American journal of clinical pathology最新文献_第6页

Laboratory-developed tests and in vitro diagnostics: A regulatory overview for anatomic pathology. 实验室开发的测试和体外诊断：对解剖病理学的监管概述。

IF 2.3 4区医学

American journal of clinical pathology Pub Date : 2025-05-17 DOI: 10.1093/ajcp/aqae181

Jonathan R Genzen, Lauren J Miller, Anton V Rets, Kajsa E Affolter

{"title":"Laboratory-developed tests and in vitro diagnostics: A regulatory overview for anatomic pathology.","authors":"Jonathan R Genzen, Lauren J Miller, Anton V Rets, Kajsa E Affolter","doi":"10.1093/ajcp/aqae181","DOIUrl":"10.1093/ajcp/aqae181","url":null,"abstract":"Objectives: The US Food and Drug Administration's Final Rule on laboratory-developed tests was published on May 6, 2024. The objective of this article is to explain the Final Rule and existing in vitro diagnostic regulations in the context of anatomic pathology.Methods: The Final Rule, US in vitro diagnostic regulations, guidance documents, government publications, websites, news articles, and publications were reviewed, with sources including the Federal Register, the Code of Federal Regulations, the US Code, statutory text, PubMed, and Internet resources. Regulations applicable to device classifications and product codes relevant to anatomic pathology were highlighted.Results: The Final Rule outlines requirements and enforcement discretion policies applicable to anatomic pathology, including the Food and Drug Administration's targeted enforcement discretion for \"1976-type\" laboratory-developed tests and partial enforcement discretion with laboratory-developed tests for unmet needs. Existing regulations, including the classification and requirements applicable to Class I, II, and III medical devices, are reviewed, including those for immunohistochemistry kits and reagents, analyte specific reagents, and research use only reagents and equipment.Conclusions: Pathologists, laboratory directors, managers, and supervisors responsible for anatomic pathology testing should be familiar with existing regulations and the Final Rule to ensure compliance with federal laws and regulations.","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":" ","pages":"730-743"},"PeriodicalIF":2.3,"publicationDate":"2025-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12086060/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143254154","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}

引用次数: 0

Flow cytometry evaluation of acute myeloid leukemia minimal residual disease based on an understanding of the normal maturation patterns in the blast compartments. 基于对母细胞室正常成熟模式的理解，流式细胞术评价急性髓系白血病微小残留病。

IF 2.3 4区医学

American journal of clinical pathology Pub Date : 2025-05-17 DOI: 10.1093/ajcp/aqae187

Mikhail Roshal, Qi Gao

{"title":"Flow cytometry evaluation of acute myeloid leukemia minimal residual disease based on an understanding of the normal maturation patterns in the blast compartments.","authors":"Mikhail Roshal, Qi Gao","doi":"10.1093/ajcp/aqae187","DOIUrl":"10.1093/ajcp/aqae187","url":null,"abstract":"Objective: Detection of minimal/measurable disease (MRD) in acute myeloid leukemia (AML) is critical for both clinical decision-making and prognostication, yet remains a challenge. Flow cytometry is a well-established method for MRD detection. Flow cytometric (FC) evaluation of MRD must consider a complex maturational pattern of normal hematopoietic development to separate normal from abnormal progenitors. Here, we offer an example of an interpretive approach based on a thorough understanding of stage- and lineage-specific hematopoietic maturation.Methods: We provide a comprehensive overview of blast maturation from early precursors (hematopoietic stem cells) to committed late-stage unilineage progenitors and commonly observed stage-specific abnormalities based on cases we have encountered in practice. We emphasize the importance of stage-specific comparisons for accurate MRD detection by flow cytometry.Results: The AML blasts almost invariably show abnormal phenotypes, and the phenotypes may evolve upon therapy. The detected phenotypes are necessarily confined to the target antigens included in the panel. It is therefore critical to evaluate a range of antigens to establish a specific stage/state of lineage commitment and detect potential common abnormalities. Moreover, enough cells must be acquired to allow for the detection of MRD at desired levels. Significant technical and analytical validation is critical.Conclusions: Flow cytometry offers a powerful single-cell-based platform for MRD detection in AML, and the results have been proven critical for disease management. Leukemia-associated phenotype-informed difference from the normal approach presented in this review presents an analytical framework for sensitive and accurate MRD detection.","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":" ","pages":"775-793"},"PeriodicalIF":2.3,"publicationDate":"2025-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143373523","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}

