ClearLLab 10-Color Panel Performance: Lot-to-Lot Reproducibility
Li Yang, Jin Zhang, Lidice Lopez Research and Development, Beckman Coulter Life Sciences, Miami, FL 33196
Introduction
ClearLLab 10C* Panels are composed of 4 multicolor tubes (T, B, M1 and M2 Cell Tubes) directed against lymphoid and myeloid lineage antigens in a ready-to-use unitized dry format. Each tube is composed of 10 monoclonal or polyclonal antibody reagents specific for different cell surface antigens, and each conjugated to a distinct fluorochrome. The purpose of this study is to assess the lot-to-lot variability for each of the 4 ClearLLab 10C* Panels. The percent positive values were collected for each marker/population and the reproducibility (%CV) of each marker was assessed and compared against acceptance criteria.
Methods
Three (3) normal whole blood specimen were tested, each in triplicate on three (3) lots of each of the four (4) ClearLLab 10C* Panels. To address markers that are not usually expressed in normal specimens, alternate cells/cell lines were utilized: Basophil cells were used to assess CD123; Granulocytes were used to assess CD10; KG1a cell line was spiked into normal blood specimens for CD34 evaluation; Mo7e cell line was spiked into normal blood specimens for CD117 evaluation. The data was acquired on a Navios flow cytometer instrument. Data was analyzed using Kaluza C software and the percent positive values were assessed for each marker/population. Variance components were estimated for each source of variability per sample. Sample variability was estimated as the sum of repeatability and between-lot variability. Standard deviation (SD) and coefficient of variation (%CV) were calculated from variance component estimates. Within Sample variability (%CV) was compared to the acceptance criteria for reproducibility (≤20%).
Materials
- The normal human whole blood specimens were provided by the Beckman Coulter in-house donor program.
- The KG1a and Mo7e cell lines were internal products of Beckman Coulter
| PANEL REAGENTS | PN # | LOT# | DOM |
|---|---|---|---|
| ClearLLab 10C B cell tube | B96805 | 220617 | 6/22/2017 |
| 70917 | 9/7/2017 | ||
| 070917_08 | 9/7/2017 | ||
| ClearLLab 10C T cell tube | B96806 | 230617 | 6/23/2017 |
| 120717 | 7/12/2017 | ||
| 130717 | 7/13/2017 | ||
| ClearLLab 10C M1 cell tube | B96807 | 50717 | 7/5/2017 |
| 180717 | 7/18/2017 | ||
| 190717 | 7/19/2017 | ||
| ClearLLab 10C M2 cell tube | B96808 | 60717 | 7/6/2017 |
| 200717 | 7/20/2017 | ||
| 210717 | 7/21/2017 |
Table 1. ClearLLab 10C* Panels
| 405 nm | 488 nm | 633 nm | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ClearLLab 10C Panels | PB1 | Krome Orange | FITC | PE | ECD | PC5.5 | PC7 | APC | APC-A7002 | APC-A7503 |
| B Cell Tube | CD19 | CD45 | kappa | lambda | CD10 | CD5 | CD200 | CD34 | CD38 | CD20 |
| T Cell Tube | CD3 | CD45 | TCRγδ | CD4 | CD2 | CD56 | CD5 | CD34 | CD7 | CD8 |
| M1 Cell Tube | CD11b | CD45 | CD16 | CD7 | CD10 | CD13 | CD64 | CD34 | CD14 | HLA-DR |
| M2 Cell Tube | CD19 | CD45 | CD15 | CD123 | CD117 | CD13 | CD33 | CD34 | CD38 | HLA-DR |
1Pacific Blue. 2APC-Alexa Fluor 700. 3APC-Alexa Fluor 750.
