Pub Date : 2025-04-01Epub Date: 2025-01-10DOI: 10.1016/j.plabm.2025.e00450
Sonak D. Pastakia , Heidi Schutz , Tena Tiruneh , Ariana Gordillo De Vivero , Lindsey Dodds
Introduction
Populations experiencing poverty often lack access to convenient lab tests. This analysis assesses trends observed from a national point of care (POC) lab donation program for free and charitable clinics across the United States.
Methods
A total of 16 clinics were selected to receive a comprehensive package of POC lab tests. De-identified data on POC test utilization and results were assessed to descriptively identify trends in utilization (primary objective) and glycemic control (secondary objective). A paired t-test was utilized to identify statistically significant changes in HbA1c from baseline to predefined 90-day time intervals for all people living with diabetes (PLWD) and those with a baseline HbA1c ≥ 9.0 % (75 mmol/mol). The main comparison of interest was the change in HbA1c from baseline to 90–179 days.
Results
A total of 17,563 POC tests were completed for 9658 patients with 3223 tests being HbA1c’s. In the secondary analysis of PLWD with a baseline HbA1c ≥ 9.0 % (75 mmol/mol), patients who completed an HbA1c between 90 and 179 days (n = 188) demonstrated a statistically significant mean reduction from baseline of -1.2 % (95 % CI, -1.6 % to −0.9 %, p < 0.01, -10 mmol/mol [95 % CI, -6 mmol/mol - -14 mmol/mol]).
Discussion
The provision of POC labs helped support the care populations experiencing poverty received at free and charitable clinics, especially for chronic diseases like diabetes.
{"title":"Observational assessment of the utilization of donated point of care tests and glycemic control at free and charitable clinics across the United States","authors":"Sonak D. Pastakia , Heidi Schutz , Tena Tiruneh , Ariana Gordillo De Vivero , Lindsey Dodds","doi":"10.1016/j.plabm.2025.e00450","DOIUrl":"10.1016/j.plabm.2025.e00450","url":null,"abstract":"<div><h3>Introduction</h3><div>Populations experiencing poverty often lack access to convenient lab tests. This analysis assesses trends observed from a national point of care (POC) lab donation program for free and charitable clinics across the United States.</div></div><div><h3>Methods</h3><div>A total of 16 clinics were selected to receive a comprehensive package of POC lab tests. De-identified data on POC test utilization and results were assessed to descriptively identify trends in utilization (primary objective) and glycemic control (secondary objective). A paired <em>t</em>-test was utilized to identify statistically significant changes in HbA1c from baseline to predefined 90-day time intervals for all people living with diabetes (PLWD) and those with a baseline HbA1c ≥ 9.0 % (75 mmol/mol). The main comparison of interest was the change in HbA1c from baseline to 90–179 days.</div></div><div><h3>Results</h3><div>A total of 17,563 POC tests were completed for 9658 patients with 3223 tests being HbA1c’s. In the secondary analysis of PLWD with a baseline HbA1c ≥ 9.0 % (75 mmol/mol), patients who completed an HbA1c between 90 and 179 days (n = 188) demonstrated a statistically significant mean reduction from baseline of -1.2 % (95 % CI, -1.6 % to −0.9 %, <em>p</em> < 0.01, -10 mmol/mol [95 % CI, -6 mmol/mol - -14 mmol/mol]).</div></div><div><h3>Discussion</h3><div>The provision of POC labs helped support the care populations experiencing poverty received at free and charitable clinics, especially for chronic diseases like diabetes.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"44 ","pages":"Article e00450"},"PeriodicalIF":1.7,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11782993/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143080406","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}
Pub Date : 2025-04-01Epub Date: 2025-01-16DOI: 10.1016/j.plabm.2025.e00454
Guoxiang Xie , Kejun Zhou , Wenting Sun , Fengjie Huang , Lu Wang , Zhangbao Zhou , Wei Jia
Background
FibraChek is a newly developed mass spectrometry (MS) assay kit approved by the National Medical Products Administration (NMPA) of China for quantifying L-tyrosine (Tyr) and taurocholic acid (TCA) in serum, aiding liver fibrosis diagnosis. This study aimed to assess its analytical performance.
Methods
The analytical performance was investigated based on NMPA and CLSI guidelines. Method suitability in the clinical context was tested by analyzing clinical samples from liver fibrosis patients confirmed via liver biopsy.
Results
The assay enables simultaneous determination of Tyr and TCA, demonstrating compliance with performance parameters such as linearity, dynamic range, limit of detection (LOD), limit of quantification (LOQ), recovery, repeatability, reproducibility, and stability. It validated a linear range of 20–1000 μmol/L for Tyr and 10.3–618 ng/ml for TCA, maintaining stability after 5 freeze-thaw cycles for 14 months. Components remained stable for up to 7 days at room temperature and 30 days at 2–8 °C. TCA and Tyr were stable for up to 36 months at −20 °C or −80 °C. The method effectively quantified Tyr and TCA in serum from liver fibrosis patients and healthy controls.