引用次数: 0

CD58 could be a leukemic marker in patients with relapsed/refractory B-cell acute lymphoblastic leukemia after multiline therapies. CD58可能是多线治疗后复发/难治性b细胞急性淋巴细胞白血病患者的白血病标志物。

IF 2.3 4区医学

American journal of clinical pathology Pub Date : 2025-05-17 DOI: 10.1093/ajcp/aqae166

Xinjian Yu, Pan Li, Heyuan Feng, Jian Kang, Yafeng Li, Shuangyou Liu

{"title":"CD58 could be a leukemic marker in patients with relapsed/refractory B-cell acute lymphoblastic leukemia after multiline therapies.","authors":"Xinjian Yu, Pan Li, Heyuan Feng, Jian Kang, Yafeng Li, Shuangyou Liu","doi":"10.1093/ajcp/aqae166","DOIUrl":"10.1093/ajcp/aqae166","url":null,"abstract":"Objectives: As a marker of minimal residual disease in B-cell acute lymphoblastic leukemia (B-ALL), CD58 has been reported in B-ALL at diagnosis and short-term follow-ups after standard chemotherapies. However, there are no data available in relapsed/refractory (r/r) patients who have received long-term and multiline therapies, especially chimeric antigen receptor (CAR) T cells; here, we focused on investigating CD58 status in these patients.Methods: CD58 expression on lymphoblasts was detected by multiparameter flow cytometry. CD58 status was evaluated in patients with r/r B-ALL before CAR-T therapy, and the patients who failed or relapsed after CAR-T.Results: Among 274 pediatric and adult patients prior to exposure to CAR-T cells (22.3% of them underwent allogeneic hematopoietic cell transplantation, allo-HCT), 228 (83.2%) showed CD58 positivity. Furthermore, among 58 patients who were CD58 positive before CAR-T failed or relapsed after CAR-T (half also received CD22 CAR-T or allo-HCT as a consolidation treatment following CD19 CAR-T), the frequency of CD58 expression was 79.3% (46/58) in all patients and 86.2% (25/29) in patients exposed to CD19 CAR-T cells alone.Conclusions: CD58 antigen was stably expressed in patients with r/r B-ALL after multiline therapies, including allo-HCT and CAR-T, indicating that it could still be a leukemic marker in heavily treated patients.","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":" ","pages":"644-648"},"PeriodicalIF":2.3,"publicationDate":"2025-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143951988","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}

引用次数: 0

Automate cancer synoptic reporting with HyperText Markup Language (HTML) and JavaScript. 自动化癌症概要报告与超文本标记语言（HTML）和JavaScript。

IF 2.3 4区医学

American journal of clinical pathology Pub Date : 2025-05-17 DOI: 10.1093/ajcp/aqae173

Aaron Duan, Kevin Guo, Huazhang Guo

{"title":"Automate cancer synoptic reporting with HyperText Markup Language (HTML) and JavaScript.","authors":"Aaron Duan, Kevin Guo, Huazhang Guo","doi":"10.1093/ajcp/aqae173","DOIUrl":"10.1093/ajcp/aqae173","url":null,"abstract":"Objectives: The College of American Pathologists (CAP) Cancer Protocols are developed to facilitate cancer synoptic reporting. CAP offers these Cancer Protocols in both free printable and commercially licensed electronic formats. Several academic institutions have also implemented these Cancer Protocols as web-based services. Due to financial and technical limitations, many resource-limited pathology laboratories still rely on the free printable Cancer Protocols that involve extensive text editing and secretarial support, and they are error-prone.This study: implemented low-cost, low-barrier, and flexible electronic CAP Cancer Protocols to automate cancer synoptic reporting.Methods: For each printable CAP Cancer Protocol, a dynamic data entry form is created using HyperText Markup Language (HTML) with embedded JavaScript, which is then presented in a web browser for pathologists to enter cancer case-specific information. Once the data entry form is complete, the case-specific information entered by the pathologists will be collected, and a synoptic report will be automatically created in the web browser by a companion JavaScript program. The synoptic report can then be copied into the corresponding pathology report.Results: We implemented the commonly used CAP Cancer Protocols into electronic form using HTML/JavaScript. Using this tool, our pathologist reported at least 50% time savings compared to the previous manual process.Conclusions: The proposed HTML/JavaScript-based Cancer Protocols are low-cost, low-barrier, and flexible alternatives to current commercially and academically available electronic CAP Cancer Protocols, especially for pathologists working in resource-limited laboratories. The same implementation methods can also be extended to implement international variants of Cancer Protocols, including non-English Cancer Protocols.","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":" ","pages":"678-687"},"PeriodicalIF":2.3,"publicationDate":"2025-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142913692","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}

