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Unsupervised k-means clustering identified routine clinical biomarkers for classifying chronic kidney disease in patients with chronic heart failure. 无监督k-均值聚类确定了慢性心力衰竭患者慢性肾脏疾病分类的常规临床生物标志物。
IF 1 Pub Date : 2026-01-07 DOI: 10.1093/labmed/lmaf080
Liang Gong, Zhanglin Hu, Xiuying Lin, Wei Chen

Introduction: We sought to identify a diagnostic panel based on routine clinical biomarkers that can distinguish chronic kidney disease (CKD) from non-CKD among patients who have chronic heart failure (HF) and predict changes in kidney function in this patient population.

Methods: A total of 432 patients with chronic HF were enrolled at Ningde Municipal Hospital of Ningde Normal University in China. The k-means clustering method was applied to identify a diagnostic panel capable of distinguishing CKD from non-CKD and predicting changes in kidney function after 1 year in patients with chronic HF.

Results: The k-means clustering method identified 2 distinct subgroups among patients with chronic HF, demonstrating 71.59% concordance with actual CKD diagnostic labels. Five biomarkers showed a statistically significant difference between identified subgroups: albumin, lymphocyte percentage, hemoglobin, cholesterol, and apolipoprotein A. The 5-biomarker panel can distinguish CKD from non-CKD in patients with chronic HF at an area under the curve (AUC) of 0.81. Furthermore, this panel demonstrated predictive value for kidney function changes, with an AUC of 0.87 for identifying improved kidney function and 0.75 for predicting worsening kidney function.

Discussion: Our findings suggested that a panel of routine clinical biomarkers can enhance the detection of CKD in patients with chronic HF and may provide additional prognostic value beyond traditional assessments, such as estimated glomerular filtration rate.

我们试图确定一种基于常规临床生物标志物的诊断面板,可以区分慢性心力衰竭(HF)患者的慢性肾脏疾病(CKD)和非CKD,并预测该患者群体的肾功能变化。方法:选取宁德师范学院宁德市立医院慢性心衰患者432例。采用k-均值聚类方法确定能够区分CKD与非CKD的诊断面板,并预测慢性心衰患者1年后肾功能的变化。结果:k均值聚类法在慢性心衰患者中确定了2个不同的亚组,与实际CKD诊断标签的一致性为71.59%。5个生物标志物在确定的亚组之间显示有统计学意义的差异:白蛋白、淋巴细胞百分比、血红蛋白、胆固醇和载脂蛋白a。5个生物标志物面板在曲线下面积(AUC)为0.81时可以区分慢性HF患者的CKD和非CKD。此外,该面板显示了肾功能变化的预测价值,识别肾功能改善的AUC为0.87,预测肾功能恶化的AUC为0.75。讨论:我们的研究结果表明,一组常规临床生物标志物可以增强慢性心衰患者CKD的检测,并可能提供比传统评估(如估计肾小球滤过率)更多的预后价值。
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引用次数: 0
The variability of cell-derived microparticles and the age of healthy blood donors. 细胞源性微粒的变异与健康献血者的年龄。
IF 1 Pub Date : 2026-01-07 DOI: 10.1093/labmed/lmaf072
Surada Lerdwana, Duangdao Palasuwan, Attakorn Palasuwan, Egarit Noulsri

Introduction: Cell-derived microparticles that promote coagulation can lead to transfusion-related complications. Although age-dependent changes in hemostasis are known, the impact of donor age on microparticle concentration variability remains largely unexplored. We sought to determine microparticle concentrations and investigate their relationship with donor age.

Methods: Whole-blood samples were collected from volunteers aged 17 to 60 years using K3EDTA as an anticoagulant. Donors were allocated to 1 of 5 age groups. Flow cytometric analysis and counting beads were used to determine microparticle concentrations and their origins.

Results: A cross-sectional study of 394 blood donors revealed a mean (SD) total microparticle count of 25 693 (1578), 26 956 (976), 26 979 (989), 24 886 (987), and 271 331 (1355) particles/µL in blood donors aged 17 to 20, 21 to 30, 31 to 40, 41 to 50, and 51 to 60 years, respectively. Similarly, there were no statistically significant differences in the concentrations of red blood cell (RBC)-derived microparticles, platelet-derived microparticles, or leukocyte-derived microparticles among the donor age groups. Linear regression analysis revealed that the r2 values between the total microparticle, RBC-derived microparticle, platelet-derived microparticle, and leukocyte-derived microparticle concentrations in whole blood and donor age were less than 0.01.

Discussion: Our assessment of microparticle concentration across different blood donor age groups revealed age-independent variability in microparticle levels. These findings enhance our understanding of how donor factors influence microparticle values.

