Influenza V 14-deu - virion\serion

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Pos: 39 /Ar bei tsanl eitungen ELISA cl assic/Gültig für all e D okumente/ELISA classic/T estauswertung/Automatische Auswer tung @ 4\mod_1255347464244_18.doc @ 21352 @ 3Method 2:Pos: 38 /Ar bei tsanl eitungen ELISA cl assic/Gültig für all e D okumente/ELISA classic/T estauswertung/Testauswertung: Methode 2 (für alle T ests) @ 4\mod_1255348201981_18.doc @ 21416 @Continuous Determination of Antibody Activities using the Standard CurveSo called interassay variations (day to day deviations and laboratory to laboratorydeviations) are compensated by multiplication of the current measured value obtained witha patient’s sample with the correction factor F. This factor is calculated as follows:F =OD-reference value (of standard serum)OD-current value (of standard serum)ENEL ENThe procedure is necessary to adjust the current test level of the user with the lot-specificstandard curve. First, daily deviations have to be corrected by calculating the correctionfactor F.1. The mean of the two OD-values of the standard serum has to be calculated andchecked that it is within the given validity range.2. Calculation of the factor F: the given reference value is divided by the mean of theextinction of the standard serum:F = reference value extinction STD serum / mean value extinction STD serum.3. All measured values of patient’s samples are multiplied by F.4. Antibody activities in IU/ml or U/ml can be determined from the standard curve withthe corrected values.CS PTenglish 17
Pos: 40 /Ar bei tsanl eitungen ELISA cl assic/Gültig für all e D okumente/ELISA classic/T estauswertung/Quantifi zierungsgrenzen @ 6\mod_1258098664276_18.doc @ 24400 @ 2Pos: 41 /Ar bei tsanl eitungen ELISA cl assic/Gültig für mehrer e D okumente/T estauswertung/Grenzwertber eich ( für T este mehrerer Ig-Klassen) @ 9\mod_1276070736543_18.doc @ 32155 @ 2Pos: 43 /Ar bei tsanl eitungen ELISA cl assic/Gültig für all e D okumente/ELISA classic/T estauswertung/Kapi tel überschrift: Interpretation der Ergebnisse @ 0\mod_1190013774869_18.doc @ 9940 @ 28.3.2 Automatic Test Evaluation with Software SERION evaluateAfter input of the four parameters and the reference value of the standard serum, antibodyactivities are calculated online from processed and measured SERION ELISA classic testruns by the evaluation software SERION evaluate.If the optical density of the standard is out of the validity range, the following message willappear.„Standard values out of ranges in following groups: Group 1-24.” or„Standard values differ more than 20 % in following groups: Group 1-24.”In these cases the test run is invalid and should be repeated.Parameters and reference value need to be changed only if there is a change of lot(evaluation table shows parameters and reference values). Correct input of the lot specificdata can be checked on the basis of the standard serum activity (in IU/ml or U/ml)assigned to the standard serum. The calculated mean value of the units has to correspondto the unit value indicated on the lot specific certificate. There is an automatic correction ofthe measured values. In the standard version the printout displays the following:Sample codeOD-valueIU/ml or U/mlEvaluation8.4 Limits of QuantificationThe limits of quantification are specified on the quality control certificate of the SERIONELISA classic test. The linearity of dilution within this range has been demonstrated incomprehensive evaluation studies. In case a patient sample shows a test result above theupper limit of quantification, the sample may be tested at a higher dilution. The therebydetermined antibody activity must be multiplied by the additional dilution factor.8.5 Borderline RangesThe borderline ranges of the SERION ELISA classic Influenza A/B Virus IgA/IgG/IgM testsare specified on the quality control certificates and indicate the range for borderline testresults. Values obtained, when testing a patient’s sample, which fall below this rangeindicate a negative test result; values above the borderline range are interpreted positive.In cases where the results are within the borderline range a definitive interpretation of theresult is not possible. In such cases, the test should be repeated in parallel with a follow-upsample taken one to two weeks later (serum pair).Pos: 42 /Ar bei tsanl eitungen ELISA cl assic/Gültig für nur ein D okument/Testauswertung/Influenza/Influenza: Gr enzwertbereiche - Zusatz @ 11\mod_1329740407994_18.doc @ 50520 @The SERION ELISA classic Influenza A/B Virus IgA/IgG test contains two quality controlcertificates with alternative borderline ranges for adults and children.english 18
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Influenza V 14-deu - virion\serion

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