{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T01:52:35Z","timestamp":1789523555178,"version":"build-2803163510"},"reference-count":25,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2023,8,22]],"date-time":"2023-08-22T00:00:00Z","timestamp":1692662400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,11,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Clozapine is a first-line therapy and the only FDA-approved drug for patients with treatment-resistant schizophrenia (TRS). However, frequent measurement of absolute neutrophil count (ANC) is required to monitor for potential adverse severe neutropenia from clozapine therapy. We evaluated 3 point-of-care (POC) instruments that perform the complete blood count (CBC) with differential to assess their analytical performance and potential to meet the clinical need for clozapine therapy management.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A CBC with differential was performed on 104 residual whole blood specimens using 3 CBC analyzers (Sight OLO, PixCell HemoScreen, and Sysmex pocH-100i) to assess analytical precision, linearity, and accuracy vs the ADVIA 2120i and manual differential reference methods. Clinical concordance of ANC between POC devices and manual differential at medical decision points for mild, moderate, or severe neutropenia, and the threshold for clozapine therapy discontinuation (1.0 \u00d7 109\/L) were determined.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>For CBC parameters, a CV \u2264 6.4% was observed on the OLO, CV \u2264 6.2% for the HemoScreen, and CV \u2264 5.1% with the pocH-100i. Each device accurately identified ANC with the greatest mean bias \u00b10.42 \u00d7 109\/L using the pocH-100i vs manual differential. For results near the medical decision points (ANC &amp;lt;1.5 \u00d7 109\/L), clinical concordance of ANC results was 55.6% for the OLO, 89.5% for the HemoScreen, and 82.4% for the pocH-100i.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The HemoScreen device demonstrated the best clinical concordance in ANC values at medical decision thresholds for clozapine therapy management.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/jalm\/jfad050","type":"journal-article","created":{"date-parts":[[2023,6,24]],"date-time":"2023-06-24T09:26:05Z","timestamp":1687598765000},"page":"1028-1041","source":"Crossref","is-referenced-by-count":6,"title":["Analytical Performance Evaluation of Three Point-of-Care CBC Analyzers for Management of Clozapine Therapy in Ambulatory Psychiatry Clinics"],"prefix":"10.1093","volume":"8","author":[{"given":"Robert D","family":"Maynard","sequence":"first","affiliation":[{"name":"Department of Pathology and Laboratory Medicine, University of North Carolina , Chapel Hill, NC , United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tony","family":"Funk","sequence":"additional","affiliation":[{"name":"McLendon Clinical Laboratories, UNC Health , Chapel Hill, NC , United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Harrill","sequence":"additional","affiliation":[{"name":"McLendon Clinical Laboratories, UNC Health , Chapel Hill, NC , United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jenny","family":"Jin","sequence":"additional","affiliation":[{"name":"McLendon Clinical Laboratories, UNC Health , Chapel Hill, NC , United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dawn","family":"Smith","sequence":"additional","affiliation":[{"name":"McLendon Clinical Laboratories, UNC Health , Chapel Hill, NC , United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gina","family":"Smith","sequence":"additional","affiliation":[{"name":"McLendon Clinical Laboratories, UNC Health , Chapel Hill, NC , United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-7924-599X","authenticated-orcid":false,"given":"Nichole","family":"Korpi-Steiner","sequence":"additional","affiliation":[{"name":"Department