ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer

K183592 · Beckman Coulter · PWD · Mar 21, 2019 · Hematology

Device Facts

• Record ID: K183592
• Device Name: ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer
• Applicant: Beckman Coulter
• Product Code: PWD · Hematology
• Decision Date: Mar 21, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7010
• Device Class: Class 2
• Attributes: Software as a Medical Device, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K183592 · Mar 21, 2019	ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer	Beckman Coulter	Residual clinical samples from routine immunophenotyping; Clinical site final patient diagnoses (standard of care)	A retrospective multi-center study was conducted to assess clinical sensitivity and specificity by comparing the device's ability to identify abnormal phenotypes in residual clinical samples against the final clinical diagnosis (malignant vs. non-malignant) established in routine clinical practice.	Retrospective study; Residual clinical samples; Clinical sensitivity and specificity; Hematopoietic neoplasms

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Multi-center retrospective clinical study; Retrospective study using residual clinical samples	Patients suspected of having hematopoietic neoplasms (chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome, myeloproliferative neoplasms); Sample Size: 453 specimens; Number of Sites: 4	Not applicable for this study	Clinical sensitivity, specificity, PPV, and NPV for detecting abnormal phenotypes compared to final clinical diagnosis

Indications for Use

The ClearLLab 10C Panels are intended for in vitro diagnostic use for qualitative identification of cell populations by multiparameter immunophenotyping on the Navios and Navios EX flow cytometers. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having, the following hematopoietic neoplasms: chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (MDS), and/or myeloproliferative neoplasms (MPN). The reagents can be used with peripheral whole blood (collected in K2EDTA, Acid Citrate Dextrose (ACD) or Heparin), bone marrow (collected in K2EDTA, ACD or Heparin) and lymph node specimens. Interpretation of the results should be confirmed by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings.

Device Story

ClearLLab 10C Panels consist of four lineage-driven antibody reagent tubes (B, T, M1, M2) for multiparameter immunophenotyping; used with Navios/Navios EX flow cytometers. Input: whole blood, bone marrow, or lymph node specimens stained with fluorochrome-conjugated monoclonal/polyclonal antibodies. Operation: specimens washed, stained, lysed, and fixed; analyzed via flow cytometry using three lasers (488nm, 638nm, 405nm) and ten fluorescence channels. Kaluza C software provides templates for gating and population identification. Output: qualitative identification of cell surface markers (CD antigens). Used in clinical laboratories by pathologists/professionals to aid differential diagnosis of hematopoietic neoplasms. Benefits: standardized, multiparameter assessment of aberrant marker expression patterns compared to normal internal controls.

Clinical Evidence

Multi-center retrospective study (4 sites, 453 specimens: 200 non-malignant, 253 malignant). Sensitivity 92.9% (95% CI: 89.0-95.5%), Specificity 95.0% (95% CI: 91.0-97.3%). Whole blood subset (n=214): Sensitivity 95.4%, Specificity 96.2%. Analytical performance included multi-site precision/reproducibility (100% qualitative agreement), LoD (1% abnormal population), and carryover (<1%).

Technological Characteristics

Flow cytometric test system using 3-laser (488nm, 638nm, 405nm) and 10-color fluorescence detection. Reagents are dry unitized panels. System includes Kaluza C software for off-line analysis. Connectivity via listmode file transfer. Quality control via Flow-Set Pro and Flow-Check Pro fluorospheres. Complies with CLSI standards (e.g., EP09-A3, EP5-A3, EP25-A).

Indications for Use

Indicated for qualitative identification of cell populations via multiparameter immunophenotyping in patients suspected of having hematopoietic neoplasms (chronic leukemia, non-Hodgkin lymphoma, myeloma, MDS, MPN). Used with peripheral whole blood, bone marrow, and lymph node specimens.

Regulatory Classification

Identification

A flow cytometric test for hematopoietic neoplasms is a device that consists of reagents for immunophenotyping of human cells in relation to the level of expression, antigen density, and distribution of specific cellular markers. These reagents are used as an aid in the differential diagnosis or monitoring of hematologically abnormal patients having or suspected of having hematopoietic neoplasms. The results should be interpreted by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include the following information: (i) The indications for use must indicate the clinical hematopoietic neoplasms for which the assay was designed and validated, for example, chronic leukemia or lymphoma. (ii) A detailed device description including the following: (A) A detailed description of all test components, all required reagents, and all instrumentation and equipment, including illustrations or photographs of nonstandard equipment or methods. (B) Detailed documentation of the device software including, but not limited to, standalone software applications and hardware-based devices that incorporate software. (C) A detailed description of methodology and assay procedure. (D) A description of appropriate internal and external quality control materials that are recommended or provided. The description must identify those control elements that are incorporated into the testing procedure, if applicable. (E) Detailed specifications for sample collection, processing, and storage. (F) Detailed specification of the criteria for test results interpretation and reporting including pre-established templates. (G) If applicable, based on the output of the results, a description of the specific number of events to collect, result outputs, and analytical sensitivity of the assay that will be reported. (iii) Information that demonstrates the performance characteristics of the test, including: (A) Device performance data from either a method comparison study comparing the specific lymphocyte cell markers to a predicate device or data collected through a clinical study demonstrating clinical validity using well-characterized clinical specimens. Samples must be representative of the intended use population of the device including hematologic neoplasms and the specific sample types for which the test is indicated for use. (B) If applicable, device performance data from a clinical study demonstrating clinical validity for parameters not established in a predicate device of this generic type using well-characterized prospectively obtained clinical specimens including all hematologic neoplasms and the specific sample types for which the device is indicated for use. (C) Device precision data using clinical samples to evaluate the within-lot, between-lot, within-run, between run, site-to-site and total variation using a minimum of three sites, of which at least two sites must be external sites. Results shall be reported as the standard deviation and percentage coefficient of variation for each level tested. (D) Reproducibility data generated using a minimum of three lots of reagents to evaluate mean fluorescence intensity and variability of the recovery of the different markers and/or cell populations. (E) Data from specimen and reagent carryover testing performed using well-established methods ( *e.g.,* CLSI H26-A2).(F) Specimen and prepared sample stability data established for each specimen matrix in the anticoagulant combinations and storage/use conditions that will be indicated. (G) A study testing anticoagulant equivalency in all claimed specimen type/anticoagulant combinations using clinical specimens that are representative of the intended use population of the device. (H) Analytic sensitivity data using a dilution panel created from clinical samples. (I) Analytical specificity data, including interference and cross-contamination. (J) Device stability data, including real-time stability of reagents under various storage times and temperatures. (K) For devices that include polyclonal antibodies, Fluorescence Minus One (FMO) studies to evaluate non-specific binding for all polyclonal antibodies. Each FMO tube is compared to reagent reference to demonstrate that no additional population appears when one marker is absent. Pre-specified acceptance criteria must be provided and followed. (L) For devices indicated for use as a semi-quantitative test, linearity data using a dilution panel created from clinical samples. (M) For devices indicated for use as a semi-quantitative test, clinically relevant analytical sensitivity data, including limit of blank, limit of detection, and limit of quantification. (iv) Identification of risk mitigation elements used by the device, including a detailed description of all additional procedures, methods, and practices incorporated into the instructions for use that mitigate risks associated with testing the device. (2) The 21 CFR 809.10 compliant labeling must include the following: (i) The intended use statement in the 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include a statement that the results should be interpreted by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings. The intended use statement must also include information on what the device detects and measures, whether the device is qualitative, semi-quantitative, and/or quantitative, the clinical indications for which the device is to be used, and the specific population(s) for which the device is intended. (ii) A detailed description of the performance studies conducted to comply with paragraph (b)(1)(iii) of this section and a summary of the results. (3) As part of the risk management activities performed under 21 CFR 820.10(c) design and development, product labeling and instruction manuals must include clear examples of all expected phenotypic patterns and gating strategies using well-defined clinical samples representative of both abnormal and normal cellular populations. These samples must be selected based upon the indications described in paragraph (b)(1)(i) of this section.

Predicate Devices

• ClearLLab Reagents (T1, T2, B1, B2, M) (DEN160047)
• Navios Flow Cytometer (K130373)
• Navios EX Flow Cytometer (K162897)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY AND INSTRUMENT COMBINATION

A. 510(k) Number:

K183592

B. Purpose for Submission:

New Device

C. Measurand:

Cluster of Differentiation (CD) Surface Markers on white blood cells

D. Type of Test:

Immunophenotyping, qualitative, flow cytometric assay

E. Applicant:

Beckman Coulter Inc.

F. Proprietary and Established Names:

Trade Name: ClearLLab 10C Panels (B, T, M1, M2)

Common Name: ClearLLab

Instruments: Navios Flow Cytometer

Navios EX Flow Cytometer

G. Regulatory Information:

1. Regulation section:

21 CFR 864.7010 – Flow Cytometric Test System for Hematopoietic Neoplasms

21 CFR 864.5220 – Automated Differential Cell Counter

2. Classification:

Class II

3. Product code:

PWD–Flow Cytometric Test System for Hematopoietic Neoplasms

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OYE-Flow Cytometric Reagents and Accessories

4. Panel:

81-Hematology

# H. Indications For Use:

1. Intended uses:

ClearLLab 10C Panels (B, T, M1, M2)

The ClearLLab 10C Panels are intended for in vitro diagnostic use for qualitative identification of cell populations by multiparameter immunophenotyping on the Navios and Navios EX flow cytometers. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having, the following hematopoietic neoplasms: chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (MDS), and/or myeloproliferative neoplasms (MPN). The reagents can be used with peripheral whole blood (collected in K2EDTA, Acid Citrate Dextrose (ACD) or Heparin), bone marrow (collected in K2EDTA, ACD or Heparin) and lymph node specimens. Interpretation of the results should be confirmed by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings.

These reagents provide multiparameter, qualitative results for the surface antigens listed below:

- ClearLLab 10C B Cell Tube: Kappa, Lambda, CD10, CD5, CD200, CD34, CD38, CD20, CD19, CD45
- ClearLLab 10C T Cell Tube: TCRγδ, CD4, CD2, CD56, CD5, CD34, CD3, CD8, CD7, CD45
- ClearLLab 10C M1 Cell Tube: CD16, CD7, CD10, CD13, CD64, CD34, CD14, HLA-DR, CD11b, CD45
- ClearLLab 10C M2 Cell Tube: CD15, CD123, CD117, CD13, CD33, CD34, CD38, HLA-DR, CD19, CD45

Navios Flow Cytometer

The Navios Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to ten fluorescent detection channels using three lasers (488 nm, 638 nm, and 405 nm) and two light scatter detection channels. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.

Navios EX Flow Cytometer

The Navios EX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to ten fluorescent detection channels using three lasers (488 nm, 638 nm, and 405 nm) and two light scatter detection channels. It is intended for use with

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in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.

2. Indications for use: same as Intended Uses
3. Special conditions for use statements:

For prescription use only.

For in vitro diagnostic use.

4. Special instrument requirements:

Beckman Coulter Navios and Navious EX flow cytometers, Kaluza C Software

### I. Device Description:

The ClearLLab Reagents panel is used with the following reagents with their respective indicated uses. A description of the reagents provided is described below in Table 1.

Table 1: Components of the ClearLLab 10C Panel Reagents

| Item | Description | Use |
| --- | --- | --- |
| The B-Cell Lineage panel | Comprising B: Kappa, Lambda, CD10, CD5, CD200, CD34, CD38,CD20, CD19, CD45Monoclonal and Polyclonal Antibody Reagents. | For use to identify lymphocytes that contain the specific cell surface markers associated with the B-cell lineage. |
| The T-Cell Lineage panel | Comprising T: TCRγδ, CD4, CD2, CD56, CD5, CD34, CD3, CD8, CD7, CD45 Monoclonal Antibody Reagents. | For use to identify lymphocytes that contain the specific cell surface markers associated with the T-cell lineage. |
| The Myeloid Lineage panels | Comprising M1 and M2: CD16, CD7, CD10, CD13, CD64, CD34, CD14, HLA-DR, CD11b, CD15, CD123, CD117, CD33, CD38, HLA-DR, CD19, CD45 Monoclonal Antibody Reagents. | For use to identify lymphocytes that contain the specific cell surface markers associated with the Myeloid lineage. |
| Accessory Reagents Required | | |
| Flow-Check Pro Fluorospheres | Flow-Check Pro Fluorospheres are a suspension of fluorescent microspheres used for daily verification of the optical alignment and fluidics for Forward Scatter (FS) and FL1-FL4 fluorescence parameters. | Instrument Alignment Quality Control Reagent to provide instrument alignment Quality Control instructions. |

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| Flow-Set Pro Fluorospheres | Flow-Set Pro Fluorospheres are a suspension of fluorescent microspheres used as an aid in standardizing forward scatter, side scatter, and fluorescence detectors on the FC 500 (FL1-FL5). | Auto Setup Reagent for standardization of flow cytometer light scatter and fluorescence intensity instrument settings to provide application-specific instrument target ranges for standardization. |
| --- | --- | --- |
| ClearLLab Compensation Kit | Compensation reagents consist of a combination of CD45-FITC, CD45-PE, CD45-ECD, CD45-PC5.5 and CD45-PC7. Color Compensation Reagents are recommended to be used with normal whole blood specimens to adjust color compensation settings on a flow cytometer, prior to multicolor analysis. | The ClearLLab Compensation Kit is used to adjust color compensation settings on a flow cytometer equipped with AutoSetup software, prior to multi-color analysis with FITC, PE, and ECD conjugated monoclonal antibody reagents. |
| ClearLLab Compensation Beads | ClearLLab Compensation Beads are to be used in conjunction with the ClearLLab Compensation Kit to establish compensation settings on the Navios and Navios EX Flow Cytometer(s) prior to multicolor analysis with the ClearLLab 10C Panels. | Used to adjust color compensation settings on a flow cytometer with AutoSetup software. Note: Color Compensation Reagents are required. It is recommended to use the reagents with normal whole blood specimens to adjust color compensation settings on a flow cytometer, prior to multi-color analysis. |
| IOTest 3 Fixative Solution | The IOTest 3 Fixative Solution, which has a formaldehyde base, specially developed for the fixing of leukocytes. | Leukocyte fixative solution used on all leukocytic preparations to enable leukocytic preparations to be stored for several hours without deterioration after staining with a fluorescent antibody. It is used to fix leukocytes following immunofluorescent staining with the fluorochrome-conjugated antibodies and lysis of the red blood cells. |
| IOTest 3 Lysing Solution | Red cell lysing reagent intended for the lysis of red blood cells in the preparation of biological samples for flow cytometry | IOTest 3 Lysing Solution is intended for the lysis of red blood cells in the preparation of biological samples for flow |

