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METHOD COMPARISON OF A NOVEL SLIDE-BASED INTEGRATED HEMATOLOGY ANALYZER AND A FLOW CYTOMETRY-BASED SYSTEM USING SAMPLES WITH TARGETED MEDICAL CONDITIONS
Author(s): ,
Henk Russcher
Affiliations:
Erasmus MC,University Medical Center Rotterdam,Rotterdam,Netherlands
,
Tania Khartabil
Affiliations:
Roche Diagnostics,Westborough,United States
,
Dan Bracco
Affiliations:
Roche Diagnostics,Westborough,United States
Tim Allen
Affiliations:
Roche Diagnostics,Westborough,United States
(Abstract release date: 05/17/18) EHA Library. Russcher H. 06/14/18; 215968; PB1882
Henk Russcher
Henk Russcher
Contributions
Abstract

Abstract: PB1882

Type: Publication Only

Background
The cobas m 511 integrated hematology analyzer (cobas m 511 system) is a novel slide-based system that performs a CBC, WBC differential, reticulocyte count, and nucleated RBC count using digital analysis.

Aims
This single-center study investigated whether the cobas m 511 system delivered comparable results to the Sysmex® XN-10 Automated Hematology Analyzer using samples from patients with medical conditions.

Methods
Laboratory hematology results were reviewed to identify subjects with 23 targeted medical conditions (including hematological malignancies and disorders of cell numbers and function). Residual whole blood samples (n=130) were processed on both systems within 8 hours of venipuncture. Consistent with CLSI EP09-A3, a method comparison was used to assess the correlation and bias between the systems for all parameters. Individual patient parameter results that were valid on both instruments were included.

Results
All 26 reportable parameters evaluated showed good-to-excellent correlation between the automated results of the cobas m 511 system and Sysmex Analyzer, with no significant bias (Table 1).

Table 1: cobas m 511 vs. Sysmex Analyzer results

Parameter [units]

Sample range

Pearson’s R

Intercept

Slope

WBC [103/µL]

(0.11-95.41)

0.999

-0.02

0.995

RBC [106/µL]

(1.79-7.68)

0.996

-0.01

0.992

HGB [g/dL]

(6.28-17.24)

0.995

-0.31

1.064

HCT [%]

(18.60-56.00)

0.982

-0.53

1.034

MCV [fL]

(69.50-107.80)

0.879

5.35

0.975

MCH [pg]

(20.22-36.48)

0.977

2.87

0.946

MCHC [g/dL]

(28.20-36.42)

0.548

14.88

0.559

RDW [%]

(11.50-27.10)

0.929

2.81

0.850

RDW-SD [fL]

(34.10-93.00)

0.908

7.46

0.910

PLT [103/µL]

(9.00-1379.00)

0.994

-2.02

0.943

MPV [fL]

(8.40-13.00)

0.843

0.82

0.915

#NRBC [103/µL]

(0.00-4.44)

0.980

N/A

N/A

#NEUT [103/µL]

(0.46-36.82)

0.999

0.03

1.008

#LYMPH [103/µL]

(0.16-4.89)

0.985

0.01

0.976

#MONO [103/µL]

(0.14-7.65)

0.991

-0.03

1.013

#EO [103/µL]

(0.00-1.23)

0.978

0.00

1.031

#BASO [103/µL]

(0.00-2.51)

0.962

-0.08

1.829

#RET [106/µL]

(0.00-0.34)

0.971

-0.01

0.982

HGB-RET [pg]

(14.68-42.04)

0.934

-2.75

1.193

Data for %NRBC, %NEUT, %LYMPH, %MONO, %EO, %BASO, and %RET not shown

Conclusion
The cobas m 511 system and Sysmex Analyzer produce comparable results for samples with targeted medical conditions. This demonstrates the robustness of the cobas m 511 system when abnormal samples are encountered.

Session topic: 6. Chronic lymphocytic leukemia and related disorders - Clinical

Keyword(s): Cytometry, flow cytometry

Abstract: PB1882

Type: Publication Only

Background
The cobas m 511 integrated hematology analyzer (cobas m 511 system) is a novel slide-based system that performs a CBC, WBC differential, reticulocyte count, and nucleated RBC count using digital analysis.

Aims
This single-center study investigated whether the cobas m 511 system delivered comparable results to the Sysmex® XN-10 Automated Hematology Analyzer using samples from patients with medical conditions.

Methods
Laboratory hematology results were reviewed to identify subjects with 23 targeted medical conditions (including hematological malignancies and disorders of cell numbers and function). Residual whole blood samples (n=130) were processed on both systems within 8 hours of venipuncture. Consistent with CLSI EP09-A3, a method comparison was used to assess the correlation and bias between the systems for all parameters. Individual patient parameter results that were valid on both instruments were included.

Results
All 26 reportable parameters evaluated showed good-to-excellent correlation between the automated results of the cobas m 511 system and Sysmex Analyzer, with no significant bias (Table 1).

Table 1: cobas m 511 vs. Sysmex Analyzer results

Parameter [units]

Sample range

Pearson’s R

Intercept

Slope

WBC [103/µL]

(0.11-95.41)

0.999

-0.02

0.995

RBC [106/µL]

(1.79-7.68)

0.996

-0.01

0.992

HGB [g/dL]

(6.28-17.24)

0.995

-0.31

1.064

HCT [%]

(18.60-56.00)

0.982

-0.53

1.034

MCV [fL]

(69.50-107.80)

0.879

5.35

0.975

MCH [pg]

(20.22-36.48)

0.977

2.87

0.946

MCHC [g/dL]

(28.20-36.42)

0.548

14.88

0.559

RDW [%]

(11.50-27.10)

0.929

2.81

0.850

RDW-SD [fL]

(34.10-93.00)

0.908

7.46

0.910

PLT [103/µL]

(9.00-1379.00)

0.994

-2.02

0.943

MPV [fL]

(8.40-13.00)

0.843

0.82

0.915

#NRBC [103/µL]

(0.00-4.44)

0.980

N/A

N/A

#NEUT [103/µL]

(0.46-36.82)

0.999

0.03

1.008

#LYMPH [103/µL]

(0.16-4.89)

0.985

0.01

0.976

#MONO [103/µL]

(0.14-7.65)

0.991

-0.03

1.013

#EO [103/µL]

(0.00-1.23)

0.978

0.00

1.031

#BASO [103/µL]

(0.00-2.51)

0.962

-0.08

1.829

#RET [106/µL]

(0.00-0.34)

0.971

-0.01

0.982

HGB-RET [pg]

(14.68-42.04)

0.934

-2.75

1.193

Data for %NRBC, %NEUT, %LYMPH, %MONO, %EO, %BASO, and %RET not shown

Conclusion
The cobas m 511 system and Sysmex Analyzer produce comparable results for samples with targeted medical conditions. This demonstrates the robustness of the cobas m 511 system when abnormal samples are encountered.

Session topic: 6. Chronic lymphocytic leukemia and related disorders - Clinical

Keyword(s): Cytometry, flow cytometry

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