This study examines the genetic and clinical profiles of Vietnamese patients with non-small cell lung cancer (NSCLC), focusing on mutations in seven driver genes: EGFR, KRAS, NRAS, BRAF, ALK, ROS1, and PIK3CA. The goal is to identify mutation patterns and their correlations with clinical factors, thereby informing personalized treatment strategies.
Materials and methods
A cross-sectional study of 299 NSCLC patients at the University Medical Center, Ho Chi Minh City (2019–2022) recorded demographics, smoking history, and tumor stage. Pre-treatment samples were analyzed via massively parallel sequencing, and survival analysis assessed the impact of EGFR/KRAS mutations on survival and TKI response.
Results
Most patients (88.6 %) were diagnosed at stage IV. EGFR mutations were found in 43.5 % of cases, predominantly in female non-smokers, while KRAS mutations (15.4 %) were more common in male smokers. EGFR exon 19 deletions (46.3 %) and L858R (39.0 %) were the most frequent, with KRAS G12C (29.8 %) as the dominant variant. EGFR-mutant patients treated with TKIs had significantly longer survival (p = 0.027); however, no survival difference was observed between the EGFR- and KRAS-mutated groups. Co-mutations (3.7 %) were rare but may indicate resistance. Logistic regression confirmed EGFR mutations' association with female non-smokers and KRAS mutations with male smokers.
Conclusions
Genetic profiling in Vietnamese NSCLC patients reveals a high prevalence of actionable driver mutations, supporting the integration of routine molecular testing into NSCLC management. EGFR-mutated patients derive significant benefits from TKI therapy, underscoring the importance of personalized treatment strategies. Further research is needed to investigate resistance mechanisms and refine targeted therapeutic approaches.
{"title":"Assessing mutation-clinical correlations and treatment outcomes in Vietnamese non-small cell lung cancer patients","authors":"Hoang-Bac Nguyen , Bang-Suong Nguyen-Thi , Huu-Huy Nguyen , Minh-Khoi Le , Quoc-Trung Lam , Tuan-Anh Nguyen","doi":"10.1016/j.plabm.2025.e00477","DOIUrl":"10.1016/j.plabm.2025.e00477","url":null,"abstract":"<div><h3>Introduction</h3><div>This study examines the genetic and clinical profiles of Vietnamese patients with non-small cell lung cancer (NSCLC), focusing on mutations in seven driver genes: <em>EGFR</em>, <em>KRAS</em>, <em>NRAS</em>, <em>BRAF</em>, <em>ALK</em>, <em>ROS1</em>, and <em>PIK3CA</em>. The goal is to identify mutation patterns and their correlations with clinical factors, thereby informing personalized treatment strategies.</div></div><div><h3>Materials and methods</h3><div>A cross-sectional study of 299 NSCLC patients at the University Medical Center, Ho Chi Minh City (2019–2022) recorded demographics, smoking history, and tumor stage. Pre-treatment samples were analyzed via massively parallel sequencing, and survival analysis assessed the impact of <em>EGFR/KRAS</em> mutations on survival and TKI response.</div></div><div><h3>Results</h3><div>Most patients (88.6 %) were diagnosed at stage IV. <em>EGFR</em> mutations were found in 43.5 % of cases, predominantly in female non-smokers, while <em>KRAS</em> mutations (15.4 %) were more common in male smokers. <em>EGFR</em> exon 19 deletions (46.3 %) and L858R (39.0 %) were the most frequent, with <em>KRAS</em> G12C (29.8 %) as the dominant variant. <em>EGFR</em>-mutant patients treated with TKIs had significantly longer survival (p = 0.027); however, no survival difference was observed between the <em>EGFR</em>- and <em>KRAS</em>-mutated groups. Co-mutations (3.7 %) were rare but may indicate resistance. Logistic regression confirmed <em>EGFR</em> mutations' association with female non-smokers and <em>KRAS</em> mutations with male smokers.</div></div><div><h3>Conclusions</h3><div>Genetic profiling in Vietnamese NSCLC patients reveals a high prevalence of actionable driver mutations, supporting the integration of routine molecular testing into NSCLC management. <em>EGFR</em>-mutated patients derive significant benefits from TKI therapy, underscoring the importance of personalized treatment strategies. Further research is needed to investigate resistance mechanisms and refine targeted therapeutic approaches.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"45 ","pages":"Article e00477"},"PeriodicalIF":1.7,"publicationDate":"2025-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144134000","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}
Pub Date : 2025-05-16DOI: 10.1016/j.plabm.2025.e00476
Cuiyuan Huang , Jiajuan Yang , Wenqiang Li , Li Liu , Wei Wang , Haiyan Hu , Jing Zhang , Jian Yang
Background
Systemic immune inflammation index (SII) is an innovative marker reflecting immune and inflammatory responses.
Objectives
To explore the predictive value of SII on the risk of death in patients with NSTEMI combined with T2DM.
Methods
An analysis of 448 patients with NSTEMI and T2DM admitted to our institution between December 2017 and May 2022 was conducted in this retrospective study. SII values were used to divide patients into high and low SII groups and investigate their impact on mortality.