导言:促进凝血的细胞源性微粒可导致输血相关并发症。虽然已知年龄依赖性止血变化,但供体年龄对微粒浓度变异性的影响在很大程度上仍未被探索。我们试图确定微粒浓度,并研究它们与供体年龄的关系。方法:采用K3EDTA作为抗凝剂,采集17 ~ 60岁志愿者全血样本。捐助者被分配到5个年龄组中的1个。采用流式细胞分析和计数珠测定微粒浓度及其来源。结果:一项对394名献血者的横断面研究显示,17 ~ 20岁、21 ~ 30岁、31 ~ 40岁、41 ~ 50岁和51 ~ 60岁献血者的平均(SD)总微粒计数分别为25693(1578)、26956(976)、26979(989)、24886(987)和27331(1355)粒/µL。同样,在供体年龄组中,红细胞(RBC)来源的微颗粒、血小板来源的微颗粒或白细胞来源的微颗粒的浓度没有统计学上的显著差异。线性回归分析显示,全血总微粒浓度、红细胞源性微粒浓度、血小板源性微粒浓度和白细胞源性微粒浓度与供者年龄之间的r2值均小于0.01。讨论:我们对不同年龄段献血者微粒浓度的评估揭示了微粒水平与年龄无关的变异性。这些发现增强了我们对供体因素如何影响微粒值的理解。
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引用次数: 0
Analysis of the clinical significance of serum anti-PLA2R antibodies in evaluating clinical features and therapeutic efficacy in idiopathic membranous nephropathy. 血清抗pla2r抗体在评价特发性膜性肾病临床特征及疗效中的临床意义分析。
IF 1 Pub Date : 2026-01-07 DOI: 10.1093/labmed/lmaf086
Hongying Tang, Xian Cai, Lining Guo, Xiaozhen Qi, Kailiang Wu

Introduction: This study aimed to evaluate the clinical utility of serum anti-phospholipase A2 receptor (PLA2R) antibodies in assessing clinical features and therapeutic responses in idiopathic membranous nephropathy (IMN).

Methods: A retrospective analysis was conducted on 99 patients with IMN admitted to Tianjin Medical University General Hospital between August 2023 and April 2024, stratified into seronegative and seropositive groups. Baseline characteristics, biochemical parameters, anti-PLA2R antibody levels, and 3 treatment strategy outcomes were analyzed. Receiver operating characteristic curve analysis assessed the diagnostic accuracy of anti-PLA2R antibodies.

Results: Results revealed statistically significant differences in albumin and urine total protein (U-TP) between the seronegative and seropositive groups (P < .05). Compared with the seropositive group, patients in the seronegative group had a better prognosis. Compared with the tacrolimus plus methylprednisolone and cyclophosphamide plus methylprednisolone treatment regimens, the recovery of microalbuminuria, U-TP, albumin, and anti-PLA2R was greatest after treatment with rituximab, and the therapeutic effect was better. Importantly, among these 4 markers, the change in anti-PLA2R was most substantial. The receiver operating characteristic analysis identified an optimal anti-PLA2R cutoff of 15.53 ng/mL, achieving 76.77% sensitivity, 100% specificity, and an area under the curve of 93.3% (P < .001).

Discussion: These findings highlight that rituximab demonstrates substantial clinical value in improving serum albumin levels, reducing U-TP, microalbuminuria, and anti-PLA2R antibody levels in patients with IMN while also underscoring the critical role of anti-PLA2R antibodies in IMN characterization and therapeutic monitoring.

本研究旨在评估血清抗磷脂酶A2受体(PLA2R)抗体在评估特发性膜性肾病(IMN)的临床特征和治疗反应中的临床应用。方法:对2023年8月至2024年4月天津医科大学总医院收治的99例IMN患者进行回顾性分析,分为血清阴性组和血清阳性组。分析基线特征、生化参数、抗pla2r抗体水平和3种治疗策略结果。受试者工作特征曲线分析评估抗pla2r抗体的诊断准确性。结果:结果显示血清阴性组和血清阳性组在白蛋白和尿总蛋白(U-TP)方面存在统计学上的显著差异(P讨论:这些发现强调了利美昔单抗在改善IMN患者血清白蛋白水平、降低U-TP、微量白蛋白尿和抗pla2r抗体水平方面具有重要的临床价值,同时也强调了抗pla2r抗体在IMN表征和治疗监测中的关键作用。
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引用次数: 0
Stability study of lactate dehydrogenase activity in serum samples at different temperatures and times according to Spanish Society of Laboratory Medicine recommendations. 根据西班牙检验医学学会的建议,在不同温度和时间下血清样品乳酸脱氢酶活性的稳定性研究。
IF 1 Pub Date : 2026-01-07 DOI: 10.1093/labmed/lmaf062
Reyes Nicolás de Blas, Miriam Menacho Román, Ignacio Arribas Gómez, Paula Orejas Rodríguez-Marqués, Rubén Gómez Rioja

Introduction: To ensure adequate quality of clinical samples, laboratories must control samples' postanalytical preservation. We checked the stability limit of lactate dehydrogenase (LDH) and confirmed the 72-hour limit the manufacturer proposes, then evaluated sample stability under our working conditions using new recommendations for stability studies.