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| | analysis. | cytometry analysis. |
| --- | --- | --- |
| Kaluza C data analysis software | A stand-alone software tool designed to work with *.fcs and *.lmd files generated by flow cytometers. Kaluza C Software allows users to graphically display data, calculate descriptive statistics and many combinations of statistical operations based on users' needs. Kaluza C Software is intended for laboratory professionals in a clinical laboratory setting. | The software tool provides detailed protocols to define population gates and a series of dual parameter histograms to identify specific cell populations, with examples of normal and clinical specimen results in the product labeling. |
| Accessory Reagents Recommended but Not Provided | | |
| ClearLLab Control Cells, normal | Stabilized preparations of assayed, lysable whole blood intended as process controls for the verification of the ClearLLab 10C panels on the Navios and Navios EX flow cytometers. Parameters assayed include: Kappa, Lambda, CD5, CD200, CD38,CD20, CD19, CD45, TCRγδ, CD4, CD2, CD56, CD3, CD7, CD8, CD16, CD10, CD13, CD64,CD14, HLA-DR, CD11b, CD15, and CD33 | Quality control material assayed for lymphocyte-, granulocyte-, and monocyte-specific antigens and single platform absolute counts. The light scatter, population distribution, fluorescence intensity, and antigen density mimic those of normal whole blood. |
| ClearLLab Control Cells, abnormal | The ClearLLab Control Cells Abnormal are stabilized preparations of assayed, lysable whole blood intended as process controls for the verification of the ClearLLab 10C panels on the Navios and Navios EX flow cytometers. Parameters assayed include: Kappa, Lambda, CD5, CD200, CD38, CD20, CD19, CD45, TCRγδ, CD4, CD2, CD56, CD3, CD7, CD8, CD16, CD10,CD13, CD64, CD14, HLA-DR, CD11b, CD15, CD33, CD34, CD117, and CD123 | Quality control material assayed for lymphocyte-, granulocyte-, and monocyte-specific antigens and single platform absolute counts. The light scatter, population distribution, fluorescence intensity, and antigen density mimic those of normal whole blood. |

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ClearLLab 10C Immunophenotyping Panel

| Lineage | FITC | PE | ECD | PC5.5 | PC7 | APC | APC-A700 | APC-A750 | Pacific Blue | Krome Orange |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| B-cell tube | Kappa | Lambda | CD10 | CD5 | CD200 | CD34 | CD38 | CD20 | CD19 | CD45 |
| T-cell tube | TCRγδ | CD4 | CD2 | CD56 | CD5 | CD34 | CD7 | CD8 | CD3 | CD45 |
| M1-cell tube | CD16 | CD7 | CD10 | CD13 | CD64 | CD34 | CD14 | HLA-DR | CD11b | CD45 |
| M2-cell tube | CD15 | CD123 | CD117 | CD13 | CD33 | CD34 | CD38 | HLA-DR | CD19 | CD45 |

### J. Substantial Equivalence Information:

#### 1. Predicate device names and numbers:

ClearLLab Reagents (T1, T2, B1, B2, M); DEN160047

Navios Flow Cytometer; K130373

Navios EX Flow Cytometer; K162897

#### 2. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | New DeviceClearLLab 10C Panels (B, T, M1, M2) | PredicateClearLLab Reagents (T1, T2, B1, B2, M) |
| Specimen Type | Human whole blood | Same |
| Technology | Flow cytometry | Same |
| Sample Preparation | Wash and prepare samples manually | Same |
| Standardization | Flow-Set Pro Fluorospheres | Same |
| Optical alignment and fluidics | Flow-Check Pro Fluorospheres | Same |

| Differences | | |
| --- | --- | --- |
| Item | New DeviceClearLLab 10C Panels (B, T, M1, M2) | PredicateClearLLab Reagents (T1, T2, B1, B2, M) |
| Intended Use | The ClearLLab 10C Panels are intended for in vitro diagnostic use for qualitative identification of cell populations by multiparameter immunophenotyping on the | The ClearLLab reagents are intended for in vitro diagnostic use as a panel for qualitative identification of cell populations by multiparameter immunophenotyping on an FC |

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| Differences | | |
| --- | --- | --- |
| Item | New Device ClearLLab 10C Panels (B, T, M1, M2) | Predicate ClearLLab Reagents (T1, T2, B1, B2, M) |
| | Navios and Navios EX flow cytometers. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having, the following hematopoietic neoplasms: chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (MDS), and/or myeloproliferative neoplasms (MPN). The reagents can be used with peripheral whole blood (collected in K2EDTA, Acid Citrate Dextrose (ACD) or Heparin), bone marrow (collected in K2EDTA, ACD or Heparin) and lymph node specimens. Interpretation of the results should be confirmed by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings. These reagents provide multiparameter, qualitative results for the surface antigens listed below: -ClearLLab 10C B Cell Tube: Kappa, Lambda, CD10, CD5, CD200, CD34, CD38,CD20, CD19, CD45 -ClearLLab 10C T Cell Tube: TCRγδ, CD4, CD2, CD56, CD5, CD34, CD3, CD8, CD7, CD45 -ClearLLab 10C M1 Cell Tube: CD16, CD7, CD10, CD13, CD64, CD34, CD14, HLA-DR, CD11b, CD45 -ClearLLab 10C M2 Cell Tube: CD15, CD123, CD117, CD13, CD33, CD34, CD38, HLA-DR, CD19, CD45 | 500 flow cytometer. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having the following hematopoietic neoplasms: chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (MDS), and/or myeloproliferative neoplasms (MPN). The reagents can be used with peripheral whole blood collected in EDTA (K2 and K3EDTA), Acid Citrate Dextrose or Heparin, bone marrow collected in K2EDTA, ACD, or Heparin, and lymph node specimens. Interpretation of the results should be confirmed by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings. These reagents provide multiparameter, qualitative results for the Cluster of Differentiation (CD) parameters listed below: - ClearLLab T1: CD2, CD56, CD7, CD5, CD45 - ClearLLab T2: CD8, CD4, CD3, CD45 - ClearLLab B1: Kappa, Lambda, CD19, CD5, CD45 - ClearLLab B2: CD20, CD10, CD19, CD38, CD45 - ClearLLab M: CD7, CD13, CD34, CD33, CD45 |

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| Differences | | |
| --- | --- | --- |
| Item | New Device ClearLLab 10C Panels (B, T, M1, M2) | Predicate ClearLLab Reagents (T1, T2, B1, B2, M) |
| CD Markers (Underlined MARKERS ARE THE SAME) | Kappa, Lambda, CD5, CD200, CD38, CD20, CD19, CD45, TCRγδ, CD4, CD2, CD56, CD3, CD7, CD8, CD16, CD10,CD13, CD64, CD14, HLA- DR, CD11b, CD15, CD33, CD34, CD117, and CD123 | CD2, CD56, CD7, CD5, CD8, CD4, CD3, CD45, Kappa, Lambda, CD19, , CD20, CD10, CD38, CD13, CD34, CD33; |
| Reagent Form | Dry unitized form (one test / panel) | Liquid Form |
| Storage Conditions | 18–30°C | 2–8°C |
| Compensation | ClearLLab Compensation Kit with ClearLLab Compensation Beads | CD45-FITC, CD45-PE and CD45-ECD from existing QuickComp 4 plus CD45- PC5.5 and CD45-PC7 |

| Differences | | |
| --- | --- | --- |
| Item | New Device Navios Navios EX | Predicate Navios K130373 Navios EX K162897 |
| Maximum Parameter Detectors | Twelve (FS, SS, FL1 – FL10) | IVD configuration – Six (FS, SS, FL1 – FL4) |
| Photomulti-plier Tubes (PMTs)/Colors | Standard 5 PMTs (FL1 – FL5) off of 488 nm laser (blue) Standard 3 PMTs (FL6 – FL8) off of 638 nm laser (red) Standard 2 PMTs (FL9 – FL10) off of 405 nm laser (violet) | IVD configuration – Standard 4 PMTs (FL1 - FL4) off of 488 nm laser |
| Lasers / Driver Boards | Navios: Blue (488 nm) • Laser Diode, 22mW Red (638 nm) • Laser Diode, 25 mW Violet (405 nm) • Laser Diode, 40 mW Navios EX: Blue (488 nm) • Laser Diode, 55mW Red (638 nm) • Laser Diode, 50 mW Violet (405 nm) • Laser Diode, 80 mW | Navios: Blue (488 nm) • Laser Diode, 22mW Navios EX: Blue (488 nm) • Laser Diode, 55mW |
| Optical Filters | Optical Filters: (SP = Short | Optical Filters: (SP = Short |

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| Differences | | |
| --- | --- | --- |
| Item | New Device Navios Navios EX | Predicate Navios K130373 Navios EX K162897 |
| | Pass, BP = Band Pass, LP=Long Pass) • FL1 FITC 550 SP - 525 BP • FL2 PE 595 SP - 575/30 BP • FL3 ECD 655 SP - 620/30 BP • FL4 PC5.5 730 SP - 695/30 BP • FL5 PC7 755 LP • FL6 APC 710 SP – 660/20 BP • FL7 APC-A700 750 SP – 725/20 BP • FL8 APC-A750 755 LP • FL9 PB 480 SP – 450/50 BP • FL10 KRO 550/40 BP Navios EX FL3 ECD is 655 SP - 614/20 BP | Pass, BP = Band Pass, LP=Long Pass) • FL1 FITC 550 SP - 525 BP • FL2 PE 595 SP - 575/30 BP • FL3 ECD 655 SP - 620/30 BP • FL4 PC5.5 730 SP - 695/30 BP Navios EX FL3 ECD is 655 SP - 614/20 BP |
| Analysis Software | Offline and Independent of Instrument: New Kaluza C data analysis software with the new ClearLLab 10C applicationthat is used off-line. | Navios or Navios EX on-board and off-line analysis software |

### K. Standards/Guidance Documents Referenced:

CLSI EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures, A Statistical Approach

CLSI EP05-A3, Evaluation of Precision Performance of Quantitative Measurement Methods

CLSI EP28-A3c, Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory

CLSI H26-A2, Validation, Verification, and Quality Assurance of Automated Hematology Analyzers

CLSI EP17-A2, Protocols for Determination of Limits of Detection and Limits of Quantitation

CLSI EP25-A, Evaluation of Stability on In Vitro Diagnostic Reagents

CLSI EP12-A2, User Protocol for Evaluation of Qualitative Test Performance

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CLSI H43-A2, Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells

## L. Test Principle:

Beckman Coulter's ClearLLab 10C Panels are comprised of lineage-driven combinations of the consensus reagents, provided in a ready-to-use dry form, for evaluation of B, T and Myeloid cell neoplasia as described in Table 3 of “2006 Bethesda International Consensus Recommendations on the Immunophenotypic Analysis of Hematolymphoid Neoplasia by Flow Cytometry: Optimal Reagents and Reporting for the Flow Cytometric Diagnosis of Hematopoietic Neoplasia”¹. The ClearLLab 10C product is intended for use on the Navios and Navios EX flow cytometers with instrument set-up performed with Flow-Check Pro Fluorospheres, Flow-Set Pro Fluorospheres, and Compensation Kit color compensation reagents and beads for alignment, voltage standardization, and compensation.

This test depends on the ability of a monoclonal or polyclonal antibody to bind to the surface of cells expressing discrete antigenic determinants. Specimens are washed to remove endogenous plasma proteins that may interfere with the binding specificity of antibodies. Specific cell staining is accomplished by incubating washed specimen cells with the appropriate antibody reagent. The ClearLLab 10C Panels are composed of four panels containing ten monoclonal or polyclonal antibody reagents, each specific for a different cell surface antigen and conjugated to a specific fluorochrome. After sample preparation, the specimens are analyzed on the flow cytometer with manual gating.

The Navios and Navios EX flow cytometers in combination with the Kaluza C Software applies the principles of flow cytometry to acquire and analyze a whole blood, bone marrow or lymph node sample. Samples are prepared and stained with a monoclonal antibody reagents followed by lysis of red blood cells prior to introduction into the instrument. Cellular populations are identified based on the specific monoclonal and polyclonal antibodies and fluorochromes used in the different panels. Detection of fluorescent antibodies bound to cells utilizes the capability of the Navios or Navios EX flow cytometer to detect fluorescence with three lasers: a blue laser with a 488 nm, a red laser with a 638 nm, and a violet laser with a 405 nm excitation; and ten different detection channels (FL1-FL10). Preset Kaluza C LMD analysis templates for the ClearLLab 10C reagent system are provided.

The Navios and Navios EX Flow Cytometer Software provides automated instrument setup of alignment, voltage standardization, color compensation, and verification when used with the quality control reagents. The software has an Auto-Set Panel which automatically standardizes the cytometer, adjusts compensation settings, passes cytometer settings to designated test protocols, and verifies cytometer setup and antibody performance. The ClearLLab 10C Panels are processed through the Navios and Navios EX Flow Cytometers and analyzed using the Kaluza C Analysis software.

¹ 2006 Bethesda International Consensus recommendations on the immunophenotypic analysis of hematolymphoid neoplasia by flow cytometry: optimal reagents and reporting for the flow cytometric diagnosis of hematopoietic neoplasia. Wood BL, Arroz M, Barnett D, DiGiuseppe J, Greig B, Kussick SJ, Oldaker T, Shenkin M, Stone E, Wallace P. Cytometry B Clin Cytom. 2007; 72 Suppl 1:S14-22

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# Sample Preparation & Analysis

Whole Blood (WB) and Bone Marrow (BM) preparation:

Specimens are prepared manually with three pre-wash steps using phosphate buffered saline (PBS) containing 2% Heat Inactivated Fetal Calf Serum (HI-FCS). The remaining white blood cell pellet is then resuspended in PBS containing HI-FCS. The washed specimen is stained with the ClearLLab 10 Color Panels. Prior to analysis, the IOTest 3 Lysing Solution is used for lysing red blood cells and the IOTest 3 Fixative Solution is used for fixation.

Lymph Node preparation:

Lymph node specimens require disaggregation of the tissue into a single cell suspension. Single cell suspensions prepared from lymphoid tissues may not require washing prior to staining if the specimen was washed during the disaggregation process. If washing steps were not performed for removal of residual soluble proteins, or if the cells were re-suspended in a buffer containing human serum or serum proteins, then pre-washing is necessary.

Sample analysis:

The Navios or Navios EX System Software is used for sample acquisition in conjunction with ClearLLab 10C Panels. The acquisition protocols are provided as part of the software and contain the following plots:

- Time/FL10 plot (Ungated) for monitoring of acquisition
- FS INT/FS Peak plot (Time) to define "Singlets" and exclude the aggregated cells
- SS INT/FS INT plot (Singlets) to define "Cells" and exclude the compromised cells (see Warning)
- FL10/SS INT plot (Cells) to define "CD45+" cells
- FL10/SS INT plot (CD45+) to define the Stop Criteria of 50,000 total CD45+ cells, define populations of "Lymphs", "Monos", "Grans", and "CD45dim".

The List Mode Data (LMD) files are analyzed offline using Kaluza C Flow Cytometry Software with an appropriate combination of subpopulation gates. The Kaluza C Flow Cytometry Software allows the user to perform the LMD analysis for data generated using any of the four ClearLLab 10C Protocols. Review of the color compensation and gating are required.

