Instruction for Use HISTO TYPE Rainbow QS6
Version: 02/2021
Page 4 of 16
5.
STORAGE AND STABILITY
The kits are shipped on blue ice. All reagents must be stored at
≤ -20°C in temperature-controlled
devices. The expiry date is indicated on the label of each reagent. The expiry date indicated on the
outer label refers to the reagent with the shortest stability contained in the kit. The freeze-thaw cycle
testing has shown that up to 12 cycles for the Plex Mix has no detrimental effects on the quality of
the kit.
6.
TEST PROCEDURE
6.1
Precautions and special remarks
Molecular genetic techniques are extremely sensitive methods and should only be performed by
qualified personnel with experience in molecular genetic techniques.
Special precautions must be met to avoid contamination and thus false reactions:
◆
Wear suitable gloves (preferably powder-free) during work.
◆
Use tips with filter insert or integrated stamp.
◆
Work in two different areas for pre-amplification (DNA-isolation, preparation of the reactions)
and post-amplification (detection); use two separate rooms if possible.
◆
Use devices and other materials only at the respective workplaces and do not exchange them.
6.2
DNA Isolation
The specimen material for the isolation of the genomic DNA must be sent in appropriate collection
systems. For genomic material from whole blood use only EDTA or citrate anticoagulants. The
presence of heparin may potentially inhibit the PCR reaction (2), therefore such collection systems
are not suitable and must not be used. It is recommended to use
IvD certified kits for the DNA
isolation.
Validated DNA Extraction Kits:
•
Qiagen QIAamp DNA Blood Kits (columns)
Both, the manual isolation and automated DNA isolation (QIAcube) are validated.
If the standard method established in the laboratory shall be applied for isolation of gDNA without
using one of the specified test kits, it must be validated by the user.
The HISTO TYPE Rainbow QS6 test requires 10
– 20 ng DNA per well. The purity indices must be
in the following range:
•
OD
260
/ OD
280
=
1,5 and < 2,0
Higher values are an indicator for the presence of RNA, lower values
indicate protein contamination.
•
OD
260
/ OD
230
=
> 1,8
Lower values indicate contamination with carbohydrates, salts or
organic solvents.
