CLINICAL CHEMISTRY临床化学
CLINICAL CHEMISTRY(英文缩写 CLIN CHEM),ISSN 0009-9147,eISSN 1530-8561,中文译名:临床化学 是一本学术期刊。本页汇总该期刊的最新影响因子、分区信息以及最新收录于 PubMed 的文献,帮助您快速了解期刊全貌。
发文量统计区间：2025-09-27 至 2026-09-27，按本站收录文献的发表日期统计。
期刊介绍
历年影响因子趋势
| JCR 数据年份 | 影响因子 | JCR 分区 |
|---|---|---|
| 2021 | 12.114 | Q1 |
| 2022 | 9.300 | Q1 |
| 2023 | 7.100 | Q1 |
| 2024 | 6.300 | Q1 |
| 2025 | 8.300 | Q1 |
CLINICAL CHEMISTRY 最新收录文献
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1. Plasma Cell Leukemia with A "Missing" Monoclonal Protein on Immunofixation.
PMID:日期:2026-09-03该文献暂无摘要。
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2. Commentary on Plasma Cell Leukemia with a "Missing" Monoclonal Protein on Immunofixation.
PMID:日期:2026-09-03该文献暂无摘要。
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3. Commentary on Plasma Cell Leukemia with a "Missing" Monoclonal Protein on Immunofixation.
PMID:日期:2026-09-03该文献暂无摘要。
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5. Predictive Biomarkers for Immune Checkpoint Inhibitor Efficacy: Challenges, Innovations, and a Pathway to Precision Medicine in the Era of Cancer Immunotherapy.
PMID:日期:2026-09-03Immune checkpoint inhibitors (ICIs) have transformed oncology practice. However, treatment response remains heterogeneous, rendering predictive biomarkers critical for optimal patient care. The 3 established biomarkers, programmed death-ligand 1, tumor mutational burden (TMB), and microsatellite instability-high/deficient mismatch repair, are approved and clinically validated but are modest predictors of benefit. As a result, multiple novel predictive biomarkers remain under investigation. This review highlights established and investigational predictive ICI efficacy biomarkers. For established biomarkers, we describe biology, assay modalities, approved companion diagnostics, landmark studies, and notable limitations. Due to the multisystem nature of antitumor immune effects, investigational biomarkers span multiple domains, including tumor genomic biomarkers (e.g., mutational signatures, TMB, neoantigen clonality), tumor microenvironment (e.g., tumor-infiltrating lymphocytes [TILs], tertiary lymphoid structures), systemic immune biomarkers (e.g., cytokines, autoantibodies, glycoproteins, peripheral blood mononuclear cells), and the microbiome (e.g., gastrointestinal microbial diversity, responder-enriched taxa). The established biomarkers PD-L1, TMB, and microsatellite instability-high/deficient mismatch repair inform ICI use in clinical practice but have important limitations. Multiple investigational biomarkers show promise in refining patient selection and optimizing therapy. Moving forward, increased assay harmonization, prospective validation, and standardized parameters may improve performance. Composite models integrating complementary signals across domains may further individualize treatment and lead to an era of personalized cancer immunotherapy.
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6. Correlation and Commutability Study between an LC-MS-Based Reference Measurement Procedure and Immunoassays Measuring Apolipoprotein A-I and Apolipoprotein B.
6. 基于LC-MS的参考测量程序与免疫测定法测定载脂蛋白A-I和载脂蛋白B之间的相关性与互换性研究PMID:日期:2026-09-03Serum concentrations of apolipoprotein A-I (ApoA-I) and apolipoprotein B (ApoB) can have a predictive value for cardiovascular events beyond the traditional lipid profile. The IFCC Working Group on Apolipoproteins by Mass Spectrometry is developing a novel reference measurement system for seven clinically relevant apolipoproteins, including ApoA-I and ApoB. The system will consist of a multiplex mass spectrometry-based reference measurement procedure (RMP) and commutable secondary reference materials (RMs). Agreement between the RMP and 8 immunoassay-based measurement procedures (MPs) was investigated using 30 clinical samples. Furthermore, the commutability of 8 candidate RMs, consisting of frozen serum pools, and the existing WHO-IFCC standards SP1-01 and SP3-08 was assessed. The harmonization level among eight immunoassay-based MPs for ApoA-I and ApoB still needs improvement. The RMP results showed a good correlation with results of the immunoassay-based MPs for both ApoA-I and ApoB. For ApoA-I, 7 candidate RMs showed good commutability, while SP1-01 and one candidate RM showed potential noncommutability for one method comparison. For ApoB, the commutability profile of the candidate RMs was more variable, and SP3-08 showed noncommutability for several method comparisons. The RMP and the immunoassay-based MPs have comparable selectivity for ApoA-I and ApoB, and a well-established reference measurement system can lead to improved harmonization. Future commutable secondary RMs can be based on frozen human serum pools; however, for ApoB, preselection of single-donor samples might be needed to limit the impact of sample-specific effects.