of Pathology and Laboratory Medicine, University of North Carolina , Chapel Hill, NC , United States"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2023,8,22]]},"reference":[{"key":"2023110702172028000_jfad050-B1","author":"RAND Corporation"},{"key":"2023110702172028000_jfad050-B2","author":"World Health Organization"},{"key":"2023110702172028000_jfad050-B3","doi-asserted-by":"crossref","first-page":"920","DOI":"10.1176\/appi.ajp.2017.17070770","article-title":"Clozapine reduces all-cause mortality","volume":"174","author":"Kane","year":"2017","journal-title":"Am J Psychiatry"},{"key":"2023110702172028000_jfad050-B4","doi-asserted-by":"crossref","first-page":"789","DOI":"10.1001\/archpsyc.1988.01800330013001","article-title":"Clozapine for the treatment-resistant schizophrenic. A double-blind comparison with chlorpromazine","volume":"45","author":"Kane","year":"1988","journal-title":"Arch Gen Psychiatry"},{"key":"2023110702172028000_jfad050-B5","doi-asserted-by":"crossref","first-page":"990","DOI":"10.1176\/appi.ajp.2017.16091097","article-title":"Mortality and self-harm in association with clozapine in treatment-resistant schizophrenia","volume":"174","author":"Wimberley","year":"2017","journal-title":"Am J Psychiatry"},{"key":"2023110702172028000_jfad050-B6","doi-asserted-by":"crossref","first-page":"1193","DOI":"10.1080\/14740338.2016.1191468","article-title":"Clozapine\u2019s critical role in treatment resistant schizophrenia: ensuring both safety and use","volume":"15","author":"Remington","year":"2016","journal-title":"Expert Opin Drug Saf"},{"key":"2023110702172028000_jfad050-B7","doi-asserted-by":"crossref","first-page":"102","DOI":"10.1186\/1471-244X-14-102","article-title":"Clozapine: a review of clinical practice guidelines and prescribing trends","volume":"14","author":"Warnez","year":"2014","journal-title":"BMC Psychiatry"},{"issue":"Suppl 1","key":"2023110702172028000_jfad050-B8","doi-asserted-by":"crossref","first-page":"27","DOI":"10.1002\/hup.917","article-title":"Haematological toxicity of drugs used in psychiatry","volume":"23","author":"Flanagan","year":"2008","journal-title":"Hum Psychopharmacol"},{"key":"2023110702172028000_jfad050-B9","doi-asserted-by":"crossref","first-page":"341","DOI":"10.1002\/wps.20567","article-title":"Management of common adverse effects of antipsychotic medications","volume":"17","author":"Stroup","year":"2018","journal-title":"World Psychiatry"},{"key":"2023110702172028000_jfad050-B10","author":"US Food and Drug Administration"},{"key":"2023110702172028000_jfad050-B11","doi-asserted-by":"crossref","DOI":"10.1097\/MD.0000000000027694","article-title":"Clozapine prescribing barriers in the management of treatment-resistant schizophrenia: a systematic review","volume":"100","author":"Baig","year":"2021","journal-title":"Medicine (Baltimore)"},{"key":"2023110702172028000_jfad050-B12","doi-asserted-by":"crossref","first-page":"8","DOI":"10.1192\/bjb.2018.67","article-title":"Barriers to using clozapine in treatment-resistant schizophrenia: systematic review","volume":"43","author":"Farooq","year":"2019","journal-title":"BJPsych Bull"},{"key":"2023110702172028000_jfad050-B13","doi-asserted-by":"crossref","first-page":"1264","DOI":"10.1002\/ajh.26295","article-title":"An artificial intelligence-assisted diagnostic platform for rapid near-patient hematology","volume":"96","author":"Bachar","year":"2021","journal-title":"Am J Hematol"},{"key":"2023110702172028000_jfad050-B14","doi-asserted-by":"crossref","first-page":"720","DOI":"10.1136\/jclinpath-2015-203484","article-title":"The HemoScreen, a novel haematology analyser for the point of care","volume":"69","author":"Ben-Yosef","year":"2016","journal-title":"J Clin Pathol"},{"key":"2023110702172028000_jfad050-B15","doi-asserted-by":"crossref","first-page":"532","DOI":"10.1093\/jalm\/jfaa186","article-title":"A novel approach to hematology testing