Table 2. List of Markers/Antigens and cell Population being assessed
| CELL POPULATION | B CELL TUBE | T CELL TUBE | M1 CELL TUBE | M2 CELL TUBE |
|---|---|---|---|---|
| KG1a Cell Line | CD34 | CD34 | CD34 | CD34 |
| Mono | CD38 | CD64, CD14, CD11b, HLA-DR | CD38 | |
| Grans | CD10 | CD16, CD13, CD10 | CD15, CD13, CD33 | |
| Lymph | Kappa, Lambda, CD19, CD5, CD20, CD200 | CD3, CD4, CD8, CD2, CD5, CD7, TCRγδ, CD56 | CD7 | CD19 |
| Basophil | CD123 | |||
| Mo7e | CD117 |
Table 3: Markers/populations* assessed for percentage positive
| NUMBER | B CELL TUBE | T CELL TUBE | M1 CELL TUBE | M2 CELL TUBE |
|---|---|---|---|---|
| 1 | CD34+ / CD45+ | CD34+ / CD45+ | CD34+ / CD45+ | CD34+ / CD45+ |
| 2 | CD19+ / Lymph | CD3+ / Lymph | CD10+ / Leukocyte | CD19+ / Lymph |
| 3 | Kappa+ / CD19+ | CD8-CD4+ / CD3+ | CD7+ / Leukocyte | CD13+ / Leukocyte |
| 4 | Lambda+ / CD19+ | CD8+CD4- / CD3+ | CD13+ / Leukocyte | CD15+ / Leukocyte |
| 5 | CD19-CD5+ / Lymph | CD2+ / Lymph | CD16+ / Leukocyte | CD33+ / Leukocyte |
| 6 | CD19+CD20+ / Lymph | CD5+ / Lymph | CD64+ / Leukocyte | CD38+ / Leukocyte |
| 7 | CD19+CD200+ / Lymph | CD7+ / Lymph | CD14+ / Leukocyte | HLA-DR+ / Leukocyte |
| 8 | CD38+ / Leukocyte | CD3+TCRγδ+ / Lymph | HLA-DR+ / Leukocyte | CD123+ / Leukocyte |
| 9 | CD10+ / Leukocyte | CD3-CD56+ / Lymph | CD11b+ / Leukocyte | CD117+ / CD45+ |
* List as marker/input gate; Leukocyte=CD45+CD34-
Table 4. %CV for B Cell Tube by donor
For Table 4 to Table 9, “P”=Percentage; CV% of “Within Sample” indicated reproducibility of each marker per specimen.
| SPECIMEN: 147328 | Repeatability | Between Lots | Within sample | Spec (% CV) | Conclusion | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Marker / Population | Unit | N | Mean | SD | CV% | SD | CV% | SD | CV% | ||
| CD10p | % | 9 | 77.97 | 0.38 | 0.49 | 0.37 | 0.48 | 0.54 | 0.69 | ≤ 20 | Pass |
| CD19p | % | 9 | 12.12 | 0.36 | 2.99 | 0.00 | 0.00 | 0.36 | 2.99 | ≤ 20 | Pass |
| CD200p | % | 9 | 8.43 | 0.73 | 8.72 | 0.00 | 0.00 | 0.73 | 8.72 | ≤ 20 | Pass |
| CD20p | % | 9 | 11.72 | 0.34 | 2.92 | 0.00 | 0.00 | 0.34 | 2.92 | ≤ 20 | Pass |
| CD34p | % | 9 | 8.06 | 0.37 | 4.61 | 0.00 | 0.00 | 0.37 | 4.61 | ≤ 20 | Pass |
| CD38p | % | 9 | 7.17 | 0.28 | 3.85 | 0.00 | 0.00 | 0.28 | 3.85 | ≤ 20 | Pass |
| CD5p | % | 9 | 64.03 | 0.41 | 0.64 | 0.45 | 0.70 | 0.61 | 0.95 | ≤ 20 | Pass |
| Kappap | % | 9 | 61.96 | 1.60 | 2.58 | 0.00 | 0.00 | 1.60 | 2.58 | ≤ 20 | Pass |
| Lambdap | % | 9 | 37.87 | 1.64 | 4.33 | 0.00 | 0.00 | 1.64 | 4.33 | ≤ 20 | Pass |
| SPECIMEN: 147446 | Repeatability | Between Lots | Within sample | Spec (% CV) | Conclusion | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Marker / Population | Unit | N | Mean | SD | CV% | SD | CV% | SD | CV% | ||