Results
According to the analysis results, elevated SII levels are significantly linked to a poor prognosis in patients with NSTEMI and T2DM. Over an average follow-up period of 22.75 months, 106 (23.7 %) all-cause deaths were recorded. The optimal threshold for predicting death was found to be an SII value of 1384.596 × 109/L through ROC curve analysis. Kaplan-Meier analysis indicated that the survival rates were higher in the low SII group compared to the high SII group (P < 0.001). Elevated SII levels were independently linked to increased mortality in patients with NSTEMI and T2DM, according to univariate (HR:3.19, 95 % Cl: 2.18–4.68) and multivariate COX (HR: 2.72, 95 % Cl: 1.81–4.09) regression analyses.
Conclusion
High SII values were strongly associated with mortality in patients with NSTEMI and T2DM. SII serves as a valuable prognostic tool, enhancing the management and prognosis of patients with concurrent NSTEMI and T2DM.
{"title":"SII as a predictor of mortality in patients with non-ST-segment elevation myocardial infarction and diabetes mellitus","authors":"Cuiyuan Huang , Jiajuan Yang , Wenqiang Li , Li Liu , Wei Wang , Haiyan Hu , Jing Zhang , Jian Yang","doi":"10.1016/j.plabm.2025.e00476","DOIUrl":"10.1016/j.plabm.2025.e00476","url":null,"abstract":"<div><h3>Background</h3><div>Systemic immune inflammation index (SII) is an innovative marker reflecting immune and inflammatory responses.</div></div><div><h3>Objectives</h3><div>To explore the predictive value of SII on the risk of death in patients with NSTEMI combined with T2DM.</div></div><div><h3>Methods</h3><div>An analysis of 448 patients with NSTEMI and T2DM admitted to our institution between December 2017 and May 2022 was conducted in this retrospective study. SII values were used to divide patients into high and low SII groups and investigate their impact on mortality.</div></div><div><h3>Results</h3><div>According to the analysis results, elevated SII levels are significantly linked to a poor prognosis in patients with NSTEMI and T2DM. Over an average follow-up period of 22.75 months, 106 (23.7 %) all-cause deaths were recorded. The optimal threshold for predicting death was found to be an SII value of 1384.596 × 10<sup>9</sup>/L through ROC curve analysis. Kaplan-Meier analysis indicated that the survival rates were higher in the low SII group compared to the high SII group (<em>P</em> < 0.001). Elevated SII levels were independently linked to increased mortality in patients with NSTEMI and T2DM, according to univariate (HR:3.19, 95 % Cl: 2.18–4.68) and multivariate COX (HR: 2.72, 95 % Cl: 1.81–4.09) regression analyses.</div></div><div><h3>Conclusion</h3><div>High SII values were strongly associated with mortality in patients with NSTEMI and T2DM. SII serves as a valuable prognostic tool, enhancing the management and prognosis of patients with concurrent NSTEMI and T2DM.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"45 ","pages":"Article e00476"},"PeriodicalIF":1.7,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144177880","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}
Colorectal cancer (CRC), according to the most recent data provided by GLOBOCAN, ranks fourth worldwide in incidence and third in mortality among all cancers. Current estimates project a global increase in colorectal cancer incidence of 60.5 % and mortality of 76.9 % between 2022 and 2045. The low sensitivity and adherence, coupled with the high costs associated with current diagnostic methods for CRC, underscore the need to explore innovative procedures for the early detection of tissue abnormalities. Existing research suggests that patients affected by this condition exhibit distinctive alterations in volatile organic compounds (VOCs) ratios in their exhaled breath.
This study presents a characterization of exhaled breath using Gas Chromatography-Mass Spectrometry (GC-MS) in patients with varying stages of the disease, as determined by conventional medical and clinical analyses. An electronic nose was utilized to develop a method aimed at rapidly analyzing a subject's exhaled breath to identify the group of belonging (healthy, affected). The aim of the study was to develop a rapid, cost-effective, and non-invasive early diagnostic system employing an electronic nose. Statistical analysis identified 12 compounds with the potential to distinguish between healthy and affected individuals and were selected for testing the application potential of the Cyranose 320 electronic nose. The ability of the method to identify the 40 subjects analyzed as Healthy Controls (HC) or CRC in terms of sensitivity and specificity (0.8 and 0.85, respectively) demonstrates the feasibility of using this method for rapid, low-cost, and non-invasive disease recognition.