Methods: Leftover outpatient samples were randomly selected. Serum tubes with separator gel were used for primary sample collection. In a preliminary study of samples from 6 patients, we made determinations at baseline, 24, 48, and 72 hours for aliquots stored at room temperature and refrigerated. An extended study in refrigerated samples was performed on 10 samples of leftover serum at baseline and 12, 24, 36, 48, 60, and 72 hours.

Results: We found no substantial variation in samples at room temperature. In the extended study, an LDH decrease of 1.5% per day is expected up to 72 hours based on the formula PD% = 0.064 ×time [h].

Discussion: The available literature on stability studies is extensive and varies in terms of working methodology. Therefore, laboratories should follow recommendations from standardized and updated documents. We modified manufacturer stability recommendations by reducing the stability of refrigerated LDH samples in our laboratory automation system from 72 hours to 48 hours.

为了保证临床样品的质量,实验室必须控制样品的分析后保存。我们检查了乳酸脱氢酶(LDH)的稳定性极限,并确认了制造商提出的72小时极限,然后使用稳定性研究的新建议在我们的工作条件下评估样品稳定性。方法:随机抽取门诊剩余样本。采用带分离凝胶的血清管进行初级样本采集。在对6例患者样本的初步研究中,我们在基线、24、48和72小时对室温和冷藏的等量液体进行了测定。在基线和12、24、36、48、60和72小时对10份剩余血清样本进行了冷藏样本的扩展研究。结果:样品在室温下无明显变化。在扩展研究中,根据公式PD% = 0.064 ×time [h],预计LDH在72小时内每天降低1.5%。讨论:关于稳定性研究的现有文献是广泛的,在工作方法方面各不相同。因此,实验室应遵循标准化和更新文件的建议。我们修改了制造商稳定性建议,将实验室自动化系统中冷藏LDH样品的稳定性从72小时降低到48小时。
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引用次数: 0
SARS-CoV-2 humoral immunity is associated with elevated hemoglobin A1c. SARS-CoV-2体液免疫与糖化血红蛋白升高有关。
IF 1 Pub Date : 2026-01-07 DOI: 10.1093/labmed/lmaf036
Darryl E Palmer-Toy, Rui Yan, Komal J Narwaney, Aida Legaspi, Michael Aragones, Jessica A Lam, John M Chang, Cecilia Portugal, Katia J Bruxvoort, Jason M Glanz, Ingrid A Binswanger

Introduction: This prospective study assessed relationships between COVID-19, humoral immunity, and common laboratory test results.

Methods: Blood and urine were collected from adults with clinical SARS-CoV-2 test results before August 2021: nucleic acid amplification (NAA) tests and antinucleocapsid protein (αN) serology. Measurements were made of αN and 13 laboratory tests, and results were compared across groups defined by NAA and αN status.

Results: Glycated hemoglobin (HbA1c) and platelet counts were clinically significantly higher among individuals who had COVID-19 than in individuals without evidence of COVID-19. Hemoglobin was more abnormal among patients without evidence of COVID-19. Glycated hemoglobin results were also much higher among patients with prior positive NAA and current or prior positive αN results than in individuals with negative αN results. No other statistically significant associations between NAA or αN and abnormal laboratory results were found.

Discussion: Elevated HbA1c results were associated with prior positive NAA findings combined with positive αN results but not with negative αN results. Further investigation into the association of dysregulated glycemic control with humoral immunity to natural infection is warranted, given the well-documented increase in incidence in type 1 and type 2 diabetes following COVID-19. Prior positive NAA results were also associated with a few nonspecific abnormalities of the complete blood cell count.

