CellMek SPS System: Precision Performance
Workflow
Sample Preparation
Sample Preparation System
10-Color dry reagent cocktail
Sample Acquisition
Introduction
The CellMek SPS is an automated sample preparation system intended for in vitro diagnostic use that can be programmed by the user to perform a variety of liquid handing operations, including sample preparation for flow cytometry. It is designed to automate staining, lysing, incubating, and washing of different biological specimen types, which enhances productivity by minimizing resource allocation for repetitive work in the clinical laboratory. The purpose of this study is to demonstrate the precision performance of CellMek SPS (repeatability and reproducibility) using a representative sample preparation workflow that utilizes the Cell Wash Module (CWM) as well as the Dry Reagent Module, which supports the DURACartridge custom dry reagent format.
Table 1. DURACartridge Custom Dry 10C Panel.
DURACartridge 10C Panel | 488 nm | 633 nm | 405 nm | |||||||
---|---|---|---|---|---|---|---|---|---|---|
FITC | PE | ECD | PC5.5 | PC7 | APC | APC-A700 | APC-A750 | PB | Krome Orange | |
Markers | Kappa | Lambda | CD10 | CD5 | CD200 | CD34 | CD38 | CD20 | CD19 | CD45 |
Methods
The test cases in this study utilized a Wash-Stain-Lyse/Fix-Wash workflow with a 10-Color (10C) cocktail in DURACartridge dry format and the IOTest 3 +0.25% fixative lysing solution. The 10C cocktail included Kappa-FITC, Lambda-PE, CD10-ECD, CD5-PC5.5, CD200-PC7, CD34-APC, CD38-AA700, CD20-AA750, CD19-PB, and CD45-KrO. Data from samples prepared by the CellMek SPS were acquired on a Navios flow cytometer and analyzed using Kaluza C software. Standard Deviation (SD) and Coefficient of Variations (%CV) were calculated for each marker by each instrument and across all instruments.
For repeatability testing, peripheral blood specimens obtained from normal donors were spiked with CD34+ KG1a Cells and processed by three CellMek SPS instruments (1 donor/instrument, 10 replicates/donor). A single-output-tube panel was defined to process 100 μL of specimen at a time, which was then run in replicate thus eliminating any system variability due to multi-dispense of specimen.
Analysis Strategy for Repeatability:
- The data files of the repeatability samples were analyzed offline using Kaluza C v1.1 software.
- Standard deviation (SD) and coefficient of variations (%CV) were calculated for each marker by each instrument (Table 3).
- Repeatability variability was compared to the specified repeatability acceptance criteria (Table 2).
For reproducibility testing, one lot of ClearLLab Control Cells, Abnormal (part number B90003) was processed on three CellMek SPS instruments. To ensure even use of both assemblies within the CWM and capture of maximum module variability, a two-output-tube panel was defined to process 100 μL of specimen in duplicate per specimen tube run, which was then assigned to two identical specimen tubes that were run in parallel (4 output tubes total). Specimen pairs were run in duplicate (8 output tubes) at least once a day (AM and/or PM) for at least five days for a total of 80 replicates per instrument. The AM and PM runs were processed at least 2 hours apart.
