Journal of Clinical Laboratory Analysis最新文献

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Development of a Machine Learning Algorithm for Differential Diagnosis Between Primary Immune Thrombocytopenia and Connective Tissue Disease-Related Thrombocytopenia in Pediatric Patients. 鉴别诊断原发性免疫性血小板减少症和结缔组织病相关血小板减少症的机器学习算法的发展
IF 2.5 4区 医学
Journal of Clinical Laboratory Analysis Pub Date : 2026-09-03 DOI: 10.1002/jcla.70337
Furong Kang, Mei Yan, Yingbin Yue, Xuemei Wang, Yu Liu
{"title":"Development of a Machine Learning Algorithm for Differential Diagnosis Between Primary Immune Thrombocytopenia and Connective Tissue Disease-Related Thrombocytopenia in Pediatric Patients.","authors":"Furong Kang, Mei Yan, Yingbin Yue, Xuemei Wang, Yu Liu","doi":"10.1002/jcla.70337","DOIUrl":"10.1002/jcla.70337","url":null,"abstract":"<p><strong>Background: </strong>To develop a machine learning model for early differentiation of primary immune thrombocytopenia (pITP) from connective tissue disease-related thrombocytopenia (CTD-TP) in children presenting with thrombocytopenia.</p><p><strong>Method: </strong>A retrospective study was conducted on 387 newly diagnosed children with thrombocytopenia. All patients were clinically diagnosed and divided into a training set and a test set in a 7:3 ratio. Six machine learning algorithms, including XGboost, RF, SVM, LR, GBDT, BPNN, were used to establish differential diagnostic models for pITP and CTD-TP. The model performance was evaluated by accuracy, precision, recall, F1 score, and area under the receiver operating characteristic curve (AUC). Explain the importance and contribution of model feature variables through the Shapley Additive Explanations (SHAP) method.</p><p><strong>Result: </strong>A total of 387 patients were included in the study, including 347 cases of pITP and 40 cases of CTD-TP. Based on the above evaluation indicators, the BPNN model had the best performance, with an F1 score of 0.95, an accuracy rate of 94.87%, and an AUC of 0.9738. According to the SHAP value, the top 10 influencing factors were selected as age, erythrocyte sedimentation rate, antinuclear antibodies, IgM, Complement C3, T + B + NK%, B cells, body weight, complement C4, lymphocyte count.</p><p><strong>Conclusion: </strong>The successful construction of the pITP and CTD-TP identification models shows that BPNN has the best performance and can provide clinical strategies for early disease identification based on the importance of its variables.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70337"},"PeriodicalIF":2.5,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13539337/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148879922","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
Laboratory Identification of Pseudohypercalcemia Induced by Hyperglobulinemia in Multiple Myeloma: A Case Report. 多发性骨髓瘤高球蛋白血症引起的假高钙血症的实验室鉴定:1例报告。
IF 2.5 4区 医学
Journal of Clinical Laboratory Analysis Pub Date : 2026-09-01 DOI: 10.1002/jcla.70342
Anjiang Zhao, Fan Zhong, Yankui Liu, Guixing Li
{"title":"Laboratory Identification of Pseudohypercalcemia Induced by Hyperglobulinemia in Multiple Myeloma: A Case Report.","authors":"Anjiang Zhao, Fan Zhong, Yankui Liu, Guixing Li","doi":"10.1002/jcla.70342","DOIUrl":"10.1002/jcla.70342","url":null,"abstract":"<p><strong>Background: </strong>Pseudohypercalcemia is easily misdiagnosed in clinical practice, potentially leading to unnecessary interventions. Multiple myeloma (MM) presenting with concurrent hypergammaglobulinemia represents a rare etiology of pseudohypercalcemia, and there are few reports of systematic laboratory validation of this pathological entity.