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


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.


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%).


  • 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

Table 1. ClearLLab 10C* Panels

1Pacific Blue. 2APC-Alexa Fluor 700. 3APC-Alexa Fluor 750.

Table 2. List of Markers/Antigens and cell Population being assessed

Table 3: Markers/populations* assessed for percentage positive

* 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.

Table 5: %CV for T Cell Tube by donor

Table 6: %CV for M1 Cell Tube by donor

Table 7: %CV for M2 Cell Tube by donor

Table 8: %CV for M2 Cell Tube by donor for CD117

Table 9: %CV for M2 Cell Tube by donor for CD123


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.


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.

Leukemia and Lymphoma

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