Instruction for Use HISTO TYPE Rainbow QS6
Version: 02/2021
Page 12 of 16
If the IAC amplification is deemed negative, or late due to O560 interference this can lead to no
result being found for the affected HLA gene locus. To automatically correct for this the thresholds
relating to the IAC have been modified for reactions where this phenomenon has been observed
(reactions 7, 20, 43, 52, 63, 84 & 85) so that correct genotypes can be generated automatically. The
software generates a message to inform the user about it.
It may still happen that the problem occurs in other reactions as well or that non-optimal shapes of
the amplification curve for other fluorophores result in a failure to generate an automatic result in
PlexTyper
®
. For a general procedure to deal with failed automatic generation of results please refer
to the PlexTyper
®
instructions for use (V4.X-1/2021
chapter 7.4.5 How to investigate ‘No results’ at
an HLA locus).
7.
WARNINGS AND DISPOSAL INSTRUCTIONS
HISTO TYPE Rainbow QS6 is
designed for in vitro diagnostic use
. The kit should only be used
by specially trained, qualified personnel. All work should be performed in accordance with Good
Laboratory Practice.
All materials of biological origin used in the test to obtain DNA (e.g. blood) should be considered as
potentially infectious. Therefore, appropriate safety precautions are recommended when handling
biological materials as required by Good Laboratory Practice standards.
Biological materials must be inactivated before disposal (e.g. by autoclaving). Disposable materials
must be autoclaved or incinerated after use.
Spilled potentially infectious material should be removed immediately with an absorbent paper towel
and the contaminated area disinfected with an appropriate disinfectant or 70% Ethanol. Material
used to remove spills must be inactivated before disposal (e.g. by autoclaving).
Disposal of all specimens, unused reagents and waste should be in accordance with the legislation
of the respective country and the local authorities.