{"title":"Breath fingerprint of colorectal cancer patients by gas chromatography-mass spectrometry analysis preparatory to e-nose analyses","authors":"Stefano Dugheri , Ilaria Rapi , Giovanni Cappelli , Niccolò Fanfani , Donato Squillaci , Simone De Sio , Beatrice Mallardi , Paola Mantellini , Fabio Staderini , Veronica Traversini , Antonio Baldassarre , Fabio Cianchi , Nicola Mucci","doi":"10.1016/j.plabm.2025.e00475","DOIUrl":"10.1016/j.plabm.2025.e00475","url":null,"abstract":"<div><div>Colorectal cancer (CRC), according to the most recent data provided by GLOBOCAN, ranks fourth worldwide in incidence and third in mortality among all cancers. Current estimates project a global increase in colorectal cancer incidence of 60.5 % and mortality of 76.9 % between 2022 and 2045. The low sensitivity and adherence, coupled with the high costs associated with current diagnostic methods for CRC, underscore the need to explore innovative procedures for the early detection of tissue abnormalities. Existing research suggests that patients affected by this condition exhibit distinctive alterations in volatile organic compounds (VOCs) ratios in their exhaled breath.</div><div>This study presents a characterization of exhaled breath using Gas Chromatography-Mass Spectrometry (GC-MS) in patients with varying stages of the disease, as determined by conventional medical and clinical analyses. An electronic nose was utilized to develop a method aimed at rapidly analyzing a subject's exhaled breath to identify the group of belonging (healthy, affected). The aim of the study was to develop a rapid, cost-effective, and non-invasive early diagnostic system employing an electronic nose. Statistical analysis identified 12 compounds with the potential to distinguish between healthy and affected individuals and were selected for testing the application potential of the Cyranose 320 electronic nose. The ability of the method to identify the 40 subjects analyzed as Healthy Controls (HC) or CRC in terms of sensitivity and specificity (0.8 and 0.85, respectively) demonstrates the feasibility of using this method for rapid, low-cost, and non-invasive disease recognition.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"45 ","pages":"Article e00475"},"PeriodicalIF":1.7,"publicationDate":"2025-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144068373","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}
Pub Date : 2025-05-08DOI: 10.1016/j.plabm.2025.e00474
Dorota Leszczyńska , Alicja Szatko , Magdalena Ostrowska , Magdalena Zgliczyńska , Konrad Kowalski , Wojciech Zgliczyński , Piotr Glinicki
Background
1α,25-dihydroxyvitamin D is the biologically active form of vitamin D3 (cholecalciferol) and vitamin D2 (ergocalciferol). The determination of 1,25(OH)2D is clinically relevant in the diagnostics of vitamin D metabolism disorders, PTH-independent hypercalceamia and hypophosphatemic syndromes. The quantitative assessment of 1,25(OH)2D may be a challenge since it circulates in picomolar concentrations in the blood.
Aims of the study
Comparison of two methods: chemiluminescent immunoassay (CLIA, LIAISON®XL) and Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS) for determinations of 1,25(OH)2D concentrations in elderly populations. The secondary aim was to assess correlation between 1,25(OH)2D for CLIALIAISON®XL and LC-MS/MS methods and selected factors (vitamin D metabolites, calcium, albumin, PTH, creatinine concentrations in serum and age).
Materials and methods
The study was conducted on 54 patients aged from 60 to 96 at the Bielański Hospital in Warsaw, Poland. The determination of 1,25(OH)2D using CLIALIAISON®XL and LC-MS/MS methods was performed.
Results
Both methods (CLIALIAISON®XL immunoassay and LC-MS/MS technique) were strongly positively correlated (r = 0.86; p < 0.001). In the LC-MS/MS technique, concentration of 1,25(OH)2D was significantly higher compared to the CLIALIAISON®XL immunoassay. The regression equation revealed method interchangeability. Concentration of 1,25(OH)2D was significantly correlated with various basic biochemical parameters (albumin and calcium levels) for both methods.
Conclusions
In our study, measurement of 1,25(OH)2D using CLIALIAISON®XL was not inferior to LC-MS/MS measurement. The assessment of 1,25(OH)2D using CLIALIAISON®XL, characterized by short turnaround time, low costs and high accuracy, may be an optimal choice for elderly patients who often require prompt diagnosis and treatment.
{"title":"1,25-dihydroxyvitamin D in the elderly population: Comparison of liquid chromatography tandem mass spectrometry and CLIA immunoassay (LIAISON®XL) methods","authors":"Dorota Leszczyńska , Alicja Szatko , Magdalena Ostrowska , Magdalena Zgliczyńska , Konrad Kowalski , Wojciech Zgliczyński , Piotr Glinicki","doi":"10.1016/j.plabm.2025.e00474","DOIUrl":"10.1016/j.plabm.2025.e00474","url":null,"abstract":"<div><h3>Background</h3><div>1α,25-dihydroxyvitamin D is the biologically active form of vitamin D<sub>3</sub> (cholecalciferol) and vitamin D<sub>2</sub> (ergocalciferol). The determination of 1,25(OH)<sub>2</sub>D is clinically relevant in the diagnostics of vitamin D metabolism disorders, PTH-independent hypercalceamia and hypophosphatemic syndromes. The quantitative assessment of 1,25(OH)<sub>2</sub>D may be a challenge since it circulates in picomolar concentrations in the blood.