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Neutrophil-Lymphocyte-Platelet Ratio as a Prognostic Marker in Rural ICU Patients: a Two-Year Cross-Sectional Study. 中性粒细胞-淋巴细胞-血小板比率作为农村ICU患者的预后指标:一项为期两年的横断面研究。
IF 0.7 4区 医学
Clinical laboratory Pub Date : 2026-10-01 DOI: 10.7754/Clin.Lab.2025.250902
Harshitha Reddy, Sunil Kumar, Sourya Acharya, Suprit Malali, Kaumudi Ayaluri, Venkat Reddy, Saket Toshniwal, Sanchit Chabra, Meraj Khan, Johar Iqbal, Mohammad S Akhter, Hina Rashid
{"title":"Neutrophil-Lymphocyte-Platelet Ratio as a Prognostic Marker in Rural ICU Patients: a Two-Year Cross-Sectional Study.","authors":"Harshitha Reddy, Sunil Kumar, Sourya Acharya, Suprit Malali, Kaumudi Ayaluri, Venkat Reddy, Saket Toshniwal, Sanchit Chabra, Meraj Khan, Johar Iqbal, Mohammad S Akhter, Hina Rashid","doi":"10.7754/Clin.Lab.2025.250902","DOIUrl":"https://doi.org/10.7754/Clin.Lab.2025.250902","url":null,"abstract":"<p><strong>Background: </strong>Early risk identification can improve treatment outcomes for sepsis patients, leading to timely intervention and better quality of life. An identification of certain parameters in such patients is necessary to determine the risk in such patients. The present study evaluated the predictive efficiency of various critical care assessment scores (CAS), including SOFA, qSOFA, APACHE IV, and biomarkers such as NLR and NLPR, for in-hospital mortality, the need for mechanical ventilation (MV), and hospital length of stay (LOS), as a risk for sepsis patients.</p><p><strong>Methods: </strong>A total of 300 patients were included in the study; however, 70 mortalities were recorded. A significant difference was observed in the hematological and biochemical parameters between the survivors and non-survivors (p < 0.001). Associations between CAS, biomarkers, and clinical outcomes were assessed by binary logistic regression, while receiver operating characteristic (ROC) curve analysis was used to determine optimal cutoffs for mortality and MV prediction.</p><p><strong>Results: </strong>SOFA was the best predictor of mortality (OR: 2.98, p < 0.001) and MV requirement (OR: 2.90, p < 0.001), with a cutoff of ≥ 9 having 94% sensitivity and 86% specificity for mortality. APACHE IV with a cutoff > 71, AUC: 0.840, and NLPR with a cutoff > 3.1, AUC: 0.716, also significantly predicted mortality. PaO2/FiO2 had a negative correlation with both mortality (OR: 0.022, p < 0.001) and MV need (OR: 0.004, p < 0.001). An inverse prediction of LOS with SOFA scores was seen (β = -0.191, p = 0.003), whereas higher PaO2/FiO2 ratios indicated prolonged hospitalization (β = 0.193, p = 0.011).</p><p><strong>Conclusions: </strong>When predicting sepsis-related mortality and MV requirement, SOFA is a better option than other CAS and biomarkers. In setups with limited resources, NLPR is a helpful substitute. Important information about mortality risk and length of hospital stay is provided by PaO2/FiO2. However, to confirm these results in various contexts, more investigation is necessary.</p>","PeriodicalId":10384,"journal":{"name":"Clinical laboratory","volume":"72 10","pages":"2126-2135"},"PeriodicalIF":0.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149134641","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Retrospective Analysis of HPV Infection Status and Genotyping in East China: 2023 - 2024. 2023 - 2024年华东地区HPV感染状况及基因分型回顾性分析
IF 0.7 4区 医学
Clinical laboratory Pub Date : 2026-10-01 DOI: 10.7754/Clin.Lab.2025.250942
Dan Jin, Yuejiao Dong
{"title":"Retrospective Analysis of HPV Infection Status and Genotyping in East China: 2023 - 2024.","authors":"Dan Jin, Yuejiao Dong","doi":"10.7754/Clin.Lab.2025.250942","DOIUrl":"https://doi.org/10.7754/Clin.Lab.2025.250942","url":null,"abstract":"<p><strong>Background: </strong>Aim is to investigate the prevalence and genotypic distribution of human papillomavirus (HPV) infections among males and females in East China, providing epidemiological evidence for cervical cancer prevention.</p><p><strong>Methods: </strong>HPV genotyping data were collected from HPV-positive individuals diagnosed through outpatient, inpatient, and physical examinations at the First Affiliated Hospital, Zhejiang University School of Medicine between January 2023 and December 2024. Genotype distribution was analyzed by age, gender, and ThinPrep Cytologic Test (TCT) results. HPV genotyping was performed based on the principles of multiplex polymerase chain reaction (PCR) and capillary electrophoresis.