</p><p><strong>Methods: </strong>We report a patient with MM who presented with markedly elevated serum total calcium on routine biochemical testing. The hypercalcemia persisted despite 1 month of calcitonin therapy administered at an external hospital. After admission, the clinical laboratory team performed a panel of confirmatory assays, including direct ionized calcium measurement, post-dilution linearity evaluation, inductively coupled plasma mass spectrometry (ICP-MS) verification, and polyethylene glycol (PEG) precipitation testing.</p><p><strong>Results and conclusions: </strong>The results confirmed that the elevation in serum total calcium was attributed to enhanced calcium binding to circulating globulins, secondary to hypergammaglobulinemia, rather than analytical interference in the detection system. During clinical follow-up, serum total calcium levels normalized progressively in parallel with the decline in globulin levels following targeted anti-myeloma therapy. This case demonstrates that clinicians and laboratory professionals should maintain a high index of suspicion for pseudohypercalcemia when encountering patients with marked paraproteinemia or abnormal circulating macromolecules. A multimodal differential diagnostic approach using complementary laboratory indicators is warranted to avoid unnecessary examinations and interventions, thereby reducing the waste of medical resources and preventing potential adverse events associated with inappropriate treatment.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70342"},"PeriodicalIF":2.5,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13534993/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148874314","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
Point of Care Testing and Recombinase Polymerase Amplification. 护理点检测和重组酶聚合酶扩增。
IF 2.5 4区 医学
Journal of Clinical Laboratory Analysis Pub Date : 2026-09-01 DOI: 10.1002/jcla.70345
Manfred Weidmann, Ahmed Abd El Wahed
{"title":"Point of Care Testing and Recombinase Polymerase Amplification.","authors":"Manfred Weidmann, Ahmed Abd El Wahed","doi":"10.1002/jcla.70345","DOIUrl":"10.1002/jcla.70345","url":null,"abstract":"","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70345"},"PeriodicalIF":2.5,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13531096/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148864685","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
Preliminary Development and Assessment of a Multiplex Assay for Human Papillomavirus Antibody Detection Using Commercial L1 Proteins. 利用商业L1蛋白检测人乳头瘤病毒抗体的多重检测方法的初步开发和评估。
IF 2.5 4区 医学
Journal of Clinical Laboratory Analysis Pub Date : 2026-09-01 DOI: 10.1002/jcla.70343
Arash Aslanabadi, Maryam Karimi, Laura Powell, Lisa Schumaker, Ashley Shutt, Mahsa Hojabri, Rahim Abbasi, Søren M Bentzen, Kevin J Cullen, Trevor A Crowell, Rebecca G Nowak, Mohammad M Sajadi
{"title":"Preliminary Development and Assessment of a Multiplex Assay for Human Papillomavirus Antibody Detection Using Commercial L1 Proteins.","authors":"Arash Aslanabadi, Maryam Karimi, Laura Powell, Lisa Schumaker, Ashley Shutt, Mahsa Hojabri, Rahim Abbasi, Søren M Bentzen, Kevin J Cullen, Trevor A Crowell, Rebecca G Nowak, Mohammad M Sajadi","doi":"10.1002/jcla.70343","DOIUrl":"10.1002/jcla.70343","url":null,"abstract":"<p><strong>Background: </strong>Human papillomavirus (HPV)-associated cancers are preventable with vaccination. Serologic assays monitor antibody responses, but their complexity and cost pose limitations when evaluating population level immunity. We developed an L1-based assay for the detection of multiple type-specific HPV antibodies.</p><p><strong>Methods: </strong>The Luminex-based assay used recombinant L1 proteins from seven HPVs (HPV-6/11/16/18/35/45/58) for the detection of type-specific immunoglobulin (Ig)G and IgA. Cutoffs were established using plasma from infants and children. The assay was optimized and qualified using a sample set from a blinded proficiency panel developed at the Frederick National Laboratory for Cancer Research.