Archives of pathology & laboratory medicine最新文献

{"title":"Conventional Cytogenetic Analysis of Constitutional Abnormalities: A 20-Year Review of Proficiency Test Results From the College of American Pathologists/American College of Medical Genetics and Genomics Cytogenetics Committee.","authors":"Brittney Boles, Juli-Anne Gardner, Catherine W Rehder, Brynn Levy, Gopalrao V Velagaleti, Reha M Toydemir, William R Sukov, Daniel P Larson, Yang Cao, Christopher Mixon, Rachel K Vanderscheldon, Ying S Zou, Caroline Astbury, Karen D Tsuchiya, Jess F Peterson","doi":"10.5858/arpa.2024-0048-CP","DOIUrl":"https://doi.org/10.5858/arpa.2024-0048-CP","url":null,"abstract":"<p><strong>Context.—: </strong>The joint College of American Pathologists/American College of Medical Genetics and Genomics Cytogenetics Committee works to ensure competency and proficiency of clinical cytogenetics testing laboratories through proficiency testing programs for various clinical tests offered by such laboratories, including the evaluation of constitutional abnormalities.</p><p><strong>Objective.—: </strong>To review and analyze 20 years of constitutional chromosome analysis proficiency testing results (2003-2022), primarily utilizing G-banded karyograms.</p><p><strong>Design.—: </strong>A retrospective review of results from 2003 through 2022 was performed, identifying challenges addressing constitutional disorders. The chromosomal abnormalities and overall performance were evaluated.</p><p><strong>Results.—: </strong>A total of 184 cases from 161 proficiency testing challenges were administered from 2003 through 2022. Challenges consisted of metaphase images and accompanying clinical history for evaluation of numerical and/or structural abnormalities. Of the 184 cases, only 2 (1%) failed to reach an 80% grading consensus for recognition of the abnormality. Both cases illustrated the limitations of correctly characterizing some chromosomal abnormalities, including recombinant chromosomal abnormalities and isochromosome identification. In addition, 2 cases failed to reach a consensus for nomenclature reporting: 1 with an isochromosome and another with a duplication.</p><p><strong>Conclusions.—: </strong>This 20-year review illustrates the high rate of competency and proficiency of cytogenetic laboratories in the correct identification of constitutional chromosome abnormalities.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141262327","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":"Measurable Residual Disease Analysis by Flow Cytometry and Correlation With Molecular Measurable Residual Disease in Acute Promyelocytic Leukemia: A Real-World Prospective Study.","authors":"Zhihao Wen, Xinran Xue, Shuhua Li, Yu Liu, Yongmei Jin, Nenggang Jiang, Hongyan Liao","doi":"10.5858/arpa.2023-0460-OA","DOIUrl":"https://doi.org/10.5858/arpa.2023-0460-OA","url":null,"abstract":"<p><strong>Context.—: </strong>Acute promyelocytic leukemia (APL) is a subtype of acute myeloid leukemia distinguished by its rapidly progressive and fatal clinical course. Measurable/minimal residual disease (MRD) monitoring is vital for the prognosis and clinical management of acute myeloid leukemia.</p><p><strong>Objective.—: </strong>To examine the immunophenotypes of the residual leukemic cells, evaluate the performance of multiparametric flow cytometry (FCM) measuring MRD, and compare it with molecular monitoring in patients diagnosed with APL.</p><p><strong>Design.—: </strong>Two hundred seventy-seven patients with APL were enrolled. Immunophenotypes were prospectively analyzed by a 1-tube-10-color antibody panel via FCM. MRD of APL with PML::RARα was detected by real-time quantitative polymerase chain reaction (RQ-PCR). The clinical value of MRD as an indicator of survival was also examined.</p><p><strong>Results.—: </strong>APL showed 5 distinct patterns of residual leukemic cells, based on CD45 and side-scatter scattergram, all with CD9 positivity and a previously unrealized loss of CD117. FCM-based MRD evaluation showed a concordance rate of 87.7% with PCR. At the end of the consolidation therapy, MRD measured by both PCR and FCM could differentiate patients with longer and shorter overall survival (OS) (P = .04 and P = .03, respectively). Patients with APL variant had a shorter OS than patients with APL who harbored PML::RARα (P < .001).