| CD10p | % | 9 | 49.19 | 1.36 | 2.76 | 0.16 | 0.33 | 1.36 | 2.77 | ≤ 20 | Pass |
| CD19p | % | 9 | 13.15 | 0.74 | 5.64 | 0.00 | 0.00 | 0.74 | 5.64 | ≤ 20 | Pass |
| CD200p | % | 9 | 10.90 | 0.48 | 4.37 | 0.34 | 3.13 | 0.59 | 5.37 | ≤ 20 | Pass |
| CD20p | % | 9 | 13.10 | 0.74 | 5.64 | 0.00 | 0.00 | 0.74 | 5.64 | ≤ 20 | Pass |
| CD34p | % | 9 | 13.97 | 0.51 | 3.65 | 0.27 | 1.94 | 0.58 | 4.14 | ≤ 20 | Pass |
| CD38p | % | 9 | 5.70 | 0.41 | 7.25 | 0.12 | 2.07 | 0.43 | 7.54 | ≤ 20 | Pass |
| CD5p | % | 9 | 70.78 | 0.40 | 0.56 | 0.36 | 0.52 | 0.54 | 0.76 | ≤ 20 | Pass |
| Kappap | % | 9 | 51.73 | 1.53 | 2.95 | 0.00 | 0.00 | 1.53 | 2.95 | ≤ 20 | Pass |
| Lambdap | % | 9 | 48.22 | 1.53 | 3.18 | 0.00 | 0.00 | 1.53 | 3.18 | ≤ 20 | Pass |
| SPECIMEN: 148383 | Repeatability | Between Lots | Within sample | Spec (% CV) | Conclusion | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Marker / Population | Unit | N | Mean | SD | CV% | SD | CV% | SD | CV% | ||
| CD10p | % | 9 | 52.87 | 4.26 | 8.05 | 0.00 | 0.00 | 4.26 | 8.05 | ≤ 20 | Pass |
| CD19p | % | 9 | 8.90 | 0.59 | 6.61 | 0.27 | 3.06 | 0.65 | 7.28 | ≤ 20 | Pass |
| CD200p | % | 9 | 7.57 | 0.41 | 5.42 | 0.11 | 1.44 | 0.42 | 5.61 | ≤ 20 | Pass |
| CD20p | % | 9 | 8.82 | 0.59 | 6.67 | 0.34 | 3.86 | 0.68 | 7.71 | ≤ 20 | Pass |
| CD34p | % | 9 | 14.37 | 1.06 | 7.38 | 0.06 | 0.39 | 1.06 | 7.39 | ≤ 20 | Pass |
| CD38p | % | 9 | 5.82 | 0.70 | 12.10 | 0.28 | 4.90 | 0.76 | 13.06 | ≤ 20 | Pass |
| CD5p | % | 9 | 66.72 | 1.57 | 2.35 | 0.00 | 0.00 | 1.57 | 2.35 | ≤ 20 | Pass |
| Kappap | % | 9 | 62.02 | 1.30 | 2.09 | 0.00 | 0.00 | 1.30 | 2.09 | ≤ 20 | Pass |
| Lambdap | % | 9 | 37.93 | 1.29 | 3.41 | 0.00 | 0.00 | 1.29 | 3.41 | ≤ 20 | Pass |
Table 5: %CV for T Cell Tube by donor
| SPECIMEN: 147328 | Repeatability | Between Lots | Within sample | Spec (% CV) | Conclusion | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Marker / Population | Unit | N | Mean | SD | CV% | SD | CV% | SD | CV% | ||
| CD2p | % | 9 | 74.73 | 0.33 | 0.44 | 0.28 | 0.37 | 0.43 | 0.58 | ≤ 20 | Pass |
| CD34p | % | 9 | 7.66 | 0.25 | 3.28 | 0.00 | 0.00 | 0.25 | 3.28 | ≤ 20 | Pass |
| CD3p | % | 9 | 64.95 | 0.52 | 0.80 | 0.00 | 0.00 | 0.52 | 0.80 | ≤ 20 | Pass |
| CD4p | % | 9 | 62.13 | 0.41 | 0.65 | 0.58 | 0.93 | 0.70 | 1.13 | ≤ 20 | Pass |
| CD5p | % | 9 | 65.37 | 0.53 | 0.82 | 0.00 | 0.00 | 0.53 | 0.82 | ≤ 20 | Pass |
| CD7p | % | 9 | 82.46 | 0.27 | 0.33 | 0.17 | 0.21 | 0.32 | 0.39 | ≤ 20 | Pass |
| CD8p | % | 9 | 29.18 | 0.26 | 0.90 | 0.38 | 1.31 | 0.46 | 1.59 | ≤ 20 | Pass |
| TCRγδp | % | 9 | 5.69 | 0.27 | 4.83 | 0.00 | 0.00 | 0.27 | 4.83 | ≤ 20 | Pass |
