Clinica Chimica Acta最新文献_第10页

Corrigendum to “Functional implications of rs9373441 with FOXP3+Treg and Tr1 for the clinical effectiveness of csDMARDs in rheumatoid arthritis” [Clinica Chimica Acta 551 (2023) 117612]

IF 3.2 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta

Pub Date : 2025-01-24 DOI: 10.1016/j.cca.2025.120146

Ting-Yu Hsieh , Jun-Fu Lin , Feng-Cheng Liu , Hsiang-Cheng Chen , Shan-Wen Lui , Yu-Tien Chang

引用次数: 0

Clinical evaluation of droplet digital PCR in suspected invasive pulmonary aspergillosis

IF 3.2 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta

Pub Date : 2025-01-23 DOI: 10.1016/j.cca.2025.120153

Yang Liu , Qiuping Tang , Sishi Tang , Hengjian Huang , Lanxi Kou , Yi Zhou , Hongxia Ruan , Yu Yuan , Chao He , Binwu Ying

Invasive pulmonary aspergillosis (IPA), the most common fungal infection, is associated with high mortality of affected patients. Traditional diagnostic methods exhibit limited sensitivity and specificity, raising big challenges for precise management of the patients. There is thus an urgent need to find out a timely and accurate diagnostic method in clinical practice. In this study, 163 patients suspected with IPA were enrolled. The medical data of the patients were retrieved from hospital information system. The 158 patients with complete data were classified into an IPA group with 122 cases (58 putative IPA, 19 probable IPA, and 45 possible IPA cases) and a non-IPA group with 36 cases. Cell-free DNA (cfDNA) of bronchoalveolar lavage fluid (BALF) or plasma samples was detected via a droplet digital PCR (ddPCR) assay targeting Aspergillus spp. Overall, this ddPCR assay demonstrated a higher sensitivity of 50.8 % for IPA diagnosis, compared with that of fungal culture (44.3 %) and smear test (10.7 %). Moreover, its sensitivity was higher in the IPA group (73.1 %) and putative IPA subgroup (88.2 %) when using BALF samples, compared with those using plasma samples (P < 0.01). It achieved a high specificity of 94.4 % for IPA diagnosis, with significant variations in cfDNA copy numbers across the subgroups (P < 0.05). In addition, the ddPCR results were associated with the prognosis of the patients at the discharge (P < 0.05). In conclusion, ddPCR assay demonstrated a good performance for IPA diagnosis when using BALF samples, especially for putative IPA. The ddPCR results could be integrated with clinical data to improve prognostic prediction.

{"title":"Clinical evaluation of droplet digital PCR in suspected invasive pulmonary aspergillosis","authors":"Yang Liu , Qiuping Tang , Sishi Tang , Hengjian Huang , Lanxi Kou , Yi Zhou , Hongxia Ruan , Yu Yuan , Chao He , Binwu Ying","doi":"10.1016/j.cca.2025.120153","DOIUrl":"10.1016/j.cca.2025.120153","url":null,"abstract":"<div><div>Invasive pulmonary aspergillosis (IPA), the most common fungal infection, is associated with high mortality of affected patients. Traditional diagnostic methods exhibit limited sensitivity and specificity, raising big challenges for precise management of the patients. There is thus an urgent need to find out a timely and accurate diagnostic method in clinical practice. In this study, 163 patients suspected with IPA were enrolled. The medical data of the patients were retrieved from hospital information system. The 158 patients with complete data were classified into an IPA group with 122 cases (58 putative IPA, 19 probable IPA, and 45 possible IPA cases) and a non-IPA group with 36 cases. Cell-free DNA (cfDNA) of bronchoalveolar lavage fluid (BALF) or plasma samples was detected via a droplet digital PCR (ddPCR) assay targeting <em>Aspergillus</em> spp. Overall, this ddPCR assay demonstrated a higher sensitivity of 50.8 % for IPA diagnosis, compared with that of fungal culture (44.3 %) and smear test (10.7 %). Moreover, its sensitivity was higher in the IPA group (73.1 %) and putative IPA subgroup (88.2 %) when using BALF samples, compared with those using plasma samples (<em>P</em> < 0.01). It achieved a high specificity of 94.4 % for IPA diagnosis, with significant variations in cfDNA copy numbers across the subgroups (<em>P</em> < 0.05). In addition, the ddPCR results were associated with the prognosis of the patients at the discharge (<em>P</em> < 0.05). In conclusion, ddPCR assay demonstrated a good performance for IPA diagnosis when using BALF samples, especially for putative IPA. The ddPCR results could be integrated with clinical data to improve prognostic prediction.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"569 ","pages":"Article 120153"},"PeriodicalIF":3.2,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143037484","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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

