Background: Clinician-ordered peripheral smear review by pathologist (CPSR) is commonly ordered and has been recommended for decades. However, the clinical utility of this labor-intensive test in the reference laboratory has not been examined. The objective of this study is to assess hematologic abnormalities identified in CPSR orders and to correlate them with complete blood count (CBC) and laboratory-derived smear review (LDSR) in the reference laboratory.
Methods: Two hundred consecutive CPSRs with corresponding CBCs from April 2023 were run by Sysmex® XN-11 analyzers, and their peripheral smears were examined by a board-certified hematopathologist. Hematologic abnormalities of CPSRs were assessed, and the correlation between CPSR and CBC/LDSR was reviewed.
Results: Nearly one-third of CPSRs (29%) had normal peripheral smears and CBCs. The majority of CPSRs showed nonspecific quantitative abnormalities. When compared against CPSR results, LDSR criteria identified 100% of hematologic abnormalities appropriately. Samples that were not flagged for review by LDSR rules were also reviewed (n = 174) to rule out clinically meaningful false negatives. One minor discrepancy (0.6% of cases) of small platelet aggregates was observed in a patient with a reported platelet count of 139 K/uL that was missed by the LDSR process.
Conclusions: In the reference laboratory setting, our findings demonstrate that LDSR adequately detects significant hematologic abnormalities and, therefore, CPSR should be discontinued.
{"title":"Clinician-Ordered Peripheral Smear Review by a Pathologist Has Low Clinical Utility-A Reference Laboratory Perspective.","authors":"Sanjai Nagendra, Jamie Mongillo, Krystin Dodge, Pratistha Ranjitkar, Betty Burns, Lavonda Allen","doi":"10.1093/jalm/jfae101","DOIUrl":"https://doi.org/10.1093/jalm/jfae101","url":null,"abstract":"<p><strong>Background: </strong>Clinician-ordered peripheral smear review by pathologist (CPSR) is commonly ordered and has been recommended for decades. However, the clinical utility of this labor-intensive test in the reference laboratory has not been examined. The objective of this study is to assess hematologic abnormalities identified in CPSR orders and to correlate them with complete blood count (CBC) and laboratory-derived smear review (LDSR) in the reference laboratory.</p><p><strong>Methods: </strong>Two hundred consecutive CPSRs with corresponding CBCs from April 2023 were run by Sysmex® XN-11 analyzers, and their peripheral smears were examined by a board-certified hematopathologist. Hematologic abnormalities of CPSRs were assessed, and the correlation between CPSR and CBC/LDSR was reviewed.</p><p><strong>Results: </strong>Nearly one-third of CPSRs (29%) had normal peripheral smears and CBCs. The majority of CPSRs showed nonspecific quantitative abnormalities. When compared against CPSR results, LDSR criteria identified 100% of hematologic abnormalities appropriately. Samples that were not flagged for review by LDSR rules were also reviewed (n = 174) to rule out clinically meaningful false negatives. One minor discrepancy (0.6% of cases) of small platelet aggregates was observed in a patient with a reported platelet count of 139 K/uL that was missed by the LDSR process.</p><p><strong>Conclusions: </strong>In the reference laboratory setting, our findings demonstrate that LDSR adequately detects significant hematologic abnormalities and, therefore, CPSR should be discontinued.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142376162","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"So I Guess I Am a Device? Making the Case for Professional Practice in the Context of the FDA's Final Rule on Laboratory-Developed Tests.","authors":"Andrew Bryan, Thomas E Grys, Erin H Graf","doi":"10.1093/jalm/jfae100","DOIUrl":"https://doi.org/10.1093/jalm/jfae100","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142298308","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Considerations for Building a Data Science Culture for the Clinical Laboratory.","authors":"Benjamin R McFadden","doi":"10.1093/jalm/jfae093","DOIUrl":"https://doi.org/10.1093/jalm/jfae093","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142298307","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Anne Leach, Kristin J Murphy, Mandana Godard, Matthew Schwartz, Lori J Sokoll