</div></div><div><h3>Aims of the study</h3><div>Comparison of two methods: chemiluminescent immunoassay (CLIA, LIAISON®XL) and Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS) for determinations of 1,25(OH)<sub>2</sub>D concentrations in elderly populations. The secondary aim was to assess correlation between 1,25(OH)<sub>2</sub>D for CLIA<sub>LIAISON®XL</sub> and LC-MS/MS methods and selected factors (vitamin D metabolites, calcium, albumin, PTH, creatinine concentrations in serum and age).</div></div><div><h3>Materials and methods</h3><div>The study was conducted on 54 patients aged from 60 to 96 at the Bielański Hospital in Warsaw, Poland. The determination of 1,25(OH)<sub>2</sub>D using CLIA<sub>LIAISON®XL</sub> and LC-MS/MS methods was performed.</div></div><div><h3>Results</h3><div>Both methods (CLIA<sub>LIAISON®XL</sub> immunoassay and LC-MS/MS technique) were strongly positively correlated (r = 0.86; p < 0.001). In the LC-MS/MS technique, concentration of 1,25(OH)<sub>2</sub>D was significantly higher compared to the CLIA<sub>LIAISON®XL</sub> immunoassay. The regression equation revealed method interchangeability. Concentration of 1,25(OH)<sub>2</sub>D was significantly correlated with various basic biochemical parameters (albumin and calcium levels) for both methods.</div></div><div><h3>Conclusions</h3><div>In our study, measurement of 1,25(OH)<sub>2</sub>D using CLIA<sub>LIAISON®XL</sub> was not inferior to LC-MS/MS measurement. The assessment of 1,25(OH)<sub>2</sub>D using CLIA<sub>LIAISON®XL</sub>, characterized by short turnaround time, low costs and high accuracy, may be an optimal choice for elderly patients who often require prompt diagnosis and treatment.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"45 ","pages":"Article e00474"},"PeriodicalIF":1.7,"publicationDate":"2025-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144147095","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}
Pub Date : 2025-05-01DOI: 10.1016/j.plabm.2025.e00472
Kuo-Chun Chiu , Jia-Rong Jhan , Hsiao-Ni Yan , Yu-Chen Liao , Wen-Hui Lu , Kuan-Yi Lee , Li-Yuan Cheng , Chung-Kang Yeh , Ya-Fen Lee , Chiung-Hui Kuo , Kuei-Pin Chung , Tzu-I Chien
<div><h3>Background</h3><div>Laboratory examinations play a crucial role in medical diagnostics and treatment, necessitating the identification of interference factors to ensure accurate results. Biotin, a common dietary supplement, can interfere with immunoassays utilizing biotin-streptavidin interactions. Studies have documented biotin's significant impact on thyroid function tests and various immunoassays, prompting the need for effective mitigation strategies.</div></div><div><h3>Methods</h3><div>Samples were collected from various clinical departments and analyzed for biotin levels. Biotin interference was evaluated using both old and new Elecsys reagents in assays for thyroglobulin (TG), alpha-fetoprotein (AFP), anti-thyroglobulin (ATG), and free thyroxine (FT4). Biotin spike-in and depletion tests were conducted to assess interference mitigation methods. Additionally, the biotin tolerance of Roche and Abbott immunoassay systems was compared.</div></div><div><h3>Results</h3><div>Biotin levels were measured in 78 participants from different clinical departments: health management center (<em>n</em> = 13), emergency department (<em>n</em> = 21), intensive care unit (<em>n</em> = 12), gynecology department(<em>n</em> = 3), and hemodialysis department (<em>n</em> = 29). Patients undergoing hemodialysis and those in the intensive care unit (ICU) demonstrated significantly elevated biotin levels (mean = 3.282 ng/mL and 3.212 ng/mL, respectively) in comparison to other patient groups (<em>p</em> < 0.05), likely attributable to the intake of biotin-containing supplements. Biotin levels >500 ng/mL caused a 20 % change in assay values, resulting in false-low results for TG and AFP and false-high results for ATG and FT4 with older Elecsys reagents. Setting a 10 % change as the threshold, the newer Elecsys reagents demonstrated improved resistance against biotin interference, tolerating concentrations of 1000 ng/mL to 3000 ng/mL depending on the specific tests, consistent with the Roche package inserts. We employed a biotin depletion method that effectively restored assay accuracy for older reagents, generally resulting in less than a 10 % change when biotin levels were below 400 ng/mL. However, this depletion method was unnecessary with the newer reagents due to their increased biotin tolerance. Comparing the Roche and Abbott systems revealed significant differences in biotin tolerance. The Abbott system demonstrated greater resilience to biotin interference, while the Roche system showed biotin interference in assays for carcinoembryonic antigen, cancer antigen 125, cancer antigen 153, cancer antigen 19-9, with changes exceeding 30 % at 500 ng/mL of biotin.</div></div><div><h3>Conclusions</h3><div>Our study highlights the high prevalence of elevated biotin levels in hemodialysis and ICU patients, serving as a critical reference for clinical result interpretation. We confirm that Roche's newer reagents exhibit enhanced biotin tolerance, consiste