Conclusions
This is the first MS-based assay for non-invasive liver fibrosis detection validated for clinical use, providing a rapid and reliable analytical protocol suitable for routine analysis.
{"title":"Analytical validation of a LC-MS/MS based in vitro diagnostic kit for the quantification of L-tyrosine and taurocholic acid for liver fibrosis diagnosis","authors":"Guoxiang Xie , Kejun Zhou , Wenting Sun , Fengjie Huang , Lu Wang , Zhangbao Zhou , Wei Jia","doi":"10.1016/j.plabm.2025.e00454","DOIUrl":"10.1016/j.plabm.2025.e00454","url":null,"abstract":"<div><h3>Background</h3><div>FibraChek is a newly developed mass spectrometry (MS) assay kit approved by the National Medical Products Administration (NMPA) of China for quantifying L-tyrosine (Tyr) and taurocholic acid (TCA) in serum, aiding liver fibrosis diagnosis. This study aimed to assess its analytical performance.</div></div><div><h3>Methods</h3><div>The analytical performance was investigated based on NMPA and CLSI guidelines. Method suitability in the clinical context was tested by analyzing clinical samples from liver fibrosis patients confirmed via liver biopsy.</div></div><div><h3>Results</h3><div>The assay enables simultaneous determination of Tyr and TCA, demonstrating compliance with performance parameters such as linearity, dynamic range, limit of detection (LOD), limit of quantification (LOQ), recovery, repeatability, reproducibility, and stability. It validated a linear range of 20–1000 μmol/L for Tyr and 10.3–618 ng/ml for TCA, maintaining stability after 5 freeze-thaw cycles for 14 months. Components remained stable for up to 7 days at room temperature and 30 days at 2–8 °C. TCA and Tyr were stable for up to 36 months at −20 °C or −80 °C. The method effectively quantified Tyr and TCA in serum from liver fibrosis patients and healthy controls.</div></div><div><h3>Conclusions</h3><div>This is the first MS-based assay for non-invasive liver fibrosis detection validated for clinical use, providing a rapid and reliable analytical protocol suitable for routine analysis.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"44 ","pages":"Article e00454"},"PeriodicalIF":1.7,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11788763/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143123354","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}
Pub Date : 2025-04-01Epub Date: 2025-01-14DOI: 10.1016/j.plabm.2025.e00453
Francesca Nencini , Alessandro Bonari , Sara Ciullini Mannurita , Alessandra Mongia , Francesca Romano , Maria Garieri , Edda Russo , Silvia Sastrucci , Graziella Marrani , Martina Tonelli , Stefano Salti , Niccola Funel , Amedeo Amedei , Carlo Dani , Alessandra Fanelli
Background and aims
The use of a POCT (Point Of Care Test) could help in reducing the impact of pre-analytical errors in particular in challenging newborn samples.
The study purpose is to compare the POCT Sight OLO® hematology analyzer, validated for >3 months patients, with the reference system Sysmex XN-9100™ in Neonatal Intensive Care Unit (NICU).
Material and methods
The two analyzers were compared through Passing-Bablok regression analysis and Bland-Altman plot.
Results
We analyzed 65 blood samples, in detail 38 from adults and 27 from newborns.
The regression analysis results performed in the newborn and adult patients showed a good agreement between the two instruments. The evaluation of the Bland-Altman plots showed comparable values of bias <10 % for the most of parameters.
The evaluation of sample flags for the presence of distributional and morphological abnormalities showed a partial accordance between the two approaches, but the POCT exhibited good performance compared to the final report revised by the laboratory specialist.
Conclusions
The comparison of the two instruments demonstrated that they provide comparable blood counts, also in patients aged <3 months. The POCT allows having reliable analytical data and faster turning around time, particularly useful in NICU.