Analysis Strategy for Reproducibility:
- The data files were analyzed offline using Kaluza C v1.1 software.
- Standard deviation (SD) and coefficient of variations (%CV) were calculated for each marker by each instrument and across all instruments (Tables 4 and 5).
- Variability was compared to the specified reproducibility acceptance criteria (Table 2).
- ClearLLab Control Cells Abnormal were used and assessed for % positive cell populations measured against the lot-specific assay sheet (Table 6)
Table 2. Precision Acceptance Criteria.
Parameter | Repeatability | Reproducibility |
---|---|---|
≤ 20% Gated | SD < 2 | SD < 2 |
> 20% Gated | < 10% CV | < 10% CV |
Results
Prep System | Donor | Immune Subset | N | Mean(%) | Repeatability | Acceptance Criteria | Conclusion | |
---|---|---|---|---|---|---|---|---|
SD | CV% | CV%/SD | ||||||
MP00023 | 146933 | CD10+ | 10 | 67.22 | 0.41 | 0.62 | CV < 10% | Pass |
CD19+CD20+ | 10 | 5.37 | 0.28 | 5.25 | SD < 2 | Pass | ||
CD20+CD200+(Ly) | 10 | 3.90 | 0.18 | 4.51 | SD < 2 | Pass | ||
CD34+ | 10 | 2.80 | 0.22 | 7.99 | SD < 2 | Pass | ||
CD38+ | 10 | 5.96 | 0.39 | 6.58 | SD < 2 | Pass | ||
CD5+CD19-(Ly) | 10 | 72.55 | 1.19 | 1.65 | CV < 10% | Pass | ||
Granulocytes | 10 | 66.72 | 1.09 | 1.64 | CV < 10% | Pass | ||
Kappa+(CD19+CD20+) | 10 | 51.45 | 1.79 | 3.47 | CV < 10% | Pass | ||
Lambda+(CD19+CD20+) | 10 | 47.84 | 1.83 | 3.82 | CV < 10% | Pass | ||
Lymphocytes | 10 | 25.17 | 0.65 | 2.60 | CV < 10% | Pass | ||
Monocytes | 10 | 6.72 | 0.36 | 5.40 | SD < 2 | Pass | ||
MP00024 | 148288 | CD10+ | 10 | 62.45 | 0.56 | 0.89 | CV < 10% | Pass |
CD19+CD20+ | 10 | 18.48 | 0.41 | 2.25 | SD < 2 | Pass | ||
CD20+CD200+(Ly) | 10 | 13.56 | 0.34 | 2.52 | SD < 2 | Pass | ||
CD34+ | 10 | 2.82 | 0.06 | 2.23 | SD < 2 | Pass | ||
CD38+ | 10 | 7.24 | 0.47 | 6.51 | SD < 2 | Pass | ||
CD5+CD19-(Ly) | 10 | 63.84 | 1.11 | 1.74 | CV < 10% | Pass | ||
Granulocytes | 10 | 62.59 | 0.45 | 0.73 | CV < 10% | Pass | ||
Kappa+(CD19+CD20+) | 10 | 61.35 | 0.93 | 1.52 | CV < 10% | Pass | ||
Lambda+(CD19+CD20+) | 10 | 37.48 | 0.82 | 2.20 | CV < 10% | Pass | ||
Lymphocytes | 10 | 28.41 | 0.53 | 1.86 | CV < 10% | Pass | ||
Monocytes | 10 | 7.56 | 0.43 | 5.63 | SD < 2 | Pass | ||
MP00026 | W36982103158900 | CD10+ | 10 | 55.10 | 0.76 | 1.39 | CV < 10% | Pass |
CD19+CD20+ | 10 | 18.54 | 0.47 | 2.52 | SD < 2 | Pass | ||
CD20+CD200+(Ly) | 10 | 14.74 | 0.32 | 2.17 | SD < 2 | Pass | ||
CD34+ | 10 | 3.31 | 0.33 | 9.89 | SD < 2 | Pass | ||
CD38+ | 10 | 9.67 | 0.37 | 3.84 | SD < 2 | Pass | ||
CD5+CD19-(Ly) | 10 | 76.14 | 0.43 | 0.57 | CV < 10% | Pass | ||
Granulocytes | 10 | 52.12 | 0.80 | 1.54 | CV < 10% | Pass | ||
Kappa+(CD19+CD20+) | 10 | 67.99 | 0.99 | 1.45 | CV < 10% | Pass | ||
Lambda+(CD19+CD20+) | 10 | 31.49 | 0.99 | 3.14 | CV < 10% | Pass | ||
Lymphocytes | 10 | 32.35 | 0.53 | 1.65 | CV < 10% | Pass | ||
Monocytes | 10 | 13.16 | 0.60 | 4.59 | SD < 2 | Pass |
Prep System | Immune Subset | N | Mean(%) | Repeatability | Acceptance Criteria | Conclusion | |
---|---|---|---|---|---|---|---|
SD | CV% | CV%/SD | |||||
MP00023 | CD10+ | 80 | 51.93 | 0.62 | 1.20 | CV < 10% | Pass |
