Instruction for Use HISTO TYPE Rainbow QS6
Version: 02/2021
Page 13 of 16
Microbial contamination of reagents while taking aliquots should be avoided. The use of sterile
disposable pipettes and pipette tips is recommended. Do not use reagents looking cloudy or
showing signs of microbial contamination.
A Material Safety Data Sheet (MSDS), respectively a declaration on Material Safety Data Sheets is
available for download at
8.
KIT SPECIFICATIONS
The combination of primers and probes allows the determination of human HLA class I and II alleles
according to lot-specific data (low to medium resolution, detection of all alleles with the exception of
single rare alleles). The accuracy and reproducibility of the reactivity of the test kit is checked for
each lot with control specimens with known HLA-alleles. The kit determines the HLA-Loci A, B, C,
DRB1, DRB3, DRB4, DRB5, DQA1, DQB1, DPA1 and DPB1.
8.1 SPECIFIC PERFORMANCE CHARACTERISTICS
8.1.1 Diagnostic sensitivity and specificity
A total of 116 DNA samples pre-typed for the relevant HLA loci or international reference cell lines
were tested with the HISTO TYPE Rainbow QS6 kit to show the correct reactivity. There was a
100% concordance of results with the pre-typings for all loci.
Locus
Number of sample pre-typed for the locus
concordant
% concordance
A
116
116
100%
B
116
116
100%
C
116
116
100%
DRB1
115
115
100%
DRB3
113
113
100%
DRB4
113
113
100%
DRB5
113
113
100%
DQA1
114
114
100%
DQB1
114
114
100%
DPA1
113
113
100%
DPB1
114
114
100%
8.1.2 Analytical sensitivity and measuring range
Validation tests have shown that variation of the amount of DNA from 8 ng to 30 ng per reaction has
no significant effect on the specific detection of HLA alleles.
