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Evaluation of Sigma metric approach for monitoring the performance of automated analyzers in hematology unit of Alexandria Main University Hospital

Introduction Sigma metric offers a quantitative framework for evaluating process performance in clinical laboratories. This study aimed to evaluate the analytical performance of automated analyzers in hematology unit of Alexandria Main University Hospital using the sigma metric approach. Materials a...

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Published in:International journal of laboratory hematology 2021-12, Vol.43 (6), p.1388-1393
Main Authors: Ahmed El‐Neanaey, Wafaa, Mahmoud AbdEllatif, Nihal, Abdel Haleem Abo Elwafa, Reham
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container_title International journal of laboratory hematology
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creator Ahmed El‐Neanaey, Wafaa
Mahmoud AbdEllatif, Nihal
Abdel Haleem Abo Elwafa, Reham
description Introduction Sigma metric offers a quantitative framework for evaluating process performance in clinical laboratories. This study aimed to evaluate the analytical performance of automated analyzers in hematology unit of Alexandria Main University Hospital using the sigma metric approach. Materials and Methods Quality control data were collected for 6 months, and sigma value was calculated from hematology analyzers SYSMEX (XN 1000, XT 1800i), ADVIA (2120i, 2120), and coagulation analyzers SYSMEX CA 1500 (3610, 6336). Results For the normal control level, satisfactory mean sigma value ≥3 was observed for all of the studied parameters by all analyzers. For the high control level, red blood cell count by ADVIA 2120, and hematocrit by ADVIA (2120i and 2120) performed poorly with a mean sigma value
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This study aimed to evaluate the analytical performance of automated analyzers in hematology unit of Alexandria Main University Hospital using the sigma metric approach. Materials and Methods Quality control data were collected for 6 months, and sigma value was calculated from hematology analyzers SYSMEX (XN 1000, XT 1800i), ADVIA (2120i, 2120), and coagulation analyzers SYSMEX CA 1500 (3610, 6336). Results For the normal control level, satisfactory mean sigma value ≥3 was observed for all of the studied parameters by all analyzers. For the high control level, red blood cell count by ADVIA 2120, and hematocrit by ADVIA (2120i and 2120) performed poorly with a mean sigma value &lt;3. For the low control level, red blood cell count by ADVIA (2120i and 2120), hemoglobin by ADVIA 2120, hematocrit by ADVIA (2120i and 2120) and SYSMEX XN 1000, platelet count by the SYSMEX XT 1800i also performed poorly with a mean sigma value &lt;3. Satisfactory mean sigma value of ≥3 was observed for prothrombin time and activated partial thromboplastin time for both normal and pathological control levels and analyzers. Conclusion Sigma metrics can be used as a guide to make QC strategy and plan QC frequency and can facilitate the comparison of the same assay performance across multiple systems. Harmonization for TEa source is recommended to standardize sigma value calculation.</description><identifier>ISSN: 1751-5521</identifier><identifier>EISSN: 1751-553X</identifier><identifier>DOI: 10.1111/ijlh.13660</identifier><identifier>PMID: 34275191</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>analytical performance ; Automation ; Blood Cell Count ; Blood Coagulation Tests ; Erythrocytes ; Hematocrit ; Hematologic Tests ; Hematology ; Hemoglobin ; Hospitals ; Humans ; Laboratories, Clinical ; Prothrombin ; Quality Control ; Reproducibility of Results ; sigma metric ; Thromboplastin ; Total Quality Management</subject><ispartof>International journal of laboratory hematology, 2021-12, Vol.43 (6), p.1388-1393</ispartof><rights>2021 John Wiley &amp; Sons Ltd</rights><rights>2021 John Wiley &amp; Sons Ltd.