Multicenter evaluation of analytical performances of platelet counts and platelet parameters: Carryover, precision, and stability

Introduction The correctness of the results of automated platelet analysis is still highly debated. The aim of this multicenter study, conducted according to international guidelines, was to verify the analytical performance of nine different types of hematology analyzers (HAs) in the automated plat...

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Veröffentlicht in:International journal of laboratory hematology 2020-10, Vol.42 (5), p.552-564
Hauptverfasser: Gioia, Maria, Da Rin, Giorgio, Manenti, Barbara, Birindelli, Sarah, Ciardelli, Maria Laura, Gentile, Roberto, Beretta, Gianluca, Lorusso, Giuseppe, Avino, Daniela, Di Fabio, Anna Maria, Dima, Francesco, Fanelli, Alessandra, Lorubbio, Maria, Francione, Sara, Marincheva, Galina, Marini, Alessandra, Papa, Angela, Giannelli, Elena, Pajola, Rachele, Panzeri, Andrea, Pipitone, Silvia, Benegiamo, Anna, Rolla, Roberta, Vidali, Matteo, Buoro, Sabrina
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container_end_page 564
container_issue 5
container_start_page 552
container_title International journal of laboratory hematology
container_volume 42
creator Gioia, Maria
Da Rin, Giorgio
Manenti, Barbara
Birindelli, Sarah
Ciardelli, Maria Laura
Gentile, Roberto
Beretta, Gianluca
Lorusso, Giuseppe
Avino, Daniela
Di Fabio, Anna Maria
Dima, Francesco
Fanelli, Alessandra
Lorubbio, Maria
Francione, Sara
Marincheva, Galina
Marini, Alessandra
Papa, Angela
Giannelli, Elena
Pajola, Rachele
Panzeri, Andrea
Pipitone, Silvia
Benegiamo, Anna
Rolla, Roberta
Vidali, Matteo
Buoro, Sabrina
description Introduction The correctness of the results of automated platelet analysis is still highly debated. The aim of this multicenter study, conducted according to international guidelines, was to verify the analytical performance of nine different types of hematology analyzers (HAs) in the automated platelet analysis. Methods Four hundred eighty‐six peripheral blood samples (PB), collected in K3EDTA tubes, were analyzed by ABX Pentra, ADVIA2120i, BC‐6800, BC‐6800 Plus, Cell‐DYN Sapphire, DxH800, XE‐2100, XE‐5000, XN‐20 with PLT‐F App. Within‐run imprecision and between‐run imprecision were carried out using PB and material control, respectively. The carryover, low limit of quantification (LoQ), and the PB stability were evaluated. Results The carryover was absent for all HAs. The LoQ of PLT ranged between 2.0 (Cell‐Dyn Sapphire) and 25.0 × 109/L (ADVIA 2120i), while immature platelet fraction (IPF) ranged between 1.0 (XN‐20) and 12.0 × 109/L (XE‐5000). The imprecision (%CV) increases as the platelet count decreases. No HAs showed desirable CVAPS for PLT counts less than 50.0 × 109/L, with the exception of Cell‐DYN Sapphire (CV 3.0% with PLT‐O mean value of 26.7 × 109/L), XN‐20 (CV 2.4% with PLT‐F mean value of 21.5 × 109/L), and BC‐6800 Plus (CV 1.9% with PLT‐O mean value of 26.5 × 109/L). The sample stability ranged between under two hours for MPV by ADVIA2120i and 8 hours for other PLT parameters and HAs. Conclusion The findings of this study may provide useful information regarding carryover, precision, and stability of platelet counts and parameters, especially in thrombocytopenic samples. Moreover, the stability of sample for platelet analysis is conditioned by the HA and by temperature and storage time.
