BAG HISTO TYPE Rainbow QS6, Instructions For Use Manual

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EN Instructions for Use
HISTO TYPE Rainbow QS6
Test kit for the determination of HLA alleles on a molecular genetic basis
IVD

0123
REF 728221
Contents
1. INTENDED USE ...................................................................................................................... 2
2. PRODUCT DESCRIPTION ...................................................................................................... 2
3. TEST PRINCIPLE .................................................................................................................... 2
4. MATERIAL ............................................................................................................................... 3
4.1 Contents of the HISTO TYPE Rainbow QS6 kit ....................................................................... 3
4.2 Additionally required reagents and devices .............................................................................. 3
4.3 Validated real time-PCR Cycler ................................................................................................ 3
5. STORAGE AND STABILITY .................................................................................................... 4
6. TEST PROCEDURE ................................................................................................................ 4
6.1 Precautions and special remarks ............................................................................................. 4
6.2 DNA Isolation ........................................................................................................................... 4
6.3 Entering sample information into PlexTyper
®
Software ............................................................ 5
6.4 Amplification ............................................................................................................................ 5
6.5 Export of results from
QuantStudio™ 6 Flex System ............................................................... 9
6.6 Evaluation and interpretation of the results ............................................................................ 10
6.7 Import of the results file into the PlexTyper
®
software ............................................................ 11
7. WARNINGS AND DISPOSAL INSTRUCTIONS .................................................................... 12
8. KIT SPECIFICATIONS .......................................................................................................... 13
8.1.1 Diagnostic sensitivity and specificity ........................................................................ 13
8.1.2 Analytical sensitivity and measuring range .............................................................. 13
8.1.3 Analytical specificity / cross reactive substances ..................................................... 14
9. LIMITS OF THE METHOD ..................................................................................................... 14
10. INTERNAL QUALITY CONTROL ........................................................................................... 14
11. TROUBLESHOOTING ........................................................................................................... 15
12. TRADE NAMES USED .......................................................................................................... 15
13. EXPLANATION OF THE SYMBOLS USED ON THE LABELS .............................................. 16
14. LITERATURE ........................................................................................................................ 16
15. REVIEW HISTORY ................................................................................................................ 16
Version: 02/2021 / Issue: 2021-06