Clinica Chimica Acta最新文献

{"title":"Statistical uncertainty and unquantified selection bias in euthyroid hyperthyroxinemia research","authors":"Linjun Wang, Haiying Hu","doi":"10.1016/j.cca.2025.120483","DOIUrl":"10.1016/j.cca.2025.120483","url":null,"abstract":"","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"577 ","pages":"Article 120483"},"PeriodicalIF":3.2,"publicationDate":"2025-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144632621","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Human diagnostic markers for intake of semi-synthetic cannabinoids (9R)- and (9S)-Hexahydrocannabinol.","authors":"Prince S Gameli, Omayema Taoussi, Sara Malaca, Annagiulia Di Trana, Livio P Tronconi, Simona Pichini, Jeremy Carlier, Marilyn A Huestis, Francesco P Busardò","doi":"10.1016/j.cca.2025.120480","DOIUrl":"https://doi.org/10.1016/j.cca.2025.120480","url":null,"abstract":"<p><strong>Background: </strong>Hexahydrocannabinol (HHC) emerged on the illicit drug market in 2022, especially in cannabinoid consumables. HHC has a chiral center and is present as 9(R) and 9(S) epimers, exhibiting different potencies. This study explores the enantioselective metabolism of 9(R)- and 9(S)-HHC to identify and differentiate intake of these two toxicants.</p><p><strong>Methods: </strong>9(R)- and 9(S)-HHC were incubated separately with human hepatocytes for 3 h and analyzed by liquid chromatography-high resolution mass spectrometry. In addition, authentic urine samples collected 0.5, 3 and 24 h after HHC intake were also analyzed to identify biomarkers. In silico predictions were performed to complement in vitro and in vivo experiments with data mining analysis.</p><p><strong>Results: </strong>In silico metabolites predicted were transformed via hydroxylation, carboxylation, and alcohol oxidation to ketones and further conjugated through phase II glucuronidation and sulfation reactions. Thirteen metabolites were identified following 9(R)-HHC in vitro incubation and nine for 9(S)-HHC incubate. In human urine, nineteen metabolites were identified, ten and six specific 9R- and 9S-HHC metabolites, respectively, and three undefined for a specific isomer. However, 9(R)- and 9(S)-HHC were not detected in the urine under these analytical conditions.</p><p><strong>Conclusion: </strong>The stereoselective metabolism of 9(R)- and 9(S)-HHC was observed in in vitro incubation and in vivo authentic urine. Phase I metabolites were substantially conjugated as glucuronides. Without hydrolysis, M_U1 and M_U10 are recommended markers for 9(R)-HHC and M_U7 for 9(S)-HHC consumption. M_U3, M_U4, and M_U16 are proposed as metabolite biomarkers for HHC intake, after hydrolysis. Additionally, difference in HHC and Δ⁹-THC metabolism was observed.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120480"},"PeriodicalIF":3.2,"publicationDate":"2025-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144636333","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Enhancing primary newborn screening efficiency for congenital adrenal hyperplasia with LC-MS/MS/MS","authors":"Alexander Gaudl,&nbsp;Laura Lehmicke,&nbsp;Ronald Biemann,&nbsp;Julia Dittrich,&nbsp;Uta Ceglarek","doi":"10.1016/j.cca.2025.120482","DOIUrl":"10.1016/j.cca.2025.120482","url":null,"abstract":"<div><h3>Background</h3><div>Newborn screening (NBS) for congenital adrenal hyperplasia (CAH) by immunoassay (IA) suffers from analytical limitations like cross reactivity and matrix effects. Alternative tandem-mass spectrometric approaches are not suitable for high-throughput screening due to long analysis times. In this study, a rapid 1.5 min LC-MS/MS/MS (MS³) assay was applied for the first time, maturity-dependent cutoffs were determined, and the diagnostic efficiency was compared to IA for primary CAH NBS.</div></div><div><h3>Methods</h3><div>1730 selected residual dried blood samples from routine NBS (gestation week 24–41) were subjected to online-SPE-LC-MS³ quantitation of 17–Hydroxyprogesterone (17-OHP). This approach utilizes two-stage fragmentation (MS³, 17-OHP <em>m</em>/<em>z</em> 329/285/123) carried out by triple quadrupole-ion trap hybrid MS. Cutoff values were calculated depending on gestational age (GA) and birthweight (BW). Diagnostic efficiency was compared to an established IA for primary CAH screening.