本前瞻性研究评估了COVID-19、体液免疫和常见实验室检测结果之间的关系。方法:采集2021年8月前SARS-CoV-2临床检测结果的成人血、尿:核酸扩增(NAA)检测和抗核衣壳蛋白(αN)血清学检测。测量αN和13项实验室测试,并将NAA和αN状态定义的组间结果进行比较。结果:COVID-19患者的糖化血红蛋白(HbA1c)和血小板计数明显高于无COVID-19证据的患者。无COVID-19证据的患者血红蛋白异常较多。先前NAA阳性、当前αN阳性或先前αN阳性的患者糖化血红蛋白结果也比αN阴性的患者高得多。NAA、αN与实验室异常结果无统计学意义。讨论:HbA1c升高与先前NAA阳性结果合并αN阳性结果相关,但与αN阴性结果无关。鉴于有充分证据表明,COVID-19后1型和2型糖尿病的发病率增加,有必要进一步调查血糖控制失调与体液免疫对自然感染的关系。先前的NAA阳性结果也与全血细胞计数的一些非特异性异常有关。
{"title":"SARS-CoV-2 humoral immunity is associated with elevated hemoglobin A1c.","authors":"Darryl E Palmer-Toy, Rui Yan, Komal J Narwaney, Aida Legaspi, Michael Aragones, Jessica A Lam, John M Chang, Cecilia Portugal, Katia J Bruxvoort, Jason M Glanz, Ingrid A Binswanger","doi":"10.1093/labmed/lmaf036","DOIUrl":"10.1093/labmed/lmaf036","url":null,"abstract":"<p><strong>Introduction: </strong>This prospective study assessed relationships between COVID-19, humoral immunity, and common laboratory test results.</p><p><strong>Methods: </strong>Blood and urine were collected from adults with clinical SARS-CoV-2 test results before August 2021: nucleic acid amplification (NAA) tests and antinucleocapsid protein (αN) serology. Measurements were made of αN and 13 laboratory tests, and results were compared across groups defined by NAA and αN status.</p><p><strong>Results: </strong>Glycated hemoglobin (HbA1c) and platelet counts were clinically significantly higher among individuals who had COVID-19 than in individuals without evidence of COVID-19. Hemoglobin was more abnormal among patients without evidence of COVID-19. Glycated hemoglobin results were also much higher among patients with prior positive NAA and current or prior positive αN results than in individuals with negative αN results. No other statistically significant associations between NAA or αN and abnormal laboratory results were found.</p><p><strong>Discussion: </strong>Elevated HbA1c results were associated with prior positive NAA findings combined with positive αN results but not with negative αN results. Further investigation into the association of dysregulated glycemic control with humoral immunity to natural infection is warranted, given the well-documented increase in incidence in type 1 and type 2 diabetes following COVID-19. Prior positive NAA results were also associated with a few nonspecific abnormalities of the complete blood cell count.</p>","PeriodicalId":94124,"journal":{"name":"Laboratory medicine","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2026-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12822492/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145380266","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Evaluation of platelet count and procalcitonin in differentiating gram-negative and gram-positive bacterial infection in emergency department patients: a retrospective cohort study. 评价血小板计数和降钙素原在鉴别急诊科患者革兰氏阴性和革兰氏阳性细菌感染中的作用:一项回顾性队列研究。
IF 1 Pub Date : 2026-01-07 DOI: 10.1093/labmed/lmaf081
Fen Wang, Lingbin Shu, Jinyi Liu, Jiacheng Lai, Xiaofeng Yang

Introduction: Early identification of whether bloodstream infections (BSIs) are caused by gram-negative or gram-positive bacteria is crucial for initiating timely and appropriate antibiotic treatment. This study aimed to investigate potential laboratory markers for predicting the type of bacterial infection in patients with suspected BSI.

Methods: Patients who presented at the emergency department with positive blood cultures were included in this study. Clinical and laboratory data collected within the first 24 hours of admission were analyzed.

Results: The study included 338 patients. Clinically significant differences in platelet count and procalcitonin (PCT) level were observed between patients with gram-positive and gram-negative infections. Platelet counts and PCT levels as predictors of infection were relatively ineffective, however, with receiver operating characteristic (ROC) area under the curve (AUC) values of 0.63 and 0.66, respectively. Subsequently, a specific cluster of patients characterized by normal to high platelet counts (170-318 ×109/L) and mildly elevated PCT levels (0-31.06 ng/mL) was identified using k means clustering. In this cluster, platelet counts of 284 ×109/L or higher combined with PCT levels of 2.73 ng/mL or less demonstrated a sensitivity of 70.3%, a specificity of 78.9%, and ROC AUC values of 0.82 for predicting gram-positive bacterial infections.

Discussion: The combined use of platelet count and PCT level could predict gram-positive bacterial infections in specific populations. This study may provide a practical strategy for the rapid identification of bacterial groups in patients with suspected BSI.