# M. Interpretation of Results

Flow cytometric immunophenotyping is multiparametric and relies on simultaneous identification and characterization of both normal and candidate malignant cell populations. Normal cells, which vary in type and relative numbers depending on the sample type, patient age, and clinical setting, display highly conserved and reproducible patterns of cell surface marker expression and light scatter. These normal internal control patterns may serve as both process controls for sample type, sample degradation, sample preparation and staining, data acquisition, and data analysis, as well as references against which candidate malignant populations may be compared. Candidate malignant populations may display aberrant loss of a marker, aberrant gain of a marker, or aberrant over- or under-expression of a marker. Any population that does not conform to the normal internal control pattern is evaluated for malignancy. Interpretation of these patterns requires expert knowledge and training in the technique. It is not possible to predict the phenotype of a particular patient's hematolymphoid malignancy and apply fixed templates for samples for detection of specific phenotypes. Even well-characterized diseases such as chronic lymphocytic leukemia may display case-to-case immunophenotypic variability and it is therefore the role of the expert interpreter to assess the significance of findings and to interpret them

11

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together with clinical history, morphological assessment, and other ancillary techniques in order to arrive at a final diagnosis. The device labeling states that interpretation of specimens should be performed by a pathologist or equivalent professional who has the appropriate training. Finally, a small number of rare samples contain no or very few normal cells and require careful evaluation and correlation with other sources of information such as clinical history and other laboratory findings to obtain the appropriate final diagnosis.

# N. Performance Characteristics:

All results provided below met the manufacturer's pre-specified acceptance criteria.

# 1. Analytical Performance:

a. Precision and Reproducibility: Precision studies were conducted according to the methodology presented in CLSI EP05-A3, Evaluation of Precision Performance of Quantitative Measurement Procedures; Approved Guideline – Third Edition.

i. Precision (repeatability): The repeatability of normal and abnormal clinical specimens representing clinical matrices and anticoagulants was evaluated with the ClearLLab 10C Panels at four sites. Eighty three specimens across the three specimen types were evaluated. Each site employed a different anticoagulant for specimens, according to their current clinical practice: K2EDTA, acid citrate dextrose (ACD), or heparin. For the three specimen matrices (i.e. whole blood [WB], bone marrow [BM], lymph node[LN]), three sites evaluated all three matrices; one did not evaluate lymph node. Two sites operated the Navios instrument, and the other two operated the Navios EX. Each site evaluated a minimum of 18 specimens. For lymph node specimens (LN), testing was conducted at two sites. Since LN specimens are not collected using an anticoagulant, this was not a variable for lymph node specimen analysis.

Unless otherwise specified, a minimum of two specimens per specimen type per panel per anticoagulant (site) were included. Each specimen per panel was analyzed twice each day. There were six sample preparations in the morning and six sample preparations in the afternoon, resulting in a total of 12 replicates per specimen per panel. From 1092 initial total replicates, 96 were excluded for reasons of specimen quality or insufficient quantity. Both quantitative and qualitative assessment were applied to the precision assessment where the presence or absence of an abnormal phenotype was reported.

All results showed 100% qualitative agreement across all sites, panels, anticoagulants, specimen types, and phenotypes. The number of samples tested is depicted in the tables below.

For repeatability evaluation, pre-defined hematopoietic lineage populations were defined as in the table below:

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| Population definitions for evaluation of multi-site reproducibility of ClearLLab 10 color | | | | |
| --- | --- | --- | --- | --- |
| Panel | Normal Population | Immunophenotype of Normal Population | Specimen Type | Abnormal Markers |
| B | Mature κ+ B cells | CD45bright SSclow CD19+ CD20+Kappa+ CD38dim CD200+ CD10-CD5- CD34- | WB | CD5CD10CD34 |
| | | | BM | |
| | | | LN | |
| | Mature λ+ B cells | CD45bright SSclow CD19+ CD20+Lambda+ CD38dim CD200+ CD10-CD5- CD34- | WB | |
| | | | BM | |
| | | | LN | |
| T | Helper T cells | CD45bright SSclow CD2+ CD3+CD4+ CD8- CD5+ CD7+ CD56-TCRγδ- CD34- | WB | CD34 |
| | | | BM | |
| | | | LN | |
| | Cytotoxic T cells | CD45bright SSclow CD2+ CD3+CD8+ CD4- CD5+ CD7+ CD56-TCRγδ- CD34- | WB | |
| | | | BM | |
| | | | LN | |
| | NK cells | CD45bright SSclow CD56+ CD2+ CD3- CD4-CD8+/- CD5- CD7+TCRγδ- CD34- | WB | |
| | | | BM | |
| | | | LN | |
| | γδ T cells | CD45bright SSclow CD2+ CD3brightTCRγδ- CD4- CD8- CD5+ CD7+CD56+ CD34- | WB | |
| | | | BM | |
| | | | LN | |
| M1 | Neutrophils | CD45dim SSchigh CD16+ CD10+CD13+ CD11b+ CD7- CD64- CD14-CD34- HLA-DR- | WB | CD7CD34 |
| | | | BM | |
| | Monocytes | CD45med SScmed CD13+ CD64+CD14+ HLA-DR+ CD11b+ CD16- CD7-CD10- CD34- | WB | |
| | | | BM | |
| M2 | Neutrophils | CD45dim SSchigh CD15+ CD13+CD33+/- CD123- CD117- CD34-CD38- HLA-DR- CD34- | WB | CD19CD34CD117 |
| | | | BM | |
| | Monocytes | CD45med SScmed CD13+ CD33+CD38+ HLA-DR+ CD15- CD123-CD19- CD34- CD117- | WB | |
| | | | BM | |
| | Basophils | CD45dim CD123bright CD38brightCD13+ CD33+ CD15- CD117-CD34- HLA-DR- CD19- | WB | |
| | | | BM | |

| Qualitative Agreement, by Specimen, by Site | | | | | |
| --- | --- | --- | --- | --- | --- |
| Site | Panel | Anticoagulant | Specimen Type | Phenotype | N |
| 1 | B | ACD | BM | Abnormal (+) | 12 |
| 1 | B | ACD | BM | Normal (−) | 12 |
| 1 | B | ACD | BM | Normal (−) | 12 |
| 1 | B | n/a | LN | Abnormal (+) | 12 |
| 1 | B | n/a | LN | Abnormal (+) | 12 |
| 1 | B | n/a | LN | Normal (−) | 12 |
| 1 | B | ACD | WB | Abnormal (+) | 12 |
| 1 | B | ACD | WB | Abnormal (+) | 12 |
| 1 | B | ACD | WB | Normal (−) | 12 |
| 2 | B | \( K_2EDTA \) | BM | Abnormal (+) | 12 |
| 2 | B | \( K_2EDTA \) | BM | Abnormal (+) | 12 |
| 2 | B | \( K_2EDTA \) | BM | Normal (−) | 12 |
| 2 | B | n/a | LN | Abnormal (+) | 12 |
| 2 | B | n/a | LN | Normal (−) | 12 |
| 2 | B | \( K_2EDTA \) | WB | Abnormal (+) | 12 |
| 2 | B | \( K_2EDTA \) | WB | Abnormal (+) | 12 |
| 3 | B | Heparin | BM | Abnormal (+) | 12 |

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| Qualitative Agreement, by Specimen, by Site | | | | | |
| --- | --- | --- | --- | --- | --- |
| Site | Panel | Anticoagulant | Specimen Type | Phenotype | N |
| 3 | B | Heparin | BM | Abnormal (+) | 12 |
| 3 | B | Heparin | WB | Abnormal (+) | 12 |
| 3 | B | Heparin | WB | Abnormal (+) | 12 |
| 3 | B | Heparin | WB | Normal (-) | 12 |
| 4 | B | K_{2}EDTA | BM | Abnormal (+) | 12 |
| 4 | B | K_{2}EDTA | BM | Abnormal (+) | 12 |
| 4 | B | n/a | LN | Abnormal (+) | 12 |
| 4 | B | n/a | LN | Abnormal (+) | 12 |
| 4 | B | n/a | LN | Normal (-) | 12 |
| 4 | B | Heparin | WB | Abnormal (+) | 12 |
| 4 | B | Heparin | WB | Abnormal (+) | 12 |
| 4 | B | Heparin | WB | Normal (-) | 12 |
| 1 | M1 | ACD | BM | Abnormal (+) | 12 |
| 1 | M1 | ACD | BM | Abnormal (+) | 12 |
| 1 | M1 | ACD | WB | Abnormal (+) | 12 |
| 1 | M1 | ACD | WB | Normal (-) | 12 |
| 2 | M1 | K_{2}EDTA | BM | Abnormal (+) | 12 |
| 2 | M1 | K_{2}EDTA | BM | Normal (-) | 12 |
| 2 | M1 | K_{2}EDTA | WB | Abnormal (+) | 12 |
| 2 | M1 | K_{2}EDTA | WB | Abnormal (+) | 12 |
| 2 | M1 | K_{2}EDTA | WB | Abnormal (+) | 12 |
| 3 | M1 | Heparin | BM | Abnormal (+) | 12 |
| 3 | M1 | Heparin | BM | Abnormal (+) | 12 |
| 3 | M1 | Heparin | WB | Abnormal (+) | 12 |
| 3 | M1 | Heparin | WB | Abnormal (+) | 12 |
| 3 | M1 | Heparin | WB | Abnormal (+) | 12 |
| 4 | M1 | K_{2}EDTA | BM | Abnormal (+) | 12 |
| 4 | M1 | K_{2}EDTA | BM | Normal (-) | 12 |
| 4 | M1 | Heparin | WB | Abnormal (+) | 12 |
| 4 | M1 | K_{2}EDTA | WB | Abnormal (+) | 12 |
| 4 | M1 | Heparin | WB | Normal (-) | 12 |
| 1 | M2 | ACD | BM | Abnormal (+) | 12 |
| 1 | M2 | ACD | BM | Abnormal (+) | 12 |
| 1 | M2 | ACD | WB | Abnormal (+) | 12 |
| 1 | M2 | ACD | WB | Normal (-) | 12 |
| 1 | M2 | ACD | WB | Normal (-) | 12 |
| 2 | M2 | K_{2}EDTA | BM | Abnormal (+) | 12 |
| 2 | M2 | K_{2}EDTA | BM | Abnormal (+) | 12 |
| 2 | M2 | K_{2}EDTA | WB | Abnormal (+) | 12 |
| 2 | M2 | K_{2}EDTA | WB | Abnormal (+) | 12 |
| 3 | M2 | Heparin | BM | Abnormal (+) | 12 |
| 3 | M2 | Heparin | BM | Abnormal (+) | 12 |
| 3 | M2 | Heparin | WB | Abnormal (+) | 12 |
| 3 | M2 | Heparin | WB | Abnormal (+) | 12 |
| 4 | M2 | K_{2}EDTA | BM | Abnormal (+) | 12 |
| 4 | M2 | K_{2}EDTA | BM | Abnormal (+) | 12 |
| 4 | M2 | K_{2}EDTA | BM | Abnormal (-) | 12 |
| 4 | M2 | Heparin | WB | Abnormal (+) | 12 |
| 4 | M2 | Heparin | WB | Abnormal (+) | 12 |
| 1 | T | ACD | BM | Normal (-) | 12 |
| 1 | T | ACD | BM | Normal (-) | 12 |
| 1 | T | ACD | BM | Normal (-) | 12 |
| 1 | T | ACD | WB | Normal (-) | 12 |
| 1 | T | ACD | WB | Normal (-) | 12 |
| 2 | T | K_{2}EDTA | BM | Normal (-) | 12 |

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| Qualitative Agreement, by Specimen, by Site | | | | | |
| --- | --- | --- | --- | --- | --- |
| Site | Panel | Anticoagulant | Specimen Type | Phenotype | N |
| 2 | T | K_{2}EDTA | BM | Normal (-) | 12 |
| 2 | T | K_{2}EDTA | WB | Normal (-) | 12 |
| 2 | T | K_{2}EDTA | WB | Normal (-) | 12 |
| 3 | T | Heparin | BM | Normal (-) | 12 |
| 3 | T | Heparin | BM | Normal (-) | 12 |
| 3 | T | Heparin | WB | Normal (-) | 12 |
| 3 | T | Heparin | WB | Normal (-) | 12 |
| 4 | T | K_{2}EDTA | BM | Abnormal (+) | 12 |
| 4 | T | K_{2}EDTA | BM | Normal (-) | 12 |
| 4 | T | Heparin | WB | Abnormal (+) | 12 |
| 4 | T | Heparin | WB | Normal (-) | 12 |

| Qualitative Agreement, by Anticoagulant and Specimen Type, across Sites and Specimens | | | | |
| --- | --- | --- | --- | --- |
| Panel | Anticoagulant | Specimen Type | Phenotype | N |
| B | ACD | BM | Normal (-) | 24 |
| B | ACD | BM | Abnormal (+) | 12 |
| B | ACD | WB | Normal (-) | 12 |
| B | ACD | WB | Abnormal (+) | 24 |
| B | Heparin | BM | Abnormal (+) | 24 |
| B | Heparin | WB | Normal (-) | 24 |
| B | Heparin | WB | Abnormal (+) | 48 |
| B | K_{2}EDTA | BM | Normal (-) | 12 |
| B | K_{2}EDTA | BM | Abnormal (+) | 48 |
| B | K_{2}EDTA | WB | Abnormal (+) | 24 |
| B | n/a | LN | Normal (-) | 36 |
| B | n/a | LN | Abnormal (+) | 60 |
| M1 | ACD | BM | Abnormal (+) | 24 |
| M1 | ACD | WB | Normal (-) | 12 |
| M1 | ACD | WB | Abnormal (+) | 12 |
| M1 | Heparin | BM | Abnormal (+) | 24 |
| M1 | Heparin | WB | Normal (-) | 24 |
| M1 | Heparin | WB | Abnormal (+) | 36 |
| M1 | K_{2}EDTA | BM | Normal (-) | 24 |
| M1 | K_{2}EDTA | BM | Abnormal (+) | 24 |
| M1 | K_{2}EDTA | WB | Abnormal (+) | 48 |
| M2 | ACD | BM | Abnormal (+) | 24 |
| M2 | ACD | WB | Normal (-) | 24 |
| M2 | ACD | WB | Abnormal (+) | 12 |
| M2 | Heparin | BM | Abnormal (+) | 24 |
| M2 | Heparin | WB | Normal (-) | 12 |
| M2 | Heparin | WB | Abnormal (+) | 36 |
| M2 | K_{2}EDTA | BM | Normal (-) | 12 |
| M2 | K_{2}EDTA | BM | Abnormal (+) | 48 |
| M2 | K_{2}EDTA | WB | Normal (-) | 12 |
| M2 | K_{2}EDTA | WB | Abnormal (+) | 12 |
| T | ACD | BM | Normal (-) | 36 |
| T | ACD | WB | Normal (-) | 24 |
| T | Heparin | BM | Normal (-) | 24 |
| T | Heparin | WB | Normal (-) | 36 |
| T | Heparin | WB | Abnormal (+) | 12 |
| T | K_{2}EDTA | BM | Normal (-) | 36 |
| T | K_{2}EDTA | BM | Abnormal (+) | 12 |
| T | K_{2}EDTA | WB | Normal (-) | 24 |