</rights><rights>Copyright © 2021 John Wiley &amp; Sons Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3570-5590418efdfd48ad9cffc4c602e19e3052eccf9582583059afe47168cc3baa963</citedby><cites>FETCH-LOGICAL-c3570-5590418efdfd48ad9cffc4c602e19e3052eccf9582583059afe47168cc3baa963</cites><orcidid>0000-0002-6379-419X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34275191$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ahmed El‐Neanaey, Wafaa</creatorcontrib><creatorcontrib>Mahmoud AbdEllatif, Nihal</creatorcontrib><creatorcontrib>Abdel Haleem Abo Elwafa, Reham</creatorcontrib><title>Evaluation of Sigma metric approach for monitoring the performance of automated analyzers in hematology unit of Alexandria Main University Hospital</title><title>International journal of laboratory hematology</title><addtitle>Int J Lab Hematol</addtitle><description>Introduction Sigma metric offers a quantitative framework for evaluating process performance in clinical laboratories. This study aimed to evaluate the analytical performance of automated analyzers in hematology unit of Alexandria Main University Hospital using the sigma metric approach. Materials and Methods Quality control data were collected for 6 months, and sigma value was calculated from hematology analyzers SYSMEX (XN 1000, XT 1800i), ADVIA (2120i, 2120), and coagulation analyzers SYSMEX CA 1500 (3610, 6336). Results For the normal control level, satisfactory mean sigma value ≥3 was observed for all of the studied parameters by all analyzers. For the high control level, red blood cell count by ADVIA 2120, and hematocrit by ADVIA (2120i and 2120) performed poorly with a mean sigma value &lt;3. For the low control level, red blood cell count by ADVIA (2120i and 2120), hemoglobin by ADVIA 2120, hematocrit by ADVIA (2120i and 2120) and SYSMEX XN 1000, platelet count by the SYSMEX XT 1800i also performed poorly with a mean sigma value &lt;3. Satisfactory mean sigma value of ≥3 was observed for prothrombin time and activated partial thromboplastin time for both normal and pathological control levels and analyzers. Conclusion Sigma metrics can be used as a guide to make QC strategy and plan QC frequency and can facilitate the comparison of the same assay performance across multiple systems. Harmonization for TEa source is recommended to standardize sigma value calculation.</description><subject>analytical performance</subject><subject>Automation</subject><subject>Blood Cell Count</subject><subject>Blood Coagulation Tests</subject><subject>Erythrocytes</subject><subject>Hematocrit</subject><subject>Hematologic Tests</subject><subject>Hematology</subject><subject>Hemoglobin</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Laboratories, Clinical</subject><subject>Prothrombin</subject><subject>Quality Control</subject><subject>Reproducibility of Results</subject><subject>sigma metric</subject><subject>Thromboplastin</subject><subject>Total Quality Management</subject><issn>1751-5521</issn><issn>1751-553X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNp9kctOHDEQRa0oEa-wyQdElrJBkYbY_fYSIcgQTZQFIGXXKtzlGY_cdsd2kzS_wQ_jZgiLLOJN2VWnrnR9CfnA2SlP54vems0pz6uKvSEHvC75oizzn29f7xnfJ4chbBkr64KJPbKfF1kaCX5AHi_uwYwQtbPUKXqt1z3QHqPXksIweAdyQ5XztHdWR-e1XdO4QTqgT90erMR5D8boeojYUbBgpgf0gWpLN5iazrj1RMe0PpNnBv-A7bwG-h0Scmv1faJ1nOjShUFHMO_JOwUm4PFLPSK3lxc358vF6sfXq_Oz1ULmZc2SMcEK3qDqVFc00AmplCxkxTLkAnNWZiilEmWTlU16CVBY1LxqpMzvAESVH5GTnW6y-WvEENteB4nGgEU3hjZL35gVWV6LhH76B9260SerMyUa1lSC8UR93lHSuxA8qnbwugc_tZy1c1TtHFX7HFWCP75Ijnc9dq_o32wSwHfAb21w-o9Ue_VttdyJPgElL6F3</recordid><startdate>202112</startdate><enddate>202112</enddate><creator>Ahmed El‐Neanaey, Wafaa</creator><creator>Mahmoud AbdEllatif, Nihal</creator><creator>Abdel Haleem Abo Elwafa, Reham</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>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>H94</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-6379-419X</orcidid></search><sort><creationdate>202112</creationdate><title>Evaluation of Sigma metric approach for monitoring the performance of automated analyzers in hematology unit