早期识别血流感染(bsi)是由革兰氏阴性菌还是革兰氏阳性菌引起的,对于及时开始适当的抗生素治疗至关重要。本研究旨在探讨预测疑似BSI患者细菌感染类型的潜在实验室标志物。方法:在急诊科出现阳性血培养的患者纳入本研究。对入院前24小时内收集的临床和实验室数据进行分析。结果:纳入338例患者。革兰氏阳性和革兰氏阴性感染患者血小板计数和降钙素原(PCT)水平的临床差异有统计学意义。然而,血小板计数和PCT水平作为感染的预测指标相对无效,受试者工作特征(ROC)曲线下面积(AUC)分别为0.63和0.66。随后,使用k均值聚类方法确定了一组以正常至高血小板计数(170-318 ×109/L)和轻度升高PCT水平(0-31.06 ng/mL)为特征的特定患者。在这个集群中,血小板计数284 ×109/L或更高,PCT水平2.73 ng/mL或更低,预测革兰氏阳性细菌感染的敏感性为70.3%,特异性为78.9%,ROC AUC值为0.82。讨论:联合使用血小板计数和PCT水平可以预测特定人群的革兰氏阳性细菌感染。本研究可能为快速鉴定疑似BSI患者的细菌群提供实用策略。
{"title":"Evaluation of platelet count and procalcitonin in differentiating gram-negative and gram-positive bacterial infection in emergency department patients: a retrospective cohort study.","authors":"Fen Wang, Lingbin Shu, Jinyi Liu, Jiacheng Lai, Xiaofeng Yang","doi":"10.1093/labmed/lmaf081","DOIUrl":"https://doi.org/10.1093/labmed/lmaf081","url":null,"abstract":"<p><strong>Introduction: </strong>Early identification of whether bloodstream infections (BSIs) are caused by gram-negative or gram-positive bacteria is crucial for initiating timely and appropriate antibiotic treatment. This study aimed to investigate potential laboratory markers for predicting the type of bacterial infection in patients with suspected BSI.</p><p><strong>Methods: </strong>Patients who presented at the emergency department with positive blood cultures were included in this study. Clinical and laboratory data collected within the first 24 hours of admission were analyzed.</p><p><strong>Results: </strong>The study included 338 patients. Clinically significant differences in platelet count and procalcitonin (PCT) level were observed between patients with gram-positive and gram-negative infections. Platelet counts and PCT levels as predictors of infection were relatively ineffective, however, with receiver operating characteristic (ROC) area under the curve (AUC) values of 0.63 and 0.66, respectively. Subsequently, a specific cluster of patients characterized by normal to high platelet counts (170-318 ×109/L) and mildly elevated PCT levels (0-31.06 ng/mL) was identified using k means clustering. In this cluster, platelet counts of 284 ×109/L or higher combined with PCT levels of 2.73 ng/mL or less demonstrated a sensitivity of 70.3%, a specificity of 78.9%, and ROC AUC values of 0.82 for predicting gram-positive bacterial infections.</p><p><strong>Discussion: </strong>The combined use of platelet count and PCT level could predict gram-positive bacterial infections in specific populations. This study may provide a practical strategy for the rapid identification of bacterial groups in patients with suspected BSI.</p>","PeriodicalId":94124,"journal":{"name":"Laboratory medicine","volume":"57 1","pages":""},"PeriodicalIF":1.0,"publicationDate":"2026-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146014018","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}
引用次数: 0
Comparison of the DRI II and LZI I fentanyl immunoassays for in vitro clinical diagnostic use. DRI II和LZI I芬太尼免疫测定法在体外临床诊断中的比较。
IF 1 Pub Date : 2026-01-07 DOI: 10.1093/labmed/lmaf079
Halimat Olaniyan, Jennifer Beckman, Elizabeth Crosby, David Shepherd, Rejwi A Dahal

Introduction: Fentanyl, a highly potent synthetic opioid, has contributed to a rapid rise in opioid-related overdoses and fatalities nationwide. Consequently, the need for accurate and timely testing for fentanyl has become critical. Immunoassay screens, reported as presumptive positive or negative, help address this need. We sought to compare the clinical performance of 2 US Food and Drug Administration (FDA)-approved fentanyl immunoassays-the Thermo Scientific DRI Fentanyl II Drugs of Abuse Assay and the Lin-Zhi International LZI Fentanyl (Q) Enzyme Immunoassay-for detection of fentanyl and its metabolites in urine, using liquid chromatography-tandem mass spectrometry (LC-MS/MS) as the reference method.

Methods: A total of 806 urine specimens were screened using 2 FDA-approved fentanyl immunoassays on Beckman Coulter DxC 700 AU Chemistry Analyzer. Of these specimens, 183 that were both positive and negative by immunoassay were further analyzed by LC-MS/MS for the presence or absence of fentanyl, norfentanyl, and 4-anilino-N-phenethylpiperidine (4-ANPP).

Results: Of the 806 specimens, 786 (98%) provided concordant results and 20 (2%) had discordant results between the 2 immunoassays. Concordance between immunoassays and LC-MS/MS was 97% for the LZI assay and 89% for the DRI assay. Among the 183 specimens tested, 4-ANPP was detected in 13 (7%).

Discussion: The 2 assays demonstrated comparable clinical utility for incorporation into a urine drug screen panel.