</p><p><strong>Conclusions.—: </strong>CD9 is a reliable marker to differentiate residual leukemic cells from normally differentiating myeloid cells. FCM demonstrated a high comparability to PCR-MRD and an excellent performance in predicting OS, and thus could potentially be used as a routine indicator in the clinical management of patients with APL.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141262513","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":"Robotic-Assisted Bronchoscopy for the Diagnosis of Lung Lesions: Experience With the Use of Frozen Sections as an Aid to Confirm the Localization of Lesions During the Procedure.","authors":"Manita Kanathanavanich, Xiaomo Li, Bernadette Boac, Shikha Bose, Ann E Walts, Taryne Imai, George Chaux, Andrew Brownlee, Alberto M Marchevsky","doi":"10.5858/arpa.2023-0458-RA","DOIUrl":"https://doi.org/10.5858/arpa.2023-0458-RA","url":null,"abstract":"<p><strong>Context.—: </strong>Robotic-assisted navigation bronchoscopy (R-ANB) is used to target peripheral pulmonary nodules that are difficult to biopsy using conventional approaches. Frozen sections are requested to confirm these lesions have been localized and/or to diagnose neoplasms that can be immediately resected.</p><p><strong>Objective.—: </strong>To estimate diagnostic concordance between frozen section diagnosis (FSD) and formalin-fixed tissue diagnosis (FFTD) in biopsies obtained with R-ANB, calculate the sensitivity and specificity of FSD and FFTD for a diagnosis of malignancy, and evaluate whether the residual tissue that can be fixed in formalin after frozen section still has sufficient material for molecular studies.</p><p><strong>Data sources.—: </strong>The results of consecutive FSD rendered on biopsies performed with R-ANB during a 30-month period were used to calculate the metrics listed above. FFTD and/or the diagnoses rendered on computed tomography-guided core biopsy subsequently performed in patients with negative R-ANB and/or lung resections in patients with malignancies were used as true-positive results. The overall concordance between FSD and FFTD in 226 lesions from 203 patients was 72%. Frozen section diagnosed 76 of 123 malignancies with 100% specificity and 68% sensitivity. Adequate material was available in 92% of biopsies where next-generation sequencing and other molecular studies were requested.</p><p><strong>Conclusions.—: </strong>Intraoperative consultations are helpful to diagnose a variety of lung lesions and help surgeons confirm that targets have been accurately reached by R-ANB. Malignancies can be diagnosed with 100% specificity but only 68% sensitivity. The performance of frozen section did not interfere with the subsequent analysis of tissue with molecular studies in most cases.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141236716","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":"Clinical Performance of the Line Immunoassay and Digital Liquid Chip Method for Detecting Autoimmune Liver Disease Autoantibodies.","authors":"Heye Lv, Ao Deng, Yijun Chen, Zhenzhen Su","doi":"10.5858/arpa.2024-0057-OA","DOIUrl":"https://doi.org/10.5858/arpa.2024-0057-OA","url":null,"abstract":"<p><strong>Context.—: </strong>The identification of autoantibodies associated with autoimmune liver disease (ALD) is crucial for diagnosis and management. Various laboratory methods have been introduced to detect autoantibody profiles. However, the variable performance of these assays may create challenges for clinicians and patients.</p><p><strong>Objective.—: </strong>To investigate the concordance rates and diagnostic performance of 2 commercially available assays, line immunoassay (LIA) and digital liquid chip method (DLCM), in patients with ALD.</p><p><strong>Design.—: </strong>A total of 291 serum samples were collected, consisting of 180 sera from patients with ALD and 111 sera from controls. The samples were detected through LIA and DLCM. The agreement and diagnostic performance of each assay were analyzed.</p><p><strong>Results.—: </strong>There was substantial to almost perfect agreement among prevalent autoantibodies (anti-mitochondrial antibody M2, antibodies against gp210, Sp100, and Ro52). Nevertheless, the Cohen κ coefficient of some uncommon autoantibodies (anti-LKM-1, anti-LC-1, and anti-SLA/LP) between the 2 methods was not ideal. LIA showed slightly better sensitivity, accuracy, and negative predictive value, while DLCM exhibited slightly higher specificity and positive predictive value.