</p><p><strong>Results: </strong>Sensitivity and specificity for anti-HPV-6/11/16/18/58 IgG were 100% at the Mean + 3 standard deviation [SD] and Mean + 5 SD thresholds. Sensitivity for HPV-45 was 100% and 92.9% at the +3 SD and +5 SD thresholds, respectively. IgA detection showed moderate positivity among vaccinated individuals, with peak estimates of 96.4% (HPV-11) and 85.7% (HPV-58) at the +3 SD threshold. IgA was correlated with IgG (Spearman's ρ = 0.74). The L1-assay differentiated high, intermediate, low, and negative response groups from the blinded samples for all HPV genotypes (p < 0.0001).</p><p><strong>Conclusion: </strong>The L1-binding assay has the potential to be a scalable option for high-throughput detection of broad-spectrum HPV immunoglobulins, but further standardization and validation are needed.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70343"},"PeriodicalIF":2.5,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13534992/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148874281","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
Development and Analytical Validation of a Laboratory-Customized TaqMan-MGB Probe Method for CYP2C19 Genotyping 实验室定制的CYP2C19基因分型TaqMan-MGB探针方法的建立及分析验证
IF 2.5 4区 医学
Journal of Clinical Laboratory Analysis Pub Date : 2026-08-31 Epub Date: 2026-07-01 DOI: 10.1002/jcla.70296
Yaqun Liu, Lianghui Chen, Xuanyi Zheng, Peikui Yang, Yicun Chen, Chengsong Xie, Zhenxia Zhang, Yuzhong Zheng
{"title":"Development and Analytical Validation of a Laboratory-Customized TaqMan-MGB Probe Method for CYP2C19 Genotyping","authors":"Yaqun Liu,&nbsp;Lianghui Chen,&nbsp;Xuanyi Zheng,&nbsp;Peikui Yang,&nbsp;Yicun Chen,&nbsp;Chengsong Xie,&nbsp;Zhenxia Zhang,&nbsp;Yuzhong Zheng","doi":"10.1002/jcla.70296","DOIUrl":"10.1002/jcla.70296","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Genetic polymorphisms in <i>CYP2C19</i> influence the metabolism of multiple clinically important drugs. Although TaqMan-based genotyping of <i>CYP2C19</i>*2 and <i>CYP2C19</i>*17 is well established, open and locally implementable workflows remain useful for laboratory validation and application. This study aimed to develop and analytically validate a laboratory-customized, open-sequence TaqMan-MGB assay for detecting <i>CYP2C19</i>*2 (rs4244285, NM_000769.4:c.681G &gt; A) and <i>CYP2C19</i>*17 (rs12248560, NM_000769.4:c.-806C &gt; T).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Specific primers and allele-specific TaqMan-MGB probes were designed. The assay was evaluated for primer/probe performance, specificity, analytical sensitivity, candidate limit of detection (LOD), and repeatability. Preliminary clinical concordance was assessed using 20 dried blood spot (DBS) samples, with Sanger sequencing as the reference.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The assay discriminated wild-type, heterozygous, and homozygous mutant genotypes for <i>CYP2C19</i>*2 and wild-type and heterozygous genotypes for <i>CYP2C19</i>*17 in tested clinical samples. Using plasmid templates, candidate LODs were 1.17 × 10<sup>2</sup> copies/μL for <i>CYP2C19</i>*2 and 0.94 × 10<sup>3</sup> copies/μL for <i>CYP2C19</i>*17. Repeatability testing with plasmid templates and representative DBS-derived clinical genomic DNA showed coefficients of variation below 10%. All 20 DBS samples were concordant with Sanger sequencing, corresponding to 100% observed sample-level concordance and an exact 95% confidence interval of 83.2%–100.0%.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>The customized TaqMan-MGB assay showed acceptable preliminary analytical specificity, sensitivity, and repeatability. Its value lies in the laboratory-customized, open-sequence design and DBS-compatible workflow. Because the clinical set was limited and lacked the <i>CYP2C19</i>*17 TT genotype, the findings should be regarded as preliminary. Larger studies including all relevant genotypes, additional <i>CYP2C19</i> alleles, and diverse populations are needed before routine clinical implementation or comprehensive <i>CYP2C19</i> phenotype assignment.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":"40 16","pages":""},"PeriodicalIF":2.5,"publicationDate":"2026-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13399776/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148368575","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