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| Quantitative Results, by Specimen, by Site for Navios | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Panel | Site | Specimen Type | Anti-coagulant | Population | N | Mean (%) | Repeatability | | Between Run | | Within Sample | |
| | | | | | | | SD | %CV | SD | %CV | SD | %CV |
| B | 1 | WB | ACD | Mature κ+ B cells | 12 | 60.01 | 0.94 | 1.57 | 1.50 | 2.50 | 1.77 | 2.95 |
| B | 1 | WB | ACD | Mature λ+ B cells | 12 | 40.08 | 0.99 | 2.47 | 1.39 | 3.47 | 1.71 | 4.26 |
| B | 1 | LN | NA | Mature κ+ B cells | 12 | 60.37 | 0.94 | 1.55 | 0.00 | 0.00 | 0.94 | 1.55 |
| B | 1 | LN | NA | Mature λ+ B cells | 12 | 39.50 | 0.94 | 2.37 | 0.00 | 0.00 | 0.94 | 2.37 |
| B | 1 | BM | ACD | Mature κ+ B cells | 12 | 45.01 | 1.44 | 3.19 | 0.00 | 0.00 | 1.44 | 3.19 |
| B | 1 | BM | ACD | Mature λ+ B cells | 12 | 15.19 | 0.95 | 6.25 | 0.00 | 0.00 | 0.95 | 6.25 |
| B | 1 | BM | ACD | Abnormal CD10+ B cells | 12 | 60.06 | 1.45 | 2.41 | 0.00 | 0.00 | 1.45 | 2.41 |
| B | 1 | WB | ACD | Abnormal CD5+ B cells | 12 | 85.62 | 0.28 | 0.33 | 0.31 | 0.37 | 0.42 | 0.49 |
| B | 1 | BM | ACD | Abnormal CD5+ B cells | 12 | 89.48 | 0.65 | 0.72 | 0.00 | 0.00 | 0.65 | 0.72 |
| B | 1 | LN | NA | Abnormal CD10+ B cells | 12 | 99.42 | 0.06 | 0.06 | 0.07 | 0.07 | 0.09 | 0.09 |
| B | 1 | WB | ACD | Abnormal CD10+ B cells | 12 | 26.53 | 1.75 | 6.59 | 2.11 | 7.96 | 2.74 | 10.33 |
| B | 1 | BM | ACD | Abnormal CD10+ B cells | 12 | 89.84 | 1.37 | 1.52 | 1.08 | 1.20 | 1.74 | 1.94 |
| B | 1 | LN | NA | Abnormal CD5+ B cells | 12 | 19.80 | 1.01 | 5.08 | 1.58 | 7.97 | 1.87 | 9.45 |
| B | 2 | WB | Heparin | Abnormal CD5+ B cells | 12 | 97.67 | 0.47 | 0.48 | 0.00 | 0.00 | 0.47 | 0.48 |
| B | 2 | BM | Heparin | Abnormal CD5+ B cells | 12 | 99.56 | 0.12 | 0.12 | 0.12 | 0.12 | 0.17 | 0.18 |
| B | 2 | BM | Heparin | Mature κ+ B cells | 12 | 3.09 | 0.21 | 6.83 | 0.25 | 7.95 | 0.32 | 10.48 |
| B | 2 | BM | Heparin | Mature λ+ B cells | 12 | 3.01 | 0.14 | 4.81 | 0.00 | 0.00 | 0.14 | 4.81 |
| B | 2 | BM | Heparin | Abnormal CD5+ B cells | 12 | 93.33 | 0.25 | 0.27 | 0.00 | 0.00 | 0.25 | 0.27 |
| B | 2 | WB | Heparin | Abnormal CD5+ B cells | 12 | 98.58 | 0.17 | 0.17 | 0.12 | 0.12 | 0.21 | 0.21 |
| B | 2 | WB | Heparin | Mature κ+ B cells | 12 | 58.53 | 1.24 | 2.13 | 0.67 | 1.15 | 1.41 | 2.42 |
| B | 2 | WB | Heparin | Mature λ+ B cells | 12 | 41.37 | 1.26 | 3.05 | 0.71 | 1.72 | 1.45 | 3.50 |
| M1 | 1 | WB | ACD | Neutrophils | 12 | 41.96 | 1.88 | 4.47 | 3.53 | 8.41 | 4.00 | 9.52 |
| M1 | 1 | WB | ACD | Monocytes | 12 | 5.67 | 0.23 | 3.97 | 0.00 | 0.00 | 0.23 | 3.97 |
| M1 | 1 | WB | ACD | Abnormal CD34+CD7+ | 12 | 17.25 | 0.25 | 1.44 | 1.07 | 6.20 | 1.10 | 6.37 |
| M1 | 1 | BM | ACD | Abnormal CD34+CD7+ | 12 | 13.50 | 0.15 | 1.10 | 0.09 | 0.63 | 0.17 | 1.27 |
| M1 | 1 | BM | ACD | Neutrophils | 12 | 28.77 | 0.47 | 1.63 | 0.63 | 2.17 | 0.78 | 2.71 |
| M1 | 1 | BM | ACD | Monocytes | 12 | 5.32 | 0.19 | 3.63 | 0.22 | 4.08 | 0.29 | 5.46 |
| M1 | 2 | BM | Heparin | Abnormal CD34+CD7+ | 12 | 22.64 | 0.21 | 0.95 | 0.00 | 0.00 | 0.21 | 0.95 |
| M1 | 2 | WB | Heparin | Abnormal CD34+CD7+ | 12 | 74.67 | 0.26 | 0.35 | 0.38 | 0.51 | 0.46 | 0.62 |
| M1 | 2 | BM | Heparin | Neutrophils | 12 | 32.01 | 1.66 | 5.17 | 0.00 | 0.00 | 1.66 | 5.17 |
| M1 | 2 | BM | Heparin | Monocytes | 12 | 3.30 | 0.14 | 4.23 | 0.00 | 0.00 | 0.14 | 4.23 |
| M1 | 2 | WB | Heparin | Abnormal CD34+CD7+ | 12 | 25.76 | 0.40 | 1.56 | 0.34 | 1.33 | 0.53 | 2.05 |
| M1 | 2 | WB | Heparin | Neutrophils | 12 | 61.46 | 1.99 | 3.23 | 3.03 | 4.93 | 3.62 | 5.90 |
| M1 | 2 | WB | Heparin | Monocytes | 12 | 3.57 | 0.18 | 4.97 | 0.13 | 3.64 | 0.22 | 6.16 |
| M2 | 1 | WB | ACD | Neutrophils | 12 | 42.92 | 1.59 | 3.70 | 3.42 | 7.96 | 3.77 | 8.78 |
| M2 | 1 | WB | ACD | Monocytes | 12 | 5.74 | 0.38 | 6.69 | 0.00 | 0.00 | 0.38 | 6.69 |
| M2 | 1 | WB | ACD | Neutrophils | 12 | 13.68 | 0.97 | 7.12 | 0.51 | 3.73 | 1.10 | 8.04 |

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| Quantitative Results, by Specimen, by Site for Navios | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Panel | Site | Specimen Type | Anti-coagulant | Population | N | Mean (%) | Repeatability | | Between Run | | Within Sample | |
| | | | | | | | SD | %CV | SD | %CV | SD | %CV |
| M2 | 1 | WB | ACD | Abnormal CD34^{+} CD123^{+} | 12 | 77.57 | 0.55 | 0.71 | 1.51 | 1.94 | 1.60 | 2.07 |
| M2 | 1 | WB | ACD | Abnormal CD117^{+} | 12 | 79.34 | 0.55 | 0.70 | 2.15 | 2.71 | 2.22 | 2.80 |
| M2 | 1 | BM | ACD | Abnormal CD34^{+} CD123^{+} | 12 | 72.64 | 0.39 | 0.53 | 0.00 | 0.00 | 0.39 | 0.53 |
| M2 | 1 | BM | ACD | Abnormal CD117^{+} | 12 | 75.39 | 0.57 | 0.76 | 0.38 | 0.51 | 0.69 | 0.91 |
| M2 | 1 | BM | ACD | Neutrophils | 12 | 33.13 | 0.67 | 2.01 | 0.36 | 1.09 | 0.76 | 2.29 |
| M2 | 1 | BM | ACD | Monocytes | 12 | 5.62 | 0.22 | 3.93 | 0.00 | 0.00 | 0.22 | 3.93 |
| M2 | 1 | BM | ACD | Abnormal CD34^{+} CD123^{+} | 12 | 45.07 | 0.42 | 0.94 | 0.56 | 1.23 | 0.70 | 1.55 |
| M2 | 1 | BM | ACD | Abnormal CD117^{+} | 12 | 47.58 | 0.46 | 0.98 | 0.50 | 1.05 | 0.68 | 1.43 |
| M2 | 2 | BM | Heparin | Neutrophils | 12 | 12.73 | 0.38 | 3.02 | 0.74 | 5.84 | 0.84 | 6.58 |
| M2 | 2 | BM | Heparin | Monocytes | 12 | 4.34 | 0.18 | 4.05 | 0.38 | 8.65 | 0.41 | 9.55 |
| M2 | 2 | BM | Heparin | Abnormal CD34^{+} CD123^{+} | 12 | 66.97 | 0.42 | 0.63 | 2.76 | 4.13 | 2.79 | 4.17 |
| M2 | 2 | BM | Heparin | Abnormal CD117^{+} | 12 | 51.66 | 0.44 | 0.85 | 1.10 | 2.14 | 1.19 | 2.30 |
| M2 | 2 | BM | Heparin | Neutrophils | 12 | 23.92 | 0.39 | 1.62 | 1.66 | 6.95 | 1.71 | 7.14 |
| M2 | 2 | BM | Heparin | Monocytes | 12 | 17.60 | 0.31 | 1.74 | 1.61 | 9.15 | 1.64 | 9.31 |
| M2 | 2 | BM | Heparin | Abnormal CD34^{+} CD123^{+} | 12 | 35.51 | 0.52 | 1.48 | 0.46 | 1.31 | 0.70 | 1.97 |
| M2 | 2 | BM | Heparin | Abnormal CD117^{+} | 12 | 34.17 | 0.46 | 1.35 | 0.00 | 0.00 | 0.46 | 1.35 |
| M2 | 2 | WB | Heparin | Neutrophils | 12 | 3.30 | 0.18 | 5.41 | 0.21 | 6.27 | 0.27 | 8.28 |
| M2 | 2 | WB | Heparin | Monocytes | 12 | 7.15 | 0.21 | 2.94 | 0.27 | 3.74 | 0.34 | 4.76 |
| M2 | 2 | WB | Heparin | Abnormal CD34^{+} CD123^{+} | 12 | 98.08 | 0.07 | 0.07 | 0.61 | 0.62 | 0.61 | 0.62 |
| M2 | 2 | WB | Heparin | Abnormal CD117^{+} | 12 | 98.33 | 0.06 | 0.06 | 0.44 | 0.45 | 0.45 | 0.46 |
| T | 1 | WB | ACD | Helper T cells | 12 | 68.87 | 0.54 | 0.78 | 0.00 | 0.00 | 0.54 | 0.78 |
| T | 1 | WB | ACD | Cytotoxic T cells | 12 | 23.79 | 0.47 | 1.96 | 0.22 | 0.94 | 0.52 | 2.17 |
| T | 1 | WB | ACD | NK cells | 12 | 11.90 | 0.22 | 1.82 | 0.15 | 1.30 | 0.27 | 2.24 |
| T | 1 | WB | ACD | γδ T cells | 12 | 2.71 | 0.14 | 5.07 | 0.00 | 0.00 | 0.14 | 5.07 |
| T | 1 | BM | ACD | Helper T cells | 12 | 55.24 | 1.02 | 1.84 | 0.18 | 0.32 | 1.03 | 1.87 |
| T | 1 | BM | ACD | Cytotoxic T cells | 12 | 27.47 | 0.97 | 3.55 | 0.00 | 0.00 | 0.97 | 3.55 |
| T | 1 | BM | ACD | NK cells | 12 | 6.94 | 0.32 | 4.61 | 0.20 | 2.85 | 0.38 | 5.42 |
| T | 1 | BM | ACD | γδ T cells | 12 | 7.14 | 0.46 | 6.39 | 0.22 | 3.07 | 0.51 | 7.09 |
| T | 1 | WB | ACD | Helper T cells | 12 | 51.20 | 0.49 | 0.95 | 0.35 | 0.68 | 0.60 | 1.17 |
| T | 1 | WB | ACD | Cytotoxic T cells | 12 | 32.09 | 1.01 | 3.14 | 0.00 | 0.00 | 1.01 | 3.14 |
| T | 1 | WB | ACD | NK cells | 12 | 1.39 | 0.07 | 4.93 | 0.00 | 0.00 | 0.07 | 4.93 |
| T | 1 | WB | ACD | γδ T cells | 12 | 3.93 | 0.21 | 5.40 | 0.00 | 0.00 | 0.21 | 5.40 |
| T | 1 | BM | ACD | Helper T cells | 12 | 81.53 | 0.72 | 0.88 | 0.00 | 0.00 | 0.72 | 0.88 |
| T | 1 | BM | ACD | Cytotoxic T cells | 12 | 9.83 | 0.34 | 3.47 | 0.22 | 2.24 | 0.41 | 4.13 |
| T | 1 | BM | ACD | NK cells | 12 | 13.26 | 0.35 | 2.60 | 0.22 | 1.68 | 0.41 | 3.10 |
| T | 1 | BM | ACD | γδ T cells | 12 | 1.79 | 0.15 | 8.66 | 0.00 | 0.00 | 0.15 | 8.66 |
| T | 1 | BM | ACD | Helper T cells | 12 | 38.68 | 1.17 | 3.04 | 0.00 | 0.00 | 1.17 | 3.04 |
| T | 1 | BM | ACD | Cytotoxic T cells | 12 | 33.46 | 1.01 | 3.03 | 0.89 | 2.65 | 1.35 | 4.02 |
| T | 1 | BM | ACD | NK cells | 12 | 44.50 | 0.96 | 2.15 | 0.96 | 2.15 | 1.35 | 3.04 |
| T | 2 | BM | Heparin | Helper T cells | 12 | 70.20 | 0.88 | 1.25 | 0.00 | 0.00 | 0.88 | 1.25 |
| T | 2 | BM | Heparin | Cytotoxic T cells | 12 | 13.27 | 0.53 | 3.96 | 0.48 | 3.61 | 0.71 | 5.36 |
| T | 2 | BM | Heparin | NK cells | 12 | 6.42 | 0.22 | 3.40 | 0.00 | 0.00 | 0.22 | 3.40 |
| T | 2 | BM | Heparin | γδ T cells | 12 | 11.92 | 0.36 | 2.98 | 0.37 | 3.09 | 0.51 | 4.30 |
| T | 2 | WB | Heparin | Helper T cells | 12 | 18.47 | 0.42 | 2.30 | 0.58 | 3.16 | 0.72 | 3.90 |
| T | 2 | WB | Heparin | Cytotoxic T cells | 12 | 49.52 | 1.16 | 2.35 | 1.43 | 2.89 | 1.84 | 3.72 |
| T | 2 | WB | Heparin | NK cells | 12 | 7.09 | 0.20 | 2.78 | 0.00 | 0.00 | 0.20 | 2.78 |
| T | 2 | WB | Heparin | γδ T cells | 12 | 17.53 | 0.47 | 2.70 | 0.39 | 2.22 | 0.61 | 3.49 |

