i.Mune™ TBNK [CE] a quantitative in vitro test to determine the percentages and absolute counts of human lymphocyte subsets in liquid venous whole blood.
i.Mune™ TBNK [CE] allows the epigenetic quantification of:
Contents:
i.Mune™ TBNK [CE] is comprised of the three (3) separate kits:
In addition, we'll provide a Data Analysis Tool (MS-Excel based)
Sample requirements:
Quantification of T-/B- and NK lymphocytes can be useful for*:
Please inquire to obtain a customized proposal:
*The above clinical applications have been established using technologies currently being employed in clinical laboratory routine (e.g. flow cytometry).
Performance Characteristics:
Performance characteristics of i.Mune™ TBNK [CE] were determined according to CLSI guidelines.
Repeatability (single-site) | CV < 12,5% |
Within Laboratory Precision (single-site) |
CV < 25% |
Reproducibility (multi-site) |
CV < 25% |
Within Laboratory Precision (multi-site) |
CV < 25% |
Linearity |
10 - 40 µl venous whole blood |
Limit of Quantification |
< 100 copies |
Reliability |
99% |
Interference |
No interference with bilirubin (0,4 mg/ml), |
Clinical Performance:
Clinical performance of i.Mune™ TBNK [CE] was evaluated according to DIN EN 13612. For this 113 liquid venous whole blood samples from self-declared healthy donors were prospectively collected in K2-EDTA blood collection tubes. Epigenetic data of 112 test samples analysed with i.Mune™ TBNK [CE] were compared to flow cytometry data using the Spearman correlation coefficient (Spearman r) for each assay (% and cells/μl).
Assay | Spearman r | p value |
CD3 cells/µl | 0.82 | <0.0001 |
CD4 cells/µl | 0.70 | <0.0001 |
CD8 cells/µl | 0.55 | <0.0001 |
BLC cells/µl | 0.79 | <0.0001 |
NKC cells/µl | 0.70 | <0.0001 |
Leukocytes/µl | 0.70 | <0.0001 |
CD3 % of Leukocytes | 0.85 | <0.0001 |
CD4 % of Leukocytes | 0.76 | <0.0001 |
CD8 % of Leukocytes | 0.53 | <0.0001 |
BLC % of Leukocytes | 0.86 | <0.0001 |
NKC % of Leukocytes | 0.78 | <0.0001 |
Comparison i.Mune™ TBNK [CE] with flow cytometry
(n=112 self declared healthy adult donors)
r = 0.90
r = 0.96