</div></div><div><h3>Results</h3><div>Intermediate precision was 10–13 % with an accuracy of 99–101 % (n = 50). Cutoff values based on GA as well as BW decreased with increasing maturity and weight of the newborns, ranging from 136 nmol/L whole blood for extreme preterm babies to 15 nmol/L whole blood for term babies. Combining LC-MS³ with GA- and BW-dependent cutoffs reduced the number of false-positive results from 731 to 15, while identifying all confirmed cases of CAH.</div></div><div><h3>Conclusion</h3><div>By application of LC-MS³ and the combinatory cutoff approach, the positive predictive value for CAH-screening improved from 1% to 32%, presenting a major benefit in diagnostic efficiency over the commonly applied IA strategy. This underlines the potential of MS³ technology in clinical use.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"578 ","pages":"Article 120482"},"PeriodicalIF":3.2,"publicationDate":"2025-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144636332","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Salivary IL-8, CYFRA 21-1, and CD44 for early detection of oral squamous cell carcinoma: a systematic review and meta-analysis","authors":"Priya Kumar,&nbsp;Kuldeep Singh,&nbsp;Aarushi Garg,&nbsp;Aadithya B. Urs,&nbsp;Jeyaseelan Augustine","doi":"10.1016/j.cca.2025.120471","DOIUrl":"10.1016/j.cca.2025.120471","url":null,"abstract":"<div><h3>Objective</h3><div>Early diagnosis of oral squamous cell carcinoma (OSCC) is a global concern, particularly in low-resource environments where invasive diagnostics limit population-wide screening. The purpose of this review is to evaluate the potential of salivary biomarkers: Interleukin-8 (IL-8), Cytokeratin 19 fragment (CYFRA 21-1), and Cluster of Differentiation 44 (CD44) in OSCC diagnosis.</div></div><div><h3>Methods</h3><div>A methodical search was conducted across PubMed, Embase, Scopus, and Web of Science databases till December 2024. Following PRISMA guidlines, studies quantifying salivary IL-8, CYFRA 21-1, and CD44 levels in OSCC patients and healthy controls were included. Using a bivariate random-effects model, we retrieved and combined sensitivity, specificity, and area under the summary receiver operating characteristic (SROC) curve. The QUADAS-2 tool was used to evaluate risk of bias. A standardized mean difference (SMD) meta-analysis was also performed to assess quantitative elevation in biomarker levels between cases and controls.</div></div><div><h3>Results</h3><div>Out of 311 articles reviewed, 20 eligible studies were included. IL-8, CYFRA 21-1, and CD44, individually, each biomarker demonstrated good diagnostic accuracy (with pooled AUCs of 0.88, 0.90, and 0.91, respectively), with CD44 showing overall highest diagnostic consistency. The combined biomarker panel exhibited significantly enhanced diagnostic precision (pooled AUC: 0.92; sensitivity: 88 %; specificity: 90 %). This combined metric was derived using a bivariate meta-analysis model applied to studies that evaluated at least two or more of the three biomarkers together. These findings were supported by corresponding forest plots and SROC curves, demonstrating low publication bias and moderate heterogeneity. Consistency across sample size, geographic origin, and assay technique were verified by subgroup analyses.</div></div><div><h3>Conclusion</h3><div>Salivary IL-8, CYFRA 21-1, and CD44 taken together provide a scientifically strong, non-invasive method for OSCC diagnosis on a uniform diagnostic panel. With good translational potential in both clinical and community-based screening systems. These results provide a strong scientific foundation for the development of a saliva-based point-of-care test (POCT) kit.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"577 ","pages":"Article 120471"},"PeriodicalIF":3.2,"publicationDate":"2025-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144632620","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"AZGP1: A proteomic biomarker in cancer","authors":"Surya Nath Pandey ,&nbsp;Muhammad Afzal ,&nbsp;Haider Ali ,&nbsp;H. Malathi ,&nbsp;Laxmidhar Maharana ,&nbsp;Kavita Goyal ,&nbsp;Mohit Rana ,&nbsp;Mohd Imran","doi":"10.1016/j.cca.2025.120481","DOIUrl":"10.1016/j.cca.2025.120481","url":null,"abstract":"<div><div>Alpha-2-glycoprotein 1, zinc-binding (AZGP1), functions as a serum AZGP1 biomarker with applications in cancer detection, prognosis, and therapeutic monitoring. This review evaluates AZGP1′s analytical performance and clinical utility in multiple malignancies