17

{17}

| Quantitative Results, by Specimen, by Site for Navios | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Panel | Site | Specimen Type | Anti-coagulant | Population | N | Mean (%) | Repeatability | | Between Run | | Within Sample | |
| | | | | | | | SD | %CV | SD | %CV | SD | %CV |
| T | 2 | WB | Heparin | Helper T cells | 12 | 64.03 | 0.53 | 0.82 | 0.00 | 0.00 | 0.53 | 0.82 |
| T | 2 | WB | Heparin | Cytotoxic T cells | 12 | 24.38 | 0.33 | 1.36 | 0.30 | 1.25 | 0.45 | 1.85 |
| T | 2 | WB | Heparin | NK cells | 12 | 9.59 | 0.26 | 2.75 | 0.19 | 1.93 | 0.32 | 3.36 |
| T | 2 | WB | Heparin | γδ T cells | 12 | 4.67 | 0.18 | 3.88 | 0.04 | 0.78 | 0.18 | 3.96 |
| T | 2 | BM | Heparin | Helper T cells | 12 | 53.86 | 0.79 | 1.47 | 0.00 | 0.00 | 0.79 | 1.47 |
| T | 2 | BM | Heparin | Cytotoxic T cells | 12 | 21.96 | 0.69 | 3.13 | 0.00 | 0.00 | 0.69 | 3.13 |
| T | 2 | BM | Heparin | NK cells | 12 | 32.55 | 0.34 | 1.05 | 0.09 | 0.27 | 0.35 | 1.08 |
| T | 2 | BM | Heparin | γδ T cells | 12 | 14.64 | 0.85 | 5.78 | 0.14 | 0.95 | 0.86 | 5.86 |

| Quantitative Results, by Specimen, by Site for Navios EX | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Panel | Site | Specimen Type | Anti-coagulant | Population | N | Mean (%) | Repeatability | | Between Run | | Within Sample | |
| | | | | | | | SD | %CV | SD | %CV | SD | %CV |
| B | 3 | BM | K_{2}EDTA | Abnormal CD10^{+} B cells | 12 | 97.17 | 0.12 | 0.12 | 0.89 | 0.92 | 0.90 | 0.93 |
| B | 3 | LN | n/a | Mature κ^{+} B cells | 12 | 56.82 | 0.40 | 0.70 | 0.19 | 0.33 | 0.44 | 0.78 |
| B | 3 | LN | n/a | Mature λ^{+} B cells | 12 | 42.33 | 0.39 | 0.93 | 0.42 | 0.99 | 0.57 | 1.35 |
| B | 3 | WB | K_{2}EDTA | Mature κ^{+} B cells | 12 | 3.39 | 0.18 | 5.20 | 0.30 | 8.93 | 0.35 | 10.34 |
| B | 3 | WB | K_{2}EDTA | Abnormal CD5^{+} B cells | 12 | 99.43 | 0.04 | 0.04 | 0.12 | 0.12 | 0.13 | 0.13 |
| B | 3 | BM | K_{2}EDTA | Abnormal CD5^{+} B cells | 12 | 17.78 | 0.69 | 3.89 | 1.29 | 7.25 | 1.46 | 8.23 |
| B | 3 | WB | K_{2}EDTA | Mature κ^{+} B cells | 12 | 2.65 | 0.22 | 8.39 | 0.10 | 3.67 | 0.24 | 9.15 |
| B | 3 | WB | K_{2}EDTA | Mature λ^{+} B cells | 12 | 1.93 | 0.05 | 2.33 | 0.16 | 8.37 | 0.17 | 8.68 |
| B | 3 | WB | K_{2}EDTA | Abnormal CD10^{+} B cells | 12 | 94.95 | 0.18 | 0.19 | 0.37 | 0.39 | 0.41 | 0.43 |
| B | 3 | BM | K_{2}EDTA | Mature κ^{+} B cells | 12 | 54.43 | 1.75 | 3.22 | 4.51 | 8.28 | 4.84 | 8.89 |
| B | 3 | BM | K_{2}EDTA | Mature λ^{+} B cells | 12 | 15.15 | 0.57 | 3.75 | 1.43 | 9.41 | 1.54 | 10.13 |
| B | 3 | LN | n/a | Abnormal CD5^{+} B cells | 12 | 16.08 | 0.22 | 1.38 | 0.00 | 0.00 | 0.22 | 1.38 |
| B | 4 | WB | Heparin | Mature κ^{+} B cells | 12 | 56.22 | 0.91 | 1.63 | 0.00 | 0.00 | 0.91 | 1.63 |
| B | 4 | WB | Heparin | Mature λ^{+} B cells | 12 | 43.76 | 0.90 | 2.06 | 0.00 | 0.00 | 0.90 | 2.06 |
| B | 4 | WB | Heparin | Abnormal CD5^{+} B cells | 12 | 86.18 | 0.37 | 0.43 | 0.36 | 0.41 | 0.51 | 0.60 |
| B | 4 | BM | K_{2}EDTA | Mature κ^{+} B cells | 12 | 67.09 | 1.07 | 1.60 | 0.72 | 1.07 | 1.29 | 1.92 |
| B | 4 | BM | K_{2}EDTA | Mature λ^{+} B cells | 12 | 30.82 | 1.20 | 3.90 | 0.78 | 2.54 | 1.44 | 4.66 |
| B | 4 | BM | K_{2}EDTA | Abnormal CD10^{+} B cells | 12 | 30.16 | 1.18 | 3.90 | 1.05 | 3.47 | 1.58 | 5.22 |
| B | 4 | BM | K_{2}EDTA | Abnormal CD5^{+} B cells | 12 | 99.17 | 0.11 | 0.11 | 0.12 | 0.12 | 0.16 | 0.16 |
| B | 4 | LN | n/a | Abnormal CD5^{+} B cells | 12 | 98.49 | 0.21 | 0.21 | 0.02 | 0.02 | 0.21 | 0.22 |
| B | 4 | WB | Heparin | Mature κ^{+} B cells | 12 | 57.89 | 1.31 | 2.27 | 0.80 | 1.38 | 1.54 | 2.66 |
| B | 4 | WB | Heparin | Mature λ^{+} B cells | 12 | 41.94 | 1.26 | 3.01 | 0.78 | 1.86 | 1.48 | 3.54 |
| B | 4 | LN | n/a | Abnormal CD5^{+} B cells | 12 | 37.81 | 1.60 | 4.22 | 2.77 | 7.32 | 3.19 | 8.45 |
| B | 4 | LN | n/a | Abnormal CD10^{+} B cells | 12 | 42.92 | 1.43 | 3.33 | 1.26 | 2.93 | 1.90 | 4.44 |
| B | 4 | LN | n/a | Mature κ^{+} B cells | 12 | 58.08 | 0.23 | 0.40 | 0.00 | 0.00 | 0.23 | 0.40 |
| B | 4 | LN | n/a | Mature λ^{+} B cells | 12 | 41.67 | 0.22 | 0.52 | 0.00 | 0.00 | 0.22 | 0.52 |
| M1 | 3 | BM | K_{2}EDTA | Neutrophils | 12 | 7.93 | 0.25 | 3.19 | 0.73 | 9.24 | 0.78 | 9.78 |
| M1 | 3 | BM | K_{2}EDTA | Monocytes | 12 | 10.71 | 0.31 | 2.89 | 0.64 | 5.96 | 0.71 | 6.63 |

18

{18}

| Quantitative Results, by Specimen, by Site for Navios EX | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Panel | Site | Specimen Type | Anti-coagulant | Population | N | Mean (%) | Repeatability | | Between Run | | Within Sample | |
| | | | | | | | SD | %CV | SD | %CV | SD | %CV |
| M1 | 3 | BM | K_{2}EDTA | Abnormal CD34^{+}CD7^{+} | 12 | 2.46 | 0.10 | 4.15 | 0.00 | 0.00 | 0.10 | 4.15 |
| M1 | 3 | WB | K_{2}EDTA | Monocytes | 12 | 5.46 | 0.29 | 5.38 | 0.13 | 2.29 | 0.32 | 5.85 |
| M1 | 3 | BM | K_{2}EDTA | Neutrophils | 12 | 27.24 | 0.67 | 2.44 | 0.00 | 0.00 | 0.67 | 2.44 |
| M1 | 3 | BM | K_{2}EDTA | Monocytes | 12 | 13.24 | 0.43 | 3.21 | 0.69 | 5.19 | 0.81 | 6.11 |
| M1 | 3 | BM | K_{2}EDTA | Abnormal CD34^{+}CD7^{+} | 12 | 1.88 | 0.14 | 7.37 | 0.12 | 6.34 | 0.18 | 9.72 |
| M1 | 3 | WB | K_{2}EDTA | Neutrophils | 12 | 22.43 | 0.48 | 2.14 | 1.41 | 6.27 | 1.49 | 6.62 |
| M1 | 3 | WB | K_{2}EDTA | Monocytes | 12 | 4.32 | 0.16 | 3.68 | 0.17 | 3.89 | 0.23 | 5.36 |
| M1 | 3 | WB | K_{2}EDTA | Abnormal CD34^{+}CD7^{+} | 12 | 90.31 | 0.34 | 0.38 | 0.76 | 0.84 | 0.83 | 0.92 |
| M1 | 4 | WB | Heparin | Neutrophils | 12 | 40.34 | 1.19 | 2.96 | 0.00 | 0.00 | 1.19 | 2.96 |
| M1 | 4 | BM | K_{2}EDTA | Neutrophils | 12 | 33.68 | 0.68 | 2.03 | 1.78 | 5.29 | 1.91 | 5.66 |
| M1 | 4 | BM | K_{2}EDTA | Monocytes | 12 | 10.42 | 0.30 | 2.86 | 0.56 | 5.37 | 0.63 | 6.08 |
| M1 | 4 | BM | K_{2}EDTA | Abnormal CD34^{+}CD7^{+} | 12 | 54.58 | 0.39 | 0.72 | 0.59 | 1.08 | 0.71 | 1.30 |
| M1 | 4 | WB | Heparin | Neutrophils | 12 | 5.30 | 0.21 | 3.99 | 0.40 | 7.61 | 0.46 | 8.59 |
| M1 | 4 | WB | Heparin | Monocytes | 12 | 5.41 | 0.20 | 3.62 | 0.00 | 0.00 | 0.20 | 3.62 |
| M1 | 4 | WB | K_{2}EDTA | Abnormal CD34^{+}CD7^{+} | 12 | 48.13 | 1.04 | 2.17 | 1.42 | 2.96 | 1.76 | 3.67 |
| M2 | 3 | BM | K_{2}EDTA | Neutrophils | 12 | 19.43 | 0.64 | 3.31 | 1.06 | 5.46 | 1.24 | 6.38 |
| M2 | 3 | BM | K_{2}EDTA | Monocytes | 12 | 7.77 | 0.30 | 3.92 | 0.66 | 8.56 | 0.73 | 9.41 |
| M2 | 3 | BM | K_{2}EDTA | Abnormal CD34^{+}CD123^{+} | 12 | 39.03 | 0.44 | 1.12 | 0.65 | 1.65 | 0.78 | 2.00 |
| M2 | 3 | BM | K_{2}EDTA | Abnormal CD117^{+} | 12 | 46.47 | 0.34 | 0.73 | 0.14 | 0.29 | 0.36 | 0.78 |
| M2 | 3 | WB | K_{2}EDTA | Abnormal CD34^{+}CD123^{+} | 12 | 25.71 | 0.62 | 2.41 | 0.95 | 3.69 | 1.13 | 4.41 |
| M2 | 3 | BM | K_{2}EDTA | Abnormal CD117^{+} | 12 | 27.58 | 0.30 | 1.07 | 0.55 | 1.99 | 0.62 | 2.27 |
| M2 | 3 | BM | K_{2}EDTA | Neutrophils | 12 | 9.83 | 0.20 | 2.05 | 0.64 | 6.53 | 0.67 | 6.84 |
| M2 | 3 | BM | K_{2}EDTA | Monocytes | 12 | 14.84 | 0.31 | 2.08 | 0.27 | 1.80 | 0.41 | 2.75 |
| M2 | 3 | BM | K_{2}EDTA | Abnormal CD34^{+}CD123^{+} | 12 | 43.88 | 0.40 | 0.92 | 1.10 | 2.50 | 1.17 | 2.66 |
| M2 | 3 | BM | K_{2}EDTA | Abnormal CD117^{+} | 12 | 51.60 | 0.38 | 0.74 | 1.08 | 2.10 | 1.15 | 2.23 |
| M2 | 3 | WB | K_{2}EDTA | Neutrophils | 12 | 66.46 | 1.07 | 1.61 | 0.23 | 0.34 | 1.09 | 1.64 |
| M2 | 3 | WB | K_{2}EDTA | Monocytes | 12 | 8.25 | 0.27 | 3.24 | 0.38 | 4.63 | 0.47 | 5.65 |
| M2 | 4 | WB | Heparin | Neutrophils | 12 | 39.49 | 0.82 | 2.07 | 0.00 | 0.00 | 0.82 | 2.07 |
| M2 | 4 | WB | Heparin | Monocytes | 12 | 5.07 | 0.26 | 5.14 | 0.24 | 4.76 | 0.36 | 7.01 |
| M2 | 4 | BM | K_{2}EDTA | Abnormal CD117^{+} | 12 | 89.69 | 0.16 | 0.18 | 0.00 | 0.00 | 0.16 | 0.18 |
| M2 | 4 | BM | K_{2}EDTA | Neutrophils | 12 | 69.13 | 1.07 | 1.55 | 0.80 | 1.16 | 1.34 | 1.94 |
| M2 | 4 | BM | K_{2}EDTA | Monocytes | 12 | 97.37 | 0.12 | 0.12 | 0.00 | 0.00 | 0.12 | 0.12 |
| M2 | 4 | BM | K_{2}EDTA | Abnormal CD34^{+}CD123^{+} | 12 | 6.10 | 0.09 | 1.48 | 0.23 | 3.82 | 0.25 | 4.09 |
| M2 | 4 | WB | Heparin | Abnormal CD34^{+}CD123^{+} | 12 | 11.57 | 0.16 | 1.35 | 0.03 | 0.24 | 0.16 | 1.38 |
| M2 | 4 | WB | Heparin | Abnormal CD117^{+} | 12 | 35.17 | 0.20 | 0.57 | 0.43 | 1.23 | 0.48 | 1.36 |
| T | 3 | WB | K_{2}EDTA | Helper T cells | 12 | 61.29 | 1.44 | 2.36 | 0.00 | 0.00 | 1.44 | 2.36 |
| T | 3 | WB | K_{2}EDTA | Cytotoxic T cells | 12 | 25.02 | 1.09 | 4.35 | 0.00 | 0.00 | 1.09 | 4.35 |
| T | 3 | WB | K_{2}EDTA | NK cells | 12 | 27.02 | 0.76 | 2.79 | 0.41 | 1.50 | 0.86 | 3.17 |
| T | 3 | BM | K_{2}EDTA | Helper T cells | 12 | 43.01 | 0.54 | 1.26 | 0.00 | 0.00 | 0.54 | 1.26 |
| T | 3 | BM | K_{2}EDTA | Cytotoxic T cells | 12 | 51.90 | 0.68 | 1.31 | 0.56 | 1.08 | 0.88 | 1.69 |
| T | 3 | BM | K_{2}EDTA | NK cells | 12 | 5.12 | 0.17 | 3.30 | 0.00 | 0.00 | 0.17 | 3.30 |
| T | 3 | BM | K_{2}EDTA | Helper T cells | 12 | 67.99 | 1.42 | 2.09 | 1.76 | 2.59 | 2.26 | 3.33 |
| T | 3 | BM | K_{2}EDTA | Cytotoxic T cells | 12 | 21.20 | 0.51 | 2.43 | 0.28 | 1.34 | 0.59 | 2.77 |
| T | 3 | BM | K_{2}EDTA | NK cells | 12 | 21.87 | 0.46 | 2.09 | 0.70 | 3.21 | 0.84 | 3.83 |