</p><p><strong>Conclusions.—: </strong>LIA and DLCM demonstrated comparable performance for the detection of common ALD-related autoantibodies. LIA seemed to be more sensitive, while DLCM displayed more specificity. However, standardization of ALD autoantibody detection still faces challenges between these diverse detection systems. Comprehensive interlaboratory validation is essential to mitigate potential misunderstanding and confusion among patients and clinicians.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141236430","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":"The Pathologist Pipeline: A Brief Look at the \"Other End\".","authors":"Edward J Gutmann","doi":"10.5858/arpa.2023-0572-ED","DOIUrl":"10.5858/arpa.2023-0572-ED","url":null,"abstract":"","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139974946","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":"Wilms Tumor: An Unexpected Diagnosis in Adult Patients.","authors":"Garrett J Chan, Bradley A Stohr, Adeboye O Osunkoya, Nicole A Croom, Soo-Jin Cho, Ronald Balassanian, Vivek Charu, Gregory R Bean, Emily Chan","doi":"10.5858/arpa.2023-0127-OA","DOIUrl":"10.5858/arpa.2023-0127-OA","url":null,"abstract":"<p><strong>Context.—: </strong>Wilms tumor (WT) in adult patients is rare and has historically been a diagnostic and therapeutic conundrum, with limited data available in the literature.</p><p><strong>Objective.—: </strong>To provide detailed diagnostic features, molecular profiling, and patient outcomes in a multi-institutional cohort of adult WT patients.</p><p><strong>Design.—: </strong>We identified and retrospectively examined 4 adult WT cases.</p><p><strong>Results.—: </strong>Two patients presented with metastatic disease, and diagnoses were made on fine-needle aspiration of their renal masses. The aspirates included malignant primitive-appearing epithelioid cells forming tubular rosettes and necrosis, and cell blocks demonstrated triphasic histology. In the remaining 2 cases, patients presented with localized disease and received a diagnosis on resection, with both patients demonstrating an epithelial-predominant morphology. Tumor cells in all cases were patchy variable positive for PAX8 and WT1 immunohistochemistry. Next-generation sequencing identified alterations previously reported in pediatric WT in 3 of 4 cases, including mutations in ASXL1 (2 of 4), WT1 (1 of 4), and the TERT promoter (1 of 4), as well as 1q gains (1 of 4); 1 case showed no alterations. Three patients were treated with pediatric chemotherapy protocols; during follow-up (range, 26-60 months), 1 patient died of disease.</p><p><strong>Conclusions.—: </strong>WT is an unexpected and difficult entity to diagnose in adults and should be considered when faced with a primitive-appearing renal or metastatic tumor. Molecular testing may help exclude other possibilities but may not be sensitive or specific because of the relatively large number of driver mutations reported in WT.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41156549","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":"Principles of Analytic Validation of Immunohistochemical Assays: Guideline Update.","authors":"Jeffrey D Goldsmith, Megan L Troxell, Sinchita Roy-Chowdhuri, Carol F Colasacco, Mary Elizabeth Edgerton, Patrick L Fitzgibbons, Regan Fulton, Thomas Haas, Patricia L Kandalaft, Tanja Kalicanin, Christina Lacchetti, Patti Loykasek, Nicole E Thomas, Paul E Swanson, Andrew M Bellizzi","doi":"10.5858/arpa.2023-0483-CP","DOIUrl":"10.5858/arpa.2023-0483-CP","url":null,"abstract":"<p><strong>Context.—: </strong>In 2014, the College of American Pathologists developed an evidence-based guideline to address analytic validation of immunohistochemical assays. Fourteen recommendations were offered. Per the National Academy of Medicine standards for developing trustworthy guidelines, guidelines should be updated when new evidence suggests modifications.</p><p><strong>Objective.—: </strong>To assess evidence published since the release of the original guideline and develop updated evidence-based recommendations.</p><p><strong>Design.