Nathan C Hogarth, Mustafa Al-Kawaaz, Mark W Linder
{"title":"Evaluation of turnaround times and performance of in-house ChromaCode high-definition PCR compared to send-out next-generation sequencing in non-small cell lung cancer.","authors":"Nathan C Hogarth, Mustafa Al-Kawaaz, Mark W Linder","doi":"10.1093/ajcp/aqaf038","DOIUrl":"https://doi.org/10.1093/ajcp/aqaf038","url":null,"abstract":"<p><strong>Objective: </strong>Lung cancer is the leading cause of cancer deaths globally, with 1.8 million deaths annually. Advances in targeted therapy and molecular testing for key mutations in non-small cell lung cancer (NSCLC) have improved survival rates. The benchmark turnaround time for molecular testing is 10 days; however, send-out next-generation sequencing (NGS) can often take 14 to 28 days.</p><p><strong>Methods: </strong>The ChromaCode NSCLC assay uses a novel \"high-definition polymerase chain reaction (PCR)\" technology on digital PCR instruments to detect mutations in 9 genes derived from the most current guidelines provided by the National Comprehensive Cancer Network, as well as separate testing guidelines as a collaborative effort by the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. This includes testing for mutations in EGFR, BRAF, KRAS (G12C only), MET and RNA fusions in RET, ROS1, ALK, and NTRK1/2/3. This study retrospectively assessed the feasibility of implementing the assay in a medium-sized academic institution, with a detailed workflow analysis using 58 paraffin-embedded tissue specimens diagnosed as NSCLC.</p><p><strong>Results: </strong>Of the 58 samples, 100% concordance was observed between NGS and ChromaCode assays, with all 5 (~8.6%) positive cases-including 1 ROS1, 1 EGFR L858R, 1 KRAS G12C, and 2 NTRK1/2/3 rearrangements-accurately detected. Implementation of the ChromaCode NSCLC assay allows for an average institution-specific turnaround time of 5.01 days, subject to logistical constraints, compared to 10.4 days for send-out next-generation sequencing (U statistic = 153; α = 0.05).</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2025-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143951979","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sandra Ixchel Sanchez, Shirin Abbasi, Mahalia T Robinson, Zahra Maleki
{"title":"Pediatric thyroid nodules: A comprehensive study of cytology, histology, molecular findings, and risk of malignancy with emphasis on atypia of undetermined significance category.","authors":"Sandra Ixchel Sanchez, Shirin Abbasi, Mahalia T Robinson, Zahra Maleki","doi":"10.1093/ajcp/aqaf034","DOIUrl":"https://doi.org/10.1093/ajcp/aqaf034","url":null,"abstract":"<p><strong>Objective: </strong>Pediatric thyroid nodules are more challenging in clinical practice than in adults. Herein, we report our comprehensive experience with pediatric thyroid nodules, including cytology, histology, and molecular correlation.</p><p><strong>Methods: </strong>Pediatric thyroid fine needle aspiration (FNA) performed from 2014 to 2024 was identified. Patients' demographics, FNA site, number and size of nodules, Bethesda category diagnosis, molecular studies, and surgical diagnoses were recorded.</p><p><strong>Results: </strong>In 310 reports, 378 nodules from 302 patients were included. Patients' mean age was 17.0 years (range, 1-21 years). Applying the Bethesda system, benign diagnoses were most common (198/378, 52.4%), while the indeterminate category of atypia of undetermined significance (AUS) was the most prevalent (51/378, 13.5%). Surgical resection was performed in 36.8% (139/378) of cases, revealing malignancy in 50.0% of AUS, 45.4% of follicular neoplasms, and 93.8% of suspicious-for-malignancy cases. Among AUS subtypes, nuclear atypia was most frequently noted (16/30, 53.3%) and linked to papillary thyroid carcinoma in half of these cases (8/16, 50.0%). The risk of malignancy (ROM) increased with age and showed a female predominance (81.9%), with 86.1% of malignancies in the 16- to 21-year age group and no malignant histology in ages 0 to 5 years. Molecular testing, including Afirma (34/38, 89.5%) and Thyroseq (4/38, 10.5%), often returned suspicious (16/34, 47.1%) or intermediate (3/4, 75.0%) results.</p><p><strong>Conclusions: </strong>Indeterminate diagnoses in pediatrics posed a significant ROM, particularly in female adolescents and early adulthood (ages 16-21 years). The AUS category was the most common among indeterminate categories, with AUS nuclear highly associated with malignancy. No malignancy was seen in ages 0 to 5 years.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2025-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143965580","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Katrina Collins, Iván A González, Muhammad T Idrees, Anita Gupta, John M Wo, Omer A M Saeed