Detection and Clinical Significance of Chromosomal Mosaicism in Prenatal Diagnosis: A Retrospective Study From a Prenatal Diagnosis Center 染色体嵌合体在产前诊断中的检测及临床意义:来自某产前诊断中心的回顾性研究。
IF 2.5 4区 医学
Journal of Clinical Laboratory Analysis Pub Date : 2026-08-31 Epub Date: 2026-08-10 DOI: 10.1002/jcla.70305
Yuanyuan Pei, Xiaojin Luo, Jian Ran, Liang Hu, Weiqiang Liu, Fengxiang Wei
{"title":"Detection and Clinical Significance of Chromosomal Mosaicism in Prenatal Diagnosis: A Retrospective Study From a Prenatal Diagnosis Center","authors":"Yuanyuan Pei,&nbsp;Xiaojin Luo,&nbsp;Jian Ran,&nbsp;Liang Hu,&nbsp;Weiqiang Liu,&nbsp;Fengxiang Wei","doi":"10.1002/jcla.70305","DOIUrl":"10.1002/jcla.70305","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>To evaluate the detection capabilities of prenatal screening and diagnostic methods for fetal chromosomal mosaicism and analyze associated pregnancy outcomes.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This retrospective study included 79 cases of fetal chromosomal mosaicism identified by karyotyping among 8106 women undergoing prenatal diagnosis. Sensitivity of screening methods (first-trimester serum screening, second-trimester serum screening, and noninvasive prenatal testing (NIPT)) and concordance of diagnostic methods (chromosomal microarray analysis (CMA), multiple STR locus analysis technique (QF–PCR)) with karyotyping were assessed. Pregnancy outcomes were analyzed.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>NIPT demonstrated significantly higher sensitivity (90.74%) compared with first-trimester serum screening (57.41%) and second-trimester serum screening (39.29%) (<i>p</i> &lt; 0.001). CMA showed high concordance with karyotyping (90.00%), whereas QF-PCR exhibited significantly lower concordance (58.21%) (<i>p</i> &lt; 0.001). The pregnancy termination rate was 57.14% (40/70). All trisomy 21 and trisomy 13 mosaicism cases resulted in termination, while decisions regarding other autosomal and sex chromosome mosaicism were more variable.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>NIPT outperforms traditional serum screening for detecting chromosomal mosaicism, though karyotyping remains essential for confirmation. CMA aligns well with karyotyping, particularly for low-level mosaicism. The high termination rate underscores the critical need for multidisciplinary genetic counseling integrating genetic, imaging, and clinical data.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":"40 16","pages":""},"PeriodicalIF":2.5,"publicationDate":"2026-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13455827/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148701476","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
Changes of CEA Diagnostic Performance Under the New Reference Interval Stratified by Age and Sex 年龄、性别分层新参考区间下CEA诊断效能的变化。
IF 2.5 4区 医学
Journal of Clinical Laboratory Analysis Pub Date : 2026-08-31 Epub Date: 2026-07-02 DOI: 10.1002/jcla.70301
Ke Zhang, Xiarui Ye
{"title":"Changes of CEA Diagnostic Performance Under the New Reference Interval Stratified by Age and Sex","authors":"Ke Zhang,&nbsp;Xiarui Ye","doi":"10.1002/jcla.70301","DOIUrl":"10.1002/jcla.70301","url":null,"abstract":"&lt;div&gt;\u0000 \u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Background&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;CEA is one of the most frequently used biomarkers for cancer, but its inappropriate reference interval, low sensitivity, and specificity limit its clinical application.