19

{19}

| Quantitative Results, by Specimen, by Site for Navios EX | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Panel | Site | Specimen Type | Anti-coagulant | Population | N | Mean (%) | Repeatability | | Between Run | | Within Sample | |
| | | | | | | | SD | %CV | SD | %CV | SD | %CV |
| T | 3 | BM | K_{2}EDTA | γδ T cells | 12 | 6.68 | 0.60 | 9.01 | 0.24 | 3.56 | 0.65 | 9.69 |
| T | 3 | WB | K_{2}EDTA | Helper T cells | 12 | 46.97 | 0.72 | 1.54 | 1.14 | 2.42 | 1.35 | 2.87 |
| T | 3 | WB | K_{2}EDTA | Cytotoxic T cells | 12 | 41.40 | 0.54 | 1.30 | 1.21 | 2.93 | 1.33 | 3.21 |
| T | 3 | WB | K_{2}EDTA | NK cells | 12 | 5.00 | 0.21 | 4.14 | 0.00 | 0.00 | 0.21 | 4.14 |
| T | 3 | WB | K_{2}EDTA | γδ T cells | 12 | 8.21 | 0.26 | 3.17 | 0.17 | 2.05 | 0.31 | 3.78 |
| T | 4 | BM | K_{2}EDTA | Helper T cells | 12 | 46.46 | 0.69 | 1.49 | 0.29 | 0.62 | 0.75 | 1.61 |
| T | 4 | BM | K_{2}EDTA | Cytotoxic T cells | 12 | 49.46 | 0.61 | 1.23 | 0.00 | 0.00 | 0.61 | 1.23 |
| T | 4 | BM | K_{2}EDTA | NK cells | 12 | 16.51 | 0.43 | 2.62 | 0.31 | 1.90 | 0.53 | 3.23 |
| T | 4 | BM | K_{2}EDTA | γδ T cells | 12 | 3.14 | 0.21 | 6.66 | 0.06 | 1.95 | 0.22 | 6.94 |
| T | 4 | WB | Heparin | Helper T cells | 12 | 62.00 | 0.46 | 0.75 | 0.00 | 0.00 | 0.46 | 0.75 |
| T | 4 | WB | Heparin | Cytotoxic T cells | 12 | 30.62 | 0.47 | 1.52 | 0.00 | 0.00 | 0.47 | 1.52 |
| T | 4 | WB | Heparin | NK cells | 12 | 10.03 | 0.20 | 2.01 | 0.04 | 0.43 | 0.21 | 2.06 |
| T | 4 | WB | Heparin | γδ T cells | 12 | 2.18 | 0.15 | 7.03 | 0.10 | 4.47 | 0.18 | 8.33 |
| T | 4 | BM | K_{2}EDTA | Helper T cells | 12 | 55.26 | 1.12 | 2.03 | 0.46 | 0.83 | 1.21 | 2.19 |
| T | 4 | BM | K_{2}EDTA | Cytotoxic T cells | 12 | 34.30 | 0.86 | 2.52 | 1.00 | 2.90 | 1.32 | 3.85 |
| T | 4 | BM | K_{2}EDTA | NK cells | 12 | 14.81 | 0.93 | 6.30 | 0.99 | 6.68 | 1.36 | 9.18 |
| T | 4 | BM | K_{2}EDTA | γδ T cells | 12 | 7.54 | 0.33 | 4.33 | 0.25 | 3.29 | 0.41 | 5.44 |
| T | 4 | WB | Heparin | Helper T cells | 12 | 61.77 | 0.39 | 0.63 | 0.00 | 0.00 | 0.39 | 0.63 |
| T | 4 | WB | Heparin | Cytotoxic T cells | 12 | 26.20 | 0.25 | 0.96 | 0.72 | 2.75 | 0.76 | 2.91 |
| T | 4 | WB | Heparin | NK cells | 12 | 5.99 | 0.19 | 3.13 | 0.31 | 5.22 | 0.36 | 6.08 |
| T | 4 | WB | Heparin | γδ T cells | 12 | 8.31 | 0.11 | 1.36 | 0.05 | 0.55 | 0.12 | 1.46 |

ii. Operator-to-operator and instrument-to-instrument imprecision: Five normal and five abnormal clinical specimens representing clinical matrices and anticoagulants were evaluated with the ClearLLab 10C Panels at one site, across three operators utilizing two Navios EX instruments. Each operator performed separate sample preparations in triplicate twice per day. Samples were acquired on each of the two instruments, the order of which was randomized. Following acquisition, each operator analyzed listmode datafiles as instructed, using Kaluza C software. A reviewer assessed each LMD analysis as normal or abnormal, and further described the immunophenotype of abnormal results. From 396 initial acquisitions, 36 replicates from one specimen were excluded for reasons of insufficient quantity.

All results showed 100% qualitative agreement across Instruments and Operators. The number of samples tested is depicted in the tables below.

| Qualitative Agreement across Instruments and Operators | | |
| --- | --- | --- |
| Panel | Phenotype | N |
| B | Normal (−) | 36 |
| B | Abnormal (+) | 108 |
| M1 | Normal (−) | 36 |
| M1 | Abnormal (+) | 36 |
| M2 | Normal (−) | 36 |
| M2 | Abnormal (+) | 36 |
| T | Normal (−) | 72 |

20

{20}

| Quantitative Results, by Instrument, by Operator | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Panel | Population | N | Mean (%) | Repeatability | | Between-Run | | Between-Instruments | | Between-Operators | | Within-Specimen | |
| | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| B | Abnormal CD5+ B cells | 36 | 99.97 | 0.02 | 0.02 | 0.00 | 0.00 | 0.01 | 0.01 | 0.01 | 0.01 | 0.02 | 0.02 |
| B | Abnormal CD10+ B cells | 36 | 96.26 | 0.19 | 0.20 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.19 | 0.20 |
| B | Abnormal CD5+ B cells | 36 | 67.67 | 1.05 | 1.55 | 0.00 | 0.00 | 0.00 | 0.00 | 0.71 | 1.04 | 1.27 | 1.87 |
| B | Mature κ+ B cells | 36 | 58.64 | 1.63 | 2.79 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 1.63 | 2.79 |
| B | Mature λ+ B cells | 36 | 41.22 | 1.61 | 3.90 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 1.61 | 3.90 |
| M1 | Abnormal CD34+ | 36 | 1.70 | 0.15 | 8.77 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.15 | 8.77 |
| M1 | Abnormal CD7+ | 36 | 5.93 | 0.47 | 7.97 | 0.00 | 0.00 | 0.14 | 2.37 | 0.00 | 0.00 | 0.49 | 8.32 |
| M1 | Neutrophils | 36 | 87.17 | 0.67 | 0.76 | 0.00 | 0.00 | 0.68 | 0.78 | 0.00 | 0.00 | 0.95 | 1.09 |
| M1 | Monocytes | 36 | 4.08 | 0.19 | 4.65 | 0.00 | 0.00 | 0.22 | 5.33 | 0.00 | 0.00 | 0.29 | 7.07 |
| M2 | Abnormal CD34+CD123+ | 36 | 76.27 | 0.49 | 0.65 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.49 | 0.65 |
| M2 | Abnormal CD117+ | 36 | 76.32 | 0.68 | 0.89 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.68 | 0.89 |
| M2 | Neutrophils | 36 | 87.15 | 0.85 | 0.97 | 0.00 | 0.00 | 0.10 | 0.11 | 0.11 | 0.12 | 0.86 | 0.98 |
| M2 | Monocytes | 36 | 9.57 | 0.56 | 5.84 | 0.00 | 0.00 | 0.16 | 1.62 | 0.00 | 0.00 | 0.58 | 6.06 |
| T | Helper T cells | 36 | 58.28 | 0.93 | 1.60 | 0.40 | 0.69 | 0.00 | 0.00 | 0.00 | 0.00 | 1.02 | 1.74 |
| T | Cytotoxic T cells | 36 | 37.49 | 1.01 | 2.69 | 0.00 | 0.00 | 0.00 | 0.00 | 0.12 | 0.32 | 1.01 | 2.71 |
| T | NK cells | 36 | 35.32 | 0.66 | 1.86 | 0.00 | 0.00 | 0.17 | 0.47 | 0.00 | 0.00 | 0.68 | 1.92 |
| T | Helper T cells | 36 | 28.22 | 0.38 | 1.34 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.38 | 1.34 |
| T | Cytotoxic T cells | 36 | 59.30 | 0.50 | 0.84 | 0.00 | 0.00 | 0.24 | 0.40 | 0.00 | 0.00 | 0.55 | 0.93 |
| T | NK cells | 36 | 14.43 | 0.26 | 1.77 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.26 | 1.77 |
| T | γδ T cells | 36 | 10.63 | 0.25 | 2.39 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.25 | 2.39 |

iii. Site-to-Site Reproducibility with Control Material: The reproducibility of the ClearLLab 10C reagent system on Navios and Navios EX flow cytometers was evaluated utilizing one lot each of control cell materials: ClearLLab Normal Control Cells and ClearLLab Abnormal Control Cells. These control materials express all surface markers comprising the ClearLLab 10C panels. For multi-site testing, control materials allow samples to be shared between sites in a manner not available for native samples. For each panel, the two controls were tested on three Navios instruments and three Navios EX instruments, across five total sites × three ClearLLab 10 color reagent lots. At site 1, testing was performed for 20 days × two runs/day × two replicates/run × three sites × one instrument/site. At sites 2 and 3, testing was performed for five days × two runs/day × three replicates/run × three sites × one instrument/site. Across all three sites, a total of 140 test results for each panel were generated; three results were excluded for operator error.

| Navios ClearLLab Normal Control Cells, across sites | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Cell Population | Panel | N | Mean (%) | Repeatability | | Between Run | | Between Days | | Between Site | | Reproducibility | |
| | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| WBC | B | 140 | 98.90 | 0.23 | 0.23 | 0.00 | 0.00 | 0.29 | 0.29 | 0.09 | 0.09 | 0.38 | 0.38 |
| lymphocyte | B | 140 | 34.28 | 0.72 | 2.10 | 0.00 | 0.00 | 0.40 | 1.16 | 0.00 | 0.00 | 0.82 | 2.40 |
| monocyte | B | 140 | 8.17 | 0.31 | 3.75 | 0.00 | 0.00 | 0.24 | 2.88 | 0.46 | 5.61 | 0.60 | 7.34 |
| granulocyte | B | 140 | 54.70 | 0.89 | 1.62 | 0.00 | 0.00 | 0.53 | 0.97 | 0.00 | 0.00 | 1.03 | 1.89 |
| CD5+ | B | 140 | 73.43 | 0.40 | 0.54 | 0.00 | 0.00 | 1.00 | 1.37 | 0.00 | 0.00 | 1.08 | 1.47 |