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7. Establishment of Pseudovirus-Based Reference Materials and Nationwide External Quality Assessment for Arboviruses during the 2025 Chikungunya Outbreak.
7. 2025年基孔肯雅热疫情期间基于假病毒的参考物质建立及虫媒病毒全国室间质量评价PMID:日期:2026-09-03Emerging arboviruses such as chikungunya virus (CHIKV), dengue virus (DENV), and Zika virus (ZIKV) pose growing public health challenges, demanding reliable diagnostic systems to support outbreak responses. During the July 2025 CHIKV outbreak in China, the absence of domestic nucleic acid reference materials (RMs) and external quality assessment (EQA) programs hindered diagnostic standardization. We developed pseudovirus-based RNA RMs for CHIKV, DENV, and ZIKV and certified their concentrations using digital PCR across 9 laboratories for each virus, ensuring stability and commutability with WHO international standards and clinical samples. Leveraging these RMs, China conducted its first nationwide arbovirus nucleic acid EQA program. All three RMs were officially approved by China's State Administration for Market Regulation, with codes GBW(E)091403, GBW(E)091405, and GBW(E)091409 for CHIKV, DENV, and ZIKV, respectively. The EQA program involved 937 laboratories across 31 provinces and employed 51 amplification kits. Over 97.5% of laboratories achieved perfect scores and >99% were qualified, reflecting strong overall testing capacity. Crucially, the EQA revealed systematic gaps: institutional differences in testing scope and performance were evident, pooled testing in blood stations missed low CHIKV levels, and reagent-dependent differences in Cycle threshold values and amplification efficiency (78.9% to 146.4%) affected low-concentration CHIKV and DENV-2 detection. These findings underscore the power of large-scale EQA to expose hidden inter-laboratory and reagent inconsistencies. By integrating standardized RMs with nationwide EQA, this work provides a robust framework for diagnostic harmonization, drives quality improvement, and strengthens preparedness for future arboviral threats.
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8. Enhancing Next-Generation Sequencing Sensitivity with High-Recovery Adapter Ligation and Cas9-Mediated Dimer Elimination.
8. 通过高恢复率接头连接和Cas9介导的二聚体消除提高下一代测序灵敏度PMID:日期:2026-09-03Accurate detection of ultra-low-frequency variants is a major challenge in clinical liquid biopsy. In early cancer detection and minimal residual disease monitoring, Circulating tumor (ctDNA) may fall below 0.1% variant allele frequency, making sensitivity highly dependent on molecular recovery during library preparation. Losses at early steps, especially adapter ligation, permanently reduce analyzable molecules and cannot be rescued by deeper sequencing or bioinformatic refinement. We developed Powerful Recovery and Improved Dimer Elimination (PRIDE) next-generation sequencing NGS, a library preparation strategy that increases adapter ligation efficiency and removes adapter dimers via sequence-specific Clustered regularly interspaced short palindromic repeats (CRISPR)/CRISPR-associated protein 9 (Cas9) cleanup. PRIDE NGS is compatible with standard clinical work flows and requires no added sequencing depth or changes to downstream bioinformatic pipelines. Performance was assessed by targeted sequencing of cell-free (cfDNA) reference standards and clinical plasma samples. PRIDE NGS improved recovery and detection of low-frequency variants vs conventional preparation. In reference standards, it detected more variants at low allele frequencies, particularly below 0.1%. In clinical plasma samples, it similarly increased detection, including variants predicted to have moderate or high functional impact. These gains occurred at comparable or lower sequencing depth, indicating sensitivity improvements driven by enhanced molecular recovery. By overcoming a key bottleneck in library preparation, PRIDE NGS lowers the practical detection threshold for ultra-low-frequency variants in liquid biopsy. This clinically applicable approach improves analytical sensitivity by lowering the detection limit without increasing the sequencing burden, supporting routine testing and longitudinal monitoring.
