EHA Library - The official digital education library of European Hematology Association (EHA)

ACCURACY EVALUATION OF LOW PLATELET COUNTS ON A NOVEL SLIDE-BASED INTEGRATED HEMATOLOGY ANALYZER
Author(s): ,
Vincent H.J. van der Velden
Affiliations:
Erasmus MC,University Medical Center Rotterdam,Rotterdam,Netherlands
,
Kaitlin Ropar
Affiliations:
Roche Diagnostics,Westborough,United States
,
Dan Bracco
Affiliations:
Roche Diagnostics,Westborough,United States
,
Tim Allen
Affiliations:
Roche Diagnostics,Westborough,United States
Henk Russcher
Affiliations:
Erasmus MC,University Medical Center Rotterdam,Rotterdam,Netherlands
(Abstract release date: 05/17/18) EHA Library. H.J. van der Velden V. 06/14/18; 216087; PB2352
Vincent H.J. van der Velden
Vincent H.J. van der Velden
Contributions
Abstract

Abstract: PB2352

Type: Publication Only

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

Aims
To assess the accuracy of low platelet (PLT) counts on the cobas m 511 compared with the Sysmex® XN-10 Automated Hematology Analyzer and BD FACSCanto™ Flow Cytometer in a single-center study.

Methods
Residual whole blood samples (n=115) in the PLT range 1-505 x103/µL (based on flow cytometery using CD61, CD41a, and CD42b antibodies) were randomly processed on each system. Sysmex samples were set to automatically reflex to PLT-F function, which is marketed as more reliable for thrombocytic or problematic samples than the standard impedance PLT-I function. Three analyses were performed: cobas m 511 and Sysmex Analyzer versus flow cytometer (reference), and cobas m 511 versus Sysmex Analyzer (reference). Data were compared using three thresholds and results included if a valid PLT result was obtained on both systems.

Results
All low PLT samples had valid results with the cobas m 511 and flow cytometry. Two (1.7%) samples were flagged with the Sysmex Analyzer (PLT-F) indicating unreliable results. The cobas m 511 demonstrated excellent accuracy compared with flow cytometry, with ≥93.6% sensitivity, specificity, and agreement, and good accuracy compared with Sysmex Analyzer (Table 1). Attempts were made to also study results for the Sysmex Analyzer PLT-I function; however, the vast majority of samples (100% for PLT counts ≤10, 80% for PLT 11–20, and 28% for PLT 21–50 x103/µL) had flags indicating unreliable values using this function which prevented any further comparison. 

Table 1: Accuracy analyses

 

PLT threshold (103/µL) 

Sensitivity (%)

Specificity (%)

Agreement (%)

cobas m 511 vs.
flow cytometer
(N = 115)
 

10

95.5

96.8

96.5

20

93.6

94.1

93.9

50

98.6

97.6

98.3

Sysmex Analyzer (PLT-F)
vs. flow cytometer
(N = 113) 

10

100.0

96.7

97.3

20

100.0

92.5

95.6

50

100.0

97.6

99.1

cobas m 511 vs.
Sysmex Analyzer (PLT-F)
(N = 113)

 

10

88.0

97.7

95.6

20

94.1

100.0

97.3

50

100.0

100.0

100.0

Conclusion
These data demonstrate the robustness and accuracy of platelet counts reported by the cobas m 511 system. Many samples were flagged using the Sysmex PLT-I function that, in routine use, would have reflexed to the PLT-F function. All samples on the cobas m 511 system had valid PLT results.

Session topic: 33.  Platelets disorders

Keyword(s): Platelet

Abstract: PB2352

Type: Publication Only

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

Aims
To assess the accuracy of low platelet (PLT) counts on the cobas m 511 compared with the Sysmex® XN-10 Automated Hematology Analyzer and BD FACSCanto™ Flow Cytometer in a single-center study.

Methods
Residual whole blood samples (n=115) in the PLT range 1-505 x103/µL (based on flow cytometery using CD61, CD41a, and CD42b antibodies) were randomly processed on each system. Sysmex samples were set to automatically reflex to PLT-F function, which is marketed as more reliable for thrombocytic or problematic samples than the standard impedance PLT-I function. Three analyses were performed: cobas m 511 and Sysmex Analyzer versus flow cytometer (reference), and cobas m 511 versus Sysmex Analyzer (reference). Data were compared using three thresholds and results included if a valid PLT result was obtained on both systems.

Results
All low PLT samples had valid results with the cobas m 511 and flow cytometry. Two (1.7%) samples were flagged with the Sysmex Analyzer (PLT-F) indicating unreliable results. The cobas m 511 demonstrated excellent accuracy compared with flow cytometry, with ≥93.6% sensitivity, specificity, and agreement, and good accuracy compared with Sysmex Analyzer (Table 1). Attempts were made to also study results for the Sysmex Analyzer PLT-I function; however, the vast majority of samples (100% for PLT counts ≤10, 80% for PLT 11–20, and 28% for PLT 21–50 x103/µL) had flags indicating unreliable values using this function which prevented any further comparison. 

Table 1: Accuracy analyses

 

PLT threshold (103/µL) 

Sensitivity (%)

Specificity (%)

Agreement (%)

cobas m 511 vs.
flow cytometer
(N = 115)
 

10

95.5

96.8

96.5

20

93.6

94.1

93.9

50

98.6

97.6

98.3

Sysmex Analyzer (PLT-F)
vs. flow cytometer
(N = 113) 

10

100.0

96.7

97.3

20

100.0

92.5

95.6

50

100.0

97.6

99.1

cobas m 511 vs.
Sysmex Analyzer (PLT-F)
(N = 113)

 

10

88.0

97.7

95.6

20

94.1

100.0

97.3

50

100.0

100.0

100.0

Conclusion
These data demonstrate the robustness and accuracy of platelet counts reported by the cobas m 511 system. Many samples were flagged using the Sysmex PLT-I function that, in routine use, would have reflexed to the PLT-F function. All samples on the cobas m 511 system had valid PLT results.

Session topic: 33.  Platelets disorders

Keyword(s): Platelet

By clicking “Accept Terms & all Cookies” or by continuing to browse, you agree to the storing of third-party cookies on your device to enhance your user experience and agree to the user terms and conditions of this learning management system (LMS).

Cookie Settings
Accept Terms & all Cookies