{"title":"Complete blood count in neonatal Intensive care Unit (NICU): Performance comparison between POCT Sight OLO® and Sysmex XN-9100™ hematology analyzers","authors":"Francesca Nencini , Alessandro Bonari , Sara Ciullini Mannurita , Alessandra Mongia , Francesca Romano , Maria Garieri , Edda Russo , Silvia Sastrucci , Graziella Marrani , Martina Tonelli , Stefano Salti , Niccola Funel , Amedeo Amedei , Carlo Dani , Alessandra Fanelli","doi":"10.1016/j.plabm.2025.e00453","DOIUrl":"10.1016/j.plabm.2025.e00453","url":null,"abstract":"<div><h3>Background and aims</h3><div>The use of a POCT (Point Of Care Test) could help in reducing the impact of pre-analytical errors in particular in challenging newborn samples.</div><div>The study purpose is to compare the POCT Sight OLO® hematology analyzer, validated for >3 months patients, with the reference system Sysmex XN-9100™ in Neonatal Intensive Care Unit (NICU).</div></div><div><h3>Material and methods</h3><div>The two analyzers were compared through Passing-Bablok regression analysis and Bland-Altman plot.</div></div><div><h3>Results</h3><div>We analyzed 65 blood samples, in detail 38 from adults and 27 from newborns.</div><div>The regression analysis results performed in the newborn and adult patients showed a good agreement between the two instruments. The evaluation of the Bland-Altman plots showed comparable values of bias <10 % for the most of parameters.</div><div>The evaluation of sample flags for the presence of distributional and morphological abnormalities showed a partial accordance between the two approaches, but the POCT exhibited good performance compared to the final report revised by the laboratory specialist.</div></div><div><h3>Conclusions</h3><div>The comparison of the two instruments demonstrated that they provide comparable blood counts, also in patients aged <3 months. The POCT allows having reliable analytical data and faster turning around time, particularly useful in NICU.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"44 ","pages":"Article e00453"},"PeriodicalIF":1.7,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11787615/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143080312","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}
2-Methoxyestradiol (2ME) is involved in the pathogenesis of preeclampsia and antitumor activity. In addition to its low concentration in healthy human serum, presence of isomers makes quantification of 2ME for clinical research and laboratory medicine difficult. The objective of this study was to develop a highly sensitive and accurate method for quantifying 2ME using LC-MS/MS combined with derivatization with 1-(2,4-dinitro-5-fluorophenyl)-4,4-dimethylpiperazinium iodide (MPDNP-F). This approach significantly enhanced the detectability of 2ME in positive electrospray ionization-tandem mass spectrometry (ESI-MS/MS) and enabled the chromatographic separation of 2ME from isomeric metabolites possessing a methoxy group, including 4-methoxyestradiol, 3-O-methyl 2-hydroxyestradiol, and 3-O-methyl 4-hydroxyestradiol (3M4OH). Although the derivatized 2ME and 3M4OH were closely eluted under the optimized LC conditions, the different fragmentation patterns of these isomers during MS/MS allowed their distinction. The lower limit of quantification for 2ME was 2.5 pg/mL, indicating a satisfactory sensitivity. These findings demonstrated that this LC-MS/MS method combined with the MPDNP-F derivatization can provide accurate and highly sensitive quantification of 2ME.
2-甲氧基雌二醇（2ME）参与子痫前期的发病机制和抗肿瘤活性。除了其在健康人血清中的低浓度外，其异构体的存在使得临床研究和实验室医学的2ME定量变得困难。本研究的目的是建立一种高灵敏度、高准确度的液相色谱-质谱联用衍生化1-（2,4-二硝基-5-氟苯基）-4,4-二甲基碘化哌嗪（MPDNP-F）定量2ME的方法。该方法显著提高了2ME在正电喷雾电离串联质谱（ESI-MS/MS）中的可检出性，并能从含有甲氧基的异构体代谢物（包括4-甲氧基雌二醇、3- o -甲基2-羟基雌二醇和3- o -甲基4-羟基雌二醇（3M4OH））中分离出2ME。虽然在优化的液相色谱条件下，衍生的2ME和3M4OH被紧密洗脱，但在质谱/质谱中，这些异构体的不同断裂模式使得它们可以被区分。2ME的定量下限为2.5 pg/mL，灵敏度令人满意。这些结果表明，结合MPDNP-F衍生化的LC-MS/MS方法可以提供准确和高灵敏度的2ME定量。
{"title":"Development of an accurate and sensitive assay for 2-methoxyestradiol using derivatization and liquid chromatography-tandem mass spectrometry","authors":"Koji Takahashi , Masaki Takiwaki , Seketsu Fukuzawa , Yoshikuni Kikutani , Kentaro Abe , Tatsuya Higashi , Hironori Kobayashi","doi":"10.1016/j.plabm.2024.e00447","DOIUrl":"10.1016/j.plabm.2024.e00447","url":null,"abstract":"<div><div>2-Methoxyestradiol (2ME) is involved in the pathogenesis of preeclampsia and antitumor activity. In addition to its low concentration in healthy human serum, presence of isomers makes quantification of 2ME for clinical research and laboratory medicine difficult. The objective of this study was to develop a highly sensitive and accurate method for quantifying 2ME using LC-MS/MS combined with derivatization with 1-(2,4-dinitro-5-fluorophenyl)-4,4-dimethylpiperazinium iodide (MPDNP-F). This approach significantly enhanced the detectability of 2ME in positive electrospray ionization-tandem mass spectrometry (ESI-MS/MS) and enabled the chromatographic separation of 2ME from isomeric metabolites possessing a methoxy group, including 4-methoxyestradiol, 3-<em>O</em>-methyl 2-hydroxyestradiol, and 3-<em>O</em>-methyl 4-hydroxyestradiol (3M4OH). Although the derivatized 2ME and 3M4OH were closely eluted under the optimized LC conditions, the different fragmentation patterns of these isomers during MS/MS allowed their distinction. The lower limit of quantification for 2ME was 2.5 pg/mL, indicating a satisfactory sensitivity. These findings demonstrated that this LC-MS/MS method combined with the MPDNP-F derivatization can provide accurate and highly sensitive quantification of 2ME.