引用次数: 0

Software solution for integration of frozen section quality assurance into daily practice. 将冷冻切片质量保证融入日常实践的软件解决方案。

IF 2.3 4区医学

American journal of clinical pathology Pub Date : 2025-05-17 DOI: 10.1093/ajcp/aqae188

Joanna A Gibson, Neil Mutnick, Peter Gershkovich, John Sinard

{"title":"Software solution for integration of frozen section quality assurance into daily practice.","authors":"Joanna A Gibson, Neil Mutnick, Peter Gershkovich, John Sinard","doi":"10.1093/ajcp/aqae188","DOIUrl":"10.1093/ajcp/aqae188","url":null,"abstract":"Objective: Diagnoses rendered using the frozen section (FS) technique during surgical procedures are used to guide intraoperative decisions. Therefore, diagnostic FS errors have the potential to affect patient safety and quality of care. Diagnostic FS errors arise due to both technical and interpretative factors and present a challenge to surgical pathology laboratories to recognize, document, and manage in a timely fashion. Thus, there is a need to monitor discrepancies between FS and permanent diagnoses and effectively communicate with the clinical teams when an error is discovered to ensure an opportunity for timely interventions, if clinically indicated.Methods: Our FS practice is complex, with many contributing variables, such as a partially generalized FS pathology practice model among pathology faculty and/or surgeons with specific subspecialty expertise and different physical locations of FS facilities. We implemented a comprehensive frozen section quality assurance (FSQA) program using custom software solutions aimed at improving patient safety by monitoring recognition, increasing documentation, and facilitating communication in cases where there is a discordance between intraoperative and permanent diagnoses.Results: Our FSQA program allows for categorizing frozen section discrepancies according to the source of error, such as interpretive vs technical errors, to understand how errors arise and to develop appropriate mitigation strategies for reducing errors.Conclusions: Overall, our intervention to improve FSQA has engaged pathology faculty in a uniform and systematic manner, and our data show that our new FSQA program led to a markedly shortened time interval of FSQA, allowing for timely management and resolution of errors.","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":" ","pages":"794-802"},"PeriodicalIF":2.3,"publicationDate":"2025-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142998674","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}

引用次数: 0

A pathologist's primer on implementing new standard-of-care molecular biomarker testing for precision prostate cancer management. 病理学家的入门实施新的标准护理分子生物标志物检测的精确前列腺癌管理。

IF 2.3 4区医学

American journal of clinical pathology Pub Date : 2025-05-17 DOI: 10.1093/ajcp/aqae186

Steven C Smith, John W Melson, John M Quillin, Matthew C Hiemenz, Scott A Tomlins, Sara E Wobker

引用次数: 0

Diffuse expression of p16 in pancreatic neuroendocrine tumors (PanNETs) and the association of morphology variants. 胰腺神经内分泌肿瘤（PanNETs）中p16的弥漫表达及其形态学变异的关联

IF 2.3 4区医学

American journal of clinical pathology Pub Date : 2025-05-17 DOI: 10.1093/ajcp/aqae184

