfor which may be taken as indicatingthe presence of the analyte with a highstatistical probability (equivalent to thelower limit of the measuring range).Confidence intervalEvery measurement value bears therisk of error, even the results for thecalibration curve. The confidenceinterval expresses the range in whichthe “true” curve lies.Standard deviation of the methodabsolute measure of the precision.Coefficient of variation for the methodrelative measure of the precision.Accuracymeasure for the approximation of theresult to the “true” value, a summaricalterm for precision and accuracy.23