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"44 ","pages":"Article e00447"},"PeriodicalIF":1.7,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11772991/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143067650","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}
Pub Date : 2025-04-01Epub Date: 2025-01-20DOI: 10.1016/j.plabm.2025.e00455
Masroor Anwar , Km Renu , Abhinay Kumar Singh , Abhilasha Nayal , Bharat Thyagarajan , Peifeng Hu , Jinkook Lee , Sharmistha Dey , A.B. Dey
Introduction
Hemolysis is a known interference factor that has been found to show erroneous effect. Present study analyzes the impact of hemolysis on the concentrations of protein biomarkers of Alzheimer's disease (Aβ42, t-Tau, p-Tau181) along with novel proteins which are currently under investigation (SIRT1,SIRT2,SIRT6,FOXO3A, NFL, Aβ40, GFAP).
Methods
Plasma samples were grouped into two categories: hemolyzed and non-hemolyzed groups. Degree of hemolysis (in percentage) was separately analyzed using Single molecule array (SIMOA) technology. Quantitative analysis for hemolyzed and non-hemolyzed samples were done using surface plasmon resonance (SPR) technology.
Results
The SIMOA analysis indicated that at high levels of hemolysis (1000 mg/dL) there was an increase in NFL protein level up to approximately 30 % whereas p-Tau181 did not show much interference even at higher hemolysate concentration. Aβ40, Aβ42 and GFAP showed modest effect up to hemolysis of 250mg/dL-500 mg/dL. SPR analysis of total Tau (t-Tau), p-Tau181, SIRT1, SIRT6 showed the consistency in the result and there was no significant difference in hemolyzed plasma compared to non-hemolyzed samples. Aβ42 and FOXO3A showed decline in hemolyzed plasma compared to non-hemolyzed samples (4.34 ± 0.18ng/ul; 4.95 ± 0.19ng/ul) and (3.83 ± 0.34ng/ul; 5.12 ± 0.46ng/ul), respectively whereas, a significant increase in the concentration was observed for SIRT2; 2.4 ± 0.10ng/ul in hemolyzed compared to 1.30 ± 0.22ng/ul in non-hemolyzed group.
Conclusions
High grade hemolysis leads to altered protein concentration associated with neurodegeneration. Present study emphasizes the need to have pre-analytical inspection for hemolysis detection especially in a multicentric biomarker study.
{"title":"Impact of hemolysis on the levels of proteins associated with aging and age-related neurodegenerative diseases in a multicentric clinical research","authors":"Masroor Anwar , Km Renu , Abhinay Kumar Singh , Abhilasha Nayal , Bharat Thyagarajan , Peifeng Hu , Jinkook Lee , Sharmistha Dey , A.B. Dey","doi":"10.1016/j.plabm.2025.e00455","DOIUrl":"10.1016/j.plabm.2025.e00455","url":null,"abstract":"<div><h3>Introduction</h3><div>Hemolysis is a known interference factor that has been found to show erroneous effect. Present study analyzes the impact of hemolysis on the concentrations of protein biomarkers of Alzheimer's disease (Aβ42, t-Tau, p-Tau181) along with novel proteins which are currently under investigation (SIRT1,SIRT2,SIRT6,FOXO3A, NFL, Aβ40, GFAP).</div></div><div><h3>Methods</h3><div>Plasma samples were grouped into two categories: hemolyzed and non-hemolyzed groups. Degree of hemolysis (in percentage) was separately analyzed using Single molecule array (SIMOA) technology. Quantitative analysis for hemolyzed and non-hemolyzed samples were done using surface plasmon resonance (SPR) technology.</div></div><div><h3>Results</h3><div>The SIMOA analysis indicated that at high levels of hemolysis (1000 mg/dL) there was an increase in NFL protein level up to approximately 30 % whereas p-Tau181 did not show much interference even at higher hemolysate concentration. Aβ40, Aβ42 and GFAP showed modest effect up to hemolysis of 250mg/dL-500 mg/dL. SPR analysis of total Tau (t-Tau), p-Tau181, SIRT1, SIRT6 showed the consistency in the result and there was no significant difference in hemolyzed plasma compared to non-hemolyzed samples. Aβ42 and FOXO3A showed decline in hemolyzed plasma compared to non-hemolyzed samples (4.34 ± 0.18ng/ul; 4.95 ± 0.19ng/ul) and (3.83 ± 0.34ng/ul; 5.12 ± 0.46ng/ul), respectively whereas, a significant increase in the concentration was observed for SIRT2; 2.4 ± 0.10ng/ul in hemolyzed compared to 1.30 ± 0.22ng/ul in non-hemolyzed group.</div></div><div><h3>Conclusions</h3><div>High grade hemolysis leads to altered protein concentration associated with neurodegeneration. Present study emphasizes the need to have pre-analytical inspection for hemolysis detection especially in a multicentric biomarker study.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"44 ","pages":"Article e00455"},"PeriodicalIF":1.7,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143140814","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}