{"title":"Loss of α-smooth muscle actin immunostaining is not a useful marker for functional impairment: a comparison from patients with and without small bowel motility disorder.","authors":"Katrina Collins, Iván A González, Muhammad T Idrees, Anita Gupta, John M Wo, Omer A M Saeed","doi":"10.1093/ajcp/aqaf033","DOIUrl":"https://doi.org/10.1093/ajcp/aqaf033","url":null,"abstract":"<p><strong>Objective: </strong>Prior studies have reported the loss of α-smooth muscle actin (α-SMA) immunoreactivity in the inner circular layer of the muscularis propria in small bowel motility disorder cases, but this remains controversial with conflicting data. In this study, we aimed to characterize α-SMA immunoreactivity in the muscularis propria of the small intestine-specifically, jejunum-in patients with and without small bowel motility disorder.</p><p><strong>Methods: </strong>A total of 28 transmural proximal jejunum biopsy specimens from adult patients with clinical impression of upper gastrointestinal dysmotility disorder and 64 control tissues were evaluated. The controls were full-thickness, longitudinal tissue sections from segmental resections performed due to gunshot wounds, multivisceral transplant donation, and tumors. Immunostaining for α-SMA was performed with appropriate controls to confirm the presence of immunoreactivity in the circular and longitudinal muscle layers of the muscularis propria in each sample and recorded as retained or diminished.</p><p><strong>Results: </strong>In the small bowel motility disorder and control cases, 42.9% (12/28) and 70.3% (49/64) of the cases showed no or minimal α-SMA immunoreactivity in the inner circular layer with peripheral accentuation, respectively.</p><p><strong>Conclusions: </strong>Loss or diminished α-SMA immunoreactivity in the inner circular layer of the muscularis propria occurs with a similar frequency in cases with and without small bowel motility disorder and does not correlate with impairment of function.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2025-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143958913","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jeremy W Jacobs, Brian D Adkins, Danny A Milner, Evan M Bloch, Quentin Eichbaum
{"title":"Survey of clinical microbiology and infectious disease testing capabilities among institutions in Africa.","authors":"Jeremy W Jacobs, Brian D Adkins, Danny A Milner, Evan M Bloch, Quentin Eichbaum","doi":"10.1093/ajcp/aqae148","DOIUrl":"10.1093/ajcp/aqae148","url":null,"abstract":"<p><strong>Objectives: </strong>Inadequate laboratory infrastructure and testing capabilities are a major impediment to addressing the infectious disease burden in Africa. Therefore, the aims of this study were to characterize the clinical microbiology/infectious disease laboratory capabilities among countries in Africa.</p><p><strong>Methods: </strong>A survey to assess the microbiological testing capabilities at hospitals, government laboratories, and free-standing public and private laboratories in African countries was developed by subject matter experts. Questions included institutional demographics and microbiology services in the broad categories of bacteriology, virology, mycology, parasitology, and rapid diagnostics/point-of-care testing. The survey was distributed using the American Society of Clinical Pathology email listserv between June and August 2022.</p><p><strong>Results: </strong>In total, 131 unique institutions in 28 countries endorsed at least 1 type of microbiology service, with parasitology (80.9%, 106/131) and bacteriology (77.9%, 102/131) being most common, while mycology (45.0%, 59/131) and virology (45.8%, 60/131) laboratories were less prevalent. The most frequently performed bacteriology test was bacterial identification (90.2%, 92/102), followed by aerobic bacterial cultures and antimicrobial susceptibility testing (both 89.2%, 91/102). Among all clinical microbiology/infectious disease laboratories, the most commonly tested agents were HIV (90.8%, 119/131), Treponema pallidum (78.6%, 103/131), Plasmodium falciparum (76.3%, 100/131), Mycobacterium tuberculosis (76.3%, 100/131), and hepatitis C virus (74.8%, 98/131).