based on immunoassay and mass spectrometry studies. ELISA and chemiluminescent immunoassays yield area-under-curve values of 0.78–0.89 for early colorectal and prostate cancer detection, often surpassing prostate-specific and carcinoembryonic antigens levels. Mass spectrometry studies have identified AZGP1 proteoforms, the abundance of which correlates with tumor burden and progression. Multivariate clinical analyses confirmed that elevated serum AZGP1 levels independently predict poorer overall and disease-free survival in colorectal, lung, and breast cancers. Simultaneously, preclinical models have demonstrated the role of AZGP1 in lipid mobilization, epithelial-mesenchymal transition, and modulation of tumor–stromal and immune interactions. We highlight the integration of mechanistic insights with proteoform-specific data and the need to harmonize preanalytical and analytical protocols. We propose a plan that includes the development of reference standards, conducting large prospective trials within biobank networks, and using artificial intelligence to discover combined proteomic signatures of the disease. These efforts aim to establish serum AZGP1 as a reliable, minimally invasive biomarker that improves early detection, prognostic stratification, and informs precision oncology.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"577 ","pages":"Article 120481"},"PeriodicalIF":3.2,"publicationDate":"2025-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144633802","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Liquid biopsy for the management of gastrointestinal cancers.","authors":"Zeinab Salehnia, Delsuz Rezaee, Sajad Ehtiati, Mohammad Bakhtiari, Mohammad Amin Khalilzad, Sajad Najafi","doi":"10.1016/j.cca.2025.120474","DOIUrl":"https://doi.org/10.1016/j.cca.2025.120474","url":null,"abstract":"<p><p>Gastrointestinal (GI) cancers are among the most lethal tumors. Early diagnosis can provide useful guide for real-time administration of anticancer therapeutics. Currently, several markers are used for the detection of affected patients, whereas the sensitivity and specificity of these markers are comparatively limited, particularly concerning early screening and diagnostic accuracy. Liquid biopsy refers to the collection of pathological specimens from non-solid sources, as opposed to the surgical excision of tissues or cells used for tissue biopsies in the diagnosis of solid tumors. Circulating tumor cells (CTCs), circulating tumor DNA (ctDNA) and cell-free nucleic acids (cfDNA and cfRNA) in addition to circulating non-coding RNAs and their exosomal forms can be detected and analyzed through investigation of liquid biopsy sources. Several characteristic features, such as minimally invasive identity, feasibility of frequent analyses, and the extent of precise data provided by liquid biopsies suggest them as potential sources for the diagnosis and monitoring response to treatment for patients with GI cancers. In this review, we provide some details of the studies reporting the predominant recent technologies used for the detection and quantification of liquid biopsy sources, their clinical implications, as well as current limitations and challenges. We particularly focus on the diagnostic and prognostic potential of liquid biopsies for the management of human GI cancers.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120474"},"PeriodicalIF":3.2,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144625453","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Blood bile acid profiles in chronic inflammatory demyelinating polyneuropathy","authors":"Chun-Wei Chang ,&nbsp;Mei-Ling Cheng ,&nbsp;Chiung-Mei Chen ,&nbsp;Tsai-Wei Liu ,&nbsp;Long-Sun Ro ,&nbsp;Yen-Shi Lo ,&nbsp;Rong-Kuo Lyu ,&nbsp;Hung-Chou Kuo ,&nbsp;Ming-Feng Liao ,&nbsp;Hong-Shiu Chang ,&nbsp;Ching-Chang Huang ,&nbsp;Yih-Ru Wu ,&nbsp;Chun-Che Chu ,&nbsp;Kuo-Hsuan Chang","doi":"10.1016/j.cca.2025.120479","DOIUrl":"10.1016/j.cca.2025.120479","url":null,"abstract":"<div><h3>Background</h3><div>Chronic inflammatory demyelinating polyneuropathy (CIDP) is an acquired immune-mediated neuropathy with demyelinating features like Guillain-Barréé syndrome (GBS). Despite established diagnostic criteria, the lack of specific blood biomarkers highlights the need for novel markers to improve early diagnosis and disease monitoring. Bile acids (BA), cholesterol-derived molecules with immune modulatory properties, have been explored as biomarkers in immune-mediated diseases. This study investigates BA profiles in CIDP and evaluates their potential for diagnosing CIDP.