Angiotensin II: A novel biomarker in vascular diseases

IF 3.2 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta

Pub Date : 2025-01-22 DOI: 10.1016/j.cca.2025.120154

Qin-Yi Zhou , Jin-Qian Pan , Wang Liu , Zhen-Tao Jiang , Fang-Ya Gao , Zhen-Wang Zhao , Chao-Ke Tang

The renin-angiotensin system (RAS), composed mainly of renin, angiotensin, and aldosterone, is a key endocrine pathway involved in cardiovascular activity regulation. Under physiological conditions, the RAS plays a vital role in water and salt metabolism, blood pressure regulation, and electrolyte balance. Angiotensin II (Ang II) is the most important active component of the RAS, and its receptors are concentrated in vascular, pulmonary, cardiac, and renal tissues in vivo. Moreover, Ang II is closely associated with the development of vascular lesions. Ang II expression is closely associated with atherosclerosis, aortic aneurysm/dissection, ischemic stroke, hypertension, pulmonary hypertension, and type 2 diabetes mellitus. Given the significant pathophysiological role of Ang II in vascular diseases and the availability of advanced detection methods, Ang II holds promise as a reliable biomarker and therapeutic target in clinical settings. This review summarizes the mechanisms through which Ang II contributes to different vascular diseases and discusses its potential application as a biomarker for disease diagnosis.

{"title":"Angiotensin II: A novel biomarker in vascular diseases","authors":"Qin-Yi Zhou , Jin-Qian Pan , Wang Liu , Zhen-Tao Jiang , Fang-Ya Gao , Zhen-Wang Zhao , Chao-Ke Tang","doi":"10.1016/j.cca.2025.120154","DOIUrl":"10.1016/j.cca.2025.120154","url":null,"abstract":"<div><div>The renin-angiotensin system (RAS), composed mainly of renin, angiotensin, and aldosterone, is a key endocrine pathway involved in cardiovascular activity regulation. Under physiological conditions, the RAS plays a vital role in water and salt metabolism, blood pressure regulation, and electrolyte balance. Angiotensin II (Ang II) is the most important active component of the RAS, and its receptors are concentrated in vascular, pulmonary, cardiac, and renal tissues <em>in vivo</em>. Moreover, Ang II is closely associated with the development of vascular lesions. Ang II expression is closely associated with atherosclerosis, aortic aneurysm/dissection, ischemic stroke, hypertension, pulmonary hypertension, and type 2 diabetes mellitus. Given the significant pathophysiological role of Ang II in vascular diseases and the availability of advanced detection methods, Ang II holds promise as a reliable biomarker and therapeutic target in clinical settings. This review summarizes the mechanisms through which Ang II contributes to different vascular diseases and discusses its potential application as a biomarker for disease diagnosis.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"568 ","pages":"Article 120154"},"PeriodicalIF":3.2,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143037487","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}

引用次数: 0

Thalassemia genetic screening of pregnant women with anemia in Northern China through comprehensive analysis of thalassemia alleles (CATSA)

IF 3.2 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta

Pub Date : 2025-01-22 DOI: 10.1016/j.cca.2025.120151

Jingwen Zhou , Chang Liu , Na Hao , Jie Feng , Zhaolin Quan , Libao Chen , Juntao Liu

Thalassemia is an inherited blood disorder and traditionally considered more prevalent in Southern China. However, with increased migration and intermarriage, more and more thalassemia carriers had been reported in Northern China. The lack of screening for thalassemia carriers may also result in missed diagnosis in Northern China. Additionally, thalassemia carriers are usually asymptomatic or mild anemia, but their anemia can get worse during pregnancy. Iron deficiency anemia (IDA) is also one of the causes of anemia during pregnancy. In particular, both IDA and thalassemia are characterized by microcytic hypochromic anemia. The overlap of symptoms and the presence of thalassemia carriers with IDA may lead to misdiagnosis. In this study, long-read sequencing based approach termed comprehensive analysis of thalassemia alleles (CATSA) had been performed for 244 pregnant women in Northern China whose results of routine blood examinations were abnormal. As a result, 16.39 % (40/244) of the anemic pregnant women carried at least one mutation of thalassemia. One Hb H patient and a rare α-globin gene triplication combined with β-thalassemia were also identified. Of the 44 thalassemia variants detected, the −α^3.7, −^SEA and HBB:c.316-197C > T were the most common variants. CATSA is of great significance for determining exact genotype of 22.50 % (9/40) thalassemia carriers because 8 variants they carried were outside the detection range of routine genetic tests. It is noted that 2 novel deletions of HBA gene were identified, expanding the genotype spectrum of α-thalassemia. Our findings demonstrate the importance of thalassemia screening in Northern China. Future research should focus on expanding screening to include more diverse populations.