—: </strong>The College of American Pathologists convened an expert panel to perform a systematic review of the literature and update the original guideline recommendations using the Grading of Recommendations Assessment, Development and Evaluation approach.</p><p><strong>Results.—: </strong>Two strong recommendations, 1 conditional recommendation, and 12 good practice statements are offered in this updated guideline. They address analytic validation or verification of predictive and nonpredictive assays, and recommended revalidation procedures following changes in assay conditions.</p><p><strong>Conclusions.—: </strong>While many of the original guideline statements remain similar, new recommendations address analytic validation of assays with distinct scoring systems, such as programmed death receptor-1 and analytic verification of US Food and Drug Administration approved/cleared assays; more specific guidance is offered for validating immunohistochemistry performed on cytology specimens.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139934659","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":"Thoracic Frozen Section Pitfalls: Lung Adenocarcinoma Versus Selected Mimics.","authors":"Sanjay Mukhopadhyay","doi":"10.5858/arpa.2024-0023-RA","DOIUrl":"https://doi.org/10.5858/arpa.2024-0023-RA","url":null,"abstract":"<p><strong>Context.—: </strong>Intraoperative (frozen section) analysis of lung lesions (nodules, masses, ground-glass opacities) can occasionally be diagnostically challenging.</p><p><strong>Objective.—: </strong>To describe selected pitfalls in thoracic frozen sections with a focus on the differential diagnosis between adenocarcinoma and its mimics, and to provide tips to prevent misinterpretation.</p><p><strong>Data sources.—: </strong>Peer-reviewed literature and the author's experience.</p><p><strong>Conclusions.—: </strong>A common challenge in thoracic frozen sections is the differential diagnosis between lung adenocarcinoma and its mimics. Diagnostic difficulties arise because mimics of adenocarcinoma often entrap reactive lung epithelium that can appear atypical on frozen section slides. Entities that can be misinterpreted as adenocarcinoma include ciliated muconodular papillary tumor/bronchiolar adenoma, hamartoma, inflammatory myofibroblastic tumor, and pulmonary Langerhans cell histiocytosis. Knowledge of the key clinical, radiologic, and histologic features of these entities can help prevent overdiagnosis of adenocarcinoma. Pathologic findings that facilitate the distinction between adenocarcinoma and its mimics at frozen section include the appearance and contour of the lesion at low magnification, growth patterns, cilia, stromal features, shape of the epithelial cells (cuboidal versus columnar), nuclear features of malignancy (crowding, hyperchromasia, irregular contours), and abruptness of the junction between the lesion and adjacent uninvolved lung. Knowledge of the clinical context, imaging findings, and the surgical consequence of the intraoperative diagnosis can also prevent diagnostic errors. Finally, since adenocarcinomas of the lung are often relatively bland and lack the stromal desmoplasia seen in adenocarcinomas of other organs, familiarity with the morphologic spectrum of lung adenocarcinomas at frozen section analysis is important.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141181641","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":"Virtual Remote Pathology Education in Support of Virtual Remote Gynecologic-Oncology Training: The Open Pathology Education Network Pilot Proof of Concept Experience.","authors":"Lewis A Hassell, Adele Wong, Vinita Parkash, Joseph S Ng, Ngoc Tb Tran, Lien Huynh, Ngoc Han Truong, Thi Nhu Quynh Tran, Thi Hong Ngoc Phan, Tu Quy Tran","doi":"10.5858/arpa.2023-0449-EP","DOIUrl":"https://doi.org/10.5858/arpa.2023-0449-EP","url":null,"abstract":"<p><strong>Context.—: </strong>The subspecialty workforce in pathology globally is inadequate for the demands of many modern therapies. The Open Pathology Education Network (OPEN) was formed to augment the global pathology workforce. The International Gynecologic Cancer Society (IGCS) virtual gynecologic-oncology (gyn-onc) fellowship training identified needs for higher-level pathology support.</p><p><strong>Objective.—: </strong>To report on an OPEN-IGCS pilot project to support gyn-onc and pathology education efforts in a developing country.