</div></div><div><h3>Methods</h3><div>Patients with treatment-naïve immune-mediated polyneuropathies (CIDP and GBS) and age-matched healthy controls (HCs) were recruited from a tertiary referral hospital. Their plasma BA profiles were analyzed using liquid chromatography-mass spectrometry. A supervised machine learning model was employed to assess the BA profiles, and a simplified tree-based algorithm was developed based on the feature importance to differentiate CIDP, GBS, and HC.</div></div><div><h3>Results</h3><div>This study included 36 CIDP patients, 70 GBS patients, and 41 HCs. Compared with HCs, CIDP patients showed elevated levels of glycochenodeoxycholic acid (GCDCA, 1,306.64 vs. 614.16 nM, <em>P</em> &lt; 0.001) and glycohyocholic acid (GHCA, 16.95 vs. 6.04 nM, <em>P</em> &lt; 0.001). CIDP patients also exhibited higher levels of GCDCA (1,306.64 vs. 734.44 nM, <em>P</em> &lt; 0.001) and cholenic acid (8.25 vs. 4.41 nM, <em>P</em> &lt; 0.001) compared to GBS patients. The support vector machine model incorporating BA profiles demonstrated strong discriminatory power (AUROC: 0.878), while a simplified tree-based algorithm using four key features achieved better performance (AUROC: 0.929).</div></div><div><h3>Conclusion</h3><div>BA profiles have potential as diagnostic biomarkers for CIDP, enabling precise and timely patient management.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"578 ","pages":"Article 120479"},"PeriodicalIF":3.2,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144625452","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Leukocyte analysis: Current status and future direction","authors":"Shaohua Hu,&nbsp;Bingchen Yu,&nbsp;Rui Xu,&nbsp;Kai Pang","doi":"10.1016/j.cca.2025.120477","DOIUrl":"10.1016/j.cca.2025.120477","url":null,"abstract":"<div><div>Leukocytes (white blood cells, WBCs) are a vital component of the human immune system, responsible for resisting foreign pathogens, repairing damaged tissues, and regulating immune responses. Abnormal changes in their number and function serve as clinical indicators of a wide range of diseases, including infection, inflammation, cancer, leukemia, and coronary artery disease. Precise analysis of their counts and functional status is invaluable for diagnosis, monitoring, and prognostic assessment. Leukocyte-testing equipment has become indispensable in modern clinical diagnostics; its significance lies not only in providing numerical read-outs but also in enabling data-driven decisions that guide therapy. These decisions directly affect patient survival rates, medical costs, and public health strategies. Leukocyte testing has progressed from an auxiliary diagnostic aid to a central element across the continuum of prediction, intervention, and individualized therapy, thereby continually advancing precision medicine. In this paper, we systematically review the evolution of leukocyte-detection technologies and compare the core principles, advantages, limitations, and application scenarios of both traditional and emerging methods. We further summarize and analyze the current bottlenecks that hinder clinical translation. Finally, we outline future directions for leukocyte detection, providing a valuable reference for its continued advancement and clinical adoption.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"577 ","pages":"Article 120477"},"PeriodicalIF":3.2,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144616569","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Determination of biological variation of Carbohydrate-Deficient transferrin and other sialotransferrin forms via a commercial HPLC procedure using indirect sampling","authors":"Medine Alpdemir,&nbsp;Ömer Faruk Çakmak,&nbsp;Mehmet Şeneş","doi":"10.1016/j.cca.2025.120461","DOIUrl":"10.1016/j.cca.2025.120461","url":null,"abstract":"<div><h3>Objective</h3><div>The study aimed to determine the biological variation (BV) components for carbohydrate-deficient transferrin (CDT-disialotransferrin) and various forms of sialylated transferrin (sialoTf) via indirect sampling and establish analytical performance targets for clinical and diagnostic applications, particularly in monitoring alcohol consumption.