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9. Standardization Challenges in Glycated Albumin Measurement: Methodological Heterogeneity and Quantification Discrepancies.
PMID:日期:2026-09-03Glycated albumin (GA) is a valuable biomarker for monitoring glycemic status. However, measurement standardization is challenged by methodological heterogeneity, where different analytical principles and target measurands cause quantification discrepancies. This study systematically compared prevailing methodologies to identify a robust reference measurement procedure for widespread standardization. We compared a targeted bottom-up proteomics method (ID-LC-MS/MS) with an enzymatic assay and the Japan Society of Clinical Chemistry (JSCC) reference method. A cohort of 129 donor serum specimens and certified reference materials (JCCRM-611) were analyzed to assess methodological comparability. Furthermore, GA concentration-dependent glycation kinetics at the Lys-525 site of albumin was examined. The optimized targeted bottom-up proteomics method showed a strong correlation (r = 0.986) with both the enzymatic assay and JSCC reference method. However, a progressively increasing negative systematic bias was observed at higher GA levels, confirming that Lys-525 underestimates GA at higher levels. In addition, with increasing overall GA concentration, the glycation ratio at the Lys-525 site consistently declined compared to the total glycated lysine residues. The standardization of GA measurements requires a precise, universally accepted definition to address analytical discrepancies. The present results indicate that quantification targeting all glycated lysine residues (as in the JSCC method) aligns more closely with biologically relevant GA values than site-specific measurement at Lys-525, which shows greater bias at higher concentrations. Therefore, further GA standardization would focus on adopting total glycated lysine residues on albumin as the preferred measurand definition, to improve detection accuracy and clinical comparability.
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10. Age-Dependent z Scores and eGFR-Adjusted Reference Ranges for Neurofilament Light: A Practical Approach for Clinical Laboratories.
10. 神经丝光的年龄依赖z评分和eGFR调整参考范围：临床实验室的实用方法PMID:日期:2026-09-03Neurofilament light (NfL) has emerged as a sensitive biomarker of neuroaxonal damage across a wide spectrum of neurological conditions, including acute brain injury as well as chronic inflammatory and neurodegenerative diseases. However, its clinical utility is compromised by physiological confounders, particularly age and renal function. The aim of the study was to establish age-dependent z scores for plasma NfL and evaluate the impact of estimated glomerular filtration rate (eGFR) on NfL concentrations to enhance interpretative accuracy. Plasma NfL was measured in 133 healthy adults (18-90 years) using the Siemens Atellica® platform; serum NfL in 20 adults (25-61 years) using Lumipulse® G. eGFR was estimated with Chronic Kidney Disease Epidemiology Collaboration (<70 years) and the Berlin Initiative Study 1 (≥70 years). Age-stratified z scores, multivariate regression, and artificial intelligence-assisted modeling assessed relationships between NfL, age, and eGFR. A novel composite index, the Age- and eGFR-Adjusted NfL Index (AGI), defined as Age2/eGFR0·5, was developed and validated. NfL concentrations demonstrated a significant positive polynomial correlation with age (r = 0.83, P < 0.001) and a negative exponential correlation with eGFR (r = -0.78, P < 0.001). The AGI Index exhibited a linear relationship with NfL concentrations (r = 0.87, P < 0.001), which strongly predicted NfL reference values. Age-stratified z scores showed high concordance with eGFR-adjusted reference intervals (Pearson r = 0.96, P < 0.001). A strong correlation (r = 0.94) was observed between the predicted and released laboratory-specific serum NfL reference ranges. This study provides the first age-dependent NfL z scores for the Siemens Atellica platform. The proposed AGI index enables individualized reference intervals, supporting broader clinical application while accounting for key physiological confounders.