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The aim of this multicenter study, conducted according to international guidelines, was to verify the analytical performance of nine different types of hematology analyzers (HAs) in the automated platelet analysis. Methods Four hundred eighty‐six peripheral blood samples (PB), collected in K3EDTA tubes, were analyzed by ABX Pentra, ADVIA2120i, BC‐6800, BC‐6800 Plus, Cell‐DYN Sapphire, DxH800, XE‐2100, XE‐5000, XN‐20 with PLT‐F App. Within‐run imprecision and between‐run imprecision were carried out using PB and material control, respectively. The carryover, low limit of quantification (LoQ), and the PB stability were evaluated. Results The carryover was absent for all HAs. The LoQ of PLT ranged between 2.0 (Cell‐Dyn Sapphire) and 25.0 × 109/L (ADVIA 2120i), while immature platelet fraction (IPF) ranged between 1.0 (XN‐20) and 12.0 × 109/L (XE‐5000). The imprecision (%CV) increases as the platelet count decreases. No HAs showed desirable CVAPS for PLT counts less than 50.0 × 109/L, with the exception of Cell‐DYN Sapphire (CV 3.0% with PLT‐O mean value of 26.7 × 109/L), XN‐20 (CV 2.4% with PLT‐F mean value of 21.5 × 109/L), and BC‐6800 Plus (CV 1.9% with PLT‐O mean value of 26.5 × 109/L). The sample stability ranged between under two hours for MPV by ADVIA2120i and 8 hours for other PLT parameters and HAs. Conclusion The findings of this study may provide useful information regarding carryover, precision, and stability of platelet counts and parameters, especially in thrombocytopenic samples. Moreover, the stability of sample for platelet analysis is conditioned by the HA and by temperature and storage time.</description><identifier>ISSN: 1751-5521</identifier><identifier>EISSN: 1751-553X</identifier><identifier>DOI: 10.1111/ijlh.13204</identifier><identifier>PMID: 32304271</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>automated counts ; Automation ; Blood Platelets - cytology ; Blood Platelets - metabolism ; Hematology ; hematology analyzers ; Humans ; immature platelet fraction ; Italy ; MPV ; Peripheral blood ; Platelet Count - instrumentation ; Platelet Count - methods ; Platelet Count - standards ; Platelet Function Tests - instrumentation ; Platelet Function Tests - methods ; Platelet Function Tests - standards ; Platelets ; Reproducibility of Results ; Sensitivity and Specificity</subject><ispartof>International journal of laboratory hematology, 2020-10, Vol.42 (5), p.552-564</ispartof><rights>2020 John Wiley &amp; Sons Ltd</rights><rights>2020 John Wiley &amp; Sons Ltd.</rights><rights>Copyright © 2020 John Wiley &amp; Sons Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><orcidid>0000-0001-7637-0727</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fijlh.13204$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fijlh.13204$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32304271$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Gioia, Maria</creatorcontrib><creatorcontrib>Da Rin, Giorgio</creatorcontrib><creatorcontrib>Manenti, Barbara</creatorcontrib><creatorcontrib>Birindelli, Sarah</creatorcontrib><creatorcontrib>Ciardelli, Maria Laura</creatorcontrib><creatorcontrib>Gentile, Roberto</creatorcontrib><creatorcontrib>Beretta, Gianluca</creatorcontrib><creatorcontrib>Lorusso, Giuseppe</creatorcontrib><creatorcontrib>Avino, Daniela</creatorcontrib><creatorcontrib>Di Fabio, Anna Maria</creatorcontrib><creatorcontrib>Dima, Francesco</creatorcontrib><creatorcontrib>Fanelli, Alessandra</creatorcontrib><creatorcontrib>Lorubbio, Maria</creatorcontrib><creatorcontrib>Francione, Sara</creatorcontrib><creatorcontrib>Marincheva, Galina</creatorcontrib><creatorcontrib>Marini, Alessandra</creatorcontrib><creatorcontrib>Papa, Angela</creatorcontrib><creatorcontrib>Giannelli, Elena</creatorcontrib><creatorcontrib>Pajola, Rachele</creatorcontrib><creatorcontrib>Panzeri, Andrea</creatorcontrib><creatorcontrib>Pipitone, Silvia</creatorcontrib><creatorcontrib>Benegiamo, Anna</creatorcontrib><creatorcontrib>Rolla, Roberta</creatorcontrib><creatorcontrib>Vidali, Matteo</creatorcontrib><creatorcontrib>Buoro, Sabrina</creatorcontrib><title>Multicenter