</div></div><div><h3>Methods</h3><div>Herein, serial sialoTf measurements via high-performance liquid chromatography (Eureka Lab Division, Sentinel Diagnostics, Italy) were collected from 141 subjects aged 18–65. The participants were grouped based on the follow-up duration (short-term: 6–9 series; long-term: ≥10 series). The BV components, including within-subject (CV_I) and between-subject (CV_G) variations, were calculated using a twofold nested ANOVA. Reference change values (RCVs), individuality index (II) values, and analytical performance specifications were also determined.</div></div><div><h3>Results</h3><div>A total of 141 patients (female:male = 24:117) were included in the study. The mean age of the participants was 37.9 ± 10.22 years, and the average number of follow-up series (min–max) per participant was 7.35 (ranging from 5 to 35 series). The median (IQR) levels for di-, tri-, tetra-, and pentasialoTf were 1.18 % (0.96–1.52), 4.19 % (3.31–5.17), 81.01 % (79.93–82.00), and 13.38 % (12.18–14.59), respectively. The CV_I and CV_G (95 % CI), respectively, were as follows: disialoTf, 26.3 (24.3–28.5) and 11.4 (6.2–17.9); trisialoTf, 23.5 (21.9–25.4) and 13.3 (9.1–18.8); tetrasialoTf, 1.5 (1.4–1.6) and 0.6 (0.4–0.9); and pentasialoTf, 9.7 (9.1–10.3) and 6.2 (4.7–8.2). The RCV% for di-, tri-, tetra-, and pentasialoTf was calculated as 91.35, 72.5, 5.2, and 36.5 %, respectively, and the II values were 2.29, 1.77, 2.36, and 1.56, respectively.</div></div><div><h3>Conclusion</h3><div>In this study, the BV components for CDT and other sialoTf forms were determined. The indirect sampling approach is a reliable alternative for BV estimation, offering valuable insights for clinical decision-making and analytical performance targets in sialoTf measurements.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"577 ","pages":"Article 120461"},"PeriodicalIF":3.2,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144596566","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Targeted next-generation sequencing of bronchoalveolar-lavage fluid specimens in the diagnosis of pulmonary infection after hematopoietic stem cell transplantation","authors":"Erya Xiao ,&nbsp;Jianjun Cheng ,&nbsp;Zhenzhen Zou ,&nbsp;Xiu Han ,&nbsp;Wenying Pan ,&nbsp;Qingzhen Han ,&nbsp;Lin Wang","doi":"10.1016/j.cca.2025.120478","DOIUrl":"10.1016/j.cca.2025.120478","url":null,"abstract":"<div><h3>Objective</h3><div>The purpose of this study was to compare the diagnostic performance of targeted next-generation sequencing (tNGS) with that of conventional microbiological tests (CMTs) in detecting pulmonary infections after hematopoietic stem cell transplantation (HSCT), to investigate pathogen distribution in pulmonary infections post-HSCT, and to provide laboratory-based evidence as a basis for the clinical diagnosis and treatment of such infections.</div></div><div><h3>Methods</h3><div>We retrospectively analyzed the clinical data of 132 patients with malignant hematological diseases complicated by pulmonary infections who were hospitalized at the Fourth Affiliated Hospital of Soochow University (Suzhou, China) from July 2023 to September 2024.</div></div><div><h3>Results</h3><div>Targeted NGS had a significantly higher overall detection rate (100 %) than CMTs (78 %; <em>P</em> &lt; 0.001), particularly for bacteria (93.31 % <em>vs.</em> 49.02 %; <em>P</em> &lt; 0.001) and viruses (91.32 % <em>vs.</em> 76.93 %; <em>P</em> &lt; 0.01). Both methods exhibited similar performance for fungal detection (72.39 % <em>vs.</em> 69.51 %; <em>P</em> = 0.799). In HSCT patients, viral–bacterial coinfections predominated, with <em>Cytomegalovirus</em> (CMV) and Epstein–Barr virus (EBV) being the most common pathogens. Targeted NGS had a shorter turnaround time (TAT) than CMTs, and antibiotic regimens were adjusted in 47.22 % of patients based on the tNGS results.</div></div><div><h3>Conclusion</h3><div>The rapid identification of pulmonary-infection pathogens in patients post-HSCT using tNGS facilitated the precise adjustment of anti-infective regimens. Our findings can provide a foundation for developing empirical anti-infective treatment strategies tailored to pathogen distribution in this patient population.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"577 ","pages":"Article 120478"},"PeriodicalIF":3.2,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144611718","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}