CD19+CD20+ | 80 | 11.22 | 0.31 | 2.73 | SD < 2 | Pass | |
CD20+CD200+(Ly) | 80 | 7.08 | 0.28 | 3.99 | SD < 2 | Pass | |
CD34+ | 80 | 8.86 | 0.30 | 3.37 | SD < 2 | Pass | |
CD38+ | 80 | 8.77 | 0.33 | 3.74 | SD < 2 | Pass | |
CD5+CD19-(Ly) | 80 | 73.80 | 0.37 | 0.50 | CV < 10% | Pass | |
Granulocytes | 80 | 53.95 | 0.71 | 1.32 | CV < 10% | Pass | |
Kappa+(CD19+CD20+) | 80 | 63.02 | 0.95 | 1.51 | CV < 10% | Pass | |
Lambda+(CD19+CD20+) | 80 | 36.99 | 0.98 | 2.65 | CV < 10% | Pass | |
Lymphocytes | 80 | 35.28 | 0.45 | 1.27 | CV < 10% | Pass | |
Monocytes | 80 | 9.05 | 0.33 | 3.70 | SD < 2 | Pass | |
MP00024 | CD10+ | 80 | 51.30 | 0.90 | 1.76 | CV < 10% | Pass |
CD19+CD20+ | 80 | 11.30 | 0.28 | 2.48 | SD < 2 | Pass | |
CD20+CD200+(Ly) | 80 | 7.22 | 0.29 | 4.05 | SD < 2 | Pass | |
CD34+ | 80 | 9.14 | 0.18 | 1.92 | SD < 2 | Pass | |
CD38+ | 80 | 9.06 | 0.29 | 3.21 | SD < 2 | Pass | |
CD5+CD19-(Ly) | 80 | 73.75 | 0.38 | 0.51 | CV < 10% | Pass | |
Granulocytes | 80 | 53.23 | 0.99 | 1.87 | CV < 10% | Pass | |
Kappa+(CD19+CD20+) | 80 | 62.93 | 1.00 | 1.59 | CV < 10% | Pass | |
Lambda+(CD19+CD20+) | 80 | 37.10 | 1.00 | 2.68 | CV < 10% | Pass | |
Lymphocytes | 80 | 35.74 | 0.74 | 2.07 | CV < 10% | Pass | |
Monocytes | 80 | 9.33 | 0.31 | 3.33 | SD < 2 | Pass | |
MP00026 | CD10+ | 80 | 51.64 | 0.82 | 1.58 | CV < 10% | Pass |
CD19+CD20+ | 80 | 11.28 | 0.24 | 2.10 | SD < 2 | Pass | |
CD20+CD200+(Ly) | 80 | 7.05 | 0.24 | 3.44 | SD < 2 | Pass | |
CD34+ | 80 | 9.05 | 0.25 | 2.71 | SD < 2 | Pass | |
CD38+ | 80 | 9.04 | 0.37 | 4.06 | SD < 2 | Pass | |
CD5+CD19-(Ly) | 80 | 73.72 | 0.38 | 0.52 | CV < 10% | Pass | |
Granulocytes | 80 | 53.60 | 0.90 | 1.69 | CV < 10% | Pass | |
Kappa+(CD19+CD20+) | 80 | 62.76 | 1.12 | 1.79 | CV < 10% | Pass | |
Lambda+(CD19+CD20+) | 80 | 37.27 | 1.12 | 3.00 | CV < 10% | Pass | |
Lymphocytes | 80 | 35.45 | 0.57 | 1.61 | CV < 10% | Pass | |
Monocytes | 80 | 9.32 | 0.37 | 4.02 | SD < 2 | Pass |
Prep System | Immune Subset | N | Mean(%) | Between Run | Acceptance Criteria | Conclusion | |
---|---|---|---|---|---|---|---|
SD | CV% | CV%/SD | |||||
MP00023 | CD10+ | 80 | 51.93 | 0.00 | 0.00 | CV < 10% | Pass |
CD19+CD20+ | 80 | 11.22 | 0.00 | 0.00 | SD < 2 | Pass | |
CD20+CD200+(Ly) | 80 | 7.08 | 0.00 | 0.00 | SD < 2 | Pass | |
CD34+ | 80 | 8.86 | 0.00 | 0.00 | SD < 2 | Pass | |
CD38+ | 80 | 8.77 | 0.00 | 0.00 | SD < 2 | Pass | |
CD5+CD19-(Ly) | 80 | 73.80 | 0.14 | 0.19 | CV < 10% | Pass | |
Granulocytes | 80 | 53.95 | 0.00 | 0.00 | CV < 10% | Pass | |
Kappa+(CD19+CD20+) | 80 | 63.02 | 0.00 | 0.00 | CV < 10% | Pass | |
Lambda+(CD19+CD20+) | 80 | 36.99 | 0.00 | 0.00 | CV < 10% | Pass | |
Lymphocytes | 80 | 35.28 | 0.00 | 0.00 | CV < 10% | Pass | |
Monocytes | 80 | 9.05 | 0.00 | 0.00 | SD < 2 | Pass | |
MP00024 | CD10+ | 80 | 51.30 | 0.00 | 0.00 | CV < 10% | Pass |
CD19+CD20+ | 80 | 11.30 | 0.09 | 0.84 | SD < 2 | Pass | |
CD20+CD200+(Ly) | 80 | 7.22 | 0.19 | 2.67 | SD < 2 | Pass | |
CD34+ | 80 | 9.14 | 0.04 | 0.47 | SD < 2 | Pass | |
CD38+ | 80 | 9.06 | 0.00 | 0.00 | SD < 2 | Pass | |
CD5+CD19-(Ly) | 80 | 73.75 | 0.04 | 0.05 | CV < 10% | Pass | |
Granulocytes | 80 | 53.23 | 0.00 | 0.00 | CV < 10% | Pass | |
Kappa+(CD19+CD20+) | 80 | 62.93 | 0.31 | 0.49 | CV < 10% | Pass | |