</p><p><strong>Conclusions: </strong>These findings provide contemporary data regarding the availability of critical infectious disease testing capabilities among institutions in Africa. These results and future additional studies will be crucial for understanding where strategic investment in the laboratory and public health infrastructure is warranted.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":" ","pages":"526-530"},"PeriodicalIF":2.3,"publicationDate":"2025-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12009664/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142612185","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"How I diagnose high-grade B-cell lymphoma.","authors":"Erika M Moore, Sarah E Gibson","doi":"10.1093/ajcp/aqae158","DOIUrl":"10.1093/ajcp/aqae158","url":null,"abstract":"<p><strong>Objectives: </strong>High-grade B-cell lymphoma (HGBL), introduced in the 2016 World Health Organization (WHO) revised fourth edition classification, included cases defined by MYC and BCL2 and/or BCL6 rearrangements or by high-grade morphology. Diagnostic criteria and nomenclature for these lymphomas were refined in the 2022 WHO fifth edition (WHO-5) classification and International Consensus Classification (ICC). This review describes our approach to the diagnosis of HGBL.</p><p><strong>Methods: </strong>Two cases are presented illustrating how we diagnose HGBL, including 1 case harboring MYC and BCL6 rearrangements and a second showing TdT expression in an HGBL with MYC and BCL2 rearrangements. The ways in which these cases are distinguished from other lymphomas with high-grade features and the appropriate nomenclature using WHO-5 and ICC classifications are emphasized.</p><p><strong>Results: </strong>An HGBL diagnosis requires integration of morphology, immunophenotype, and genetics and exclusion of other lymphomas with high-grade morphology, including Burkitt lymphoma, B-lymphoblastic leukemia/lymphoma (B-LBL/ALL), and blastoid mantle cell lymphoma. A diagnosis of HGBL/large B-cell lymphoma with 11q aberration should also be considered in certain patient populations.</p><p><strong>Conclusions: </strong>High-grade B-cell lymphomas are subclassified based on morphologic and genetic features. There are differences in the nomenclature and definition of these lymphomas in the WHO-5 and ICC classifications. Distinguishing HGBLs from other mature B-cell lymphomas and B-LBL/ALL is critical so that patients receive appropriate treatment.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":" ","pages":"487-500"},"PeriodicalIF":2.3,"publicationDate":"2025-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142845592","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Princess Morales, Andrés Pérez-López, Mohammed Suleiman, Carl Bjorkhammer, Andrés Pérez-López
{"title":"Correspondence: Integrating automated messaging with laboratory information systems for critical result communication.","authors":"Princess Morales, Andrés Pérez-López, Mohammed Suleiman, Carl Bjorkhammer, Andrés Pérez-López","doi":"10.1093/ajcp/aqae164","DOIUrl":"10.1093/ajcp/aqae164","url":null,"abstract":"","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":" ","pages":"642"},"PeriodicalIF":2.3,"publicationDate":"2025-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143373510","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Evaluation of enterochromaffin-like cell hyperplasia can help categorize patients with Helicobacter-negative atrophic gastritis.","authors":"Feidi Chen, Raul S Gonzalez","doi":"10.1093/ajcp/aqae159","DOIUrl":"10.1093/ajcp/aqae159","url":null,"abstract":"<p><strong>Objectives: </strong>Atrophic gastritis (AG) is characterized by atrophy of gastric glands-in particular, oxyntic glands-in the setting of chronic inflammation; it is often autoimmune. The diagnosis is confirmed by immunohistochemistry (IHC) for gastrin (to confirm biopsy site), and pathologists often use IHC for neuroendocrine markers to evaluate for enterochromaffin-like cell hyperplasia (ECL-H). The utility of neuroendocrine staining is unclear, and we undertook this study to determine whether ECL pattern provided any additional information in cases of Helicobacter-negative AG.