John Yablonski, Chanjuan Shi, Wei Chen

{"title":"Diffuse expression of p16 in pancreatic neuroendocrine tumors (PanNETs) and the association of morphology variants.","authors":"John Yablonski, Chanjuan Shi, Wei Chen","doi":"10.1093/ajcp/aqae184","DOIUrl":"10.1093/ajcp/aqae184","url":null,"abstract":"Objective: Distinguishing grade 3 pancreatic neuroendocrine tumors (PanNETs) from neuroendocrine carcinomas (PanNECs) is sometimes challenging. Recently, a diffuse p16-positive pattern was reported in PanNECs but not in grade 3 PanNETs, suggesting that p16 could help differentiate these entities. This study aimed to investigate p16 expression in PanNETs of various grades and its association with clinicopathologic features.Methods: A total of 114 PanNETs were selected, and their H&E resection slides were reviewed for pathologic features, with a focus on morphologic variants. Tissue microarrays were constructed, and p16 immunohistochemistry was performed. The results were categorized as diffuse positive, partial positive, or negative. Patient electronic health records were reviewed for follow-up data.Results: Among the 114 PanNETs reviewed, 13 (11.4%) exhibited diffuse p16 expression, 40 (35.1%) were negative, and 61 (53.5%) had partial expression. Diffuse p16 expression occurred in 6 of 38 (15.8%) grade 1, 6 of 60 (10.0%) grade 2, and 1 of 16 (6.3%) grade 3 tumors. Expression did not differ substantially with patient demographics, tumor size, grading, staging, or survival, but diffuse p16 expression was more frequent in body/tail tumors (12/65 [18.5%], P = .019) and in stromal-rich tumors (10/23 [43.5%], P < .001).Conclusions: Diffuse p16 expression is not uncommon in PanNETs and may be associated with stroma-rich variants.","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":" ","pages":"758-765"},"PeriodicalIF":2.3,"publicationDate":"2025-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143031764","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}

引用次数: 0

Sensitivity and specificity of immunohistochemistry for the diagnosis of filamentous fungal infections. 免疫组织化学诊断丝状真菌感染的敏感性和特异性。

IF 2.3 4区医学

American journal of clinical pathology Pub Date : 2025-05-10 DOI: 10.1093/ajcp/aqaf037

Victoria L Thomas, Alvaro C Laga, Isaac H Solomon

{"title":"Sensitivity and specificity of immunohistochemistry for the diagnosis of filamentous fungal infections.","authors":"Victoria L Thomas, Alvaro C Laga, Isaac H Solomon","doi":"10.1093/ajcp/aqaf037","DOIUrl":"https://doi.org/10.1093/ajcp/aqaf037","url":null,"abstract":"Objectives: Many fungal species share overlapping morphologic features in tissue sections, preventing reliable identification and optimal treatment. We sought to determine whether immunohistochemistry (IHC) using a panel of commercially available antibodies could effectively distinguish between fungi commonly encountered in anatomic pathology specimens.Methods: Anti-Aspergillus, anti-Rhizopus, and anti-Candida IHC was performed on formalin-fixed, paraffin-embedded tissue sections from 24 cases with fungal infections identified by culture or sequencing (including 4 polyfungal infections).Results: Anti-Aspergillus IHC was positive in 6 of 6 Aspergillus and focally in 1 of 4 Candida species infections and negative in all cases of Fusarium, Scedosporium, Rhizopus, and Mucor species, yielding overall sensitivity of 100% and specificity of 95%. Anti-Rhizopus IHC was positive in 4 of 4 Rhizopus and 1 of 3 Mucor species infections and negative in all other cases, with a sensitivity of 71% and a specificity of 100%. Anti-Candida IHC was positive in 4 of 4 Candida species infections and showed some cross-reactivity in all other cases, resulting in 100% sensitivity and 0% specificity.Conclusions: Anti-Aspergillus IHC was highly sensitive and specific in its ability to distinguish Aspergillus from other similar-appearing hyaline molds, including Fusarium and Scedosporium species. Anti-Rhizopus IHC was moderately sensitive and highly specific, while anti-Candida IHC was highly sensitive but had minimal specificity.","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2025-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143959013","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}

引用次数: 0

Residual red blood cells in liquid plasma products: A quality assessment. 血浆产品中残留红细胞：质量评价。

IF 2.3 4区医学

American journal of clinical pathology Pub Date : 2025-05-10 DOI: 10.1093/ajcp/aqaf036