{"title":"Biotin interference in routine clinical immunoassays","authors":"Kuo-Chun Chiu , Jia-Rong Jhan , Hsiao-Ni Yan , Yu-Chen Liao , Wen-Hui Lu , Kuan-Yi Lee , Li-Yuan Cheng , Chung-Kang Yeh , Ya-Fen Lee , Chiung-Hui Kuo , Kuei-Pin Chung , Tzu-I Chien","doi":"10.1016/j.plabm.2025.e00472","DOIUrl":"10.1016/j.plabm.2025.e00472","url":null,"abstract":"<div><h3>Background</h3><div>Laboratory examinations play a crucial role in medical diagnostics and treatment, necessitating the identification of interference factors to ensure accurate results. Biotin, a common dietary supplement, can interfere with immunoassays utilizing biotin-streptavidin interactions. Studies have documented biotin's significant impact on thyroid function tests and various immunoassays, prompting the need for effective mitigation strategies.</div></div><div><h3>Methods</h3><div>Samples were collected from various clinical departments and analyzed for biotin levels. Biotin interference was evaluated using both old and new Elecsys reagents in assays for thyroglobulin (TG), alpha-fetoprotein (AFP), anti-thyroglobulin (ATG), and free thyroxine (FT4). Biotin spike-in and depletion tests were conducted to assess interference mitigation methods. Additionally, the biotin tolerance of Roche and Abbott immunoassay systems was compared.</div></div><div><h3>Results</h3><div>Biotin levels were measured in 78 participants from different clinical departments: health management center (<em>n</em> = 13), emergency department (<em>n</em> = 21), intensive care unit (<em>n</em> = 12), gynecology department(<em>n</em> = 3), and hemodialysis department (<em>n</em> = 29). Patients undergoing hemodialysis and those in the intensive care unit (ICU) demonstrated significantly elevated biotin levels (mean = 3.282 ng/mL and 3.212 ng/mL, respectively) in comparison to other patient groups (<em>p</em> < 0.05), likely attributable to the intake of biotin-containing supplements. Biotin levels >500 ng/mL caused a 20 % change in assay values, resulting in false-low results for TG and AFP and false-high results for ATG and FT4 with older Elecsys reagents. Setting a 10 % change as the threshold, the newer Elecsys reagents demonstrated improved resistance against biotin interference, tolerating concentrations of 1000 ng/mL to 3000 ng/mL depending on the specific tests, consistent with the Roche package inserts. We employed a biotin depletion method that effectively restored assay accuracy for older reagents, generally resulting in less than a 10 % change when biotin levels were below 400 ng/mL. However, this depletion method was unnecessary with the newer reagents due to their increased biotin tolerance. Comparing the Roche and Abbott systems revealed significant differences in biotin tolerance. The Abbott system demonstrated greater resilience to biotin interference, while the Roche system showed biotin interference in assays for carcinoembryonic antigen, cancer antigen 125, cancer antigen 153, cancer antigen 19-9, with changes exceeding 30 % at 500 ng/mL of biotin.</div></div><div><h3>Conclusions</h3><div>Our study highlights the high prevalence of elevated biotin levels in hemodialysis and ICU patients, serving as a critical reference for clinical result interpretation. We confirm that Roche's newer reagents exhibit enhanced biotin tolerance, consiste","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"45 ","pages":"Article e00472"},"PeriodicalIF":1.7,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143901916","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}
Pub Date : 2025-04-25DOI: 10.1016/j.plabm.2025.e00473
Ida Branzell , Gabriella Lillsunde Larsson , Dieter Samyn , Paul Pettersson-Pablo
Background and aim
Evaluate the diagnostic performance of automated, quantitative bilirubin measurement, modified to extend its lower measurement ranges, in cerebrospinal fluid (CSF) using the Siemens analyzer Advia XPT. Results were compared with the gold standard spectrophotometry for diagnosis of subarachnoid haemorrhage (SAH).
Method
Eighty clinical samples were analyzed on an Advia XPT, and results were compared to spectrophotometric results using the Agilent Cary 100 bio system. Method performance at low concentrations were evaluated using diluted control material and patient plasma and CSF samples. ROC curve analysis determined a suitable cutoff.
Result
Evaluation of low-concentration performance, below 2 μmol/L on Advia XPT, showed a measurement bias of -1.0 %, and a linear regression equation of y = 0.843x + 0.0351 (R2 of 0.975), describing the relationship between measured and expected concentrations of diluted samples. The coefficient of variation, (CV), was 2.92 % at 0.598 μmol/L and 26.6 % at 0.161 μmol/L. Using the outcome of the analysis on Agilent Cary 100 as reference, sensitivity was 100 % and specificity 96 %, employing a cutoff of 0.41 μmol/L.
Conclusion
Quantitative measurement of bilirubin in CSF using the bilirubin oxidase method on the automated Advia XPT platform perform well, with the analysis of low concentrations of bilirubin displaying a high precision and a high concordance with the results of spectrophotometry. These preliminary findings are indicative of the merits of quantitative measurement, that warrants further study of its diagnostic potential as an alternative to the more cumbersome spectrophotometry for diagnosing SAH.