| SPECIMEN: 147446 | Repeatability | Between Lots | Within sample | Spec (% CV) | Conclusion | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Marker / Population | Unit | N | Mean | SD | CV% | SD | CV% | SD | CV% | ||
| CD2p | % | 9 | 80.57 | 0.48 | 0.59 | 0.00 | 0.00 | 0.48 | 0.59 | ≤ 20 | Pass |
| CD34p | % | 9 | 14.72 | 0.49 | 3.34 | 0.31 | 2.10 | 0.58 | 3.94 | ≤ 20 | Pass |
| CD3p | % | 9 | 70.36 | 0.41 | 0.58 | 0.00 | 0.00 | 0.41 | 0.58 | ≤ 20 | Pass |
| CD4p | % | 9 | 71.18 | 0.37 | 0.52 | 0.19 | 0.27 | 0.41 | 0.58 | ≤ 20 | Pass |
| CD5p | % | 9 | 71.34 | 0.45 | 0.63 | 0.00 | 0.00 | 0.45 | 0.63 | ≤ 20 | Pass |
| CD7p | % | 9 | 80.34 | 0.53 | 0.65 | 0.00 | 0.00 | 0.53 | 0.65 | ≤ 20 | Pass |
| CD8p | % | 9 | 23.86 | 0.34 | 1.42 | 0.19 | 0.80 | 0.39 | 1.63 | ≤ 20 | Pass |
| TCRγδp | % | 9 | 1.96 | 0.06 | 2.95 | 0.00 | 0.00 | 0.06 | 2.95 | ≤ 20 | Pass |
| SPECIMEN: 148383 | Repeatability | Between Lots | Within sample | Spec (% CV) | Conclusion | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Marker / Population | Unit | N | Mean | SD | CV% | SD | CV% | SD | CV% | ||
| CD2p | % | 9 | 85.78 | 0.29 | 0.34 | 0.17 | 0.19 | 0.33 | 0.39 | ≤ 20 | Pass |
| CD34p | % | 9 | 14.77 | 0.42 | 2.85 | 0.00 | 0.00 | 0.42 | 2.85 | ≤ 20 | Pass |
| CD3p | % | 9 | 69.78 | 0.17 | 0.25 | 0.36 | 0.51 | 0.40 | 0.57 | ≤ 20 | Pass |
| CD4p | % | 9 | 49.78 | 0.41 | 0.82 | 0.00 | 0.00 | 0.41 | 0.82 | ≤ 20 | Pass |
| CD5p | % | 9 | 67.80 | 0.29 | 0.43 | 0.21 | 0.30 | 0.36 | 0.53 | ≤ 20 | Pass |
| CD7p | % | 9 | 75.10 | 0.35 | 0.47 | 0.57 | 0.77 | 0.68 | 0.90 | ≤ 20 | Pass |
| CD8p | % | 9 | 44.93 | 0.43 | 0.96 | 0.00 | 0.00 | 0.43 | 0.96 | ≤ 20 | Pass |
| TCRγδp | % | 9 | 3.74 | 0.12 | 3.26 | 0.02 | 0.43 | 0.12 | 3.29 | ≤ 20 | Pass |
Table 6: %CV for M1 Cell Tube by donor
| SPECIMEN: 147328 | Repeatability | Between Lots | Within sample | Spec (% CV) | Conclusion | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Marker / Population | Unit | N | Mean | SD | CV% | SD | CV% | SD | CV% | ||
| CD10p | % | 9 | 78.17 | 0.60 | 0.77 | 0.00 | 0.00 | 0.60 | 0.77 | ≤ 20 | Pass |
| CD11bp | % | 9 | 7.31 | 0.26 | 3.61 | 0.00 | 0.00 | 0.26 | 3.61 | ≤ 20 | Pass |
| CD13p | % | 9 | 78.10 | 0.62 | 0.80 | 0.00 | 0.00 | 0.62 | 0.80 | ≤ 20 | Pass |
| CD14p | % | 9 | 7.45 | 0.27 | 3.66 | 0.00 | 0.00 | 0.27 | 3.66 | ≤ 20 | Pass |
| CD16p | % | 9 | 75.57 | 0.58 | 0.76 | 0.00 | 0.00 | 0.58 | 0.76 | ≤ 20 | Pass |
| CD34p | % | 9 | 8.48 | 0.27 | 3.16 | 0.00 | 0.00 | 0.27 | 3.16 | ≤ 20 | Pass |
| CD64p | % | 9 | 7.10 | 0.27 | 3.88 | 0.00 | 0.00 | 0.27 | 3.88 | ≤ 20 | Pass |
| CD7p | % | 9 | 10.92 | 0.26 | 2.39 | 0.00 | 0.00 | 0.26 | 2.39 | ≤ 20 | Pass |
