CellMek SPS System: Precision Performance

Workflow

Sample Preparation

CellMek SPS Sample Preparation Station main unit

CellMek SPS

Sample Preparation System

DURACartridges with the packaging

DURACartridges

10-Color dry reagent cocktail

Sample Acquisition

Navios EX Flow Cytometer

Navios Flow Cytometer

Sample Analysis

Kaluza C Analysis Software 10 Color Data

Kaluza C

Flow Cytometry Analysis Software

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.

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