XN-1000 Hematology Analyzer as an Alternative to Flow Cytometry for Measuring Residual Cells in Blood Components

Measuring residual cells in blood products is legally required for monitoring the manufacturing process and ensuring recipient safety. We compared the accuracy and performance of the two methodologies. Residual white blood cells (rWBCs), red blood cells (rRBCs), and platelets (rPLTs) were measured i...

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Published inAnnals of laboratory medicine Vol. 45; no. 4; pp. 437 - 449
Main Authors Siller, Anita, Seekircher, Lisa, Schmidt, Daniela, Tschiderer, Lena, Willeit, Peter, Schennach, Harald, Amato, Marco
Format Journal Article
LanguageEnglish
Published Korea (South) Korean Society for Laboratory Medicine 01.07.2025
대한진단검사의학회
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ISSN2234-3806
2234-3814
2234-3814
DOI10.3343/alm.2024.0448

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Abstract Measuring residual cells in blood products is legally required for monitoring the manufacturing process and ensuring recipient safety. We compared the accuracy and performance of the two methodologies. Residual white blood cells (rWBCs), red blood cells (rRBCs), and platelets (rPLTs) were measured in RBC concentrates (rWBCs), fresh frozen plasma (rWBCs, rRBCs, and rPLTs), and PLT concentrates (rWBCs and rRBCs) using the Sysmex XN-1000 hematology analyzer (Sysmex, Kobe, Japan) equipped with Blood Bank mode and standard flow cytometry (fluorescence-activated cell sorting; FACS). rWBC counts in RBC concentrates and plasma were similar between XN-1000 and FACS. In pooled pathogen-inactivated PLT concentrates, XN-1000 yielded higher rWBC counts. Correlations between XN-1000 and FACS were moderate for rWBCs (0.42, 95% confidence interval: 0.15-0.69) in RBC inline-filtrated WBC-depleted RBC concentrates. In plasma, correlations were high for rWBC, rRBC, and rPLT counts, with Spearman correlation coefficients of 0.82-0.97. In pathogen-inactivated PLT concentrates, correlations were moderate for rWBCs (0.58, 0.33-0.84) and rRBCs (0.61, 0.35-0.87) in pooled samples but not significant in apheresis-derived samples. Median differences between FACS and XN-1000 were generally low, but XN-1000 overestimated residual cell counts in a subset of measurements. Residual cell cut-off values were surpassed in >90% of RBC concentrates, plasma, and apheresis pathogen-inactivated PLT concentrates using both methods. In pooled pathogen-inactivated PLT concentrates, 91.2% and 70.6% surpassed the cut-off using FACS and XN-1000, respectively. Sysmex XN-1000 is suitable for residual cell measurements in RBC concentrates and plasma, with some limitations for PLT concentrates.
AbstractList Background: Measuring residual cells in blood products is legally required for monitoring the manufacturing process and ensuring recipient safety. We compared the accuracy and performance of the two methodologies. Methods: Residual white blood cells (rWBCs), red blood cells (rRBCs), and platelets (rPLTs) were measured in RBC concentrates (rWBCs), fresh frozen plasma (rWBCs, rRBCs, and rPLTs), and PLT concentrates (rWBCs and rRBCs) using the Sysmex XN-1000 hematology analyzer (Sysmex, Kobe, Japan) equipped with Blood Bank mode and standard flow cytom- etry (fluorescence-activated cell sorting; FACS). Results: rWBC counts in RBC concentrates and plasma were similar between XN-1000 and FACS. In pooled pathogen-inactivated PLT concentrates, XN-1000 yielded higher rWBC counts. Correlations between XN-1000 and FACS were moderate for rWBCs (0.42, 95% confidence interval: 0.15–0.69) in RBC inline-filtrated WBC-depleted RBC concentrates. In plasma, correlations were high for rWBC, rRBC, and rPLT counts, with Spearman correla- tion coefficients of 0.82–0.97. In pathogen-inactivated PLT concentrates, correlations were moderate for rWBCs (0.58, 0.33–0.84) and rRBCs (0.61, 0.35–0.87) in pooled samples but not significant in apheresis-derived samples. Median differences between FACS and XN-1000 were generally low, but XN-1000 overestimated residual cell counts in a subset of measurements. Residual cell cut-off values were surpassed in >90% of RBC concen- trates, plasma, and apheresis pathogen-inactivated PLT concentrates using both methods. In pooled pathogen-inactivated PLT concentrates, 91.2% and 70.6% surpassed the cut-off using FACS and XN-1000, respectively. Conclusions: Sysmex XN-1000 is suitable for residual cell measurements in RBC concen- trates and plasma, with some limitations for PLT concentrates. KCI Citation Count: 0
Measuring residual cells in blood products is legally required for monitoring the manufacturing process and ensuring recipient safety. We compared the accuracy and performance of the two methodologies.BackgroundMeasuring residual cells in blood products is legally required for monitoring the manufacturing process and ensuring recipient safety. We compared the accuracy and performance of the two methodologies.Residual white blood cells (rWBCs), red blood cells (rRBCs), and platelets (rPLTs) were measured in RBC concentrates (rWBCs), fresh frozen plasma (rWBCs, rRBCs, and rPLTs), and PLT concentrates (rWBCs and rRBCs) using the Sysmex XN-1000 hematology analyzer (Sysmex, Kobe, Japan) equipped with Blood Bank mode and standard flow cytometry (fluorescence-activated cell sorting; FACS).MethodsResidual white blood cells (rWBCs), red blood cells (rRBCs), and platelets (rPLTs) were measured in RBC concentrates (rWBCs), fresh frozen plasma (rWBCs, rRBCs, and rPLTs), and PLT concentrates (rWBCs and rRBCs) using the Sysmex XN-1000 hematology analyzer (Sysmex, Kobe, Japan) equipped with Blood