</p><p><strong>Results: </strong>A total of 15,315 HPV-positive cases were identified. Single-genotype infections accounted for 65.81% of cases, dual-genotype infections for 21.53%, and multiple-genotype infections for 12.66%. The five most prevalent high-risk HPV genotypes were HPV52 (24.19%), HPV58 (13.47%), HPV16 (9.72%), HPV51 (9.68%), and HPV39 (8.54%). The leading low-risk genotypes were HPV42, HPV81, and HPV43. The highest infection rate occurred in the 30 - 39 age group (30.89%), and the lowest in individuals under 20 (0.9%), with significant differences across age groups (χ² = 9,891.28, p < 0.001). Males were primarily infected with HPV6, 52, and 11, while females most commonly harbored HPV52, 58, 51, 16, and 81. Genotypes HPV58, HPV52, and HPV16 were more frequently associated with TCT abnormalities. Specifically, HPV39 was linked to atypical squamous cells (ASC), HPV16 to low-grade lesions (LSIL), and HPV53 to high-grade lesions (HSIL). HPV52 showed the highest frequency across all abnormal cytological categories.</p><p><strong>Conclusions: </strong>HPV infections are highly prevalent in East China, mainly involving single genotypes. Infection patterns vary by age and gender, and certain genotypes are closely linked to cervical cytological abnormalities.</p>","PeriodicalId":10384,"journal":{"name":"Clinical laboratory","volume":"72 10","pages":"2187-2193"},"PeriodicalIF":0.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149134949","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Standardized Estimation of Measurement Uncertainty in Clinical Chemistry Using ISO 20914. 使用ISO 20914的临床化学测量不确定度的标准化估计。
IF 0.7 4区 医学
Clinical laboratory Pub Date : 2026-10-01 DOI: 10.7754/Clin.Lab.2025.250645
Mohammad I Ahmad, Fayha S Ahmed, Deepa Rao, Mohamedi Begum, Shiefa Joan
{"title":"Standardized Estimation of Measurement Uncertainty in Clinical Chemistry Using ISO 20914.","authors":"Mohammad I Ahmad, Fayha S Ahmed, Deepa Rao, Mohamedi Begum, Shiefa Joan","doi":"10.7754/Clin.Lab.2025.250645","DOIUrl":"https://doi.org/10.7754/Clin.Lab.2025.250645","url":null,"abstract":"<p><strong>Background: </strong>The degree to which one is certain of results for a particular measurement/testing process is expressed as a confidence level within a range. Measurement uncertainty (MU) is a critical parameter in clinical chemistry, reflecting the degree of confidence in laboratory test results and directly influencing diagnostic accuracy and patient care.</p><p><strong>Methods: </strong>The study calculated MU for 27 general chemistry analytes using the ISO 20914:2019 top-down approach, which uses long-term internal quality control (IQC) data and manufacturer calibrator traceability certificate values. The study was conducted at Nad al Hammar Health Center, Dubai Health, Dubai, using Roche Cobas Pure analyzers. The study compared calculated MU values with maximum allowable uncertainty (MAU) thresh-olds obtained from the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) biological variation database.</p><p><strong>Results: </strong>The results show that 17 analytes met the desirable MAU criteria at IQC level 1, confirming robust analytical performance. However, 10 analytes - including albumin, alkaline phosphatase, calcium, magnesium, phosphorus, transferrin, troponin T hs, uric acid, urine albumin, and vitamin D - exceeded the desirable MAU limits, suggesting potential areas for method optimization or high signal to noise ratio at quality control level 1.</p><p><strong>Conclusions: </strong>The findings underscore the importance of MU estimation in ensuring metrological traceability, fulfilling ISO 15189 accreditation requirements, and supporting risk-based quality management in clinical laboratories. This study highlights the practicality of ISO 20914 for routine MU assessment and advocates for its broader adoption to enhance result reliability and inter-laboratory comparability.</p>","PeriodicalId":10384,"journal":{"name":"Clinical laboratory","volume":"72 10","pages":"2091-2096"},"PeriodicalIF":0.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149135041","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Proposal of a Diagnostic Workflow for Peripheral Blood Smear Testing Based on Complete Blood Count Flag Analysis. 基于全血细胞计数标记分析的外周血涂片检测诊断流程的提出。
IF 0.7 4区 医学
Clinical laboratory Pub Date : 2026-10-01 DOI: 10.7754/Clin.Lab.2025.250936
Mijin Kang, Bo Kyeung Jung, Jae Kyung Kim