芬太尼是一种强效的合成阿片类药物,已导致全国阿片类药物过量和死亡人数迅速上升。因此,对芬太尼进行准确和及时的检测变得至关重要。报告推定阳性或阴性的免疫测定筛查有助于解决这一需求。我们采用液相色谱-串联质谱(LC-MS/MS)作为参比方法,比较美国食品和药物管理局(FDA)批准的两种芬太尼免疫测定法——Thermo Scientific DRI fentanyl II药物滥用测定法和Lin-Zhi International LZI fentanyl (Q)酶免疫测定法检测尿液中芬太尼及其代谢物的临床性能。方法:采用经fda批准的2种芬太尼免疫分析法,在Beckman Coulter DxC 700 AU化学分析仪上对806份尿液标本进行筛选。其中183例免疫测定阳性和阴性的标本,进一步采用LC-MS/MS分析芬太尼、去芬太尼和4-苯胺- n -苯乙基哌啶(4-ANPP)的存在或不存在。结果:806例标本中,786例(98%)免疫检测结果一致,20例(2%)免疫检测结果不一致。免疫测定法与LC-MS/MS之间LZI测定法的一致性为97%,DRI测定法的一致性为89%。183例标本中检出4-ANPP 13例(7%)。讨论:这两种检测方法在纳入尿药物筛查组方面具有可比性的临床效用。
{"title":"Comparison of the DRI II and LZI I fentanyl immunoassays for in vitro clinical diagnostic use.","authors":"Halimat Olaniyan, Jennifer Beckman, Elizabeth Crosby, David Shepherd, Rejwi A Dahal","doi":"10.1093/labmed/lmaf079","DOIUrl":"10.1093/labmed/lmaf079","url":null,"abstract":"<p><strong>Introduction: </strong>Fentanyl, a highly potent synthetic opioid, has contributed to a rapid rise in opioid-related overdoses and fatalities nationwide. Consequently, the need for accurate and timely testing for fentanyl has become critical. Immunoassay screens, reported as presumptive positive or negative, help address this need. We sought to compare the clinical performance of 2 US Food and Drug Administration (FDA)-approved fentanyl immunoassays-the Thermo Scientific DRI Fentanyl II Drugs of Abuse Assay and the Lin-Zhi International LZI Fentanyl (Q) Enzyme Immunoassay-for detection of fentanyl and its metabolites in urine, using liquid chromatography-tandem mass spectrometry (LC-MS/MS) as the reference method.</p><p><strong>Methods: </strong>A total of 806 urine specimens were screened using 2 FDA-approved fentanyl immunoassays on Beckman Coulter DxC 700 AU Chemistry Analyzer. Of these specimens, 183 that were both positive and negative by immunoassay were further analyzed by LC-MS/MS for the presence or absence of fentanyl, norfentanyl, and 4-anilino-N-phenethylpiperidine (4-ANPP).</p><p><strong>Results: </strong>Of the 806 specimens, 786 (98%) provided concordant results and 20 (2%) had discordant results between the 2 immunoassays. Concordance between immunoassays and LC-MS/MS was 97% for the LZI assay and 89% for the DRI assay. Among the 183 specimens tested, 4-ANPP was detected in 13 (7%).</p><p><strong>Discussion: </strong>The 2 assays demonstrated comparable clinical utility for incorporation into a urine drug screen panel.</p>","PeriodicalId":94124,"journal":{"name":"Laboratory medicine","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2026-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145608091","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}
引用次数: 0
Hepatocellular carcinoma: PIVKA-II may be unsuitable for Indian patients. 肝细胞癌:PIVKA-II可能不适合印度患者。
IF 1 Pub Date : 2026-01-07 DOI: 10.1093/labmed/lmaf065
Dinesh Jothimani, Sathish Srinivasan, Evangeline Simon, Lexmi Priya Raju, Hemalatha Ramachandran, Abraham Sam Rajan, Komalavalli Subbiah, Mukul Vij, Mohamed Rela

Introduction: Hepatocellular carcinoma (HCC) diagnosis requires a combination of elevated ɑ-fetoprotein (AFP) levels and liver imaging. We evaluated the role of prothrombin induced by vitamin K antagonist-II (PIVKA-II) in patients with suspected HCC.

Methods: A retrospective analysis was conducted on adult Indian patients with suspected HCC who had elevated AFP and PIVKA-II levels and had undergone radiologic investigation.

Results: Among 178 suspected cases, 144 (80.99%) were diagnosed with HCC; the median age of these 144 patients was 62 years (IQR, 54-68 years). The median AFP and PIVKA-II levels were 14.68 ng/mL (IQR, 3.83-146.50 ng/mL) and 354.50 ng/mL (IQR, 49.41-4293.40 ng/mL), respectively. The sensitivity and specificity were 52.08% and 88.24% for AFP (≥10 ng/mL) and 80.56% and 32.35% for PIVKA-II (≥40 ng/mL). The false positivity rate of PIVKA-II was 67.60%. PIVKA-II showed moderate correlation (r = 0.413) with HCC size and was more reliable than AFP for HCC lesions larger than 5 cm (area under the curve = 0.731 vs 0.627). PIVKA-II levels were lower following therapy for HCC (682.98-122.50 ng/mL; P < .001) than AFP levels (15.05-6.50 ng/mL; P = .30). Among AFP-negative patients with HCC, 68.10% had elevated PIVKA-II levels.

Discussion: With its higher false positivity rate, PIVKA-II may not be a reliable marker for HCC, although it may be useful in larger HCC lesions and in AFP-negative patients. Establishing a newer cutoff value for PIVKA-II among the Indian population may improve its specificity in the diagnosis and management of HCC.