| HLA-DRp | % | 9 | 6.75 | 0.27 | 4.05 | 0.20 | 2.91 | 0.34 | 4.99 | ≤ 20 | Pass |
| SPECIMEN: 147446 | Repeatability | Between Lots | Within sample | Spec (% CV) | Conclusion | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Marker / Population | Unit | N | Mean | SD | CV% | SD | CV% | SD | CV% | ||
| CD10p | % | 9 | 48.57 | 1.01 | 2.08 | 0.00 | 0.00 | 1.01 | 2.08 | ≤ 20 | Pass |
| CD11bp | % | 9 | 6.58 | 0.10 | 1.51 | 0.00 | 0.00 | 0.10 | 1.51 | ≤ 20 | Pass |
| CD13p | % | 9 | 48.45 | 1.02 | 2.10 | 0.00 | 0.00 | 1.02 | 2.10 | ≤ 20 | Pass |
| CD14p | % | 9 | 6.70 | 0.11 | 1.64 | 0.00 | 0.00 | 0.11 | 1.64 | ≤ 20 | Pass |
| CD16p | % | 9 | 45.36 | 0.97 | 2.15 | 0.00 | 0.00 | 0.97 | 2.15 | ≤ 20 | Pass |
| CD34p | % | 9 | 13.91 | 0.58 | 4.17 | 0.00 | 0.00 | 0.58 | 4.17 | ≤ 20 | Pass |
| CD64p | % | 9 | 6.67 | 0.14 | 2.05 | 0.00 | 0.00 | 0.14 | 2.05 | ≤ 20 | Pass |
| CD7p | % | 9 | 34.34 | 0.64 | 1.88 | 0.00 | 0.00 | 0.64 | 1.88 | ≤ 20 | Pass |
| HLA-DRp | % | 9 | 6.31 | 0.14 | 2.19 | 0.00 | 0.00 | 0.14 | 2.19 | ≤ 20 | Pass |
| SPECIMEN: 148383 | Repeatability | Between Lots | Within sample | Spec (% CV) | Conclusion | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Marker / Population | Unit | N | Mean | SD | CV% | SD | CV% | SD | CV% | ||
| CD10p | % | 9 | 54.15 | 2.13 | 3.93 | 0.00 | 0.00 | 2.13 | 3.93 | ≤ 20 | Pass |
| CD11bp | % | 9 | 6.97 | 0.58 | 8.28 | 0.28 | 4.07 | 0.64 | 9.23 | ≤ 20 | Pass |
| CD13p | % | 9 | 53.96 | 2.18 | 4.04 | 0.00 | 0.00 | 2.18 | 4.04 | ≤ 20 | Pass |
| CD14p | % | 9 | 6.97 | 0.60 | 8.67 | 0.21 | 3.06 | 0.64 | 9.19 | ≤ 20 | Pass |
| CD16p | % | 9 | 49.26 | 1.98 | 4.01 | 0.00 | 0.00 | 1.98 | 4.01 | ≤ 20 | Pass |
| CD34p | % | 9 | 15.71 | 1.08 | 6.87 | 1.21 | 7.71 | 1.62 | 10.33 | ≤ 20 | Pass |
| CD64p | % | 9 | 7.10 | 0.64 | 9.04 | 0.00 | 0.00 | 0.64 | 9.04 | ≤ 20 | Pass |
| CD7p | % | 9 | 27.84 | 1.10 | 3.96 | 0.00 | 0.00 | 1.10 | 3.96 | ≤ 20 | Pass |
| HLA-DRp | % | 9 | 6.27 | 0.51 | 8.08 | 0.00 | 0.00 | 0.51 | 8.08 | ≤ 20 | Pass |
Table 7: %CV for M2 Cell Tube by donor
| SPECIMEN: 42440 | Repeatability | Between Lots | Within sample | Spec (% CV) | Conclusion | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Marker / Population | Unit | N | Mean | SD | CV% | SD | CV% | SD | CV% | ||
| CD13p | % | 9 | 64.65 | 0.82 | 1.27 | 4.35 | 6.73 | 4.43 | 6.85 | ≤ 20 | Pass |
| CD15p | % | 9 | 62.70 | 0.59 | 0.94 | 3.25 | 5.18 | 3.30 | 5.27 | ≤ 20 | Pass |
| CD19p | % | 9 | 11.09 | 0.31 | 2.79 | 0.00 | 0.00 | 0.31 | 2.79 | ≤ 20 | Pass |
| CD33p | % | 9 | 6.62 | 0.14 | 2.18 | 0.22 | 3.29 | 0.26 | 3.95 | ≤ 20 | Pass |
| CD34p | % | 9 | 12.64 | 0.52 | 4.12 | 0.30 | 2.38 | 0.60 | 4.76 | ≤ 20 | Pass |