</p><p><strong>Design.—: </strong>Curriculum with learning objectives and content from open sources was assembled. Mentoring sessions included bidirectional case sharing. Trainees received sequential curricula assignments and had options for communication outside mentoring sessions. Pretest and posttest digital slide assessments were included. Mentors attended the gynecology tumor board, allowing for the assessment of quality and accuracy of pathology diagnosis for cases discussed.</p><p><strong>Results.—: </strong>Learners completing the pretest and posttest showed substantial improvement, with 2 practicing pathologists improving their diagnostic scores from 60% to an average of 95%. A third trainee-level participant also improved, but to a lesser degree. Qualitative assessments included increased confidence in presentation and an increased ability to anticipate questions, raise issues of expanded differential diagnoses, and articulate appropriate workup. Observations of clinicians who participated also noted increased confidence in participating pathologists. Secondary value included establishing an expanded network of support in other subspecialties for participants. Pathologic issues at the tumor board decreased, from more than 50% in the first 3 months of study to 0% in the last 3 months of study. The curriculum was embedded into a self-paced learning portal at courses.open-pathology.org.</p><p><strong>Conclusions.—: </strong>The OPEN-IGCS collaboration model shows the potential to provide subspecialty pathology training remotely.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141158534","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":"A Microfluidic, Multi-Antibody Cell Capture Method to Evaluate Tumor Cells in Cerebrospinal Fluid in Patients With Suspected Leptomeningeal Metastases.","authors":"Nathan T Sweed, Hao-Ching Hsiao, Barbara Blouw, Tony J Pircher, Deanna Fisher, Katrina Rose Naluz, Julie Ann Mayer, Michael C Dugan, Akanksha Sharma, Jose Carrillo, Santosh Kesari","doi":"10.5858/arpa.2023-0295-OA","DOIUrl":"https://doi.org/10.5858/arpa.2023-0295-OA","url":null,"abstract":"<p><strong>Context.—: </strong>Leptomeningeal disease (LMD) is a clinical sequela of central nervous system metastasis involving the cerebrospinal fluid (CSF), often seen in late-stage solid tumors. It has a grave prognosis without urgent treatment. Standard of care methodologies to diagnose LMD include CSF cytology, magnetic resonance imaging, and clinical evaluation. These methods offer limited sensitivity and specificity for the evaluation of LMD. Here, we describe the analytic performance characteristics of a microfluidic-based tumor cell enrichment and detection assay optimized to detect epithelial cells in CSF using both contrived samples as well as CSF from patients having suspected or confirmed LMD from carcinomas.</p><p><strong>Objective.—: </strong>To demonstrate the feasibility of using a microfluidic, multi-antibody cell capture assay to identify and quantify tumor cells in CSF.</p><p><strong>Design.—: </strong>An artificial CSF solution was spiked with 34 different human carcinoma cell lines at different concentrations and assayed for the ability to detect tumor cells to assess analytic accuracy. Two cell lines were selected to assess linearity, intra-assay precision, interinstrument precision, and sample stability. Clinical verification was performed on 65 CSF specimens from patients. Parameters assessed included the number of tumor cells, coefficient of variation percentage, and percentage of tumor cell capture (TCC).</p><p><strong>Results.—: </strong>Among contrived samples, average tumor cell capture ranged from 50% to 82% (261 of 522; 436 of 531), and coefficients of variation ranged from 7% to 67%. The cell capture assay demonstrated a sensitivity of 92% and a specificity of 95% among clinical samples.</p><p><strong>Conclusions.—: </strong>This assay demonstrated the ability to detect and enumerate epithelial cells in contrived and clinical specimens in an accurate and reproducible fashion. The use of cell capture assays in CSF may be useful as a sensitive test for the diagnosis and longitudinal monitoring of LMD from solid tumors.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141155924","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}