Pub Date : 2025-04-01Epub Date: 2024-12-24DOI: 10.1016/j.plabm.2024.e00445
Shitong Cheng , Dongliang Man , Zhiwei Zhou , Hui Kang
Objectives
China is promoting the mutual recognition of clinical laboratory test results to reduce redundant testing, provide more convenient medical services, and lower economic burdens. This study aimed to enhance the consistency of test results across laboratories using a linear transformation method, focusing on five representative biochemical parameters: ALP, CA, TBIL, TC, and TG.
Methods
Five ISO 15189 accredited laboratories participated in this study. We established inter-laboratory and intra-laboratory conversion relationships using patient sample comparisons and daily quality control (QC) data. These relationships were used to develop a web-based tool enabling real-time conversion and mutual recognition of laboratory test results.
Results
The study found that the linear transformation method effectively improved the consistency of test results. After three stages of conversion, most test results showed deviations within ±1/2 TEa when compared to a reference laboratory. However, some parameters in the low-value range exhibited less significant conversion effects, likely due to the sensitivity of percentage deviation measurements in this range.
Conclusions
The developed approach and web-based tool show potential for enhancing result consistency and facilitating mutual recognition across laboratories. Despite its effectiveness, the study's limitations, such as a small sample size and a narrow focus on five biochemical parameters, indicate the need for further research and broader application.
{"title":"Enhancing laboratory test consistency through linear transformation: A multi-center study","authors":"Shitong Cheng , Dongliang Man , Zhiwei Zhou , Hui Kang","doi":"10.1016/j.plabm.2024.e00445","DOIUrl":"10.1016/j.plabm.2024.e00445","url":null,"abstract":"<div><h3>Objectives</h3><div>China is promoting the mutual recognition of clinical laboratory test results to reduce redundant testing, provide more convenient medical services, and lower economic burdens. This study aimed to enhance the consistency of test results across laboratories using a linear transformation method, focusing on five representative biochemical parameters: ALP, CA, TBIL, TC, and TG.</div></div><div><h3>Methods</h3><div>Five ISO 15189 accredited laboratories participated in this study. We established inter-laboratory and intra-laboratory conversion relationships using patient sample comparisons and daily quality control (QC) data. These relationships were used to develop a web-based tool enabling real-time conversion and mutual recognition of laboratory test results.</div></div><div><h3>Results</h3><div>The study found that the linear transformation method effectively improved the consistency of test results. After three stages of conversion, most test results showed deviations within ±1/2 TEa when compared to a reference laboratory. However, some parameters in the low-value range exhibited less significant conversion effects, likely due to the sensitivity of percentage deviation measurements in this range.</div></div><div><h3>Conclusions</h3><div>The developed approach and web-based tool show potential for enhancing result consistency and facilitating mutual recognition across laboratories. Despite its effectiveness, the study's limitations, such as a small sample size and a narrow focus on five biochemical parameters, indicate the need for further research and broader application.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"44 ","pages":"Article e00445"},"PeriodicalIF":1.7,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11786656/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143080313","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}
Pub Date : 2025-04-01Epub Date: 2025-01-16DOI: 10.1016/j.plabm.2025.e00449
Ayman Mohamed Nabil , Hayat Mirza Alsaif , Muneer Ahmad Aljamaan , Abdullah Abdullah H. Algafly , Rashad Hassan aleid , Raji Ali Helal , Zainab Ali Hussain almutawah , Amani Abdulkareem S. Alzayer , Walaa Ali Hussain Almutawah , Badr Abdullah Motlaq AlKhalaf
Background
The main challenges of clinical laboratories concerning quality control include cost-effectiveness, variability in standardized materials, and evolving technologies across various diagnostic fields. While traditional QC practices and automation systems provide for accuracy, gaps exist, especially when applying Westgard rules to control lots for multiple assays. Such gaps result in inconsistent QC outcomes and unaddressed challenges in diagnostic reliability.