| CD38p | % | 9 | 6.44 | 0.06 | 0.86 | 0.21 | 3.21 | 0.21 | 3.32 | ≤ 20 | Pass |
| HLA-DRp | % | 9 | 6.58 | 0.10 | 1.56 | 0.20 | 3.11 | 0.23 | 3.48 | ≤ 20 | Pass |
| SPECIMEN: 51554 | Repeatability | Between Lots | Within sample | Spec (% CV) | Conclusion | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Marker / Population | Unit | N | Mean | SD | CV% | SD | CV% | SD | CV% | ||
| CD13p | % | 9 | 69.96 | 1.31 | 1.87 | 0.97 | 1.38 | 1.63 | 2.33 | ≤ 20 | Pass |
| CD15p | % | 9 | 68.12 | 1.29 | 1.90 | 0.89 | 1.30 | 1.57 | 2.30 | ≤ 20 | Pass |
| CD19p | % | 9 | 9.56 | 0.23 | 2.44 | 0.14 | 1.50 | 0.27 | 2.86 | ≤ 20 | Pass |
| CD33p | % | 9 | 7.35 | 0.16 | 2.13 | 0.16 | 2.18 | 0.22 | 3.04 | ≤ 20 | Pass |
| CD34p | % | 9 | 9.07 | 0.23 | 2.50 | 0.24 | 2.62 | 0.33 | 3.62 | ≤ 20 | Pass |
| CD38p | % | 9 | 7.23 | 0.20 | 2.74 | 0.15 | 2.04 | 0.25 | 3.41 | ≤ 20 | Pass |
| HLA-DRp | % | 9 | 7.37 | 0.19 | 2.58 | 0.28 | 3.84 | 0.34 | 4.63 | ≤ 20 | Pass |
| SPECIMEN: 52884 | Repeatability | Between Lots | Within sample | Spec (% CV) | Conclusion | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Marker / Population | Unit | N | Mean | SD | CV% | SD | CV% | SD | CV% | ||
| CD13p | % | 9 | 68.87 | 0.41 | 0.59 | 0 | 0 | 0.41 | 0.59 | ≤ 20 | Pass |
| CD15p | % | 9 | 65.49 | 0.43 | 0.65 | 0 | 0 | 0.43 | 0.65 | ≤ 20 | Pass |
| CD19p | % | 9 | 11.6 | 0.28 | 2.41 | 0 | 0 | 0.28 | 2.41 | ≤ 20 | Pass |
| CD33p | % | 9 | 6.66 | 0.08 | 1.18 | 0.13 | 1.93 | 0.15 | 2.26 | ≤ 20 | Pass |
| CD34p | % | 9 | 11.96 | 0.24 | 1.99 | 0.26 | 2.16 | 0.35 | 2.93 | ≤ 20 | Pass |
| CD38p | % | 9 | 6.38 | 0.08 | 1.29 | 0.13 | 2.09 | 0.16 | 2.45 | ≤ 20 | Pass |
| HLA-DRp | % | 9 | 6.6 | 0.12 | 1.74 | 0.12 | 1.86 | 0.17 | 2.55 | ≤ 20 | Pass |
Table 8: %CV for M2 Cell Tube by donor for CD117
| SPECIMEN: 146862 | Repeatability | Between Lots | Within sample | Spec (% CV) | Conclusion | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Marker / Population | Unit | N | Mean | SD | CV% | SD | CV% | SD | CV% | ||
| CD117p | % | 9 | 2.92 | 0.19 | 6.39 | 0 | 0 | 0.19 | 6.39 | ≤ 20 | Pass |
| SPECIMEN: 148238 | Repeatability | Between Lots | Within sample | Spec (% CV) | Conclusion | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Marker / Population | Unit | N | Mean | SD | CV% | SD | CV% | SD | CV% | ||
| CD117p | % | 9 | 4.41 | 0.3 | 6.78 | 0 | 0 | 0.3 | 6.78 | ≤ 20 | Pass |
| SPECIMEN: 50206 | Repeatability | Between Lots | Within sample | Spec (% CV) | Conclusion | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Marker / Population | Unit | N | Mean | SD | CV% | SD | CV% | SD | CV% | ||
| CD117p | % | 9 | 4.57 | 0.38 | 8.3 | 0 | 0 | 0.38 | 8.3 | ≤ 20 | Pass |
Table 9: %CV for M2 Cell Tube by donor for CD123