Furkan Yigitbilek, Suchitra Pandey, Tho Pham, Mrigender Singh Virk

{"title":"Residual red blood cells in liquid plasma products: A quality assessment.","authors":"Furkan Yigitbilek, Suchitra Pandey, Tho Pham, Mrigender Singh Virk","doi":"10.1093/ajcp/aqaf036","DOIUrl":"https://doi.org/10.1093/ajcp/aqaf036","url":null,"abstract":"Objectives: Liquid plasma (LP) is an increasingly utilized blood product due to its immediate availability for transfusion without requiring thawing. While concerns exist regarding the presence of intact residual red blood cells (RBCs) in plasma products that have never been frozen, limited data are available on their levels in LP. This study aimed to evaluate residual RBC content in LP products to assess their safety for transfusion.Methods: Liquid plasma units were prepared from whole-blood donations at the Stanford Blood Center. Seven group AB-positive, 1 group AB-negative, 10 group A-positive, and 2 group A-negative whole-blood units were collected in citrate phosphate dextrose anticoagulant, stored at 1 °C to 6 °C for 24 hours, centrifuged, and processed into LP. On day 2 of storage, 2-mL plasma samples were analyzed for RBC count, hemoglobin, and hematocrit.Results: No residual RBCs were detected in any LP units, with all samples showing RBC counts below the limit of detection, hemoglobin levels of 0 g/dL, and hematocrit values of 0%. Given the uniform absence of RBC contamination, statistical analysis was not required.Conclusions: The findings confirm that LP prepared under current blood processing standards contains no detectable residual RBCs, supporting its safety for transfusion with ABO-compatible products without the need for consideration of RhD compatibility.","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2025-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143952151","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}

引用次数: 0

Impact of PlGF immunoassay imprecision on preeclampsia risk assessment with the sFlt-1 to PlGF ratio. 用sFlt-1 / PlGF比值评估PlGF免疫测定不精确性对子痫前期风险评估的影响

IF 2.3 4区医学

American journal of clinical pathology Pub Date : 2025-05-08 DOI: 10.1093/ajcp/aqaf032

Guanmin Chen, Clarence W Chan, Richard F Schaefer, Sarosh Rana, Kiang-Teck J Yeo

{"title":"Impact of PlGF immunoassay imprecision on preeclampsia risk assessment with the sFlt-1 to PlGF ratio.","authors":"Guanmin Chen, Clarence W Chan, Richard F Schaefer, Sarosh Rana, Kiang-Teck J Yeo","doi":"10.1093/ajcp/aqaf032","DOIUrl":"https://doi.org/10.1093/ajcp/aqaf032","url":null,"abstract":"Objective: The US Food and Drug Administration recently approved the ratio of soluble FMS-like tyrosine kinase 1 (sFlt-1) to placental growth factor (PlGF) using the Thermo Fisher Scientific B·R·A·H·M·S KRYPTOR autoanalyzer-the first preeclampsia marker used for clinical testing. We evaluated the analytical precision of the sFlt-1 and PlGF assays, focusing on the effects of PlGF imprecision on the sFlt-1 to PlGF ratio interpretation and clinical reliability for preeclampsia risk assessment.Methods: We measured sFlt-1 and PlGF on the KRYPTOR instrument using a homogeneous sandwich fluoroimmunoassay. Between-day precision was assessed using 3 levels of commercial quality control (QC) materials and analyzed over 3 months. In all, 180 samples obtained from 161 hospitalized pregnant women were analyzed to assess the relationship between PlGF levels and the sFlt-1 to PlGF ratio.Results: The sFlt-1 assay demonstrated good precision (coefficient of variation (s/x̄) × 100 [CV] = approximately 3.0%) across all QC levels, while the PlGF assay exhibited higher imprecision, particularly at low QC levels (CV = 7.7%-11.3%). Long-term QC monitoring revealed a downward drift in PlGF values, with improved stability after reagent lot changes. Despite higher imprecision at lower PlGF levels (23.1-34.7 ng/L), the clinical interpretation of the sFlt-1 to PlGF ratio remained robust because low PlGF consistently correlated with ratios well above the critical cutoff of 40.Conclusions: Despite the suboptimal precision observed at low QC levels and potential drifts in PlGF results, the sFlt-1 to PlGF ratio remains a reliable tool for preeclampsia risk assessment. This study highlights the need for critical evaluation of analytical performance beyond FDA approval and the importance of assessing the potential impact of assay imprecision on patient care for individual biomarkers.","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2025-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143956331","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}

引用次数: 0