FTD Respiratory pathogens 21 - Mikrogen

Table of Contents
FTD Respiratory pathogens 21 version 3/ March 2012 english
FTD Respiratory pathogens 21
1. IDENTIFICATION OF THE MANUFACTURER ............................................... 3
2. IDENTIFICATION OF THE PRODUCT .......................................................... 3
3. INTENDED USE ........................................................................................... 3
4. PATHOGEN INFORMATION ........................................................................ 4
5. CONTENTS .................................................................................................. 6
6. PRECAUTIONS AND WARNINGS ................................................................ 7
6.1 SAFETY INFORMATIONS ................................................................................ 7
6.2 HANDLING REQUIREMENTS ............................................................................ 7
6.3 SAFE WASTE DISPOSAL ................................................................................. 7
7. STORAGE AND STABILITY CONDITIONS .................................................... 7
8. PRINCIPLE OF THE METHOD ...................................................................... 8
9. ADDITIONALLY REQUIRED EQUIPMENT .................................................... 8
10. SAMPLES .................................................................................................... 9
11. PROCEDURE ............................................................................................... 9
11.1 PRELIMINARY PROCEDURE WITH USING THE EASYMAG ....................................... 9
11.2 MAIN PCR SETUP PROCEDURE WITH USING THE AGPATH ONE-STEP RT-PCR KIT ... 10
12. PROGRAMMING OF THE THERMO CYCLER ............................................... 14
13. ASSAY VALIDATION ................................................................................. 15
14. CALCULATION OF THE RESULTS ON THE ABI 7500 .................................. 16
15. INTERPRETATION OF RESULTS ................................................................ 18
16. TROUBLESHOOTING ................................................................................ 20
17. VALIDATION ............................................................................................ 21
17.1. SPECIFICITY .................................................................................... 21
17.2. SENSITIVITY .................................................................................... 22
17.3. CLINICAL EVALUATION ........................................................................ 24
18. LEGEND OF SYMBOLS ............................................................................... 26
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