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| Navios ClearLLab Normal Control Cells, across sites | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Cell Population | Panel | N | Mean (%) | Repeatability | | Between Run | | Between Days | | Between Site | | Reproducibility | |
| | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| CD10+ | B | 140 | 53.36 | 0.85 | 1.59 | 0.00 | 0.00 | 0.47 | 0.89 | 1.51 | 2.82 | 1.79 | 3.36 |
| CD19+CD20+ | B | 140 | 11.18 | 0.26 | 2.32 | 0.04 | 0.38 | 0.16 | 1.40 | 0.57 | 5.11 | 0.65 | 5.79 |
| CD38+ | B | 140 | 8.67 | 0.31 | 3.60 | 0.00 | 0.00 | 0.23 | 2.68 | 0.26 | 3.00 | 0.47 | 5.40 |
| CD200+ | B | 140 | 10.24 | 0.26 | 2.53 | 0.03 | 0.29 | 0.21 | 2.01 | 0.80 | 7.80 | 0.86 | 8.44 |
| Kappa+ | B | 140 | 57.02 | 1.34 | 2.34 | 0.00 | 0.00 | 0.36 | 0.64 | 1.14 | 2.00 | 1.79 | 3.14 |
| Lambda+ | B | 140 | 40.44 | 1.24 | 3.07 | 0.25 | 0.61 | 0.00 | 0.00 | 0.81 | 2.01 | 1.50 | 3.71 |
| WBC | M1 | 140 | 98.59 | 0.24 | 0.24 | 0.00 | 0.00 | 0.35 | 0.36 | 0.07 | 0.07 | 0.43 | 0.43 |
| lymphocyte | M1 | 140 | 33.98 | 0.76 | 2.23 | 0.00 | 0.00 | 0.55 | 1.61 | 0.12 | 0.36 | 0.94 | 2.77 |
| monocyte | M1 | 140 | 8.07 | 0.30 | 3.77 | 0.00 | 0.00 | 0.24 | 2.92 | 1.01 | 12.56 | 1.08 | 13.43 |
| granulocyte | M1 | 140 | 54.88 | 1.02 | 1.86 | 0.00 | 0.00 | 0.71 | 1.30 | 0.16 | 0.29 | 1.26 | 2.29 |
| CD7+ | M1 | 140 | 84.45 | 0.48 | 0.57 | 0.00 | 0.00 | 0.51 | 0.61 | 0.67 | 0.79 | 0.97 | 1.15 |
| CD10+ | M1 | 140 | 54.28 | 0.90 | 1.66 | 0.00 | 0.00 | 0.56 | 1.03 | 0.66 | 1.22 | 1.25 | 2.30 |
| CD14+CD11b+ | M1 | 140 | 7.76 | 0.31 | 3.94 | 0.00 | 0.00 | 0.18 | 2.28 | 0.39 | 5.09 | 0.53 | 6.83 |
| CD13+ | M1 | 140 | 56.10 | 0.92 | 1.65 | 0.00 | 0.00 | 0.75 | 1.34 | 0.74 | 1.32 | 1.470 | 2.50 |
| CD16+ | M1 | 140 | 52.63 | 0.82 | 1.56 | 0.12 | 0.23 | 0.65 | 1.23 | 0.18 | 0.35 | 1.07 | 2.03 |
| CD14+CD64+ | M1 | 140 | 7.64 | 0.28 | 3.66 | 0.02 | 0.31 | 0.18 | 2.36 | 0.27 | 3.52 | 0.43 | 5.61 |
| HLA-DR+ | M1 | 140 | 8.90 | 0.31 | 3.52 | 0.00 | 0.00 | 0.23 | 2.61 | 0.00 | 0.00 | 0.39 | 4.38 |
| WBC | M2 | 140 | 98.60 | 0.16 | 0.16 | 0.00 | 0.00 | 0.32 | 0.32 | 0.00 | 0.00 | 0.36 | 0.36 |
| lymphocyte | M2 | 140 | 34.17 | 0.78 | 2.27 | 0.00 | 0.00 | 0.54 | 1.59 | 0.50 | 1.46 | 1.07 | 3.13 |
| monocyte | M2 | 140 | 8.24 | 0.34 | 4.15 | 0.00 | 0.00 | 0.26 | 3.17 | 0.45 | 5.40 | 0.62 | 7.51 |
| granulocyte | M2 | 140 | 54.08 | 1.03 | 1.90 | 0.00 | 0.00 | 0.77 | 1.43 | 1.02 | 1.88 | 1.64 | 3.03 |
| CD13+ | M2 | 140 | 54.78 | 0.92 | 1.67 | 0.00 | 0.00 | 0.69 | 1.25 | 0.00 | 0.00 | 1.15 | 2.09 |
| CD15+ | M2 | 140 | 54.77 | 0.90 | 1.63 | 0.00 | 0.00 | 0.80 | 1.45 | 0.00 | 0.00 | 1.20 | 2.19 |
| CD19+ | M2 | 140 | 9.22 | 0.37 | 4.05 | 0.00 | 0.00 | 0.39 | 4.28 | 1.27 | 13.76 | 1.38 | 14.97 |
| CD33+ | M2 | 140 | 8.81 | 0.40 | 4.58 | 0.00 | 0.00 | 0.24 | 2.77 | 0.30 | 3.38 | 0.56 | 6.33 |
| CD38+ | M2 | 140 | 8.66 | 0.35 | 4.03 | 0.00 | 0.00 | 0.23 | 2.66 | 0.22 | 2.50 | 0.47 | 5.44 |
| HLA-DR+ | M2 | 140 | 8.79 | 0.33 | 3.72 | 0.00 | 0.00 | 0.18 | 2.10 | 0.24 | 2.77 | 0.45 | 5.09 |
| WBC | T | 140 | 99.04 | 0.19 | 0.20 | 0.00 | 0.00 | 0.31 | 0.31 | 0.00 | 0.00 | 0.36 | 0.37 |
| lymphocyte | T | 140 | 33.95 | 0.68 | 1.99 | 0.00 | 0.00 | 0.57 | 1.68 | 0.62 | 1.84 | 1.08 | 3.19 |
| monocyte | T | 140 | 8.31 | 0.33 | 3.94 | 0.00 | 0.00 | 0.27 | 3.22 | 0.66 | 7.92 | 0.78 | 9.42 |
| granulocyte | T | 140 | 54.70 | 0.91 | 1.67 | 0.00 | 0.00 | 0.61 | 1.11 | 0.56 | 1.02 | 1.23 | 2.25 |
| CD2+ | T | 140 | 84.31 | 0.40 | 0.48 | 0.00 | 0.00 | 0.35 | 0.42 | 0.65 | 0.77 | 0.84 | 1.00 |
| CD3+ | T | 140 | 74.33 | 0.45 | 0.60 | 0.00 | 0.00 | 0.63 | 0.85 | 1.02 | 1.37 | 1.28 | 1.72 |
| CD4+CD8- | T | 140 | 53.15 | 0.51 | 0.96 | 0.00 | 0.00 | 0.44 | 0.82 | 0.52 | 0.99 | 0.85 | 1.60 |
| CD4-CD8+ | T | 140 | 38.32 | 0.50 | 1.31 | 0.04 | 0.10 | 0.21 | 0.54 | 0.64 | 1.67 | 0.84 | 2.19 |
| CD5+ | T | 140 | 75.30 | 0.42 | 0.56 | 0.00 | 0.00 | 0.45 | 0.59 | 0.61 | 0.82 | 0.87 | 1.15 |
| CD7+ | T | 140 | 83.98 | 0.50 | 0.60 | 0.00 | 0.00 | 0.48 | 0.57 | 0.78 | 0.93 | 1.04 | 1.24 |
| CD3-CD56+ | T | 140 | 11.27 | 0.31 | 2.71 | 0.00 | 0.00 | 0.13 | 1.18 | 2.08 | 18.42 | 2.10 | 18.66 |
| TCRγδ+ | T | 140 | 4.37 | 0.15 | 3.51 | 0.04 | 0.93 | 0.05 | 1.24 | 0.08 | 1.83 | 0.19 | 4.25 |

| Navios ClearLLab Abnormal Control Cells, across sites | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Cell Population | Panel | N | Mean (%) | Repeatability | | Between Run | | Between Days | | Between Site | | Reproducibility | |
| | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| WBC | B | 140 | 98.79 | 0.18 | 0.18 | 0.00 | 0.00 | 0.43 | 0.43 | 0.00 | 0.00 | 0.47 | 0.47 |
| lymphocyte | B | 140 | 34.23 | 0.78 | 2.29 | 0.00 | 0.00 | 0.61 | 1.78 | 0.26 | 0.75 | 1.02 | 2.99 |
| monocyte | B | 140 | 8.03 | 0.27 | 3.38 | 0.00 | 0.00 | 0.17 | 2.16 | 0.62 | 7.77 | 0.70 | 8.74 |
| granulocyte | B | 140 | 54.65 | 0.93 | 1.71 | 0.00 | 0.00 | 0.65 | 1.18 | 0.00 | 0.00 | 1.13 | 2.08 |
| CD5+ | B | 140 | 73.80 | 0.40 | 0.55 | 0.00 | 0.00 | 0.62 | 0.84 | 0.00 | 0.00 | 0.74 | 1.00 |
| CD10+ | B | 140 | 53.66 | 0.91 | 1.69 | 0.00 | 0.00 | 0.64 | 1.18 | 0.64 | 1.18 | 1.28 | 2.38 |
| CD19+CD20+ | B | 140 | 11.12 | 0.27 | 2.43 | 0.17 | 1.51 | 0.24 | 2.15 | 0.51 | 4.57 | 0.65 | 5.81 |
| CD34+ | B | 140 | 8.58 | 0.19 | 2.23 | 0.00 | 0.00 | 0.12 | 1.39 | 0.04 | 0.43 | 0.23 | 2.66 |

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| Navios ClearLLab Abnormal Control Cells, across sites | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Cell Population | Panel | N | Mean (%) | Repeatability | | Between Run | | Between Days | | Between Site | | Reproducibility | |
| | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| CD38+ | B | 140 | 8.69 | 0.26 | 2.95 | 0.11 | 1.31 | 0.11 | 1.29 | 0.46 | 5.32 | 0.55 | 6.36 |
| CD200+ | B | 140 | 10.08 | 0.27 | 2.71 | 0.14 | 1.39 | 0.28 | 2.74 | 0.70 | 3.91 | 0.81 | 8.04 |
| Kappa+ | B | 140 | 57.09 | 1.36 | 2.37 | 0.00 | 0.00 | 0.18 | 0.32 | 1.44 | 2.52 | 1.98 | 3.48 |
| Lambda+ | B | 140 | 40.43 | 1.31 | 3.25 | 0.00 | 0.00 | 0.15 | 0.37 | 0.25 | 0.61 | 1.34 | 3.32 |
| WBC | M1 | 139 | 98.34 | 0.27 | 0.27 | 0.00 | 0.00 | 0.37 | 0.38 | 0.01 | 0.01 | 0.46 | 0.47 |
| lymphocyte | M1 | 139 | 34.25 | 0.74 | 2.16 | 0.00 | 0.00 | 0.72 | 2.10 | 0.00 | 0.00 | 1.03 | 3.01 |
| monocyte | M1 | 139 | 7.96 | 0.33 | 4.19 | 0.00 | 0.00 | 0.24 | 2.98 | 1.20 | 15.03 | 1.26 | 15.88 |
| granulocyte | M1 | 139 | 54.59 | 0.94 | 1.72 | 0.00 | 0.00 | 0.79 | 1.45 | 0.00 | 0.00 | 1.23 | 2.25 |
| CD7+ | M1 | 139 | 84.30 | 0.43 | 0.51 | 0.00 | 0.00 | 0.62 | 0.73 | 0.80 | 0.95 | 1.10 | 1.30 |
| CD10+ | M1 | 139 | 53.73 | 0.82 | 1.52 | 0.00 | 0.00 | 0.83 | 1.54 | 0.27 | 0.50 | 1.19 | 2.22 |
| CD14+CD11b+ | M1 | 139 | 7.74 | 0.25 | 3.24 | 0.00 | 0.00 | 0.12 | 1.54 | 0.20 | 2.55 | 0.34 | 4.40 |
| CD13+ | M1 | 139 | 55.82 | 0.78 | 1.39 | 0.26 | 0.47 | 0.85 | 1.53 | 0.88 | 1.58 | 1.47 | 2.64 |
| CD16+ | M1 | 139 | 51.78 | 0.77 | 1.49 | 0.00 | 0.00 | 0.74 | 1.44 | 0.00 | 0.00 | 1.07 | 2.07 |
| CD34+ | M1 | 139 | 8.52 | 0.19 | 2.21 | 0.00 | 0.00 | 0.12 | 1.41 | 0.00 | 0.00 | 0.22 | 2.62 |
| CD14+CD64+ | M1 | 139 | 7.63 | 0.25 | 3.30 | 0.00 | 0.00 | 0.10 | 1.37 | 0.11 | 1.49 | 0.30 | 3.87 |
| HLA-DR+ | M1 | 139 | 8.87 | 0.28 | 3.16 | 0.00 | 0.00 | 0.16 | 1.78 | 0.12 | 1.32 | 0.34 | 3.86 |
| WBC | M2 | 140 | 98.33 | 0.16 | 0.16 | 0.00 | 0.00 | 0.38 | 0.38 | 0.00 | 0.00 | 0.41 | 0.41 |
| lymphocyte | M2 | 140 | 34.28 | 0.74 | 2.15 | 0.00 | 0.00 | 0.58 | 1.69 | 0.72 | 2.09 | 1.18 | 3.45 |
| monocyte | M2 | 140 | 7.81 | 0.26 | 3.34 | 0.00 | 0.00 | 0.28 | 3.63 | 1.02 | 13.08 | 1.09 | 13.98 |
| granulocyte | M2 | 140 | 54.41 | 0.86 | 1.58 | 0.18 | 0.33 | 0.66 | 1.21 | 0.00 | 0.00 | 1.10 | 2.02 |
| CD13+ | M2 | 140 | 54.76 | 0.85 | 1.56 | 0.11 | 0.21 | 0.74 | 1.35 | 0.09 | 0.17 | 1.14 | 2.08 |
| CD15+ | M2 | 140 | 54.40 | 0.86 | 1.58 | 0.00 | 0.00 | 0.78 | 1.44 | 0.43 | 0.80 | 1.24 | 2.28 |
| CD19+ | M2 | 140 | 9.00 | 0.37 | 4.15 | 0.00 | 0.00 | 0.34 | 3.76 | 1.13 | 12.52 | 1.23 | 13.71 |
| CD33+ | M2 | 140 | 8.42 | 0.30 | 3.51 | 0.00 | 0.00 | 0.20 | 2.41 | 0.35 | 4.16 | 0.50 | 5.96 |
| CD34+ | M2 | 140 | 8.51 | 0.18 | 2.08 | 0.02 | 0.20 | 0.10 | 1.14 | 0.15 | 1.79 | 0.25 | 2.98 |
| CD38+ | M2 | 140 | 8.55 | 0.30 | 3.47 | 0.00 | 0.00 | 0.18 | 2.13 | 0.32 | 3.70 | 0.47 | 5.50 |
| CD117+ | M2 | 140 | 8.57 | 0.18 | 2.10 | 0.03 | 0.36 | 0.08 | 0.96 | 0.14 | 1.64 | 0.24 | 2.86 |
| CD123+ | M2 | 140 | 8.57 | 0.17 | 2.03 | 0.05 | 0.57 | 0.10 | 1.12 | 0.17 | 1.96 | 0.26 | 3.09 |
| HLA-DR+ | M2 | 140 | 8.80 | 0.26 | 2.97 | 0.00 | 0.00 | 0.12 | 1.32 | 0.28 | 3.13 | 0.40 | 4.51 |
| WBC | T | 139 | 98.82 | 0.20 | 0.20 | 0.00 | 0.00 | 0.45 | 0.46 | 0.06 | 0.06 | 0.50 | 0.50 |
| lymphocyte | T | 139 | 34.00 | 0.72 | 2.11 | 0.21 | 0.63 | 0.67 | 1.97 | 0.63 | 1.87 | 1.19 | 3.50 |
| monocyte | T | 139 | 7.92 | 0.24 | 3.08 | 0.08 | 1.04 | 0.22 | 2.80 | 0.56 | 7.10 | 0.66 | 8.30 |
| granulocyte | T | 139 | 54.77 | 0.84 | 1.53 | 0.23 | 0.41 | 0.73 | 1.34 | 0.68 | 1.24 | 1.32 | 2.42 |
| CD2+ | T | 139 | 84.17 | 0.34 | 0.40 | 0.00 | 0.00 | 0.34 | 0.41 | 0.62 | 0.74 | 0.79 | 0.94 |
| CD3+ | T | 139 | 74.11 | 0.40 | 0.54 | 0.00 | 0.00 | 0.68 | 0.91 | 0.70 | 0.94 | 1.05 | 1.42 |
| CD4+CD8- | T | 139 | 53.47 | 0.48 | 0.89 | 0.19 | 0.35 | 0.36 | 0.66 | 0.55 | 1.04 | 0.84 | 1.56 |
| CD4-CD8+ | T | 139 | 38.26 | 0.46 | 1.20 | 0.18 | 0.47 | 0.14 | 0.36 | 0.30 | 0.79 | 0.59 | 1.55 |
| CD5+ | T | 139 | 75.34 | 0.40 | 0.53 | 0.00 | 0.00 | 0.51 | 0.67 | 0.63 | 0.84 | 0.90 | 1.20 |
| CD7+ | T | 139 | 83.54 | 0.37 | 0.44 | 0.00 | 0.00 | 0.50 | 0.60 | 0.89 | 1.07 | 1.09 | 1.30 |
| CD34+ | T | 139 | 8.35 | 0.17 | 2.01 | 0.00 | 0.00 | 0.13 | 1.58 | 0.16 | 1.88 | 0.26 | 3.17 |
| CD3-CD56+ | T | 139 | 10.71 | 0.28 | 2.60 | 0.00 | 0.00 | 0.21 | 1.99 | 1.60 | 14.91 | 1.63 | 15.26 |
| TCRγδ+ | T | 139 | 4.24 | 0.16 | 3.74 | 0.02 | 0.48 | 0.03 | 0.67 | 0.07 | 1.67 | 0.18 | 4.17 |