{"title":"Thalassemia genetic screening of pregnant women with anemia in Northern China through comprehensive analysis of thalassemia alleles (CATSA)","authors":"Jingwen Zhou , Chang Liu , Na Hao , Jie Feng , Zhaolin Quan , Libao Chen , Juntao Liu","doi":"10.1016/j.cca.2025.120151","DOIUrl":"10.1016/j.cca.2025.120151","url":null,"abstract":"<div><div>Thalassemia is an inherited blood disorder and traditionally considered more prevalent in Southern China. However, with increased migration and intermarriage, more and more thalassemia carriers had been reported in Northern China. The lack of screening for thalassemia carriers may also result in missed diagnosis in Northern China. Additionally, thalassemia carriers are usually asymptomatic or mild anemia, but their anemia can get worse during pregnancy. Iron deficiency anemia (IDA) is also one of the causes of anemia during pregnancy. In particular, both IDA and thalassemia are characterized by microcytic hypochromic anemia. The overlap of symptoms and the presence of thalassemia carriers with IDA may lead to misdiagnosis. In this study, long-read sequencing based approach termed comprehensive analysis of thalassemia alleles (CATSA) had been performed for 244 pregnant women in Northern China whose results of routine blood examinations were abnormal. As a result, 16.39 % (40/244) of the anemic pregnant women carried at least one mutation of thalassemia. One Hb H patient and a rare α-globin gene triplication combined with β-thalassemia were also identified. Of the 44 thalassemia variants detected, the −α<sup>3.7</sup>, −<sup>SEA</sup> and <em>HBB</em>:c.316-197C > T were the most common variants. CATSA is of great significance for determining exact genotype of 22.50 % (9/40) thalassemia carriers because 8 variants they carried were outside the detection range of routine genetic tests. It is noted that 2 novel deletions of <em>HBA</em> gene were identified, expanding the genotype spectrum of α-thalassemia. Our findings demonstrate the importance of thalassemia screening in Northern China. Future research should focus on expanding screening to include more diverse populations.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"569 ","pages":"Article 120151"},"PeriodicalIF":3.2,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143037486","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}

引用次数: 0

Unveiling the biological variation of lymphocyte subset counts: Insights from a full-spectrum flow cytometer and the BD MultitestTM 6-Color TBNK kit

IF 3.2 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta

Pub Date : 2025-01-21 DOI: 10.1016/j.cca.2025.120152

Kai Guo , Xiaoran Feng , Lei Xu , Zhongli Du , Yating Ma , Hong Lu , Chenbin Li , Mingting Peng

Background and aims

To estimate the biological variation (BV) for lymphocyte subset counts in healthy adults based on full-spectrum flow cytometry (FS-FCM) and the most commonly used BD Multitest^TM 6-Color TBNK kit in China.

Materials and methods

The study was designed according to the BV Data Critical Appraisal Checklist (BIVAC). Peripheral blood samples were collected from 60 healthy adults every two weeks for a period of 20 weeks (10 samples from each subject). Lymphocyte subsets were quantified using FS-FCM and the kit mentioned above. Bayesian models were used to analyze within-subject BV (CV_I) and between-subject BV (CV_G). Accordingly, the analytical performance specifications (APS) and more were derived. Additionally, the allowable total error (TEa) derived from the BV data in this study was compared with that based on state-of-the-art (SOTA).