evaluation of analytical performances of platelet counts and platelet parameters: Carryover, precision, and stability</title><title>International journal of laboratory hematology</title><addtitle>Int J Lab Hematol</addtitle><description>Introduction The correctness of the results of automated platelet analysis is still highly debated. The aim of this multicenter study, conducted according to international guidelines, was to verify the analytical performance of nine different types of hematology analyzers (HAs) in the automated platelet analysis. Methods Four hundred eighty‐six peripheral blood samples (PB), collected in K3EDTA tubes, were analyzed by ABX Pentra, ADVIA2120i, BC‐6800, BC‐6800 Plus, Cell‐DYN Sapphire, DxH800, XE‐2100, XE‐5000, XN‐20 with PLT‐F App. Within‐run imprecision and between‐run imprecision were carried out using PB and material control, respectively. The carryover, low limit of quantification (LoQ), and the PB stability were evaluated. Results The carryover was absent for all HAs. The LoQ of PLT ranged between 2.0 (Cell‐Dyn Sapphire) and 25.0 × 109/L (ADVIA 2120i), while immature platelet fraction (IPF) ranged between 1.0 (XN‐20) and 12.0 × 109/L (XE‐5000). The imprecision (%CV) increases as the platelet count decreases. No HAs showed desirable CVAPS for PLT counts less than 50.0 × 109/L, with the exception of Cell‐DYN Sapphire (CV 3.0% with PLT‐O mean value of 26.7 × 109/L), XN‐20 (CV 2.4% with PLT‐F mean value of 21.5 × 109/L), and BC‐6800 Plus (CV 1.9% with PLT‐O mean value of 26.5 × 109/L). The sample stability ranged between under two hours for MPV by ADVIA2120i and 8 hours for other PLT parameters and HAs. Conclusion The findings of this study may provide useful information regarding carryover, precision, and stability of platelet counts and parameters, especially in thrombocytopenic samples. Moreover, the stability of sample for platelet analysis is conditioned by the HA and by temperature and storage time.</description><subject>automated counts</subject><subject>Automation</subject><subject>Blood Platelets - cytology</subject><subject>Blood Platelets - metabolism</subject><subject>Hematology</subject><subject>hematology analyzers</subject><subject>Humans</subject><subject>immature platelet fraction</subject><subject>Italy</subject><subject>MPV</subject><subject>Peripheral blood</subject><subject>Platelet Count - instrumentation</subject><subject>Platelet Count - methods</subject><subject>Platelet Count - standards</subject><subject>Platelet Function Tests - instrumentation</subject><subject>Platelet Function Tests - methods</subject><subject>Platelet Function Tests - standards</subject><subject>Platelets</subject><subject>Reproducibility of Results</subject><subject>Sensitivity and Specificity</subject><issn>1751-5521</issn><issn>1751-553X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkUlLBDEQhYMo7hd_gDR48eBotp50e5PBlREvCt6aLNWYIb2YpJU--s_NjBtYlyrqfbzDewgdEHxK0pzZhXs5JYxivoa2icjJJM_Z8_rvTckW2glhgXEuOC430RajDHMqyDb6uB9ctBraCD6DN-kGGW3XZl2dyVa6MWnSZT34uvONbDWEpdQ7GcFBzHQ3tDEk1Pz9eullA8kvnGcz6f3YvYE_yXoP2obkfbLCQ5TKOhvHPbRRSxdg_3vvoqery8fZzWT-cH07u5hPeloQPlGcG5pDIZSqAYtprgpFNDegeW2MUYwwUktSA9FaCU6NmOoSC8ixEKYoSraLjr98e9-9DhBi1digwTnZQjeEirKSlMm3wAk9-ocuusGnOBLF-bTMBZ2KRB1-U4NqwFS9t430Y_UTbgLIF_BuHYy_OsHVsrZqWVu1qq26vZvfrC72CfKyjW4</recordid><startdate>202010</startdate><enddate>202010</enddate><creator>Gioia, Maria</creator><creator>Da