Bank mode and standard flow cytometry (fluorescence-activated cell sorting; FACS).rWBC counts in RBC concentrates and plasma were similar between XN-1000 and FACS. In pooled pathogen-inactivated PLT concentrates, XN-1000 yielded higher rWBC counts. Correlations between XN-1000 and FACS were moderate for rWBCs (0.42, 95% confidence interval: 0.15-0.69) in RBC inline-filtrated WBC-depleted RBC concentrates. In plasma, correlations were high for rWBC, rRBC, and rPLT counts, with Spearman correlation coefficients of 0.82-0.97. In pathogen-inactivated PLT concentrates, correlations were moderate for rWBCs (0.58, 0.33-0.84) and rRBCs (0.61, 0.35-0.87) in pooled samples but not significant in apheresis-derived samples. Median differences between FACS and XN-1000 were generally low, but XN-1000 overestimated residual cell counts in a subset of measurements. Residual cell cut-off values were surpassed in ⟩90% of RBC concentrates, plasma, and apheresis pathogen-inactivated PLT concentrates using both methods. In pooled pathogen-inactivated PLT concentrates, 91.2% and 70.6% surpassed the cut-off using FACS and XN-1000, respectively.ResultsrWBC counts in RBC concentrates and plasma were similar between XN-1000 and FACS. In pooled pathogen-inactivated PLT concentrates, XN-1000 yielded higher rWBC counts. Correlations between XN-1000 and FACS were moderate for rWBCs (0.42, 95% confidence interval: 0.15-0.69) in RBC inline-filtrated WBC-depleted RBC concentrates. In plasma, correlations were high for rWBC, rRBC, and rPLT counts, with Spearman correlation coefficients of 0.82-0.97. In pathogen-inactivated PLT concentrates, correlations were moderate for rWBCs (0.58, 0.33-0.84) and rRBCs (0.61, 0.35-0.87) in pooled samples but not significant in apheresis-derived samples. Median differences between FACS and XN-1000 were generally low, but XN-1000 overestimated residual cell counts in a subset of measurements. Residual cell cut-off values were surpassed in ⟩90% of RBC concentrates, plasma, and apheresis pathogen-inactivated PLT concentrates using both methods. In pooled pathogen-inactivated PLT concentrates, 91.2% and 70.6% surpassed the cut-off using FACS and XN-1000, respectively.Sysmex XN-1000 is suitable for residual cell measurements in RBC concentrates and plasma, with some limitations for PLT concentrates.ConclusionsSysmex XN-1000 is suitable for residual cell measurements in RBC concentrates and plasma, with some limitations for PLT concentrates.
Measuring residual cells in blood products is legally required for monitoring the manufacturing process and ensuring recipient safety. We compared the accuracy and performance of the two methodologies. Residual white blood cells (rWBCs), red blood cells (rRBCs), and platelets (rPLTs) were measured in RBC concentrates (rWBCs), fresh frozen plasma (rWBCs, rRBCs, and rPLTs), and PLT concentrates (rWBCs and rRBCs) using the Sysmex XN-1000 hematology analyzer (Sysmex, Kobe, Japan) equipped with Blood Bank mode and standard flow cytometry (fluorescence-activated cell sorting; FACS). rWBC counts in RBC concentrates and plasma were similar between XN-1000 and FACS. In pooled pathogen-inactivated PLT concentrates, XN-1000 yielded higher rWBC counts. Correlations between XN-1000 and FACS were moderate for rWBCs (0.42, 95% confidence interval: 0.15-0.69) in RBC inline-filtrated WBC-depleted RBC concentrates. In plasma, correlations were high for rWBC, rRBC, and rPLT counts, with Spearman correlation coefficients of 0.82-0.97. In pathogen-inactivated PLT concentrates, correlations were moderate for rWBCs (0.58, 0.33-0.84) and rRBCs (0.61, 0.35-0.87) in pooled samples but not significant in apheresis-derived samples. Median differences between FACS and XN-1000 were generally low, but XN-1000 overestimated residual cell counts in a subset of measurements. Residual cell cut-off values were surpassed in >90% of RBC concentrates, plasma, and apheresis pathogen-inactivated PLT concentrates using both methods. In pooled pathogen-inactivated PLT concentrates, 91.2% and 70.6% surpassed the cut-off using FACS and XN-1000, respectively. Sysmex XN-1000 is suitable for residual cell measurements in RBC concentrates and plasma, with some limitations for PLT concentrates.
Author Schmidt, Daniela
Seekircher, Lisa
Tschiderer, Lena
Willeit, Peter
Siller, Anita
Schennach, Harald
Amato, Marco
AuthorAffiliation 3 Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK
1 Central Institute for Blood Transfusion and Immunology, University Hospital of Innsbruck, Tirol Kliniken GmbH, Innsbruck, Austria
2 Institute of Clinical Epidemiology, Public Health, Health Economics, Medical Statistics and Informatics, Medical University of Innsbruck, Innsbruck, Austria
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Issue 4
Keywords Residual cells
Flow cytometry
Blood components
Blood bank mode
Sysmex XN-1000
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대한진단검사의학회
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Snippet Measuring residual cells in blood products is legally required for monitoring the manufacturing process and ensuring recipient safety. We compared the accuracy...
Background: Measuring residual cells in blood products is legally required for monitoring the manufacturing process and ensuring recipient safety. We compared...
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SubjectTerms Blood Platelets - cytology
Erythrocytes - cytology
Flow Cytometry - methods
Humans
Leukocytes - cytology
Original
Plasma - cytology
병리학
Title XN-1000 Hematology Analyzer as an Alternative to Flow Cytometry for Measuring Residual Cells in Blood Components
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