Lambda+(CD19+CD20+) | 80 | 37.10 | 0.34 | 0.92 | CV < 10% | Pass | |
Lymphocytes | 80 | 35.74 | 0.00 | 0.00 | CV < 10% | Pass | |
Monocytes | 80 | 9.33 | 0.00 | 0.00 | SD < 2 | Pass | |
MP00026 | CD10+ | 80 | 51.64 | 0.00 | 0.00 | CV < 10% | Pass |
CD19+CD20+ | 80 | 11.28 | 0.00 | 0.00 | SD < 2 | Pass | |
CD20+CD200+(Ly) | 80 | 7.05 | 0.05 | 0.77 | SD < 2 | Pass | |
CD34+ | 80 | 9.05 | 0.00 | 0.00 | SD < 2 | Pass | |
CD38+ | 80 | 9.04 | 0.00 | 0.00 | SD < 2 | Pass | |
CD5+CD19-(Ly) | 80 | 73.72 | 0.00 | 0.00 | CV < 10% | Pass | |
Granulocytes | 80 | 53.60 | 0.00 | 0.00 | CV < 10% | Pass | |
Kappa+(CD19+CD20+) | 80 | 62.76 | 0.00 | 0.00 | CV < 10% | Pass | |
Lambda+(CD19+CD20+) | 80 | 37.27 | 0.00 | 0.00 | CV < 10% | Pass | |
Lymphocytes | 80 | 35.45 | 0.00 | 0.00 | CV < 10% | Pass | |
Monocytes | 80 | 9.32 | 0.00 | 0.00 | SD < 2 | Pass |
Prep System | Immune Subset | N | Mean(%) | Between Time | Acceptance Criteria | Conclusion | |
---|---|---|---|---|---|---|---|
SD | CV% | CV%/SD | |||||
MP00023 | CD10+ | 80 | 51.93 | 0.16 | 0.31 | CV < 10% | Pass |
CD19+CD20+ | 80 | 11.22 | 0.04 | 0.34 | SD < 2 | Pass | |
CD20+CD200+(Ly) | 80 | 7.08 | 0.09 | 1.29 | SD < 2 | Pass | |
CD34+ | 80 | 8.86 | 0.00 | 0.00 | SD < 2 | Pass | |
CD38+ | 80 | 8.77 | 0.00 | 0.00 | SD < 2 | Pass | |
CD5+CD19-(Ly) | 80 | 73.80 | 0.37 | 0.50 | CV < 10% | Pass | |
Granulocytes | 80 | 53.95 | 0.00 | 0.00 | CV < 10% | Pass | |
Kappa+(CD19+CD20+) | 80 | 63.02 | 0.00 | 0.00 | CV < 10% | Pass | |
Lambda+(CD19+CD20+) | 80 | 36.99 | 0.00 | 0.00 | CV < 10% | Pass | |
Lymphocytes | 80 | 35.28 | 0.11 | 0.30 | CV < 10% | Pass | |
Monocytes | 80 | 9.05 | 0.00 | 0.00 | SD < 2 | Pass | |
MP00024 | CD10+ | 80 | 51.30 | 0.00 | 0.00 | CV < 10% | Pass |
CD19+CD20+ | 80 | 11.30 | 0.06 | 0.52 | SD < 2 | Pass | |
CD20+CD200+(Ly) | 80 | 7.22 | 0.10 | 1.44 | SD < 2 | Pass | |
CD34+ | 80 | 9.14 | 0.01 | 0.12 | SD < 2 | Pass | |
CD38+ | 80 | 9.06 | 0.00 | 0.00 | SD < 2 | Pass | |
CD5+CD19-(Ly) | 80 | 73.75 | 0.18 | 0.24 | CV < 10% | Pass | |
Granulocytes | 80 | 53.23 | 0.00 | 0.00 | CV < 10% | Pass | |
Kappa+(CD19+CD20+) | 80 | 62.93 | 0.00 | 0.00 | CV < 10% | Pass | |
Lambda+(CD19+CD20+) | 80 | 37.10 | 0.00 | 0.00 | CV < 10% | Pass | |
Lymphocytes | 80 | 35.74 | 0.00 | 0.00 | CV < 10% | Pass | |
Monocytes | 80 | 9.33 | 0.00 | 0.00 | SD < 2 | Pass | |
MP00026 | CD10+ | 80 | 51.64 | 0.00 | 0.00 | CV < 10% | Pass |
CD19+CD20+ | 80 | 11.28 | 0.00 | 0.00 | SD < 2 | Pass | |
CD20+CD200+(Ly) | 80 | 7.05 | 0.08 | 1.08 | SD < 2 | Pass | |
CD34+ | 80 | 9.05 | 0.00 | 0.00 | SD < 2 | Pass | |
CD38+ | 80 | 9.04 | 0.00 | 0.00 | SD < 2 | Pass | |
CD5+CD19-(Ly) | 80 | 73.72 | 0.37 | 0.50 | CV < 10% | Pass | |
Granulocytes | 80 | 53.60 | 0.00 | 0.00 | CV < 10% | Pass | |
Kappa+(CD19+CD20+) | 80 | 62.76 | 0.00 | 0.00 | CV < 10% | Pass | |
Lambda+(CD19+CD20+) | 80 | 37.27 | 0.00 | 0.00 | CV < 10% | Pass | |
Lymphocytes | 80 | 35.45 | 0.00 | 0.00 | CV < 10% | Pass | |
Monocytes | 80 | 9.32 | 0.00 | 0.00 | SD < 2 | Pass |
Prep System | Immune Subset | N | Mean(%) | Between Days | Acceptance Criteria | Conclusion | |
---|---|---|---|---|---|---|---|
SD | CV% | CV%/SD | |||||