</p><p><strong>Methods: </strong>We reviewed clinicopathologic findings in 184 cases from 184 patients with histologic AG and no evidence of Helicobacter infection. Using neuroendocrine IHC markers, cases were divided into 3 groups: Group 1 showed complete ECL-H (both qualitative and quantitative criteria met), group 2 showed focal ECL-H (qualitative but not quantitative criteria met), and group 3 showed no ECL-H (neither criteria met).</p><p><strong>Results: </strong>Group 1 patients were more likely to have positive autoantibody serologies (73%, P = .0007 vs group 2) and higher mean gastrin levels (700 pg/mL, P = .017 vs group 3), and only these patients developed gastric neuroendocrine tumors. Group 2 patients were more likely to take proton pump inhibitors (64%, P = .0002 vs group 1). Group 3 patients were more likely to be male (70%, P = .008 vs group 1) and to have microcytic anemia (44%, P = .022 vs group 2) and less likely to have intestinal metaplasia (50%, P = .044 vs group 1).</p><p><strong>Conclusions: </strong>Stratification based on degree of ECL-H is not necessary for diagnosis of AG but does lead to statistically significant clinical and pathologic differences among groups.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":" ","pages":"601-609"},"PeriodicalIF":2.3,"publicationDate":"2025-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142891359","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jeremy W Jacobs, Melissa S Stuart, Julie I Tange, Rachel R Leger, Aneel A Ashrani, Dong Chen, Rajiv K Pruthi, Meera Sridharan, Jansen N Seheult
{"title":"Evaluating the potential for iodinated radiocontrast agents to interfere with ADAMTS13 activity testing via fluorescence resonance energy transfer methodology.","authors":"Jeremy W Jacobs, Melissa S Stuart, Julie I Tange, Rachel R Leger, Aneel A Ashrani, Dong Chen, Rajiv K Pruthi, Meera Sridharan, Jansen N Seheult","doi":"10.1093/ajcp/aqae160","DOIUrl":"10.1093/ajcp/aqae160","url":null,"abstract":"<p><strong>Objectives: </strong>Fluorescence resonance energy transfer (FRET)-based ADAMTS13 activity assays are critical for the diagnosis of thrombotic thrombocytopenic purpura. However, these assays are susceptible to interference. As iodide has been suggested to interfere in laboratory testing via fluorophore quenching or promotion, we aimed to determine whether iodinated contrast (Omnipaque) interferes with the ATS-13 ADAMTS13 Activity Assay 2.0.</p><p><strong>Methods: </strong>We evaluated the excitation, emission, and absorbance spectrum of Omnipaque alone and spiked in patient plasma with known ADAMTS13 activity and ADAMTS13 activity on Omnipaque alone, an abnormal control of patient plasma previously observed to display elevated baseline relative fluorescent units, and variable concentrations of patient plasma with known ADAMTS13 activity spiked with Omnipaque.</p><p><strong>Results: </strong>No atypical fluorescent peaks were observed on any sample (Omnipaque alone or spiked in plasma) between 250 and 700 nm. There was no difference in the mean ADAMTS13 activity among the various concentrations of plasma spiked with Omnipaque or plasma spiked with saline.</p><p><strong>Conclusions: </strong>Iodinated contrast does not appear to interfere-either via spectral overlap of the fluorophore or through physiologic inhibition of the ADAMTS13 enzyme-with ADAMTS13 activity FRET-based assays based on the findings from this in vitro analysis. Delaying sample collection for ADAMTS13 activity testing from suspected patients with thrombotic thrombocytopenic purpura following administration of iodinated radiocontrast agents is not necessary, and recent contrast administration should not yield erroneous ADAMTS13 activity results.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":" ","pages":"610-617"},"PeriodicalIF":2.3,"publicationDate":"2025-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12009666/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142826969","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Bahadir Yildiz, Jerome Jean-Gilles, Ellen J Giampoli, Sierra Kovar-Peltz, Qi Yang, Hiroshi Miyamoto, Ying Wang