| Navios EX ClearLLab Normal Control Cells, across sites | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Cell Population | Panel | N | Mean (%) | Repeatability | | Between Run | | Between Days | | Between Site | | Reproducibility | |
| | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| WBC | B | 140 | 98.97 | 0.23 | 0.24 | 0.00 | 0.00 | 0.20 | 0.20 | 0.19 | 0.19 | 0.36 | 0.36 |
| lymphocyte | B | 140 | 33.21 | 1.15 | 3.45 | 0.00 | 0.00 | 0.45 | 1.34 | 0.85 | 2.55 | 1.49 | 4.50 |
| monocyte | B | 140 | 8.39 | 0.43 | 5.08 | 0.00 | 0.00 | 0.36 | 4.28 | 0.15 | 1.84 | 0.58 | 6.90 |
| granulocyte | B | 140 | 55.58 | 1.23 | 2.22 | 0.18 | 0.33 | 0.58 | 1.05 | 1.76 | 3.17 | 2.23 | 4.02 |
| CD5+ | B | 140 | 74.52 | 0.52 | 0.70 | 0.00 | 0.00 | 0.45 | 0.60 | 0.43 | 0.58 | 0.81 | 1.09 |

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| Navios EX ClearLLab Normal Control Cells, across sites | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Cell Population | Panel | N | Mean (%) | Repeatability | | Between Run | | Between Days | | Between Site | | Reproducibility | |
| | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| CD10+ | B | 140 | 55.95 | 1.27 | 2.27 | 0.00 | 0.00 | 0.58 | 1.04 | 1.60 | 2.86 | 2.12 | 3.80 |
| CD19+CD20+ | B | 140 | 11.31 | 0.37 | 3.24 | 0.00 | 0.00 | 0.18 | 1.55 | 0.39 | 3.49 | 0.57 | 5.01 |
| CD38+ | B | 140 | 8.73 | 0.44 | 5.00 | 0.03 | 0.32 | 0.26 | 3.02 | 0.66 | 7.58 | 0.84 | 9.58 |
| CD200+ | B | 140 | 10.16 | 0.35 | 3.46 | 0.00 | 0.00 | 0.18 | 1.77 | 0.78 | 7.68 | 0.87 | 8.61 |
| Kappa+ | B | 140 | 57.30 | 1.22 | 2.14 | 0.35 | 0.61 | 0.50 | 0.87 | 0.00 | 0.00 | 1.37 | 2.39 |
| Lambda+ | B | 140 | 39.79 | 1.26 | 3.18 | 0.00 | 0.00 | 0.36 | 0.92 | 0.98 | 2.45 | 1.64 | 4.12 |
| WBC | M1 | 140 | 98.08 | 0.15 | 0.16 | 0.00 | 0.00 | 0.10 | 0.10 | 0.23 | 0.24 | 0.30 | 0.30 |
| lymphocyte | M1 | 140 | 33.62 | 1.11 | 3.30 | 0.00 | 0.00 | 0.69 | 2.05 | 0.45 | 1.33 | 1.38 | 4.10 |
| monocyte | M1 | 140 | 9.01 | 0.47 | 5.23 | 0.00 | 0.00 | 0.43 | 4.80 | 0.66 | 7.33 | 0.92 | 10.20 |
| granulocyte | M1 | 140 | 54.57 | 1.27 | 2.33 | 0.00 | 0.00 | 0.79 | 1.45 | 1.67 | 3.06 | 2.24 | 4.11 |
| CD7+ | M1 | 140 | 84.64 | 0.46 | 0.55 | 0.07 | 0.09 | 0.62 | 0.74 | 0.28 | 0.33 | 0.83 | 0.98 |
| CD10+ | M1 | 140 | 55.02 | 1.22 | 2.22 | 0.00 | 0.00 | 0.87 | 1.58 | 1.79 | 3.25 | 2.33 | 4.24 |
| CD14+CD11b+ | M1 | 140 | 7.88 | 0.41 | 5.22 | 0.00 | 0.00 | 0.32 | 4.03 | 0.29 | 3.64 | 0.59 | 7.53 |
| CD13+ | M1 | 140 | 55.25 | 1.21 | 2.19 | 0.00 | 0.00 | 0.87 | 1.57 | 2.13 | 3.85 | 2.60 | 4.70 |
| CD16+ | M1 | 140 | 53.22 | 1.23 | 2.32 | 0.00 | 0.00 | 0.81 | 1.51 | 1.56 | 2.94 | 2.15 | 4.04 |
| CD14+CD64+ | M1 | 140 | 7.75 | 0.39 | 5.06 | 0.00 | 0.00 | 0.27 | 3.54 | 0.23 | 2.91 | 0.53 | 6.83 |
| HLA-DR+ | M1 | 140 | 8.78 | 0.40 | 4.52 | 0.04 | 0.51 | 0.34 | 3.88 | 0.52 | 5.97 | 0.74 | 8.45 |
| WBC | M2 | 140 | 98.12 | 0.20 | 0.21 | 0.00 | 0.00 | 0.16 | 0.16 | 0.46 | 0.47 | 0.53 | 0.54 |
| lymphocyte | M2 | 140 | 33.95 | 1.02 | 2.99 | 0.00 | 0.00 | 1.03 | 3.03 | 1.54 | 4.52 | 2.11 | 6.21 |
| monocyte | M2 | 140 | 8.79 | 0.49 | 5.63 | 0.18 | 2.02 | 0.18 | 2.06 | 0.56 | 6.32 | 0.79 | 8.94 |
| granulocyte | M2 | 140 | 54.65 | 1.20 | 2.19 | 0.00 | 0.00 | 0.91 | 1.67 | 2.16 | 3.96 | 2.63 | 4.82 |
| CD13+ | M2 | 140 | 55.50 | 1.21 | 2.18 | 0.00 | 0.00 | 0.99 | 1.79 | 2.57 | 4.63 | 3.01 | 5.43 |
| CD15+ | M2 | 140 | 55.20 | 1.12 | 2.04 | 0.00 | 0.00 | 1.10 | 1.98 | 2.41 | 4.37 | 2.88 | 5.21 |
| CD19+ | M2 | 140 | 10.39 | 0.41 | 3.97 | 0.00 | 0.00 | 0.17 | 1.61 | 0.76 | 7.28 | 0.88 | 8.45 |
| CD33+ | M2 | 140 | 8.31 | 0.43 | 5.16 | 0.19 | 2.25 | 0.36 | 4.30 | 0.71 | 8.50 | 0.92 | 11.06 |
| CD38+ | M2 | 140 | 8.39 | 0.41 | 4.92 | 0.15 | 1.73 | 0.24 | 2.91 | 0.76 | 9.04 | 0.91 | 10.84 |
| HLA-DR+ | M2 | 140 | 8.44 | 0.43 | 5.06 | 0.12 | 1.46 | 0.30 | 3.53 | 0.62 | 7.30 | 0.82 | 9.67 |
| WBC | T | 140 | 99.03 | 0.18 | 0.18 | 0.00 | 0.00 | 0.12 | 0.12 | 0.21 | 0.21 | 0.30 | 0.30 |
| lymphocyte | T | 140 | 33.72 | 0.96 | 2.84 | 0.00 | 0.00 | 0.75 | 2.24 | 0.55 | 1.64 | 1.34 | 3.97 |
| monocyte | T | 140 | 8.56 | 0.44 | 5.15 | 0.00 | 0.00 | 0.36 | 4.18 | 0.27 | 3.19 | 0.63 | 7.36 |
| granulocyte | T | 140 | 54.95 | 1.16 | 2.12 | 0.14 | 0.25 | 0.66 | 1.20 | 1.49 | 2.72 | 2.01 | 3.66 |
| CD2+ | T | 140 | 84.71 | 0.29 | 0.35 | 0.19 | 0.23 | 0.14 | 0.17 | 0.20 | 0.24 | 0.43 | 0.51 |
| CD3+ | T | 140 | 75.18 | 0.35 | 0.47 | 0.27 | 0.36 | 0.21 | 0.29 | 0.12 | 0.16 | 0.51 | 0.68 |
| CD4+CD8- | T | 140 | 53.37 | 0.54 | 1.02 | 0.24 | 0.46 | 0.00 | 0.00 | 0.42 | 0.79 | 0.73 | 1.37 |
| CD4-CD8+ | T | 140 | 38.79 | 0.46 | 1.19 | 0.24 | 0.62 | 0.02 | 0.06 | 0.16 | 0.42 | 0.55 | 1.41 |
| CD5+ | T | 140 | 76.35 | 0.40 | 0.53 | 0.12 | 0.16 | 0.13 | 0.18 | 0.89 | 1.17 | 0.99 | 1.30 |
| CD7+ | T | 140 | 85.16 | 0.49 | 0.57 | 0.28 | 0.32 | 0.13 | 0.15 | 0.30 | 0.36 | 0.65 | 0.76 |
| CD3-CD56+ | T | 140 | 11.24 | 0.30 | 2.70 | 0.10 | 0.85 | 0.24 | 2.12 | 0.30 | 2.68 | 0.50 | 4.44 |
| TCRγδ+ | T | 140 | 4.40 | 0.17 | 3.82 | 0.03 | 0.69 | 0.09 | 2.03 | 0.07 | 1.57 | 0.20 | 4.65 |

| Navios EX ClearLLab Abnormal Control Cells, across sites | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Cell Population | Panel | N | Mean (%) | Repeatability | | Between Run | | Between Days | | Between Site | | Reproducibility | |
| | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| WBC | B | 140 | 99.13 | 0.13 | 0.13 | 0.02 | 0.02 | 0.19 | 0.19 | 0.24 | 0.24 | 0.33 | 0.33 |
| lymphocyte | B | 140 | 33.39 | 1.05 | 3.14 | 0.00 | 0.00 | 1.37 | 4.09 | 0.00 | 0.00 | 1.72 | 5.16 |
| monocyte | B | 140 | 8.55 | 0.40 | 4.69 | 0.00 | 0.00 | 0.25 | 2.94 | 0.18 | 2.08 | 0.51 | 5.91 |
| granulocyte | B | 140 | 55.31 | 1.23 | 2.22 | 0.00 | 0.00 | 1.33 | 2.41 | 1.10 | 1.98 | 2.12 | 3.83 |
| CD5+ | B | 140 | 74.54 | 0.55 | 0.74 | 0.00 | 0.00 | 0.35 | 0.47 | 0.57 | 0.76 | 0.87 | 1.16 |
| CD10+ | B | 140 | 55.04 | 1.17 | 2.12 | 0.00 | 0.00 | 1.28 | 2.32 | 1.23 | 2.23 | 2.12 | 3.85 |
| CD19+CD20+ | B | 140 | 11.44 | 0.30 | 2.59 | 0.00 | 0.00 | 0.16 | 1.37 | 0.32 | 2.81 | 0.46 | 4.06 |
| CD34+ | B | 140 | 8.72 | 0.32 | 3.70 | 0.00 | 0.00 | 0.23 | 2.61 | 0.39 | 4.48 | 0.56 | 6.37 |

24

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| Navios EX ClearLLab Abnormal Control Cells, across sites | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Cell Population | Panel | N | Mean (%) | Repeatability | | Between Run | | Between Days | | Between Site | | Reproducibility | |
| | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| CD38+ | B | 140 | 8.97 | 0.35 | 3.90 | 0.00 | 0.00 | 0.00 | 0.00 | 0.60 | 6.71 | 0.70 | 7.76 |
| CD200+ | B | 140 | 10.21 | 0.28 | 2.76 | 0.00 | 0.00 | 0.20 | 1.98 | 0.69 | 6.74 | 0.77 | 7.55 |
| Kappa+ | B | 140 | 56.54 | 1.16 | 2.06 | 0.00 | 0.00 | 0.72 | 1.27 | 0.00 | 0.00 | 1.37 | 2.42 |
| Lambda+ | B | 140 | 40.15 | 1.19 | 2.96 | 0.00 | 0.00 | 0.70 | 1.74 | 0.80 | 1.99 | 1.59 | 3.97 |
| WBC | M1 | 140 | 98.02 | 0.17 | 0.17 | 0.00 | 0.00 | 0.20 | 0.21 | 0.02 | 0.02 | 0.27 | 0.27 |
| lymphocyte | M1 | 140 | 33.71 | 1.09 | 3.23 | 0.00 | 0.00 | 1.93 | 5.72 | 0.43 | 1.27 | 2.25 | 6.69 |
| monocyte | M1 | 140 | 8.93 | 0.36 | 4.04 | 0.08 | 0.86 | 0.33 | 3.75 | 0.30 | 3.32 | 0.58 | 6.49 |
| granulocyte | M1 | 140 | 54.50 | 1.19 | 2.19 | 0.00 | 0.00 | 2.03 | 3.73 | 1.14 | 2.10 | 2.62 | 4.80 |
| CD7+ | M1 | 140 | 84.29 | 0.50 | 0.60 | 0.00 | 0.00 | 0.58 | 0.69 | 0.50 | 0.60 | 0.92 | 1.09 |
| CD10+ | M1 | 140 | 54.43 | 1.21 | 2.23 | 0.00 | 0.00 | 2.01 | 3.70 | 1.66 | 3.05 | 2.88 | 5.29 |
| CD14+CD11b+ | M1 | 140 | 8.01 | 0.34 | 4.28 | 0.00 | 0.00 | 0.26 | 3.30 | 0.15 | 1.92 | 0.46 | 5.74 |
| CD13+ | M1 | 140 | 54.80 | 1.15 | 2.10 | 0.00 | 0.00 | 2.07 | 3.78 | 1.19 | 2.18 | 2.65 | 4.84 |
| CD16+ | M1 | 140 | 52.41 | 1.14 | 2.18 | 0.00 | 0.00 | 1.96 | 3.73 | 1.67 | 3.18 | 2.81 | 5.37 |
| CD34+ | M1 | 140 | 8.94 | 0.30 | 3.38 | 0.00 |…