SERION ELISAclassic - virion\serion

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Pos: 31 /Ar bei tsanl eitungen ELISA cl assic/Gültig für all e D okumente/ELISA classic/T estdurchführung/Positi vkontroll e / Richtigkeitskontroll e @ 8\mod_1260286311409_18.doc @ 27530 @ 2 Pos: 32 /Ar bei tsanl eitungen ELISA cl assic/Gültig für all e D okumente/ELISA classic/T estauswertung/Kapi tel überschrift: TESTAU SWER TUNG + Erreg er @ 1\mod_1197038305478_18.doc @ 11386 @ 1 7.6 Automated Test Procedure EN SERION ELISA are suited for processing on automats and evaluated for use with Immunomat TM as well as with DYNEX DSX ® and DS2 ® . The automated processing is performed analogous to manual use. Please note, that under special working-conditions internal laboratory adaptations of the incubation times may be necessary. 7.7 Positive Control / Accuracy Control For the periodic verification of the test method, in order to fulfil the requirements of laboratory internal quality management systems, we recommend using SERION ELISA controls to determine precision and accuracy of SERION ELISA classic test runs. The use of SERION ELISA controls is described in specific instruction manuals. english 13
Pos: 34 /Ar bei tsanl eitungen ELISA cl assic/Gültig für all e D okumente/ELISA classic/T estauswertung/Testauswertung: Testgültig kei tskriterien @ 4\mod_1255348317229_18.doc @ 21432 @ 2 8 TEST EVALUATION SERION ELISA classic Echovirus IgA/IgG/IgM Pos: 33 /Ar bei tsanl eitungen ELISA cl assic/Gültig für all e D okumente/ELISA classic/T estauswertung/Testauswertung: Ei n-Punkt-Quantifizi erung @ 4\mod_1255348099107_18.doc @ 21400 @ 2 8.1 Single-Point Quantification with the 4PL Method Optimised assignment of extinction signals to quantitative values is guaranteed by using non-linear functions, which adjust a sigmoide curve without any further transformation to OD-values. Determination of antibody concentrations with the SERION ELISA classic is carried out by the 4 parameter logistic-log-model (4 PL) which is ideal for exact curvefitting. It is based on the formula: OD = A + 1 + e D - A B(C - ln Conc.) The parameters A, B, C, and D are representative for the exact shape of the curve: 1. lower asymptote parameter A 2. slope of the curve parameter B 3. turning point parameter C 4. upper asymptote parameter D For each lot the standard curve is evaluated by Institut Virion\Serion GmbH (Würzburg, Germany) in repeated test runs under optimal conditions. Time consuming and cost intensive construction of the standard curve by the user is not necessary. For evaluation of antibody concentrations a lot specific standard curve as well as a lot specific evaluation table is included with each SERION ELISA classic test kit. The evaluation software SERION evaluate as well as the Microsoft ® Excel-based software tool SERION activity are available on request. To compensate for normal test variations and also for test run control a standard serum is used in each individual test run. For this control serum a reference value with a validity range is determined by the quality control of the producer. Within this range a correct quantification of antibody concentration is ensured. english 14
Page 1 and 2: Manufacturer Fabricante Κατασ
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Page 5 and 6: 4 KIT COMPONENTS Test Components Pi
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Page 27 and 28: 4 COMPONENTES DEL KIT Componentes d
Page 35 and 36: 7.5 Procedimiento manual 1. Coloque
Page 43 and 44: 9.2 Reproducibilidad Pos: 50 /Ar be
Page 45 and 46: === Ende der Liste für T extmar ke
Page 49 and 50: 4 ΠΕΡΙΕΧΟΜΕΝΟ ΚΑΙ Σ
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9.2 Επαναληψιµότητα
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=== Ende der Liste für T extmar ke
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Pos: 1 /Arbeitsanl eitung en ELISA
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4 COMPONENTES DO KIT Componentes do
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Pos: 12 /Ar bei tsanl eitungen ELIS
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7.5 Realização do teste pelo mét
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9.2 Reprodutibilidade Pos: 50 /Ar b
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Pos: 1 /Arbeitsanl eitung en ELISA
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4 SLOŽENÍ KITU Složky testu Odd
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7.5 Postup při ručním zpracován
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AK CAG STD POS C/O NEG APC Antikör
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SERION ELISA classic 102 Masern Vir
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