of Alexandria Main University Hospital</title><author>Ahmed El‐Neanaey, Wafaa ; Mahmoud AbdEllatif, Nihal ; Abdel Haleem Abo Elwafa, Reham</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3570-5590418efdfd48ad9cffc4c602e19e3052eccf9582583059afe47168cc3baa963</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>analytical performance</topic><topic>Automation</topic><topic>Blood Cell Count</topic><topic>Blood Coagulation Tests</topic><topic>Erythrocytes</topic><topic>Hematocrit</topic><topic>Hematologic Tests</topic><topic>Hematology</topic><topic>Hemoglobin</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Laboratories, Clinical</topic><topic>Prothrombin</topic><topic>Quality Control</topic><topic>Reproducibility of Results</topic><topic>sigma metric</topic><topic>Thromboplastin</topic><topic>Total Quality Management</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ahmed El‐Neanaey, Wafaa</creatorcontrib><creatorcontrib>Mahmoud AbdEllatif, Nihal</creatorcontrib><creatorcontrib>Abdel Haleem Abo Elwafa, Reham</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>International journal of laboratory hematology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ahmed El‐Neanaey, Wafaa</au><au>Mahmoud AbdEllatif, Nihal</au><au>Abdel Haleem Abo Elwafa, Reham</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of Sigma metric approach for monitoring the performance of automated analyzers in hematology unit of Alexandria Main University Hospital</atitle><jtitle>International journal of laboratory hematology</jtitle><addtitle>Int J Lab Hematol</addtitle><date>2021-12</date><risdate>2021</risdate><volume>43</volume><issue>6</issue><spage>1388</spage><epage>1393</epage><pages>1388-1393</pages><issn>1751-5521</issn><eissn>1751-553X</eissn><abstract>Introduction Sigma metric offers a quantitative framework for evaluating process performance in clinical laboratories. This study aimed to evaluate the analytical performance of automated analyzers in hematology unit of Alexandria Main University Hospital using the sigma metric approach. Materials and Methods Quality control data were collected for 6 months, and sigma value was calculated from hematology analyzers SYSMEX (XN 1000, XT 1800i), ADVIA (2120i, 2120), and coagulation analyzers SYSMEX CA 1500 (3610, 6336). Results For the normal control level, satisfactory mean sigma value ≥3 was observed for all of the studied parameters by all analyzers. For the high control level, red blood cell count by ADVIA 2120, and hematocrit by ADVIA (2120i and 2120) performed poorly with a mean sigma value &lt;3. For the low control level, red blood cell count by ADVIA (2120i and 2120), hemoglobin by ADVIA 2120, hematocrit by ADVIA (2120i and 2120) and SYSMEX XN 1000, platelet count by the SYSMEX XT 1800i also performed poorly with a mean sigma value &lt;3. Satisfactory mean sigma value of ≥3 was observed for prothrombin time and activated partial thromboplastin time for both normal and pathological control levels and analyzers. Conclusion Sigma metrics can be used as a guide to make QC strategy and plan QC frequency and can facilitate the comparison of the same assay performance across multiple systems. Harmonization for TEa source is recommended to standardize sigma value calculation.</abstract><cop>England</cop><pub>Wiley Subscription Services, Inc</pub><pmid>34275191</pmid><doi>10.1111/ijlh.13660</doi><tpages>6</tpages><orcidid>https://orcid.org/0000-0002-6379-419X</orcidid></addata></record>
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subjects analytical performance
Automation
Blood Cell Count
Blood Coagulation Tests
Erythrocytes
Hematocrit
Hematologic Tests
Hematology
Hemoglobin
Hospitals
Humans
Laboratories, Clinical
Prothrombin
Quality Control
Reproducibility of Results
sigma metric
Thromboplastin
Total Quality Management
title Evaluation of Sigma metric approach for monitoring the performance of automated analyzers in hematology unit of Alexandria Main University Hospital
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