Results

The CV_Is for the percentages of CD3⁺, CD3⁺CD4⁺, CD3⁺CD8⁺, CD3^-CD19⁺, and CD3^-CD16/CD56⁺ cells were 3.60 %, 7.05 %, 4.19 %, 10.73 %, and 19.17 %, respectively. The CV_Is for the absolute counts were 13.99 %, 13.51 %, 16.19 %, 16.30 %, and 28.64 %, respectively. The CV_Gs for the percentages were 11.78 %, 21.33 %, 35.20 %, 33.69 %, and 44.36 %, and those for the absolute counts were 30.27 %, 28.84 %, 43.11 %, 46.69 %, and 49.21 %, respectively. No significant differences were observed in the CV_I and CV_G of males and females. The maximum allowable imprecision parameter based on the BV model was absolute CD3^-CD16/56⁺ cell counts (14.3 %). For most lymphocyte subset parameters, TEa based on SOTA in China was less than the optimal TEa obtained from the BV data of this study.

Conclusions

To the best of our knowledge, this study is the first to estimate the BV of lymphocyte subset counts based on FS-FCM and the clinically commonly used BD Multitest^TM 6-Color TBNK kit.

{"title":"Unveiling the biological variation of lymphocyte subset counts: Insights from a full-spectrum flow cytometer and the BD MultitestTM 6-Color TBNK kit","authors":"Kai Guo , Xiaoran Feng , Lei Xu , Zhongli Du , Yating Ma , Hong Lu , Chenbin Li , Mingting Peng","doi":"10.1016/j.cca.2025.120152","DOIUrl":"10.1016/j.cca.2025.120152","url":null,"abstract":"<div><h3>Background and aims</h3><div>To estimate the biological variation (BV) for lymphocyte subset counts in healthy adults based on full-spectrum flow cytometry (FS-FCM) and the most commonly used BD Multitest<sup>TM</sup> 6-Color TBNK kit in China.</div></div><div><h3>Materials and methods</h3><div>The study was designed according to the BV Data Critical Appraisal Checklist (BIVAC). Peripheral blood samples were collected from 60 healthy adults every two weeks for a period of 20 weeks (10 samples from each subject). Lymphocyte subsets were quantified using FS-FCM and the kit mentioned above. Bayesian models were used to analyze within-subject BV (CV<sub>I</sub>) and between-subject BV (CV<sub>G</sub>). Accordingly, the analytical performance specifications (APS) and more were derived. Additionally, the allowable total error (TEa) derived from the BV data in this study was compared with that based on state-of-the-art (SOTA).</div></div><div><h3>Results</h3><div>The CV<sub>I</sub>s for the percentages of CD3<sup>+</sup>, CD3<sup>+</sup>CD4<sup>+</sup>, CD3<sup>+</sup>CD8<sup>+</sup>, CD3<sup>-</sup>CD19<sup>+</sup>, and CD3<sup>-</sup>CD16/CD56<sup>+</sup> cells were 3.60 %, 7.05 %, 4.19 %, 10.73 %, and 19.17 %, respectively. The CV<sub>I</sub>s for the absolute counts were 13.99 %, 13.51 %, 16.19 %, 16.30 %, and 28.64 %, respectively. The CV<sub>G</sub>s for the percentages were 11.78 %, 21.33 %, 35.20 %, 33.69 %, and 44.36 %, and those for the absolute counts were 30.27 %, 28.84 %, 43.11 %, 46.69 %, and 49.21 %, respectively. No significant differences were observed in the CV<sub>I</sub> and CV<sub>G</sub> of males and females. The maximum allowable imprecision parameter based on the BV model was absolute CD3<sup>-</sup>CD16/56<sup>+</sup> cell counts (14.3 %). For most lymphocyte subset parameters, TEa based on SOTA in China was less than the optimal TEa obtained from the BV data of this study.</div></div><div><h3>Conclusions</h3><div>To the best of our knowledge, this study is the first to estimate the BV of lymphocyte subset counts based on FS-FCM and the clinically commonly used BD Multitest<sup>TM</sup> 6-Color TBNK kit.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"569 ","pages":"Article 120152"},"PeriodicalIF":3.2,"publicationDate":"2025-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143028066","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}

引用次数: 0

Development of a time-resolved fluoroimmunoassay for rituximab and its application to therapeutic drug monitoring

IF 3.2 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta

Pub Date : 2025-01-20 DOI: 10.1016/j.cca.2025.120142

Shangbin Kao , Xiaobin Liu , Juan Jin , Lin Zhang , Ting Shen , Jialong Wu , Yuan Qin , Xiumei Zhou , Xueqin Zhao , Liang Wang , Qiang He , Biao Huang

Background

Rituximab pharmacokinetics in patients with membranous nephropathy (MN) exhibit significant interindividual variability. Accurate measurement of serum rituximab concentrations is essential for effective therapeutic monitoring. This study develops a highly sensitive time-resolved fluoroimmunoassay (TRFIA) for rituximab (rituximab-TRFIA) with a wide detection range, aimed at enhancing therapeutic drug monitoring in MN treatment.