Objective
This study aims to assess the effect of the cross-over coefficient of variation (CV) and mean values for different assay control lots on implementing Westgard rules to improve QC practices and enhance the accuracy and reliability of diagnostic tests in molecular laboratories.
Methods
Data from 18 Levy-Jennings charts, with two assay control lots, were analyzed. Statistical comparisons of failure rates before and after setting the actual SD were performed using chi-square or T-tests at p < 0.05.
Results
The analysis of 18 Levy-Jennings charts showed a significant reduction in failure rates after establishing actual mean and SD values compared to cross-over CV. Of the charts, 11 exhibited differences in failure occurrences, particularly rejection failures, highlighting improved QC reliability.
Conclusion
These results emphasize the importance of accurate SD calculation in enhancing the effectiveness of Westgard rules. Therefore, establishing mean and SD values enhances QC reliability, reduces false failures, and ensures accurate Westgard rules application, while ongoing training in QC practices enhances diagnostic accuracy.
{"title":"Impact of using cross-over CV and mean for two different lots of assay control on implementation of Westgard rules in chemical diagnostic tests","authors":"Ayman Mohamed Nabil , Hayat Mirza Alsaif , Muneer Ahmad Aljamaan , Abdullah Abdullah H. Algafly , Rashad Hassan aleid , Raji Ali Helal , Zainab Ali Hussain almutawah , Amani Abdulkareem S. Alzayer , Walaa Ali Hussain Almutawah , Badr Abdullah Motlaq AlKhalaf","doi":"10.1016/j.plabm.2025.e00449","DOIUrl":"10.1016/j.plabm.2025.e00449","url":null,"abstract":"<div><h3>Background</h3><div>The main challenges of clinical laboratories concerning quality control include cost-effectiveness, variability in standardized materials, and evolving technologies across various diagnostic fields. While traditional QC practices and automation systems provide for accuracy, gaps exist, especially when applying Westgard rules to control lots for multiple assays. Such gaps result in inconsistent QC outcomes and unaddressed challenges in diagnostic reliability.</div></div><div><h3>Objective</h3><div>This study aims to assess the effect of the cross-over coefficient of variation (CV) and mean values for different assay control lots on implementing Westgard rules to improve QC practices and enhance the accuracy and reliability of diagnostic tests in molecular laboratories.</div></div><div><h3>Methods</h3><div>Data from 18 Levy-Jennings charts, with two assay control lots, were analyzed. Statistical comparisons of failure rates before and after setting the actual SD were performed using chi-square or T-tests at p < 0.05.</div></div><div><h3>Results</h3><div>The analysis of 18 Levy-Jennings charts showed a significant reduction in failure rates after establishing actual mean and SD values compared to cross-over CV. Of the charts, 11 exhibited differences in failure occurrences, particularly rejection failures, highlighting improved QC reliability.</div></div><div><h3>Conclusion</h3><div>These results emphasize the importance of accurate SD calculation in enhancing the effectiveness of Westgard rules. Therefore, establishing mean and SD values enhances QC reliability, reduces false failures, and ensures accurate Westgard rules application, while ongoing training in QC practices enhances diagnostic accuracy.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"44 ","pages":"Article e00449"},"PeriodicalIF":1.7,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11788727/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143123434","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}
Visceral leishmaniasis (VL), or kala-azar, is a deadly disease with high fatality rates if diagnosis and treatment are delayed. Diagnosis is often delayed due to symptoms that mimic other conditions. Sample isolation and diagnostic procedures are labor-intensive and time-consuming. Rapid immunochromatographic tests cannot differentiate active cases from past infections. In the present study we investigated the utility of peripheral blood samples for molecular diagnosis of VL. Whole genomic DNA from the erythrocyte fraction of blood from VL and cutaneous leishmaniasis (CL) suspected patients was used for PCR using multiple markers (k-DNA, ITS-Ⅰ, and 18s rRNA). PCR amplification of k-DNA, ITS-Ⅰ, and 18s rRNA genes yielded positive results in VL symptomatic patients. However, the same PCR approach with peripheral blood samples from CL patients was not significant. Hence, peripheral blood samples can effectively distinguish active VL cases through PCR using multiple markers, offering a less invasive and labor-intensive diagnostic alternative.