{"title":"Proficiency Testing Customization in Clinical Trials: How the pSMILE Project Ensures High-Quality Proficiency Testing Coverage for International Laboratories.","authors":"Anne Leach, Kristin J Murphy, Mandana Godard, Matthew Schwartz, Lori J Sokoll","doi":"10.1093/jalm/jfae050","DOIUrl":"https://doi.org/10.1093/jalm/jfae050","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":"9 5","pages":"1097-1102"},"PeriodicalIF":1.8,"publicationDate":"2024-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142120863","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jonathan J Tucci, Raeshun T Glover, Joesph R Wiencek
{"title":"A Pregnant Patient with a Positive Hepatitis C Antibody.","authors":"Jonathan J Tucci, Raeshun T Glover, Joesph R Wiencek","doi":"10.1093/jalm/jfae015","DOIUrl":"10.1093/jalm/jfae015","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"1084-1088"},"PeriodicalIF":1.8,"publicationDate":"2024-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140319508","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Correction to: Screening for Primary Aldosteronism by Mass Spectrometry Versus Immunoassay Measurements of Aldosterone: A Prospective Within-Patient Study.","authors":"","doi":"10.1093/jalm/jfae041","DOIUrl":"10.1093/jalm/jfae041","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"1106"},"PeriodicalIF":1.8,"publicationDate":"2024-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140899696","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Carlos Castillo Pérez, Laura Rodríguez Alonso, Marta Cebrián Ballesteros, Blanca Torrubia, M J Torrejón
{"title":"Persistent Mild Increase of Human Chorionic Gonadotropin in a Male Patient with Testicular Pain.","authors":"Carlos Castillo Pérez, Laura Rodríguez Alonso, Marta Cebrián Ballesteros, Blanca Torrubia, M J Torrejón","doi":"10.1093/jalm/jfae042","DOIUrl":"10.1093/jalm/jfae042","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"1064-1069"},"PeriodicalIF":1.8,"publicationDate":"2024-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141307081","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Breaking the Chain: Navigating the Pitfalls of Total Laboratory Automation.","authors":"Joe M El-Khoury","doi":"10.1093/jalm/jfae061","DOIUrl":"10.1093/jalm/jfae061","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":"9 5","pages":"1095-1096"},"PeriodicalIF":1.8,"publicationDate":"2024-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142120861","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: To evaluate diagnostic tests for low prevalence conditions, classification accuracy metrics such as sensitivity, specificity, and positive likelihood ratio (PLR) and negative likelihood ratio (NLR) are advantageous because they are prevalence-independent and thus estimable in studies enriched for the condition. However, classification accuracy goals are often chosen without a clear understanding of whether they are clinically meaningful. Pennello (2021) proposed a risk stratification framework for determining classification accuracy goals. A software application is needed to determine the goals and provide data analysis.
Methods: We introduce DxGoals, a freely available, R-Shiny software application for determining, visualizing, and analyzing classification accuracy goals for diagnostic tests. Given prevalence p for the target condition and specification that a test's positive and negative predictive values PPVand NPV=1-cNPV should satisfy PPV>PPV* and cNPV
Results: We illustrate DxGoals on tests for penicillin allergy, ovarian cancer, and cervical cancer. The inputs cNPV*,p, and PPV* were informed by clinical management guidelines.
Conclusions: DxGoals facilitates determination, visualization, and analysis of clinically meaningful standalone and comparative classification accuracy goals. It is a potentially useful tool for diagnostic test evaluation.