Methods

A capture -type rituximab-TRFIA was developed using streptavidin-coated microplates, biotinylated anti-rituximab idiotypic antibodies, and Eu³⁺-labeled mouse anti-human IgG targeting the Fc fragment of rituximab. The assay was used to measure rituximab serum concentrations in MN patients treated with rituximab.

Results

The linear range of rituximab-TRFIA is 0.50 to 2500 ng/mL, with a limit of detection (LOD) of 0.062 ng/mL. The intra-assay coefficient of variation (CV) ranges from 1.97 % to 9.50 %, while the inter-assay CV ranges from 7.44 % to 9.99 %. The recovery rate ranges from 99.14 % to 107.75 %. No cross-reactivity was observed with other monoclonal antibody drugs (mAbs). The detection range is two orders of magnitude higher, and the sensitivity is six times greater than that of the enzyme-linked immunosorbent assay (ELISA). Rituximab-TRFIA showed strong consistency within the same measurement range compared to ELISA (P < 0.0001). The serum rituximab levels in MN patients were significantly higher than those in the control group (P < 0.0001). Among patients who did not achieve remission, 60 % to 70 % had insufficient drug concentrations, and rituximab pharmacokinetics followed the expected trends.

Conclusions

The rituximab-TRFIA provides high sensitivity, a wide detection range, and reliable performance for monitoring serum rituximab concentrations in MN patients, supporting personalized treatment strategies.

{"title":"Development of a time-resolved fluoroimmunoassay for rituximab and its application to therapeutic drug monitoring","authors":"Shangbin Kao , Xiaobin Liu , Juan Jin , Lin Zhang , Ting Shen , Jialong Wu , Yuan Qin , Xiumei Zhou , Xueqin Zhao , Liang Wang , Qiang He , Biao Huang","doi":"10.1016/j.cca.2025.120142","DOIUrl":"10.1016/j.cca.2025.120142","url":null,"abstract":"<div><h3>Background</h3><div>Rituximab pharmacokinetics in patients with membranous nephropathy (MN) exhibit significant interindividual variability. Accurate measurement of serum rituximab concentrations is essential for effective therapeutic monitoring. This study develops a highly sensitive time-resolved fluoroimmunoassay (TRFIA) for rituximab (rituximab-TRFIA) with a wide detection range, aimed at enhancing therapeutic drug monitoring in MN treatment.</div></div><div><h3>Methods</h3><div>A capture -type rituximab-TRFIA was developed using streptavidin-coated microplates, biotinylated anti-rituximab idiotypic antibodies, and Eu<sup>3+</sup>-labeled mouse anti-human IgG targeting the Fc fragment of rituximab. The assay was used to measure rituximab serum concentrations in MN patients treated with rituximab.</div></div><div><h3>Results</h3><div>The linear range of rituximab-TRFIA is 0.50 to 2500 ng/mL, with a limit of detection (LOD) of 0.062 ng/mL. The intra-assay coefficient of variation (CV) ranges from 1.97 % to 9.50 %, while the inter-assay CV ranges from 7.44 % to 9.99 %. The recovery rate ranges from 99.14 % to 107.75 %. No cross-reactivity was observed with other monoclonal antibody drugs (mAbs). The detection range is two orders of magnitude higher, and the sensitivity is six times greater than that of the enzyme-linked immunosorbent assay (ELISA). Rituximab-TRFIA showed strong consistency within the same measurement range compared to ELISA (P < 0.0001). The serum rituximab levels in MN patients were significantly higher than those in the control group (P < 0.0001). Among patients who did not achieve remission, 60 % to 70 % had insufficient drug concentrations, and rituximab pharmacokinetics followed the expected trends.</div></div><div><h3>Conclusions</h3><div>The rituximab-TRFIA provides high sensitivity, a wide detection range, and reliable performance for monitoring serum rituximab concentrations in MN patients, supporting personalized treatment strategies.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"568 ","pages":"Article 120142"},"PeriodicalIF":3.2,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143022323","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}

引用次数: 0

Development of highly sensitive lateral flow immunoassay using PdNPs for detection of Plasmodium species