{"title":"Molecular diagnosis of visceral leishmaniasis from blood samples using different genetic markers: A simple, sensitive and less invasive diagnostic approach","authors":"Harish Kumar Shah , K.R. Rajesh , P.A. Fathima , R.S. Aiswarya , P.M. Ajithlal , Prasanta Saini","doi":"10.1016/j.plabm.2025.e00448","DOIUrl":"10.1016/j.plabm.2025.e00448","url":null,"abstract":"<div><div>Visceral leishmaniasis (VL), or kala-azar, is a deadly disease with high fatality rates if diagnosis and treatment are delayed. Diagnosis is often delayed due to symptoms that mimic other conditions. Sample isolation and diagnostic procedures are labor-intensive and time-consuming. Rapid immunochromatographic tests cannot differentiate active cases from past infections. In the present study we investigated the utility of peripheral blood samples for molecular diagnosis of VL. Whole genomic DNA from the erythrocyte fraction of blood from VL and cutaneous leishmaniasis (CL) suspected patients was used for PCR using multiple markers (k-DNA, ITS-Ⅰ, and 18s rRNA). PCR amplification of k-DNA, ITS-Ⅰ, and 18s rRNA genes yielded positive results in VL symptomatic patients. However, the same PCR approach with peripheral blood samples from CL patients was not significant. Hence, peripheral blood samples can effectively distinguish active VL cases through PCR using multiple markers, offering a less invasive and labor-intensive diagnostic alternative.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"44 ","pages":"Article e00448"},"PeriodicalIF":1.7,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11786688/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143080316","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}
Myoglobin (Mb) has been used as a biomarker for acute myocardial infarction. This study aimed to evaluate the stability of liquid Mb as quality control materials for Mb determination. Mb protein was expressed in Escherichia coli system and purified using Ni2+ chelate affinity chromatography. The purity of purified recombinant Mb reached to 95 %. The immunoreactivity of Mb was investigated using Mb assay kits. The coefficient of determination (R2) of the curve fitted with dilution ratio and Mb concentration as variables was greater than 0.95, which indicated that Mb had good immunoreactivity. The concentrations per gradient measured using different kits had no significant difference (p-value>0.05), which indicated that the reactivity between the Mb antigen and Mb antibodies with different epitopes was good. The effects of different storage buffer, storage temperature and storage times on the stability of liquid Mb were investigated by detecting the concentration changes. At 2–8 °C for two months, Mb concentration in buffer B (Tris-HCl, pH 7.8, containing 1 % BSA and 0.05 % NaN3) decreased within 10 % compared with the initial concentration. The long-term storage stability was investigated by the thermal acceleration experiment. At 37 °C for one week, Mb concentration decreased by less than 15 %, indicating that the Mb had good long-term storage stability. The prepared liquid Mb had good immunoreactivity and stability, avoiding storage in freeze-dried powder. It was a promising alternative as the quality control material for Mb detection.
{"title":"Preparation of recombinant myoglobin and investigation of the liquid antigen stability for quality control materials","authors":"Yu-Hui Wang, Xi-Feng Sun, Chun-Xin Xu, Feng-Qiang Sun, Rong-Rong Wang, Xiao-Kun Bian, Zhan-Zhao Wang, Qiang Wu","doi":"10.1016/j.plabm.2025.e00456","DOIUrl":"10.1016/j.plabm.2025.e00456","url":null,"abstract":"<div><div>Myoglobin (Mb) has been used as a biomarker for acute myocardial infarction. This study aimed to evaluate the stability of liquid Mb as quality control materials for Mb determination. Mb protein was expressed in <em>Escherichia coli</em> system and purified using Ni<sup>2+</sup> chelate affinity chromatography. The purity of purified recombinant Mb reached to 95 %. The immunoreactivity of Mb was investigated using Mb assay kits. The coefficient of determination (R<sup>2</sup>) of the curve fitted with dilution ratio and Mb concentration as variables was greater than 0.95, which indicated that Mb had good immunoreactivity. The concentrations per gradient measured using different kits had no significant difference (p-value>0.05), which indicated that the reactivity between the Mb antigen and Mb antibodies with different epitopes was good. The effects of different storage buffer, storage temperature and storage times on the stability of liquid Mb were investigated by detecting the concentration changes. At 2–8 °C for two months, Mb concentration in buffer B (Tris-HCl, pH 7.8, containing 1 % BSA and 0.05 % NaN<sub>3</sub>) decreased within 10 % compared with the initial concentration. The long-term storage stability was investigated by the thermal acceleration experiment. At 37 °C for one week, Mb concentration decreased by less than 15 %, indicating that the Mb had good long-term storage stability. The prepared liquid Mb had good immunoreactivity and stability, avoiding storage in freeze-dried powder. It was a promising alternative as the quality control material for Mb detection.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"44 ","pages":"Article e00456"},"PeriodicalIF":1.7,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143140800","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}
To evaluate the diagnostic value of loop-mediated isothermal amplification(LAMP) chip method (hereinafter referred to as "LAMP") in the detection of pathogens in children with lower respiratory tract infections(LRTIs).
