Download Package Insert - Sekisui Diagnostics

Contents
1
Intended Use ......................................................................................................................... 3
2
Diagnostic Relevance ............................................................................................................ 3
3
Test Principle......................................................................................................................... 4
4
Package Contents (IgG/IgM Testkit) ...................................................................................... 4
5
Storage and Shelflife of the Testkit and the ready to use reagents ....................................... 4
6
Precautions and Warnings .................................................................................................... 5
7
Material required but not supplied......................................................................................... 5
8
Test Procedure SERUM DI AGNOSTIC ................................................................................... 5
8.1
8.2
8.3
8.4
9
Test Evaluation SERUM DIAGNOSTIC ................................................................................... 6
9.1
9.2
9.3
9.4
10
Examination Material....................................................................................................................................................... 5
Preparation of Reagents ................................................................................................................................................. 5
Virotech ELISA Test Procedure....................................................................................................................................... 5
Usage of ELISA processors ............................................................................................................................................ 6
Test function control........................................................................................................................................................ 6
Calculation of the Vir otech Units (VE) ............................................................................................................................. 6
Interpretation Scheme IgG and IgM ................................................................................................................................ 8
Limits of the Test............................................................................................................................................................. 8
Performance Data SERUM DI AGNOSTI C ............................................................................... 8
10.2 Detection limits ................................................................................................................................................................ 10
10.3 Cross reactivity ................................................................................................................................................................ 10
10.4 Intra–assay coefficient of variation (repeatability) IgG and IgM........................................................................................ 11
10.5 Inter assay coefficient of variation (reproducibility) .......................................................................................................... 11
11
Performance Data CSF DIAGNOSTIC TESTING ................................................................... 12
11.1
11.2
11.3
11.4
Analytic al sensitivity ...................................................................................................................................................... 12
Analytic al specific ity ...................................................................................................................................................... 12
Intra-assay coefficient of variation (repeatability) .......................................................................................................... 12
Inter-assay coefficient of variation (reproducibility)........................................................................................................ 13
12
Literature ............................................................................................................................. 13
13
Test Procedure Scheme ...................................................................................................... 14
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CMV ELISA IgG/IgM GB
REV 9
Druckdatum 03.02.2014