MP00023 | CD10+ | 80 | 51.93 | 0.41 | 0.80 | CV < 10% | Pass |
CD19+CD20+ | 80 | 11.22 | 0.07 | 0.65 | SD < 2 | Pass | |
CD20+CD200+(Ly) | 80 | 7.08 | 0.04 | 0.51 | SD < 2 | Pass | |
CD34+ | 80 | 8.86 | 0.08 | 0.95 | SD < 2 | Pass | |
CD38+ | 80 | 8.77 | 0.00 | 0.00 | SD < 2 | Pass | |
CD5+CD19-(Ly) | 80 | 73.80 | 0.13 | 0.17 | CV < 10% | Pass | |
Granulocytes | 80 | 53.95 | 0.33 | 0.61 | CV < 10% | Pass | |
Kappa+(CD19+CD20+) | 80 | 63.02 | 0.45 | 0.71 | CV < 10% | Pass | |
Lambda+(CD19+CD20+) | 80 | 36.99 | 0.43 | 1.17 | CV < 10% | Pass | |
Lymphocytes | 80 | 35.28 | 0.25 | 0.70 | CV < 10% | Pass | |
Monocytes | 80 | 9.05 | 0.00 | 0.00 | SD < 2 | Pass | |
MP00024 | CD10+ | 80 | 51.30 | 0.25 | 0.48 | CV < 10% | Pass |
CD19+CD20+ | 80 | 11.30 | 0.00 | 0.00 | SD < 2 | Pass | |
CD20+CD200+(Ly) | 80 | 7.22 | 0.00 | 0.00 | SD < 2 | Pass | |
CD34+ | 80 | 9.14 | 0.10 | 1.06 | SD < 2 | Pass | |
CD38+ | 80 | 9.06 | 0.00 | 0.00 | SD < 2 | Pass | |
CD5+CD19-(Ly) | 80 | 73.75 | 0.12 | 0.16 | CV < 10% | Pass | |
Granulocytes | 80 | 53.23 | 0.00 | 0.00 | CV < 10% | Pass | |
Kappa+(CD19+CD20+) | 80 | 62.93 | 0.00 | 0.00 | CV < 10% | Pass | |
Lambda+(CD19+CD20+) | 80 | 37.10 | 0.00 | 0.00 | CV < 10% | Pass | |
Lymphocytes | 80 | 35.74 | 0.15 | 0.43 | CV < 10% | Pass | |
Monocytes | 80 | 9.33 | 0.00 | 0.00 | SD < 2 | Pass | |
MP00026 | CD10+ | 80 | 51.64 | 0.28 | 0.54 | CV < 10% | Pass |
CD19+CD20+ | 80 | 11.28 | 0.12 | 1.04 | SD < 2 | Pass | |
CD20+CD200+(Ly) | 80 | 7.05 | 0.19 | 2.71 | SD < 2 | Pass | |
CD34+ | 80 | 9.05 | 0.00 | 0.00 | SD < 2 | Pass | |
CD38+ | 80 | 9.04 | 0.00 | 0.00 | SD < 2 | Pass | |
CD5+CD19-(Ly) | 80 | 73.72 | 0.00 | 0.00 | CV < 10% | Pass | |
Granulocytes | 80 | 53.60 | 0.21 | 0.40 | CV < 10% | Pass | |
Kappa+(CD19+CD20+) | 80 | 62.76 | 0.00 | 0.00 | CV < 10% | Pass | |
Lambda+(CD19+CD20+) | 80 | 37.27 | 0.00 | 0.00 | CV < 10% | Pass | |
Lymphocytes | 80 | 35.45 | 0.27 | 0.75 | CV < 10% | Pass | |
Monocytes | 80 | 9.32 | 0.00 | 0.00 | SD < 2 | Pass |
Prep System | Immune Subset | N | Mean(%) | Within Prep System | Acceptance Criteria | Conclusion | |
---|---|---|---|---|---|---|---|
SD | CV% | CV%/SD | |||||
MP00023 | CD10+ | 80 | 51.93 | 0.77 | 1.48 | CV < 10% | Pass |
CD19+CD20+ | 80 | 11.22 | 0.32 | 2.83 | SD < 2 | Pass | |
CD20+CD200+(Ly) | 80 | 7.08 | 0.30 | 4.22 | SD < 2 | Pass | |
CD34+ | 80 | 8.86 | 0.31 | 3.50 | SD < 2 | Pass | |
CD38+ | 80 | 8.77 | 0.33 | 3.74 | SD < 2 | Pass | |
CD5+CD19-(Ly) | 80 | 73.80 | 0.56 | 0.76 | CV < 10% | Pass | |
Granulocytes | 80 | 53.95 | 0.78 | 1.45 | CV < 10% | Pass | |
Kappa+(CD19+CD20+) | 80 | 63.02 | 1.05 | 1.67 | CV < 10% | Pass | |
Lambda+(CD19+CD20+) | 80 | 36.99 | 1.07 | 2.90 | CV < 10% | Pass | |
Lymphocytes | 80 | 35.28 | 0.52 | 1.48 | CV < 10% | Pass | |
Monocytes | 80 | 9.05 | 0.33 | 3.70 | SD < 2 | Pass | |
MP00024 | CD10+ | 80 | 51.30 | 0.94 | 1.83 | CV < 10% | Pass |
CD19+CD20+ | 80 | 11.30 | 0.30 | 2.67 | SD < 2 | Pass | |
CD20+CD200+(Ly) | 80 | 7.22 | 0.37 | 5.06 | SD < 2 | Pass | |
CD34+ | 80 | 9.14 | 0.21 | 2.25 | SD < 2 | Pass | |
CD38+ | 80 | 9.06 | 0.29 | 3.21 | SD < 2 | Pass | |
CD5+CD19-(Ly) | 80 | 73.75 | 0.44 | 0.59 | CV < 10% | Pass | |
Granulocytes | 80 | 53.23 | 0.99 | 1.87 | CV < 10% | Pass | |