| SPECIMEN: 146862 | Repeatability | Between Lots | Within sample | Spec (% CV) | Conclusion | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Marker / Population | Unit | N | Mean | SD | CV% | SD | CV% | SD | CV% | ||
| CD123p | % | 9 | 1.37 | 0.07 | 5.12 | 0 | 0 | 0.07 | 5.12 | ≤ 20 | Pass |
| SPECIMEN: 148238 | Repeatability | Between Lots | Within sample | Spec (% CV) | Conclusion | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Marker / Population | Unit | N | Mean | SD | CV% | SD | CV% | SD | CV% | ||
| CD123p | % | 9 | 1.01 | 0.01 | 1.29 | 0 | 0 | 0.01 | 1.29 | ≤ 20 | Pass |
| SPECIMEN: 50206 | Repeatability | Between Lots | Within sample | Spec (% CV) | Conclusion | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Marker / Population | Unit | N | Mean | SD | CV% | SD | CV% | SD | CV% | ||
| CD123p | % | 9 | 1.2 | 0.05 | 4.14 | 0 | 0 | 0.05 | 4.14 | ≤ 20 | Pass |
Conclusions
The verification data of four (4) ClearLLab 10C* Panel Lot-To-Lot Reproducibility for three (3) lots of panel reagents, three (3) specimens and three (3) replicates were within the specifications of 20% CV. Thus, the results met the acceptance criteria.
The data has demonstrated that each of the 4 ClearLLab 10C* Panels has consistent performance between different lots.
Acknowledgment
We are grateful for the following support: Robert Magari, Karen Lo, Fatima Boudiaf, Cecile Loucif, all members of Apollo 10C project team.
*CE-IVD For In Vitro Diagnostic Use. For Non-Hodgkin’s lymphoma only.
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- Panel Design and Marker Combinations of ClearLLab 10C
- ClearLLab LS Webinar
- Interpretation of Flow Cytometry for Leukemia and Lymphoma Diagnosis
- Meet the Expert on the ClearLLab 10C System
- Meet The Experts on ClearLLab LS Lymphoid Screen Antibody Panel
- Meet The Experts on DURA Innovation Dry Reagent Technology
-
Standardized Results - Clinical Vignettes
- The ClearLLab 10C Casebook
- Download your FREE e-Casebook: ClearLLab 10C Panels
- Download your FREE e-Casebook: ClearLLab 10C Panels
- Case 2: Chronic lymphocytic leukemia/small lymphocytic lymphoma
- Case 3: B-lymphoblastic leukemia/lymphoma
- Case 4: B Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma
- Case 5: T-Lymphoblastic Leukemia/Lymphoma
- Case 7: Acute myeloid leukemia
- Case 7: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- Case 14: T Lymphoblastic Leukemia/ T Lymphoblastic Lymphoma
- Case 16: T-Cell Lymphoproliferative Disorder
- Case 18: Acute Myeloid Leukemia
- Case 22: Acute Monocytic Leukemia
- FREE e-Casebook: ClearLLab LS Lymphoid Screen Reagent
- ClearLLab LS Lymphoid Screen Casebook
- Global Health