{"title":"TRPS1 is a useful marker in differentiating metastatic breast carcinoma from pancreatic adenocarcinoma in fine-needle aspiration specimens.","authors":"Bahadir Yildiz, Jerome Jean-Gilles, Ellen J Giampoli, Sierra Kovar-Peltz, Qi Yang, Hiroshi Miyamoto, Ying Wang","doi":"10.1093/ajcp/aqae155","DOIUrl":"10.1093/ajcp/aqae155","url":null,"abstract":"<p><strong>Objectives: </strong>Distinction of metastatic breast carcinoma (BC) to the pancreas from primary pancreatic adenocarcinoma (PAC) is essential but challenging. Breast carcinoma shares similar morphology and exhibits an overlapping immunohistochemistry (IHC) profile with PAC. We investigated the utility of recently reported trichorhinophalangeal syndrome type 1 (TRPS1) IHC in differentiating metastatic BC from PAC in fine-needle aspiration (FNA) specimens.</p><p><strong>Methods: </strong>We assessed consecutive patients of PAC (n = 49). Due to limited cases of metastatic BC to the pancreas (n = 3), cases of metastatic BC (n = 23) in various locations, including lymph node, lung, bone, or soft tissue, were included. Immunohistochemistry for TRPS1 was performed by using the cell blocks obtained from FNA. A quantitative score for TRPS1 expression was calculated by multiplying the intensity and the percentage of positive cells. Immunoreactivity scores were assigned as negative, low positive, intermediate positive, or high positive.</p><p><strong>Results: </strong>In 49 PAC cases, 47 (95.9%) exhibited negative while 2 (4.1%) exhibited low positive TRPS1 expression. However, TRPS1 expression was high positive in 23 (88.0%) of 26 metastatic BC cases, including 10 (83.3%) of 12 triple-negative BC (TNBC) and 13 (92.9%) of 14 non-TNBC cases.</p><p><strong>Conclusions: </strong>Our results suggest that TRPS1 IHC represents a highly accurate and reliable method for differentiating metastatic BC from PAC.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":" ","pages":"581-585"},"PeriodicalIF":2.3,"publicationDate":"2025-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142827013","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Analytical performance of a point-of-care CBC hematology analyzer, including a 5-part differential: A prospective study to evaluate a microfluidic flow cytometry-based analyzer in waived settings.","authors":"Jane F Emerson, Hao Wang, Imran N Siddiqi","doi":"10.1093/ajcp/aqae149","DOIUrl":"10.1093/ajcp/aqae149","url":null,"abstract":"<p><strong>Objectives: </strong>A microfluidic flow cytometer-based point-of-care (POC) analyzer was validated against an in-laboratory hematology analyzer (Sysmex XN Automated Hematology System). Concordance on a full complete blood cell count (CBC) with 5-part differential, as performed by operators with no prior clinical laboratory experience, was evaluated.</p><p><strong>Methods: </strong>We prospectively collected 376 venous blood specimens (376) from individuals with self-reported medical conditions and from apparently healthy individuals. Forty-six additional remnant specimens were acquired to ensure coverage of analytic measuring ranges. Parallel testing was performed, with up to 7 hours between testing on the POC and Sysmex XN analyzers.</p><p><strong>Results: </strong>Regression analysis resulted in r values of 0.998 to 0.932 for all parameters of a 5-part differential CBC other than basophils (0.709). The mean percentage bias from the reference method, inclusive of the upper and lower reporting limits, was less than 2% for parameters other than lymphocytes (-6.4%), monocytes (25.9%), eosinophils (12.2%), and basophils (-15%). Overall agreement on abnormal flagging was 93.3%.</p><p><strong>Conclusions: </strong>The Cito CBC microflow cytometer (CytoChip Inc) provides a CBC with a 5-part differential with accuracy, precision, and abnormal flagging equivalent to a moderate-complexity hematology analyzer. It has the key features required of a POC device that can be operated in a waived setting: minimum space requirements, rapid results, single-action measurement (no sample processing or dilution), ease of use, and minimal blood volume.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":" ","pages":"531-544"},"PeriodicalIF":2.3,"publicationDate":"2025-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142612147","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}