Kappa+(CD19+CD20+) | 80 | 62.93 | 1.04 | 1.66 | CV < 10% | Pass | |
Lambda+(CD19+CD20+) | 80 | 37.10 | 1.05 | 2.84 | CV < 10% | Pass | |
Lymphocytes | 80 | 35.74 | 0.75 | 2.11 | CV < 10% | Pass | |
Monocytes | 80 | 9.33 | 0.31 | 3.33 | SD < 2 | Pass | |
MP00026 | CD10+ | 80 | 51.64 | 0.86 | 1.67 | CV < 10% | Pass |
CD19+CD20+ | 80 | 11.28 | 0.26 | 2.35 | SD < 2 | Pass | |
CD20+CD200+(Ly) | 80 | 7.05 | 0.32 | 4.57 | SD < 2 | Pass | |
CD34+ | 80 | 9.05 | 0.25 | 2.71 | SD < 2 | Pass | |
CD38+ | 80 | 9.04 | 0.37 | 4.06 | SD < 2 | Pass | |
CD5+CD19-(Ly) | 80 | 73.72 | 0.53 | 0.72 | CV < 10% | Pass | |
Granulocytes | 80 | 53.60 | 0.93 | 1.73 | CV < 10% | Pass | |
Kappa+(CD19+CD20+) | 80 | 62.76 | 1.12 | 1.79 | CV < 10% | Pass | |
Lambda+(CD19+CD20+) | 80 | 37.27 | 1.12 | 3.00 | CV < 10% | Pass | |
Lymphocytes | 80 | 35.45 | 0.63 | 1.78 | CV < 10% | Pass | |
Monocytes | 80 | 9.32 | 0.37 | 4.02 | SD < 2 | Pass |
Immune Subset | Total N | Mean(%) | Repeatability (Within Run) | Acceptance Criteria | Conclusion | |
---|---|---|---|---|---|---|
SD | CV% | CV%/SD | ||||
CD10+ | 240 | 51.62 | 0.79 | 1.54 | CV < 10% | Pass |
CD19+CD20+ | 240 | 11.26 | 0.28 | 2.49 | SD < 2 | Pass |
CD20+CD200+(Ly) | 240 | 7.12 | 0.28 | 3.90 | SD < 2 | Pass |
CD34+ | 240 | 9.02 | 0.25 | 2.73 | SD < 2 | Pass |
CD38+ | 240 | 8.96 | 0.33 | 3.68 | SD < 2 | Pass |
CD5+CD19-(Ly) | 240 | 73.76 | 0.38 | 0.51 | CV < 10% | Pass |
Granulocytes | 240 | 53.59 | 0.88 | 1.64 | CV < 10% | Pass |
Kappa+(CD19+CD20+) | 240 | 62.90 | 1.05 | 1.67 | CV < 10% | Pass |
Lambda+(CD19+CD20+) | 240 | 37.12 | 1.06 | 2.85 | CV < 10% | Pass |
Lymphocytes | 240 | 35.49 | 0.60 | 1.69 | CV < 10% | Pass |
Monocytes | 240 | 9.23 | 0.34 | 3.69 | SD < 2 | Pass |
Immune Subset | Total N | Mean(%) | Between Run | Acceptance Criteria | Conclusion | |
---|---|---|---|---|---|---|
SD | CV% | CV%/SD | ||||
CD10+ | 240 | 51.62 | 0.00 | 0.00 | CV < 10% | Pass |
CD19+CD20+ | 240 | 11.26 | 0.02 | 0.14 | SD < 2 | Pass |
CD20+CD200+(Ly) | 240 | 7.12 | 0.10 | 1.35 | SD < 2 | Pass |
CD34+ | 240 | 9.02 | 0.00 | 0.00 | SD < 2 | Pass |
CD38+ | 240 | 8.96 | 0.00 | 0.00 | SD < 2 | Pass |
CD5+CD19-(Ly) | 240 | 73.76 | 0.08 | 0.11 | CV < 10% | Pass |
Granulocytes | 240 | 53.59 | 0.00 | 0.00 | CV < 10% | Pass |
Kappa+(CD19+CD20+) | 240 | 62.90 | 0.00 | 0.00 | CV < 10% | Pass |
Lambda+(CD19+CD20+) | 240 | 37.12 | 0.00 | 0.00 | CV < 10% | Pass |
Lymphocytes | 240 | 35.49 | 0.00 | 0.00 | CV < 10% | Pass |
Monocytes | 240 | 9.23 | 0.00 | 0.00 | SD < 2 | Pass |
Immune Subset | Total N | Mean(%) | Between Time | Acceptance Criteria | Conclusion | |
---|---|---|---|---|---|---|
SD | CV% | CV%/SD | ||||
CD10+ | 240 | 51.62 | 0.00 | 0.00 | CV < 10% | Pass |
CD19+CD20+ | 240 | 11.26 | 0.04 | 0.38 | SD < 2 | Pass |
CD20+CD200+(Ly) | 240 | 7.12 | 0.11 | 1.57 | SD < 2 | Pass |
CD34+ | 240 | 9.02 | 0.00 | 0.00 | SD < 2 | Pass |
CD38+ | 240 | 8.96 | 0.00 | 0.00 | SD < 2 | Pass |
CD5+CD19-(Ly) | 240 | 73.76 | 0.32 | 0.43 | CV < 10% | Pass |
Granulocytes | 240 | 53.59 | 0.00 | 0.00 | CV < 10% | Pass |
Kappa+(CD19+CD20+) | 240 | 62.90 | 0.00 | 0.00 | CV < 10% | Pass |
Lambda+(CD19+CD20+) | 240 | 37.12 | 0.00 | 0.00 | CV < 10% | Pass |