{"title":"Measurement of bilirubin in cerebrospinal fluid using the oxidase method on automated chemistry system advia XPT","authors":"Ida Branzell , Gabriella Lillsunde Larsson , Dieter Samyn , Paul Pettersson-Pablo","doi":"10.1016/j.plabm.2025.e00473","DOIUrl":"10.1016/j.plabm.2025.e00473","url":null,"abstract":"<div><h3>Background and aim</h3><div>Evaluate the diagnostic performance of automated, quantitative bilirubin measurement, modified to extend its lower measurement ranges, in cerebrospinal fluid (CSF) using the Siemens analyzer Advia XPT. Results were compared with the gold standard spectrophotometry for diagnosis of subarachnoid haemorrhage (SAH).</div></div><div><h3>Method</h3><div>Eighty clinical samples were analyzed on an Advia XPT, and results were compared to spectrophotometric results using the Agilent Cary 100 bio system. Method performance at low concentrations were evaluated using diluted control material and patient plasma and CSF samples. ROC curve analysis determined a suitable cutoff.</div></div><div><h3>Result</h3><div>Evaluation of low-concentration performance, below 2 μmol/L on Advia XPT, showed a measurement bias of -1.0 %, and a linear regression equation of y = 0.843x + 0.0351 (R<sup>2</sup> of 0.975), describing the relationship between measured and expected concentrations of diluted samples. The coefficient of variation, (CV), was 2.92 % at 0.598 μmol/L and 26.6 % at 0.161 μmol/L. Using the outcome of the analysis on Agilent Cary 100 as reference, sensitivity was 100 % and specificity 96 %, employing a cutoff of 0.41 μmol/L.</div></div><div><h3>Conclusion</h3><div>Quantitative measurement of bilirubin in CSF using the bilirubin oxidase method on the automated Advia XPT platform perform well, with the analysis of low concentrations of bilirubin displaying a high precision and a high concordance with the results of spectrophotometry. These preliminary findings are indicative of the merits of quantitative measurement, that warrants further study of its diagnostic potential as an alternative to the more cumbersome spectrophotometry for diagnosing SAH.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"45 ","pages":"Article e00473"},"PeriodicalIF":1.7,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143887321","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}
Pub Date : 2025-04-17DOI: 10.1016/j.plabm.2025.e00471
Yuting Wang , Quan Li , Yuhang Deng , Wenqing Wu , Cuiping Zhang , Yichi Zheng , Ming Guan , Haoqin Jiang
Catecholamines (CAs) and their metabolites in human cerebrospinal fluid (CSF) and plasma are potential biomarkers of Alzheimer's disease (AD) and facilitate early diagnosis. Liquid chromatography-tandem mass spectrometry is the gold standard method for analyzing CAs. The objective of this study was to develop and validate a liquid chromatography-tandem mass spectrometry assay capable of simultaneously quantifying dopamine (DA), epinephrine (E), norepinephrine (NE), metanephrine (MN), normetanephrine (NMN), and 3-methoxytyramine (3-MT) in both human CSF and plasma. Samples were processed by solid-phase extraction with a weak cation exchange adsorbent and then separated using an ultra-performance reversed-phase chromatography column. Analyte detection was performed using a triple quadrupole mass spectrometer operated in positive-ion multiple reaction monitoring mode. The developed assay was validated according to standard guidelines. The linearity, specificity, precision, accuracy, carryover and stability were assessed to ensure compliance with specified criteria. The lower limits of quantification for DA, E, NE, MN, NMN, and 3-MT were 4.5, 2.5, 4.5, 2.5, 2, and 0.3 pg mL−1, respectively. The total runtime for a single sample was 6.5 min. These results demonstrated that the method was sensitive, rapid, and reliable for the simultaneous quantification of DA, E, NE, MN, NMN, and 3-MT in clinical practice. We successfully detected CAs and their metabolites in plasma and CSF samples from patients with normal cognition and AD. This study demonstrates an efficient laboratory workflow for high-throughput analysis of CAs and their metabolites and lays a foundation for further studies on AD biomarkers.
{"title":"Liquid chromatography-tandem mass spectrometry assay for simultaneous quantification of catecholamines and metabolites in human plasma and cerebrospinal fluid","authors":"Yuting Wang , Quan Li , Yuhang Deng , Wenqing Wu , Cuiping Zhang , Yichi Zheng , Ming Guan , Haoqin Jiang","doi":"10.1016/j.plabm.2025.e00471","DOIUrl":"10.1016/j.plabm.2025.e00471","url":null,"abstract":"<div><div>Catecholamines (CAs) and their metabolites in human cerebrospinal fluid (CSF) and plasma are potential biomarkers of Alzheimer's disease (AD) and facilitate early diagnosis. Liquid chromatography-tandem mass spectrometry is the gold standard method for analyzing CAs. The objective of this study was to develop and validate a liquid chromatography-tandem mass spectrometry assay capable of simultaneously quantifying dopamine (DA), epinephrine (E), norepinephrine (NE), metanephrine (MN), normetanephrine (NMN), and 3-methoxytyramine (3-MT) in both human CSF and plasma. Samples were processed by solid-phase extraction with a weak cation exchange adsorbent and then separated using an ultra-performance reversed-phase chromatography column. Analyte detection was performed using a triple quadrupole mass spectrometer operated in positive-ion multiple reaction monitoring mode. The developed assay was validated according to standard guidelines. The linearity, specificity, precision, accuracy, carryover and stability were assessed to ensure compliance with specified criteria. The lower limits of quantification for DA, E, NE, MN, NMN, and 3-MT were 4.5, 2.5, 4.5, 2.5, 2, and 0.3 pg mL<sup>−1</sup>, respectively. The total runtime for a single sample was 6.5 min. These results demonstrated that the method was sensitive, rapid, and reliable for the simultaneous quantification of DA, E, NE, MN, NMN, and 3-MT in clinical practice. We successfully detected CAs and their metabolites in plasma and CSF samples from patients with normal cognition and AD. This study demonstrates an efficient laboratory workflow for high-throughput analysis of CAs and their metabolites and lays a foundation for further studies on AD biomarkers.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"45 ","pages":"Article e00471"},"PeriodicalIF":1.7,"publicationDate":"2025-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143851953","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}
Anti-IH exhibits complex specificity, strongly reacting with cells expressing both H and I antigens at cold temperatures. Its clinical significance has been increasingly recognized, particularly in patients with hematologic conditions such as myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML).