IF 3.2 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta

Pub Date : 2025-01-20 DOI: 10.1016/j.cca.2025.120149

Kashyap Pandya , Preeti Sharma , Maulik Rachh , Jayendra Patel

A lateral flow immunoassay (LFIA) employing palladium nanoparticles (PdNPs) labelled with antibodies has been innovatively designed for the precise detection of Plasmodium falciparum pLDH and HRPII antigen. This study focuses on development of LFIA based on PdNPs detection system to substantially enhance the visual detectability (vLOD), achieving an impressive 12 parasites/microliter (p/µl) vLOD in comparison with conventional system represented 50 p/µl vLOD. The research introduces a novel amplification system that not only heightens the sensitivity of LFIA but also maintains intense coloration. This novel system relies on direct detection of the malaria pLDH and HRPII antigen. In this innovative assay, HRPII antigen interacts with PdNP-conjugated Anti-HRPII detector antibodies, forming an immune complex with Anti-HRPII capture antibodies. The detection limit for HRPII antigen was found to be 8 times higher than that of conventional systems. Moreover, the novel approach for synthesis of PdNPs and their conjugation with antibodies makes this system robust and universally applicable and also extends its potential use to detect various other compounds, including antigens or antibodies from different diseases. This sensitive LFIA detection system presents itself as an efficient screening tool for medical monitoring and point-of-care (POC) settings, offering promising prospects for enhancing disease diagnosis and surveillance.

{"title":"Development of highly sensitive lateral flow immunoassay using PdNPs for detection of Plasmodium species","authors":"Kashyap Pandya , Preeti Sharma , Maulik Rachh , Jayendra Patel","doi":"10.1016/j.cca.2025.120149","DOIUrl":"10.1016/j.cca.2025.120149","url":null,"abstract":"<div><div>A lateral flow immunoassay (LFIA) employing palladium nanoparticles (PdNPs) labelled with antibodies has been innovatively designed for the precise detection of <em>Plasmodium falciparum</em> pLDH and HRPII antigen. This study focuses on development of LFIA based on PdNPs detection system to substantially enhance the visual detectability (vLOD), achieving an impressive 12 parasites/microliter (p/µl) vLOD in comparison with conventional system represented 50 p/µl vLOD. The research introduces a novel amplification system that not only heightens the sensitivity of LFIA but also maintains intense coloration. This novel system relies on direct detection of the malaria pLDH and HRPII antigen. In this innovative assay, HRPII antigen interacts with PdNP-conjugated Anti-HRPII detector antibodies, forming an immune complex with Anti-HRPII capture antibodies. The detection limit for HRPII antigen was found to be 8 times higher than that of conventional systems. Moreover, the novel approach for synthesis of PdNPs and their conjugation with antibodies makes this system robust and universally applicable and also extends its potential use to detect various other compounds, including antigens or antibodies from different diseases. This sensitive LFIA detection system presents itself as an efficient screening tool for medical monitoring and point-of-care (POC) settings, offering promising prospects for enhancing disease diagnosis and surveillance.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"568 ","pages":"Article 120149"},"PeriodicalIF":3.2,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143022338","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}

引用次数: 0

Surface-Enhanced Raman Scattering (SERS) for exosome detection

IF 3.2 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta

Pub Date : 2025-01-20 DOI: 10.1016/j.cca.2025.120148

Biqing Chen, Xiaohong Qiu

Background

Exosomes, nanoscale extracellular vesicles secreted by various cells, are abundantly present in biological fluids. They have been identified as carriers of specific molecules, suggesting their potential role in early disease detection. However, their clinical application is hindered by several challenges, including the need for large sample volumes for enrichment, limitations of traditional detection methods, and the complexity involved in phenotype analysis and separation.

Objective

This review aims to explore the application of Surface-Enhanced Raman Scattering (SERS) technology in exosome detection. SERS, known for its unique photonic properties and high sensitivity, offers a promising solution for detecting exosomes without the need for large sample volumes or extensive phenotypic analysis. This review focuses on the real-time and non-invasive assessment capabilities of SERS in exosome detection, providing insights into its potential for early disease diagnosis.

Conclusion

The review concludes by emphasizing the potential of SERS-based exosome detection in advancing early disease diagnosis. By overcoming existing challenges, SERS technology offers a promising approach for the development of sensitive and specific diagnostic assays, contributing to better patient outcomes and personalized medicine.