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Methods&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;We retrospectively analyzed carcinoembryonic antigen levels in 49,752 apparently healthy Chinese individuals (23,967 men vs. 25,785 women), 9830 patients with lung cancer (4493 men vs. 5337 women), 5104 women with breast cancer, and 4154 patients with colorectal cancer (2590 men vs. 1564 women) to investigate effects of age and sex on CEA levels, as well as to analyze the changes in CEA diagnostic performance for three common cancers under the new reference interval.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Results&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;The concentration distribution of CEA in apparently healthy populations was associated with both sex and age. The positive rates of CEA for apparently healthy Chinese males and females were 6.49% and 1.26%. The positive rates of CEA among patients with breast cancer, lung cancer, and colorectal cancer were 8.19%, 21.55%, and 26.62%, respectively. According to the updated reference interval, the sensitivity and Youden index increased, while specificity, positive predictive value, and positive likelihood ratio decreased in male patients &lt; 40 years and female cases &lt; 70 years. Conversely, sensitivity and Youden index decreased, while specificity, positive predictive value, and positive likelihood ratio increased in male patients ≥ 50 years and female cases ≥ 70 years.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Conclusions&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;The concentration distribution of CEA in apparently healthy populations is associated with sex and age. Although adjusting to a lower threshold may enhance sensitivity, it can lead to the misclassification of numerous non-cancer cases.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Impact Statement&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;In the era of precision medicine, tumor markers have become increasingly important given that their results may be critical determinants in the decision to proceed with or withhold effective therapies that may have substantial toxicities; they also play an important role in the risk assessment and prognosis model of cancer. The main disadvantages of existing serum markers are lack of sensitivity and specificity. In addition, inappropriate reference intervals can profoundly influence the clinical application of tumor markers. Our study included patients with lung cancer, breast cancer, and ","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":"40 16","pages":""},"PeriodicalIF":2.5,"publicationDate":"2026-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13399920/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148368654","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
sFlt-1/PlGF Ratio in the Diagnosis of Preeclampsia on the MAGLUMI X3 Analyzer sFlt-1/PlGF比值在MAGLUMI X3分析仪诊断子痫前期中的应用
IF 2.5 4区 医学
Journal of Clinical Laboratory Analysis Pub Date : 2026-08-31 Epub Date: 2026-07-05 DOI: 10.1002/jcla.70302
Pavel Broz, Simona Kukralova, Zdenek Sebesta, Katerina Brslicova, Michal Kozerovsky, Jaroslav Racek, Daniel Rajdl
{"title":"sFlt-1/PlGF Ratio in the Diagnosis of Preeclampsia on the MAGLUMI X3 Analyzer","authors":"Pavel Broz,&nbsp;Simona Kukralova,&nbsp;Zdenek Sebesta,&nbsp;Katerina Brslicova,&nbsp;Michal Kozerovsky,&nbsp;Jaroslav Racek,&nbsp;Daniel Rajdl","doi":"10.1002/jcla.70302","DOIUrl":"10.1002/jcla.70302","url":null,"abstract":"&lt;p&gt;Preeclampsia (PE) is a pregnancy-specific disorder diagnosed after 20 weeks of gestation, typically characterized by new-onset hypertension and proteinuria and/or other signs of maternal organ dysfunction. In severe cases, it may progress to eclampsia, defined by the occurrence of seizures, or to HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), the diagnosis of which relies predominantly on laboratory findings [&lt;span&gt;1&lt;/span&gt;].