Case report
We present an 83-year-old Thai female with MDS who was transfusion-dependent. She presented with severe anemia requiring an urgent transfusion. The patient was group A RhD-positive. Antibody screening and identification using column agglutination technology (CAT) showed weak polyagglutination. Auto-control and direct antiglobulin tests (DAT) were negative. Red cell typing showed absence of H antigen and presence of A1 antigen. Further testing with cord O cells revealed no agglutination, confirming the A1 blood group with anti-IH. Antibody screening and identification studies showed cold-reactivity, with weak reactivity at 37 °C and in the AHG phase. Crossmatching with two group A leukocyte-poor red cells was compatible, and transfusion was uneventful.
Conclusion
This is the first reported case of anti-IH in a Thai patient. Anti-IH may complicate pre-transfusion testing and mask alloantibodies, necessitating careful interpretation and confirmatory testing to prevent transfusion-related complications.
{"title":"Anti-IH in myelodysplastic syndrome","authors":"Ketsaraporn Wongba , Pornlada Nuchnoi , Chotiros Plabplueng , Charuporn Promwong","doi":"10.1016/j.plabm.2025.e00468","DOIUrl":"10.1016/j.plabm.2025.e00468","url":null,"abstract":"<div><h3>Background</h3><div>Anti-IH exhibits complex specificity, strongly reacting with cells expressing both H and I antigens at cold temperatures. Its clinical significance has been increasingly recognized, particularly in patients with hematologic conditions such as myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML).</div></div><div><h3>Case report</h3><div>We present an 83-year-old Thai female with MDS who was transfusion-dependent. She presented with severe anemia requiring an urgent transfusion. The patient was group A RhD-positive. Antibody screening and identification using column agglutination technology (CAT) showed weak polyagglutination. Auto-control and direct antiglobulin tests (DAT) were negative. Red cell typing showed absence of H antigen and presence of A1 antigen. Further testing with cord O cells revealed no agglutination, confirming the A1 blood group with anti-IH. Antibody screening and identification studies showed cold-reactivity, with weak reactivity at 37 °C and in the AHG phase. Crossmatching with two group A leukocyte-poor red cells was compatible, and transfusion was uneventful.</div></div><div><h3>Conclusion</h3><div>This is the first reported case of anti-IH in a Thai patient. Anti-IH may complicate pre-transfusion testing and mask alloantibodies, necessitating careful interpretation and confirmatory testing to prevent transfusion-related complications.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"45 ","pages":"Article e00468"},"PeriodicalIF":1.7,"publicationDate":"2025-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143783210","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}
The aim of this study was to establish the reference intervals of renal, hepatic and micronutrient biomarkers in the course of normal pregnancy.
Methods
This was a descriptive, cross-sectional, exploratory study of the occurrence of biochemical changes in reference intervals during the course of normal pregnancy between June 15, 2021 and March 30, 2022. A total of 473 pregnant women were recruited from 16 hospitals in Kinshasa. Reference intervals at 2.5 and 97.5 percentiles were established according to the recommendations of the International Federation of Clinical Chemistry. The statistical significance was set at p < 0.05. Ethical consideration was obtained from the Comité National d'Ethique en Santé and received approval under number 362/CNES/BN/PMMF/2022.
Results
Mean age was 29 ± 6 years. Reference intervals (RIs) for urea, creatinine, uric acid albumin, phosphorus, calcium and magnesium; alkaline phosphatase, GGT, ALAT and ASAT were 5.4–24.7 mg/dL; 0.39–1.11 mg/dL; 2–6.4 mg/dL; 40.9–53.05 mg/dL; 2. 2–5.9 mg/dL; 6.8–11.6 mg/dL; and 1.3–3.6 mg/dL; 39–246 IU/L; 3–43IU/L; 3.78–26.19 IU/L; 7.8–35.3 IU/L.
Conclusion
The established reference intervals (RIs) will be used to manage pregnancies of pregnant women in Kinshasa.