Lymphocytes | 240 | 35.49 | 0.00 | 0.00 | CV < 10% | Pass |
Monocytes | 240 | 9.23 | 0.00 | 0.00 | SD < 2 | Pass |
Immune Subset | Total N | Mean(%) | Between Days | Acceptance Criteria | Conclusion | |
---|---|---|---|---|---|---|
SD | CV% | CV%/SD | ||||
CD10+ | 240 | 51.62 | 0.33 | 0.63 | CV < 10% | Pass |
CD19+CD20+ | 240 | 11.26 | 0.07 | 0.67 | SD < 2 | Pass |
CD20+CD200+(Ly) | 240 | 7.12 | 0.10 | 1.40 | SD < 2 | Pass |
CD34+ | 240 | 9.02 | 0.07 | 0.82 | SD < 2 | Pass |
CD38+ | 240 | 8.96 | 0.00 | 0.00 | SD < 2 | Pass |
CD5+CD19-(Ly) | 240 | 73.76 | 0.00 | 0.00 | CV < 10% | Pass |
Granulocytes | 240 | 53.59 | 0.22 | 0.41 | CV < 10% | Pass |
Kappa+(CD19+CD20+) | 240 | 62.90 | 0.20 | 0.32 | CV < 10% | Pass |
Lambda+(CD19+CD20+) | 240 | 37.12 | 0.21 | 0.57 | CV < 10% | Pass |
Lymphocytes | 240 | 35.49 | 0.24 | 0.67 | CV < 10% | Pass |
Monocytes | 240 | 9.23 | 0.00 | 0.00 | SD < 2 | Pass |
Immune Subset | Total N | Mean(%) | Between Prep System | Acceptance Criteria | Conclusion | |
---|---|---|---|---|---|---|
SD | CV% | CV%/SD | ||||
CD10+ | 240 | 51.62 | 0.27 | 0.52 | CV < 10% | Pass |
CD19+CD20+ | 240 | 11.26 | 0.00 | 0.00 | SD < 2 | Pass |
CD20+CD200+(Ly) | 240 | 7.12 | 0.04 | 0.62 | SD < 2 | Pass |
CD34+ | 240 | 9.02 | 0.13 | 1.40 | SD < 2 | Pass |
CD38+ | 240 | 8.96 | 0.16 | 1.78 | SD < 2 | Pass |
CD5+CD19-(Ly) | 240 | 73.76 | 0.00 | 0.00 | CV < 10% | Pass |
Granulocytes | 240 | 53.59 | 0.33 | 0.61 | CV < 10% | Pass |
Kappa+(CD19+CD20+) | 240 | 62.90 | 0.00 | 0.00 | CV < 10% | Pass |
Lambda+(CD19+CD20+) | 240 | 37.12 | 0.00 | 0.00 | CV < 10% | Pass |
Lymphocytes | 240 | 35.49 | 0.19 | 0.53 | CV < 10% | Pass |
Monocytes | 240 | 9.23 | 0.16 | 1.70 | SD < 2 | Pass |
Immune Subset | Total N | Mean(%) | Reproducibility | Acceptance Criteria | Conclusion | |
---|---|---|---|---|---|---|
SD | CV% | CV%/SD | ||||
CD10+ | 240 | 51.62 | 0.90 | 1.74 | CV < 10% | Pass |
CD19+CD20+ | 240 | 11.26 | 0.29 | 2.61 | SD < 2 | Pass |
CD20+CD200+(Ly) | 240 | 7.12 | 0.33 | 4.67 | SD < 2 | Pass |
CD34+ | 240 | 9.02 | 0.29 | 3.18 | SD < 2 | Pass |
CD38+ | 240 | 8.96 | 0.37 | 4.09 | SD < 2 | Pass |
CD5+CD19-(Ly) | 240 | 73.76 | 0.50 | 0.68 | CV < 10% | Pass |
Granulocytes | 240 | 53.59 | 0.96 | 1.79 | CV < 10% | Pass |
Kappa+(CD19+CD20+) | 240 | 62.90 | 1.07 | 1.70 | CV < 10% | Pass |
Lambda+(CD19+CD20+) | 240 | 37.12 | 1.08 | 2.90 | CV < 10% | Pass |
Lymphocytes | 240 | 35.49 | 0.67 | 1.89 | CV < 10% | Pass |
Monocytes | 240 | 9.23 | 0.38 | 4.06 | SD < 2 | Pass |
Prep System | Immune Subset | N | Mean(%) | Expected Results (Lot 11020217) | Conclusion | ||
---|---|---|---|---|---|---|---|
Mean (%) | Low Limit (%) | High Limit (%) | |||||
MP00023 | CD10+ | 80 | 51.93 | 61.49 | 48.82 | 74.16 | Mean Within Range |
CD19+CD20+ | 80 | 11.22 | 10.90 | 7.50 | 14.30 | Mean Within Range | |
CD20+CD200+(Ly) | 80 | 7.97 | 10.62 | 5.73 | 15.51 | Mean Within Range | |
CD34+ | 80 | 8.86 | 8.80 | 6.34 | 11.26 | Mean Within Range | |
CD38+ | 80 | 8.77 | 7.82 | 1.53 | 14.11 | Mean Within Range | |
CD5+CD19-(Ly) | 80 | 73.80 | 76.53 | 71.64 | 81.42 | Mean Within Range | |
Granulocytes | 80 | 53.95 | 60.98 | 47.16 | 74.80 | Mean Within Range | |