Methods
Sputum samples from 1723 children with LRTIs hospitalized from April 2020 to April 2021 were collected. Pathogen detection was performed using both LAMP and sputum culture method(SCM).Detection rates and consistency between the two methods were analyzed using the Chi-square test and Kappa analysis.
Results
The positive detection rates of the LAMP and the SCM were 58.97 %(1016/1723) and 43.64 %(752/1723), respectively(P<0.001). The detection rates of Streptococcus pneumoniae (Spn)(24.26 %/13.52 %), Staphylococcus aureus(Sau)(13.12 %/10.39 %), Acinetobacter baumannii (Aba)(1.33 %/0.48 %), Stenotrophomonas maltophilia (Sma)(0.58 %/0.12 %), and Haemophilus influenzae(Hin)(31.05 %/16.19 %) were significantly higher with the LAMP than with the SCM(P<0.05). Both methods showed that single infections were predominant among children, with positive rates of 65.06 % and 87.23 %, respectively, with Hin(49.92 %/33.69 %) being the most common pathogen.In mixed infections, the positive rates were 34.94 % and 12.77 %, respectively, with mixed infections of Hin and Spn being the most common, accounting for 48.89 % and 32.29 % of cases, respectively. There were significant differences in the detection rates of Spn, Sau, Klebsiella pneumoniae(Kpn), Sma, Hin, and Escherichia coli(Eco) between single and mixed infections(P < 0.05). The detection results of Spn, Sau, Kpn, Hin, and Eco exhibited high consistency between the two methods, while the consistency for Pseudomonas aeruginosa(Pae), Aba, and Sma was lower.
Conclusion
The LAMP is simpler, faster, more sensitive and specific than SCM, offering a reliable laboratory diagnostic basis for clinical management of LRTIs in children.
{"title":"The value of loop-mediated isothermal amplification in diagnosing lower respiratory tract infections in children","authors":"Feng Yan, Shikun Xu, Meijing Shen, Yu Zhao, Huabo Tong, Kaifeng Wu, He Zha","doi":"10.1016/j.plabm.2025.e00463","DOIUrl":"10.1016/j.plabm.2025.e00463","url":null,"abstract":"<div><h3>Objective</h3><div>To evaluate the diagnostic value of loop-mediated isothermal amplification(LAMP) chip method (hereinafter referred to as \"LAMP\") in the detection of pathogens in children with lower respiratory tract infections(LRTIs).</div></div><div><h3>Methods</h3><div>Sputum samples from 1723 children with LRTIs hospitalized from April 2020 to April 2021 were collected. Pathogen detection was performed using both LAMP and sputum culture method(SCM).Detection rates and consistency between the two methods were analyzed using the Chi-square test and Kappa analysis.</div></div><div><h3>Results</h3><div>The positive detection rates of the LAMP and the SCM were 58.97 %(1016/1723) and 43.64 %(752/1723), respectively(<em>P<</em>0.001). The detection rates of <em>Streptococcus pneumoniae</em> (Spn)(24.26 %/13.52 %), <em>Staphylococcus aureus</em>(Sau)(13.12 %/10.39 %), <em>Acinetobacter baumannii</em> (Aba)(1.33 %/0.48 %), <em>Stenotrophomonas maltophilia</em> (Sma)(0.58 %/0.12 %), and <em>Haemophilus influenzae</em>(Hin)(31.05 %/16.19 %) were significantly higher with the LAMP than with the SCM(<em>P<</em>0.05). Both methods showed that single infections were predominant among children, with positive rates of 65.06 % and 87.23 %, respectively, with Hin(49.92 %/33.69 %) being the most common pathogen.In mixed infections, the positive rates were 34.94 % and 12.77 %, respectively, with mixed infections of Hin and Spn being the most common, accounting for 48.89 % and 32.29 % of cases, respectively. There were significant differences in the detection rates of Spn, Sau, <em>Klebsiella pneumoniae</em>(Kpn), Sma, Hin, and <em>Escherichia coli</em>(Eco) between single and mixed infections(<em>P</em> < 0.05). The detection results of Spn, Sau, Kpn, Hin, and Eco exhibited high consistency between the two methods, while the consistency for <em>Pseudomonas aeruginosa</em>(Pae), Aba, and Sma was lower.</div></div><div><h3>Conclusion</h3><div>The LAMP is simpler, faster, more sensitive and specific than SCM, offering a reliable laboratory diagnostic basis for clinical management of LRTIs in children.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"44 ","pages":"Article e00463"},"PeriodicalIF":1.7,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143620684","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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