本研究的目的是建立正常妊娠过程中肾脏、肝脏和微量营养素生物标志物的参考区间。方法对2021年6月15日至2022年3月30日正常妊娠期间参考区间生化变化的发生情况进行描述性、横断面性、探索性研究。从金沙萨的16家医院共招募了473名孕妇。参考区间为2.5和97.5百分位，是根据国际临床化学联合会的建议建立的。统计学意义设为p <；0.05. 伦理考虑已获得法国国家伦理委员会（comit National d’ethque en sant）的批准，并获得第362/CNES/BN/PMMF/2022号批准。结果患者平均年龄29±6岁。尿素、肌酐、尿酸白蛋白、磷、钙和镁的参考区间（RIs）；碱性磷酸酶、GGT、ALAT、ASAT为5.4 ~ 24.7 mg/dL；0.39 - -1.11毫克/分升;2 - 6.4 mg / dL;40.9 - -53.05毫克/分升;2. 2 - 5.9 mg / dL;6.8 - -11.6毫克/分升;1.3 ~ 3.6 mg/dL；39 - 246 IU / L;3-43IU / L;3.78 - -26.19 IU / L;7.8 - -35.3 IU / L。结论建立的参考区间（RIs）可用于金沙萨孕妇妊娠管理。
{"title":"Evolution of reference intervals for renal-hepatic biomarkers and micronutrients in normal pregnancy during Covid-19 pandemic (2021–2022) in some hospitals of Kinshasa, Democratic Republic of the Congo","authors":"Eddy Bakemo , Benjamin Longo- Mbenza , Bienvenue Kuyangisa , Dophie Beya , Gédéon Bongo , Mireille Nganga","doi":"10.1016/j.plabm.2025.e00466","DOIUrl":"10.1016/j.plabm.2025.e00466","url":null,"abstract":"<div><h3>Background</h3><div>The aim of this study was to establish the reference intervals of renal, hepatic and micronutrient biomarkers in the course of normal pregnancy.</div></div><div><h3>Methods</h3><div>This was a descriptive, cross-sectional, exploratory study of the occurrence of biochemical changes in reference intervals during the course of normal pregnancy between June 15, 2021 and March 30, 2022. A total of 473 pregnant women were recruited from 16 hospitals in Kinshasa. Reference intervals at 2.5 and 97.5 percentiles were established according to the recommendations of the International Federation of Clinical Chemistry. The statistical significance was set at p < 0.05. Ethical consideration was obtained from the Comité National d'Ethique en Santé and received approval under number 362/CNES/BN/PMMF/2022.</div></div><div><h3>Results</h3><div>Mean age was 29 ± 6 years. Reference intervals (RIs) for urea, creatinine, uric acid albumin, phosphorus, calcium and magnesium; alkaline phosphatase, GGT, ALAT and ASAT were 5.4–24.7 mg/dL; 0.39–1.11 mg/dL; 2–6.4 mg/dL; 40.9–53.05 mg/dL; 2. 2–5.9 mg/dL; 6.8–11.6 mg/dL; and 1.3–3.6 mg/dL; 39–246 IU/L; 3–43IU/L; 3.78–26.19 IU/L; 7.8–35.3 IU/L.</div></div><div><h3>Conclusion</h3><div>The established reference intervals (RIs) will be used to manage pregnancies of pregnant women in Kinshasa.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"45 ","pages":"Article e00466"},"PeriodicalIF":1.7,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144190114","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}
Pub Date : 2025-03-21DOI: 10.1016/j.plabm.2025.e00464
Farzin Mirzaei-nasab , Ahmad Majd , Yousef Seyedena , Nazanin Hosseinkhan , Najma Farahani , Mehrdad Hashemi
Background
Hepatocellular carcinoma (HCC) is a significant global health challenge with complex molecular underpinnings. Recent advancements in understanding the role of non-coding RNAs (ncRNAs) and exosomes in cancer biology have opened new avenues for research into potential diagnostic and therapeutic strategies.
Methods
This study utilized a comprehensive approach to analyze gene expression patterns and regulatory networks in HCC. We integrated RNA sequencing data gathered from both tissue samples and exosomes. The WGCNA and limma R packages were employed to construct co-expression networks and identify differentially expressed ncRNAs, including long non-coding RNAs (lncRNAs) and circular RNAs (circRNAs).
Results
Our analysis demonstrated distinct expression profiles of various ncRNAs in HCC, revealing their intricate interactions with cancer-related genes. Key findings include the identification of a network of microRNAs that interact with selected lncRNAs and their potential roles as biomarkers. Moreover, exosomal RNA was shown to effectively reflect tissue-specific gene expression changes.
Conclusions
The results of this study highlight the significance of exosomal ncRNAs in the progression of liver cancer, suggesting their potential as both diagnostic biomarkers and therapeutic targets. Future research should focus on the functional implications of these ncRNAs to further elucidate their roles in HCC and explore their applications in clinical settings.
{"title":"Integrative analysis of exosomal ncRNAs and their regulatory networks in liver cancer progression","authors":"Farzin Mirzaei-nasab , Ahmad Majd , Yousef Seyedena , Nazanin Hosseinkhan , Najma Farahani , Mehrdad Hashemi","doi":"10.1016/j.plabm.2025.e00464","DOIUrl":"10.1016/j.plabm.2025.e00464","url":null,"abstract":"<div><h3>Background</h3><div>Hepatocellular carcinoma (HCC) is a significant global health challenge with complex molecular underpinnings. Recent advancements in understanding the role of non-coding RNAs (ncRNAs) and exosomes in cancer biology have opened new avenues for research into potential diagnostic and therapeutic strategies.</div></div><div><h3>Methods</h3><div>This study utilized a comprehensive approach to analyze gene expression patterns and regulatory networks in HCC. We integrated RNA sequencing data gathered from both tissue samples and exosomes. The WGCNA and limma R packages were employed to construct co-expression networks and identify differentially expressed ncRNAs, including long non-coding RNAs (lncRNAs) and circular RNAs (circRNAs).</div></div><div><h3>Results</h3><div>Our analysis demonstrated distinct expression profiles of various ncRNAs in HCC, revealing their intricate interactions with cancer-related genes. Key findings include the identification of a network of microRNAs that interact with selected lncRNAs and their potential roles as biomarkers. Moreover, exosomal RNA was shown to effectively reflect tissue-specific gene expression changes.</div></div><div><h3>Conclusions</h3><div>The results of this study highlight the significance of exosomal ncRNAs in the progression of liver cancer, suggesting their potential as both diagnostic biomarkers and therapeutic targets. Future research should focus on the functional implications of these ncRNAs to further elucidate their roles in HCC and explore their applications in clinical settings.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"45 ","pages":"Article e00464"},"PeriodicalIF":1.7,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143704683","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}
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