肝细胞癌(HCC)的诊断需要结合升高的胎儿蛋白(AFP)水平和肝脏影像学检查。我们评估了维生素K拮抗剂- ii (PIVKA-II)诱导的凝血酶原在疑似HCC患者中的作用。方法:回顾性分析AFP和PIVKA-II水平升高并行放射学检查的印度成年疑似HCC患者。结果:178例疑似病例中,144例(80.99%)确诊为HCC;144例患者的中位年龄为62岁(IQR, 54-68岁)。中位AFP和PIVKA-II水平分别为14.68 ng/mL (IQR, 3.83 ~ 146.50 ng/mL)和354.50 ng/mL (IQR, 49.41 ~ 4293.40 ng/mL)。AFP(≥10 ng/mL)的敏感性为52.08%,特异性为88.24%;PIVKA-II(≥40 ng/mL)的敏感性为80.56%,特异性为32.35%。PIVKA-II假阳性率为67.60%。PIVKA-II与HCC大小呈中等相关性(r = 0.413),对于大于5 cm的HCC病变,PIVKA-II比AFP更可靠(曲线下面积= 0.731 vs 0.627)。PIVKA-II水平在HCC治疗后较低(682.98-122.50 ng/mL); P讨论:由于其较高的假阳性率,PIVKA-II可能不是HCC的可靠标志物,尽管它可能对较大的HCC病变和afp阴性患者有用。在印度人群中建立一个新的PIVKA-II的临界值可能会提高其在HCC诊断和治疗中的特异性。
{"title":"Hepatocellular carcinoma: PIVKA-II may be unsuitable for Indian patients.","authors":"Dinesh Jothimani, Sathish Srinivasan, Evangeline Simon, Lexmi Priya Raju, Hemalatha Ramachandran, Abraham Sam Rajan, Komalavalli Subbiah, Mukul Vij, Mohamed Rela","doi":"10.1093/labmed/lmaf065","DOIUrl":"10.1093/labmed/lmaf065","url":null,"abstract":"<p><strong>Introduction: </strong>Hepatocellular carcinoma (HCC) diagnosis requires a combination of elevated ɑ-fetoprotein (AFP) levels and liver imaging. We evaluated the role of prothrombin induced by vitamin K antagonist-II (PIVKA-II) in patients with suspected HCC.</p><p><strong>Methods: </strong>A retrospective analysis was conducted on adult Indian patients with suspected HCC who had elevated AFP and PIVKA-II levels and had undergone radiologic investigation.</p><p><strong>Results: </strong>Among 178 suspected cases, 144 (80.99%) were diagnosed with HCC; the median age of these 144 patients was 62 years (IQR, 54-68 years). The median AFP and PIVKA-II levels were 14.68 ng/mL (IQR, 3.83-146.50 ng/mL) and 354.50 ng/mL (IQR, 49.41-4293.40 ng/mL), respectively. The sensitivity and specificity were 52.08% and 88.24% for AFP (≥10 ng/mL) and 80.56% and 32.35% for PIVKA-II (≥40 ng/mL). The false positivity rate of PIVKA-II was 67.60%. PIVKA-II showed moderate correlation (r = 0.413) with HCC size and was more reliable than AFP for HCC lesions larger than 5 cm (area under the curve = 0.731 vs 0.627). PIVKA-II levels were lower following therapy for HCC (682.98-122.50 ng/mL; P < .001) than AFP levels (15.05-6.50 ng/mL; P = .30). Among AFP-negative patients with HCC, 68.10% had elevated PIVKA-II levels.</p><p><strong>Discussion: </strong>With its higher false positivity rate, PIVKA-II may not be a reliable marker for HCC, although it may be useful in larger HCC lesions and in AFP-negative patients. Establishing a newer cutoff value for PIVKA-II among the Indian population may improve its specificity in the diagnosis and management of HCC.</p>","PeriodicalId":94124,"journal":{"name":"Laboratory medicine","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2026-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145575198","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}
引用次数: 0
Correction to: Evaluation of CD73, PD-1, circHIPK3, and circNRIP1 expression in the peripheral blood of patients with colorectal cancer. 修正:评估CD73、PD-1、circHIPK3和circNRIP1在结直肠癌患者外周血中的表达。
IF 1 Pub Date : 2026-01-07 DOI: 10.1093/labmed/lmaf063
{"title":"Correction to: Evaluation of CD73, PD-1, circHIPK3, and circNRIP1 expression in the peripheral blood of patients with colorectal cancer.","authors":"","doi":"10.1093/labmed/lmaf063","DOIUrl":"10.1093/labmed/lmaf063","url":null,"abstract":"","PeriodicalId":94124,"journal":{"name":"Laboratory medicine","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2026-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145764706","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}
引用次数: 0
The clinical value of metagenomic next-generation sequencing for diagnosing pulmonary infections in kidney transplant recipients. 新一代宏基因组测序诊断肾移植受者肺部感染的临床价值。
IF 1 Pub Date : 2026-01-07 DOI: 10.1093/labmed/lmaf035
Xiaohong Qin, Panyan Liu, DaQing Lu, Tingting Lu, Chunhong Li, Zhenfeng Deng, Zhiang Liu

Introduction: Rapid and accurate identification of pathogens is essential for managing lung infections in patients following kidney transplantation. This study aimed to compare the diagnostic performance and clinical utility of conventional detection methods and metagenomic next-generation sequencing (NGS) in kidney transplant recipients with respiratory infections.