Rin, Giorgio</creator><creator>Manenti, Barbara</creator><creator>Birindelli, Sarah</creator><creator>Ciardelli, Maria Laura</creator><creator>Gentile, Roberto</creator><creator>Beretta, Gianluca</creator><creator>Lorusso, Giuseppe</creator><creator>Avino, Daniela</creator><creator>Di Fabio, Anna Maria</creator><creator>Dima, Francesco</creator><creator>Fanelli, Alessandra</creator><creator>Lorubbio, Maria</creator><creator>Francione, Sara</creator><creator>Marincheva, Galina</creator><creator>Marini, Alessandra</creator><creator>Papa, Angela</creator><creator>Giannelli, Elena</creator><creator>Pajola, Rachele</creator><creator>Panzeri, Andrea</creator><creator>Pipitone, Silvia</creator><creator>Benegiamo, Anna</creator><creator>Rolla, Roberta</creator><creator>Vidali, Matteo</creator><creator>Buoro, Sabrina</creator><general>Wiley Subscription Services, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7T5</scope><scope>H94</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-7637-0727</orcidid></search><sort><creationdate>202010</creationdate><title>Multicenter evaluation of analytical performances of platelet counts and platelet parameters: Carryover, precision, and stability</title><author>Gioia, Maria ; 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The aim of this multicenter study, conducted according to international guidelines, was to verify the analytical performance of nine different types of hematology analyzers (HAs) in the automated platelet analysis. Methods Four hundred eighty‐six peripheral blood samples (PB), collected in K3EDTA tubes, were analyzed by ABX Pentra, ADVIA2120i, BC‐6800, BC‐6800 Plus, Cell‐DYN Sapphire, DxH800, XE‐2100, XE‐5000, XN‐20 with PLT‐F App. Within‐run imprecision and between‐run imprecision were carried out using PB and material control, respectively. The carryover, low limit of quantification (LoQ), and the PB stability were evaluated. Results The carryover was absent for all HAs. The LoQ of PLT ranged between 2.0 (Cell‐Dyn Sapphire) and 25.0 × 109/L (ADVIA 2120i), while immature platelet fraction (IPF) ranged between 1.0 (XN‐20) and 12.0 × 109/L (XE‐5000). The imprecision (%CV) increases as the platelet count decreases. No HAs showed desirable CVAPS for PLT counts less than 50.0 × 109/L, with the exception of Cell‐DYN Sapphire (CV 3.0% with PLT‐O mean value of 26.7 × 109/L), XN‐20 (CV 2.4% with PLT‐F mean value of 21.5 × 109/L), and BC‐6800 Plus (CV 1.9% with PLT‐O mean value of 26.5 × 109/L). The sample stability ranged between under two hours for MPV by ADVIA2120i and 8 hours for other PLT parameters and HAs. Conclusion The findings of this study may provide useful information regarding carryover, precision, and stability of platelet counts and parameters, especially in thrombocytopenic samples. Moreover, the stability of sample for platelet analysis is conditioned by the HA and by temperature and storage time.</abstract><cop>England</cop><pub>Wiley Subscription Services, Inc</pub><pmid>32304271</pmid><doi>10.1111/ijlh.13204</doi><tpages>13</tpages><orcidid>https://orcid.org/0000-0001-7637-0727</orcidid></addata></record>
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subjects automated counts
Automation
Blood Platelets - cytology
Blood Platelets - metabolism
Hematology
hematology analyzers
Humans
immature platelet fraction
Italy
MPV
Peripheral blood
Platelet Count - instrumentation
Platelet Count - methods
Platelet Count - standards
Platelet Function Tests - instrumentation
Platelet Function Tests - methods
Platelet Function Tests - standards
Platelets
Reproducibility of Results
Sensitivity and Specificity
title Multicenter evaluation of analytical performances of platelet counts and platelet parameters: Carryover, precision, and stability
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