{"title":"DxGoals: A Software Tool for Determining and Analyzing Clinically Meaningful Classification Accuracy Goals for Diagnostic Tests.","authors":"Ngoc-Ty Nguyen, Gene A Pennello","doi":"10.1093/jalm/jfae054","DOIUrl":"https://doi.org/10.1093/jalm/jfae054","url":null,"abstract":"<p><strong>Background: </strong>To evaluate diagnostic tests for low prevalence conditions, classification accuracy metrics such as sensitivity, specificity, and positive likelihood ratio (PLR) and negative likelihood ratio (NLR) are advantageous because they are prevalence-independent and thus estimable in studies enriched for the condition. However, classification accuracy goals are often chosen without a clear understanding of whether they are clinically meaningful. Pennello (2021) proposed a risk stratification framework for determining classification accuracy goals. A software application is needed to determine the goals and provide data analysis.</p><p><strong>Methods: </strong>We introduce DxGoals, a freely available, R-Shiny software application for determining, visualizing, and analyzing classification accuracy goals for diagnostic tests. Given prevalence p for the target condition and specification that a test's positive and negative predictive values PPVand NPV=1-cNPV should satisfy PPV>PPV* and cNPV<cNPV*, DxGoals uses Bayes Theorem to determine equivalent goals for PLR and NLR and implied goals for sensitivity and specificity. When study data are provided, DxGoals analyzes whether the determined goals are met with statistical significance. When comparing 2 tests, DxGoals translates a superiority or noninferiority goals for the differences PPV-p and p-cNPV to equivalent goals for PLR and NLR and analyzes the goals when data are provided.</p><p><strong>Results: </strong>We illustrate DxGoals on tests for penicillin allergy, ovarian cancer, and cervical cancer. The inputs cNPV*,p, and PPV* were informed by clinical management guidelines.</p><p><strong>Conclusions: </strong>DxGoals facilitates determination, visualization, and analysis of clinically meaningful standalone and comparative classification accuracy goals. It is a potentially useful tool for diagnostic test evaluation.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":"9 5","pages":"952-962"},"PeriodicalIF":1.8,"publicationDate":"2024-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142120862","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Caroline J Waddell, Gerald J Pellegrini, Neela Persad, Thomas D Filardo, Namrata Prasad, William C Carson, Terese Navarra, Michael B Townsend, Panayampalli S Satheshkumar, David Lowe, Deborah Borne, Nnenna Okoye, Julia Janssen, Anamaría Bejarano, Emily Mosites, Grace E Marx
Background: People experiencing homelessness (PEH) are underrepresented in public health and clinical research. Study methods that can improve participation by this group are needed.
Methods: In late 2022, the Centers for Disease Control and Prevention conducted an mpox serological survey using venipuncture among PEH in San Francisco, California. Blood collection by a minimally invasive device was offered if venipuncture was not possible or preferred. Participants who had a successful blood draw using the device were asked about device acceptability.
Results: Of the 209 successful blood collections, 137 (66%) were among participants who underwent venipuncture and 72 (34%) were among participants who used the device. Use of the device increased overall blood collection participation by 53%. Participants reported high acceptability and preference for the device over venipuncture.
Conclusions: Minimally invasive blood collection devices may increase participation and representation of PEH in serosurveys.
{"title":"Minimally Invasive Blood Collection for an Mpox Serosurvey among People Experiencing Homelessness.","authors":"Caroline J Waddell, Gerald J Pellegrini, Neela Persad, Thomas D Filardo, Namrata Prasad, William C Carson, Terese Navarra, Michael B Townsend, Panayampalli S Satheshkumar, David Lowe, Deborah Borne, Nnenna Okoye, Julia Janssen, Anamaría Bejarano, Emily Mosites, Grace E Marx","doi":"10.1093/jalm/jfae035","DOIUrl":"10.1093/jalm/jfae035","url":null,"abstract":"<p><strong>Background: </strong>People experiencing homelessness (PEH) are underrepresented in public health and clinical research. Study methods that can improve participation by this group are needed.</p><p><strong>Methods: </strong>In late 2022, the Centers for Disease Control and Prevention conducted an mpox serological survey using venipuncture among PEH in San Francisco, California. Blood collection by a minimally invasive device was offered if venipuncture was not possible or preferred. Participants who had a successful blood draw using the device were asked about device acceptability.</p><p><strong>Results: </strong>Of the 209 successful blood collections, 137 (66%) were among participants who underwent venipuncture and 72 (34%) were among participants who used the device. Use of the device increased overall blood collection participation by 53%. Participants reported high acceptability and preference for the device over venipuncture.</p><p><strong>Conclusions: </strong>Minimally invasive blood collection devices may increase participation and representation of PEH in serosurveys.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"1014-1019"},"PeriodicalIF":1.8,"publicationDate":"2024-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141260713","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}