Kappa+(CD19+CD20+) | 80 | 63.02 | 61.97 | 55.79 | 68.15 | Mean Within Range | |
Lambda+(CD19+CD20+) | 80 | 36.99 | 37.53 | 32.34 | 42.72 | Mean Within Range | |
Lymphocytes | 80 | 35.28 | 28.67 | 18.08 | 39.26 | Mean Within Range | |
Monocytes | 80 | 9.05 | 7.30 | 0.61 | 13.99 | Mean Within Range | |
CD45+ | 80 | 99.83 | 97.54 | 95.08 | 100.00 | Mean Within Range | |
MP00024 | CD10+ | 80 | 51.30 | 61.49 | 48.82 | 74.16 | Mean Within Range |
CD19+CD20+ | 80 | 11.30 | 10.90 | 7.50 | 14.30 | Mean Within Range | |
CD20+CD200+(Ly) | 80 | 7.22 | 10.62 | 5.73 | 15.51 | Mean Within Range | |
CD34+ | 80 | 9.14 | 8.80 | 6.34 | 11.26 | Mean Within Range | |
CD38+ | 80 | 9.06 | 7.82 | 1.53 | 14.11 | Mean Within Range | |
CD5+CD19-(Ly) | 80 | 73.75 | 76.53 | 71.64 | 81.42 | Mean Within Range | |
Granulocytes | 80 | 53.23 | 60.98 | 47.16 | 74.80 | Mean Within Range | |
Kappa+(CD19+CD20+) | 80 | 62.93 | 61.97 | 55.79 | 68.15 | Mean Within Range | |
Lambda+(CD19+CD20+) | 80 | 37.10 | 37.53 | 32.34 | 42.72 | Mean Within Range | |
Lymphocytes | 80 | 35.74 | 28.67 | 18.08 | 39.26 | Mean Within Range | |
Monocytes | 80 | 9.33 | 7.30 | 0.61 | 13.99 | Mean Within Range | |
CD45+ | 80 | 99.82 | 97.54 | 95.08 | 100.00 | Mean Within Range | |
MP00026 | CD10+ | 80 | 51.64 | 61.49 | 48.82 | 74.16 | Mean Within Range |
CD19+CD20+ | 80 | 11.28 | 10.90 | 7.50 | 14.30 | Mean Within Range | |
CD20+CD200+(Ly) | 80 | 7.05 | 10.62 | 5.73 | 15.51 | Mean Within Range | |
CD34+ | 80 | 9.05 | 8.80 | 6.34 | 11.26 | Mean Within Range | |
CD38+ | 80 | 9.04 | 7.82 | 1.53 | 14.11 | Mean Within Range | |
CD5+CD19-(Ly) | 80 | 73.72 | 76.53 | 71.64 | 81.42 | Mean Within Range | |
Granulocytes | 80 | 53.60 | 60.98 | 47.16 | 74.80 | Mean Within Range | |
Kappa+(CD19+CD20+) | 80 | 62.76 | 61.97 | 55.79 | 68.15 | Mean Within Range | |
Lambda+(CD19+CD20+) | 80 | 37.27 | 37.53 | 32.34 | 42.72 | Mean Within Range | |
Lymphocytes | 80 | 35.45 | 28.67 | 18.08 | 39.26 | Mean Within Range | |
Monocytes | 80 | 9.32 | 7.30 | 0.61 | 13.99 | Mean Within Range | |
CD45+ | 80 | 99.82 | 97.54 | 95.08 | 100.00 | Mean Within Range |
Conclusion
Data of the repeatability and reproducibility samples were analyzed for each marker by each instrument and across all instruments. For each immune subset, the SD was less than 2 when the population was ≤ 20%, and the %CV was less than 10 when the population was > 20%.
Acknowledgements
We are grateful to the whole technical team, Beckman Coulter Blood Services, University of Miami and Beckman Coulter Bangalore Development Center. Special thanks to Xu Gang and Karen Lo for the statistical data analysis.
Learn More about CellMek SPS
-
CellMek SPS
- Becoming a lean laboratory
- Addressing the 8 Process Wastes in Sample Preparation
- CellMek SPS System: Optimized Time to Result
- Laboratory labor savings: Manual vs Automated
- CellMek SPS System: Precision Performance
- CellMek SPS System: Sample Preparation Performance
- CellMek SPS: Audit Trail Features
- CellMek SPS System: Panel Designer Software
- CellMek SPS System: Instrument Features
- CellMek SPS System: Specimen Traceability
- CellMek SPS System: Video Gallery
- CellMek SPS Accessories and Consumables
- Workflow