{"title":"Surface-Enhanced Raman Scattering (SERS) for exosome detection","authors":"Biqing Chen, Xiaohong Qiu","doi":"10.1016/j.cca.2025.120148","DOIUrl":"10.1016/j.cca.2025.120148","url":null,"abstract":"<div><h3>Background</h3><div>Exosomes, nanoscale extracellular vesicles secreted by various cells, are abundantly present in biological fluids. They have been identified as carriers of specific molecules, suggesting their potential role in early disease detection. However, their clinical application is hindered by several challenges, including the need for large sample volumes for enrichment, limitations of traditional detection methods, and the complexity involved in phenotype analysis and separation.</div></div><div><h3>Objective</h3><div>This review aims to explore the application of Surface-Enhanced Raman Scattering (SERS) technology in exosome detection. SERS, known for its unique photonic properties and high sensitivity, offers a promising solution for detecting exosomes without the need for large sample volumes or extensive phenotypic analysis. This review focuses on the real-time and non-invasive assessment capabilities of SERS in exosome detection, providing insights into its potential for early disease diagnosis.</div></div><div><h3>Conclusion</h3><div>The review concludes by emphasizing the potential of SERS-based exosome detection in advancing early disease diagnosis. By overcoming existing challenges, SERS technology offers a promising approach for the development of sensitive and specific diagnostic assays, contributing to better patient outcomes and personalized medicine.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"568 ","pages":"Article 120148"},"PeriodicalIF":3.2,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143022340","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}

引用次数: 0

Cytokeratin 18 fragment in liver inflammation and fibrosis: Systematic review and meta-analysis 细胞角蛋白18片段在肝脏炎症和纤维化中的作用：系统回顾和荟萃分析。

IF 3.2 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta

Pub Date : 2025-01-19 DOI: 10.1016/j.cca.2025.120147

Junzhao Ye , Jiaming Lai , Ling Luo , Ting Zhou , Yanhong Sun , Bihui Zhong

Background

This meta-analysis aimed to summarize the diagnostic accuracy and cut-off values of cytokeratin (CK) 18 measurements, specifically M30 and M65, as candidate biomarkers for the pathological evaluation of biopsy specimens used to stage liver inflammation and fibrosis in patients with chronic liver diseases.

Methods

Databases were searched for studies collected up to January 11th, 2025. Pooled sensitivity, specificity, area under the receiver-operating characteristic curves, and mean cut-off values were calculated using random-effects models regardless of heterogeneity. A meta-regression analysis and subgroup analysis were performed to explore heterogeneity.

Results

Sixty-three studies comprising 9137 patients were included. The summarized AUROC curve of CK18 M30 for the diagnosis of significant liver inflammation, fibrosis ≥F1, ≥F2, ≥F3, and =F4 according to the METAVIR score system were 0.82, 0.75, 0.78, 0.78 and 0.76, with mean cut-off values of 264.3, 188.0, 276.9, 322.8 and 169.4 U/L. For M65, the summarized AUROC curve for detecting significant liver inflammation, fibrosis ≥F1, ≥F2, and =F4 were 0.79, 0.70, 0.76, 0.64 and 0.72, with mean cut-off values of 541.1, 417.6, 500.1, 424.6 and 674.0 U/L. The subgroup analyses implied that ethnicity may be the primary factor related to heterogeneity in CK18 M30 when applied to detect significant inflammation. Asian patients had values 79.7 U/L higher than those of non-Asian patients (p = 0.0157).

Conclusions

CK18 M30 and M65 have clinically meaningful accuracy as alternative diagnostic tools for determining liver inflammation and fibrosis using biopsy specimens of patients with steatotic liver disease or viral hepatitis.

Registration: PROSPERO registration number: CRD42022364598.

背景：本荟萃分析旨在总结细胞角蛋白（CK） 18测量值的诊断准确性和临界值，特别是M30和M65，作为用于慢性肝病患者肝脏炎症和纤维化分期的活检标本病理评估的候选生物标志物。方法：检索截至2025年1月11日的文献。在不考虑异质性的情况下，使用随机效应模型计算合并敏感性、特异性、受试者工作特征曲线下面积和平均截止值。采用meta回归分析和亚组分析探讨异质性。结果：纳入63项研究，9137例患者。根据METAVIR评分系统，CK18 M30诊断肝脏明显炎症、纤维化≥F1、≥F2、≥F3、=F4的AUROC曲线汇总为0.82、0.75、0.78、0.78、0.76，平均临界值分别为264.3、188.0、276.9、322.8、169.4 U/L。M65检测肝脏明显炎症、纤维化≥F1、≥F2、=F4的AUROC曲线总结值分别为0.79、0.70、0.76、0.64、0.72，平均截断值分别为541.1、417.6、500.1、424.6、674.0 U/L。亚组分析表明，当用于检测显著炎症时，种族可能是与ck18m30异质性相关的主要因素。亚裔患者比非亚裔患者高79.7 U/L （p = 0.0157）。结论：CK18 M30和M65作为脂肪肝或病毒性肝炎患者活检标本确定肝脏炎症和纤维化的替代诊断工具具有临床意义的准确性。注册：普洛斯彼罗注册号：CRD42022364598。