at the point of care","volume":"6","author":"Bransky","year":"2021","journal-title":"J Appl Lab Med"},{"key":"2023110702172028000_jfad050-B16","first-page":"225","article-title":"Performance evaluation of a new compact hematology analyzer, the Sysmex pocH-100i","volume":"9","author":"Briggs","year":"2003","journal-title":"Lab Hematol"},{"key":"2023110702172028000_jfad050-B17","author":"posit"},{"key":"2023110702172028000_jfad050-B18","doi-asserted-by":"crossref","DOI":"10.1177\/20451253211000865","article-title":"Using a fingerstick test for haematological monitoring in patients treated with clozapine","volume":"11","author":"Atkins","year":"2021","journal-title":"Ther Adv Psychopharmacol"},{"key":"2023110702172028000_jfad050-B19","doi-asserted-by":"crossref","first-page":"66","DOI":"10.1016\/j.jpsychires.2022.11.027","article-title":"Haematological point of care testing for clozapine monitoring","volume":"157","author":"Atkins","year":"2023","journal-title":"J Psychiatr Res"},{"key":"2023110702172028000_jfad050-B20","doi-asserted-by":"crossref","first-page":"1126","DOI":"10.1002\/jha2.566","article-title":"Hemoscreen hematology analyzer compared to Sysmex XN for complete blood count, white blood cell differential, and detection of leukocyte abnormalities","volume":"3","author":"Linko-Parvinen","year":"2022","journal-title":"EJHaem"},{"key":"2023110702172028000_jfad050-B21","doi-asserted-by":"crossref","first-page":"52","DOI":"10.1111\/ijlh.13330","article-title":"The HemoScreen hematology point-of-care device is suitable for rapid evaluation of acute leukemia patients","volume":"43","author":"Kristian Kur","year":"2021","journal-title":"Int J Lab Hematol"},{"key":"2023110702172028000_jfad050-B22","doi-asserted-by":"crossref","first-page":"1013","DOI":"10.1080\/09537104.2018.1557619","article-title":"Rapid testing of red blood cells, white blood cells and platelets in intensive care patients using the HemoScreen\u2122 point-of-care analyzer","volume":"30","author":"Larsson","year":"2019","journal-title":"Platelets"},{"key":"2023110702172028000_jfad050-B23","doi-asserted-by":"crossref","first-page":"77","DOI":"10.1186\/s12875-019-0971-2","article-title":"Rapid testing of red blood cell parameters in primary care patients using HemoScreen\u2122 point of care instrument","volume":"20","author":"Larsson","year":"2019","journal-title":"BMC Fam Pract"},{"key":"2023110702172028000_jfad050-B24","doi-asserted-by":"crossref","first-page":"248","DOI":"10.1179\/acb.2010.054","article-title":"Evaluation of the Sysmex pocH-100i haematology analyser in an outdoor oncology service","volume":"65","author":"Van Hecke","year":"2010","journal-title":"Acta Clin Belg"},{"key":"2023110702172028000_jfad050-B25","doi-asserted-by":"crossref","first-page":"120","DOI":"10.1016\/j.cca.2007.12.006","article-title":"Evaluation of a new point of care automated complete blood count (CBC) analyzer in various clinical settings","volume":"389","author":"Rao","year":"2008","journal-title":"Clin Chim Acta"}],"container-title":["The Journal of Applied Laboratory Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/jalm\/article-pdf\/8\/6\/1028\/52760169\/jfad050.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jalm\/article-pdf\/8\/6\/1028\/52760169\/jfad050.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,11,6]],"date-time":"2023-11-06T21:20:27Z","timestamp":1699305627000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/jalm\/article\/8\/6\/1028\/7248581"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,8,22]]},"references-count":25,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2023,8,22]]},"published-print":{"date-parts":[[2023,11,2]]}},"URL":"https:\/\/doi.org\/10.1093\/jalm\/jfad050","relation":{},"ISSN":["2475-7241"],"issn-type":[{"value":"2475-7241","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2023,11]]},"published":{"date-parts":[[2023,8,22]]}}}