Methods: We conducted a retrospective analysis of metagenomic NGS and conventional detection method results in 71 patients, examining the spectrum of pathogen detection characteristics between the 2 methods.

Results: The overall positivity rate of conventional detection methods was statistically significantly lower than that of metagenomic NGS (61.97% vs 84.51%, P = .004). Among the 38 participants who tested positive by both methods, metagenomic NGS identified a greater number of pathogens than conventional detection methods. Following metagenomic NGS results, antibiotic therapy was modified in 71.83% of participants, leading to improved prognoses in 33.33% of patients. In additionally, metagenomic NGS demonstrated a shorter turnaround time than conventional detection methods. The most prevalent bacteria identified in pulmonary infections among kidney transplant recipients were Klebsiella pneumoniae, while cytomegalovirus was the most common virus and Pneumocystis jirovecii was the predominant fungus.

Discussion: This study offers preliminary insights into the spectrum of pathogens responsible for pulmonary infections following kidney transplantation, laying the foundation for better understanding their clinical characteristics. In patients with post-transplant pulmonary infections, metagenomic NGS outperforms conventional detection methods in terms of pathogen detection, speed, positivity rate, sensitivity, and ability to diagnose mixed infections.

快速准确地鉴定病原体对于处理肾移植后患者肺部感染至关重要。本研究旨在比较传统检测方法和新一代宏基因组测序(NGS)对肾移植受者呼吸道感染的诊断性能和临床应用。方法:回顾性分析71例患者宏基因组NGS和常规检测结果,比较两种方法的病原菌检测谱特征。结果:常规检测方法的总阳性率低于宏基因组NGS (61.97% vs 84.51%, P = 0.004)。在两种检测方法均呈阳性的38名参与者中,宏基因组NGS比传统检测方法鉴定出更多的病原体。宏基因组NGS结果显示,71.83%的参与者改变了抗生素治疗,33.33%的患者预后改善。此外,宏基因组NGS比传统检测方法的周转时间更短。肾移植受者肺部感染中最常见的细菌是肺炎克雷伯菌,而巨细胞病毒是最常见的病毒,而肺囊虫是主要的真菌。讨论:本研究提供了对肾移植后肺部感染病原体谱的初步认识,为更好地理解其临床特征奠定了基础。在移植后肺部感染患者中,宏基因组NGS在病原体检测、速度、阳性率、敏感性和诊断混合感染能力等方面优于传统检测方法。
{"title":"The clinical value of metagenomic next-generation sequencing for diagnosing pulmonary infections in kidney transplant recipients.","authors":"Xiaohong Qin, Panyan Liu, DaQing Lu, Tingting Lu, Chunhong Li, Zhenfeng Deng, Zhiang Liu","doi":"10.1093/labmed/lmaf035","DOIUrl":"10.1093/labmed/lmaf035","url":null,"abstract":"<p><strong>Introduction: </strong>Rapid and accurate identification of pathogens is essential for managing lung infections in patients following kidney transplantation. This study aimed to compare the diagnostic performance and clinical utility of conventional detection methods and metagenomic next-generation sequencing (NGS) in kidney transplant recipients with respiratory infections.</p><p><strong>Methods: </strong>We conducted a retrospective analysis of metagenomic NGS and conventional detection method results in 71 patients, examining the spectrum of pathogen detection characteristics between the 2 methods.</p><p><strong>Results: </strong>The overall positivity rate of conventional detection methods was statistically significantly lower than that of metagenomic NGS (61.97% vs 84.51%, P = .004). Among the 38 participants who tested positive by both methods, metagenomic NGS identified a greater number of pathogens than conventional detection methods. Following metagenomic NGS results, antibiotic therapy was modified in 71.83% of participants, leading to improved prognoses in 33.33% of patients. In additionally, metagenomic NGS demonstrated a shorter turnaround time than conventional detection methods. The most prevalent bacteria identified in pulmonary infections among kidney transplant recipients were Klebsiella pneumoniae, while cytomegalovirus was the most common virus and Pneumocystis jirovecii was the predominant fungus.</p><p><strong>Discussion: </strong>This study offers preliminary insights into the spectrum of pathogens responsible for pulmonary infections following kidney transplantation, laying the foundation for better understanding their clinical characteristics. In patients with post-transplant pulmonary infections, metagenomic NGS outperforms conventional detection methods in terms of pathogen detection, speed, positivity rate, sensitivity, and ability to diagnose mixed infections.</p>","PeriodicalId":94124,"journal":{"name":"Laboratory medicine","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2026-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145380359","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}
引用次数: 0
期刊
Laboratory medicine
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