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引用次数: 0

The clinical significance of mirror patterns of cerebrospinal fluid oligoclonal immunoglobulin G bands (IgG-OCBs) in peripheral neuropathy disorders 脑脊液寡克隆免疫球蛋白G带镜像模式在周围神经病变中的临床意义

IF 3.2 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta

Pub Date : 2025-01-19 DOI: 10.1016/j.cca.2025.120145

Jingluan Tian , Xiaoni Liu , Yarong Li , Yuehua Gu , Bo Deng , Wenbo Yang , Hai Yu , Xiang Zhang , Xiangjun Chen

Background

CSF (cerebrospinal fluid) oligoclonal immunoglobulin G bands (IgG-OCBs) analysis plays a crucial role in diagnosis of various neurological disorders. However, the clinical significance of mirror pattern bands remains unclear, and their precise application is not well understood.

Methods

We retrospectively reviewed a total of 7597 IgG-OCB records detected using isoelectric focusing from May 2020 and August 2023 at Huashan Hospital. Among these, 121 mirror pattern bands (62 type IV and 59 type V) were identified in patients with neurological disorders. Basic clinical data, including discharge diagnosis, gender, and age, were collected. Additionally, CSF and serum immunological parameters, as well as monoclonal protein (M protein) detection, were reviewed.

Results

Although mirror pattern bands are rarely observed in neurological diseases, approximately half of these patterns were found in patients with peripheral neuropathy (PN). In the type IV group, 40.74 % of cases were associated with immune-mediated PN, while type V pattern was predominantly observed in cancer-related/lymphoproliferative PN, comprising 63.33 % of the cases. Patients with cancer-related or lymphoproliferative PN showed significantly higher IgG-CSF concentrations (p = 0.017) and 24-h intrathecal IgG synthesis rate (p = 0.022), indicating a stronger humoral immune response. Additionally, both patients with immune-mediated PN and cancer-related/lymphoproliferative PN exhibited abnormal intrathecal synthesis rate and moderate to severe blood–brain barrier impairment. Furthermore, the type V group also exhibited a high prevalence of M protein positivity.

Conclusions

The differential immunological responses and distinct patterns of OCBs observed in our study underscore the critical role of OCB analysis in the diagnostic workup of PN.

背景：CSF（脑脊液）寡克隆免疫球蛋白G带（IgG-OCBs）分析在各种神经系统疾病的诊断中起着至关重要的作用。然而，镜像带的临床意义尚不清楚，其精确应用也不清楚。方法：回顾性分析华山医院2020年5月至2023年8月共7597例IgG-OCB等电聚焦检测记录。其中，121个镜像带（62个IV型和59个V型）在神经系统疾病患者中被发现。收集出院诊断、性别、年龄等基本临床资料。此外，还对脑脊液和血清免疫学参数以及单克隆蛋白（M蛋白）检测进行了综述。结果：虽然镜像带在神经系统疾病中很少观察到，但在周围神经病变（PN）患者中发现了大约一半的镜像带。在IV型组中，40.74 %的病例与免疫介导的PN相关，而V型模式主要观察到癌症相关/淋巴增生性PN，占63.33 %的病例。肿瘤相关或淋巴增生性PN患者IgG- csf浓度（p = 0.017）和24小时鞘内IgG合成率（p = 0.022）均显著升高，提示体液免疫反应更强。此外，免疫介导的PN和癌症相关/淋巴增生性PN患者均表现出鞘内合成率异常和中度至重度血脑屏障损伤。此外，V型组也表现出较高的M蛋白阳性患病率。结论：本研究中观察到的OCB的不同免疫反应和不同模式强调了OCB分析在PN诊断工作中的关键作用。

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引用次数: 0