&lt;/p&gt;&lt;p&gt;The exact pathophysiology of PE remains incompletely understood. Placental vascular dysfunction occurs with the subsequent release of agents affecting the overall maternal hemodynamics. Pro-angiogenic and anti-angiogenic factors play an important role in the development of PE. These are the pro-angiogenic PlGF (placental growth factor), the anti-angiogenic sFlt-1 (soluble fms-like tyrosine kinase-1), and their sFlt-1/PlGF ratio, the value of which is indicative of the risk of developing PE. These biomarkers can be detected in the serum of pregnant women before the manifestation of clinical signs of the disease [&lt;span&gt;2&lt;/span&gt;]. Laboratory testing is becoming an increasingly important part of the diagnosis and prediction of PE. The primary goal of the present study was to compare the performance of the MAGLUMI X3 analyzer (Snibe) with the routinely used Cobas e602 analyzer (Roche) in measuring sFlt-1 and PlGF concentrations. A secondary objective was to investigate whether any potential analytical differences between these methods could influence the clinical classification of patients based on the sFlt-1 and PlGF ratio.&lt;/p&gt;&lt;p&gt;A total of 192 serum samples from 164 women were included in the analytical comparison. For clinical performance analysis, 149 patients with complete clinical data were included. Basic analytical properties, including repeatability, bias, and related parameters, are stated in Tables 1 and Table 2. Repeatability was measured using serum samples from patients.&lt;/p&gt;&lt;p&gt;Spearman's correlation coefficient for sFlt-1 values was 0.99, and for PlGF values, 0.97, respectively. Bland–Altman plots and Passing–Bablok analysis are presented in Figure 1. The average bias (95% CI) for sFlt-1 was −869.9 (−1,035.6 to −704.2) ng/L, &lt;i&gt;p&lt;/i&gt; &lt; 0.0001, and for PlGF, 6.2 (−4.6 to 17.0) ng/L, &lt;i&gt;p&lt;/i&gt; = 0.26, indicating that the Roche method measured lower values compared to the Snibe method for sFlt-1.&lt;/p&gt;&lt;p&gt;The ROC curves of early and late PE and corresponding results are presented in Figure 2. Among the subset with complete clinical data used for clinical analyses, early PE was diagnosed in 22 of 82 cases, whereas late PE was diagnosed in 17 of 67 cases. The DeLong test showed no significant differences (&lt;i&gt;p&lt;/i&gt; = 0.71 for late and &lt;i&gt;p&lt;/i&gt; = 0.32 for early PE). Values of Cohen's kappa were 0.97 for early and 0.89 for late PE. Data with sensitivity, specificity, and accuracy, including 95% CI, are presented in Table 3. For transparency, 2 × 2 cross-tabulations at the proposed cut-of","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":"40 16","pages":""},"PeriodicalIF":2.5,"publicationDate":"2026-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13399780/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148387617","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
Revisiting Burn Wound Infections: A Comprehensive Review on the Dual Potential of Phages and Probiotics Against Acinetobacter baumannii 重访烧伤创面感染:噬菌体和益生菌抗鲍曼不动杆菌双重潜力的综合综述。
IF 2.5 4区 医学
Journal of Clinical Laboratory Analysis Pub Date : 2026-08-31 Epub Date: 2026-07-28 DOI: 10.1002/jcla.70293
Zeinab Fagheei Aghmiyuni, Shahrzad Aliniay Sharafshadehi, Roghayeh Afifirad, Elnaz Bafandeh, Maryam Mokhtaryan, Roya Ghanavati, Atieh Darbandi
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引用次数: 0
A Comprehensive Study of Bidirectional Interactions Between the Human Microbiome and Blood Malignancies and Hematologic Conditions: Focus on Novel Therapeutic Strategies 人类微生物组与血液恶性肿瘤和血液疾病双向相互作用的综合研究:关注新的治疗策略。
IF 2.5 4区 医学
Journal of Clinical Laboratory Analysis Pub Date : 2026-08-31 Epub Date: 2026-07-09 DOI: 10.1002/jcla.70306
Alireza Molajafari, Hadi Sedigh Ebrahim-Saraie, Majid Taati Moghadam, Meysam Hasannejad-Bibalan
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引用次数: 0
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