{"title":"Proposal of a Diagnostic Workflow for Peripheral Blood Smear Testing Based on Complete Blood Count Flag Analysis.","authors":"Mijin Kang, Bo Kyeung Jung, Jae Kyung Kim","doi":"10.7754/Clin.Lab.2025.250936","DOIUrl":"https://doi.org/10.7754/Clin.Lab.2025.250936","url":null,"abstract":"<p><strong>Background: </strong>Leukemia requires early detection, especially in acute forms, but standard tests such as bone marrow biopsy and molecular assays are often costly and unavailable in smaller hospitals. In these settings, complete blood count with peripheral blood smear examination provides a practical alternative. Analyzer-generated flags may suggest abnormal cells, yet false positives are common, and without a standardized protocol, smear review is often overlooked, leading to delayed diagnosis. This study aimed to develop and validate a stepwise peripheral blood smear protocol for small hospitals by analyzing blast-flagged complete blood count cases, correlating findings with diagnoses, and facilitating early leukemia detection and timely referral in resource-limited settings.</p><p><strong>Methods: </strong>This retrospective study was conducted at a small hospital in South Korea. Three datasets were analyzed: 1) 60 patients diagnosed with leukemia (Jan 2020 - Dec 2024), 2) 633 CBC samples flagged with \"Blast/Abn Lympho?\" or \"Left Shift\" (Feb 2023 - Jan 2025), and 3) 43,450 CBC samples without any flagging or hematological abnormalities (control group). The flags were automated alerts indicating the presence of immature or abnor-mal white blood cells (WBCs), prompting PBS review. Descriptive statistics summarized demographic and hematological parameters, and group comparisons were performed using chi-squared and independent t-tests, with significance set at p < 0.05.</p><p><strong>Results: </strong>Of the 633 flagged samples, 20 cases (3.2%) showed blast cells on PBS, 19 of which occurred in samples with elevated WBC counts. Several were confirmed as leukemia and referred early for treatment. Flagged cases showed significantly higher WBCs and lower hemoglobin levels than control cases (p < 0.0001), supporting the clinical relevance of analyzer flagging.</p><p><strong>Conclusions: </strong>The proposed workflow facilitates the early detection of hematological malignancies using existing CBC flagging. Our study also underscores the pivotal role of clinical laboratory scientists in diagnostic decision-making, especially in resource-limited environments.</p>","PeriodicalId":10384,"journal":{"name":"Clinical laboratory","volume":"72 10","pages":"2179-2186"},"PeriodicalIF":0.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149134801","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
The Current Status of CA15-3 Measurement Based on a Commutable External Quality Assessment Program. 基于可交换外部质量评价方案的CA15-3测量现状
IF 0.7 4区 医学
Clinical laboratory Pub Date : 2026-10-01 DOI: 10.7754/Clin.Lab.2025.251106
Tingting Jia, Ziran Zhang, Yuhong Yue, Jianping Zhang, Jing Yan, Mo Wang, Shunli Zhang, Yanwei Hu
{"title":"The Current Status of CA15-3 Measurement Based on a Commutable External Quality Assessment Program.","authors":"Tingting Jia, Ziran Zhang, Yuhong Yue, Jianping Zhang, Jing Yan, Mo Wang, Shunli Zhang, Yanwei Hu","doi":"10.7754/Clin.Lab.2025.251106","DOIUrl":"https://doi.org/10.7754/Clin.Lab.2025.251106","url":null,"abstract":"<p><strong>Background: </strong>The goal was to evaluate the external quality assessment (EQA) performance of breast cancer-related tumor marker CA15-3.</p><p><strong>Methods: </strong>CA15-3 EQA materials were distributed to each participating laboratory by cold chain transportation each round, and the laboratories returned results through the official website. The participating hospitals were grouped according to the testing reagents and methods. The median was taken as the target value. Evaluation criterion, 20.83%, was based on desirable specification derived from intra- and inter-individual biological variation. The robust CV was used to evaluate the variation trend between laboratories. The choice of high, medium, and low concentration levels was used to compare the differences between detection systems, and the pass rate was used to evaluate the test quality of the laboratory.</p><p><strong>Results: </strong>In the five CA15-3 EQA from 2023 to 2025, the number of participating laboratories was 504 - 817. There was a significant difference in the composition ratio of hospitals at different levels between the rounds. In the classification of reagents, the range of robust CV was 6.48 to 7.63, and the robust CV of the first EQA of CA15-3 in 2025 was lower than that of the second EQA in 2024; the pass rates of the two quality assessments in 2024 were both higher than that of the second EQA in 2023. Of a total of 63 pairwise comparisons, the vast majority showed statistically significant differences. There was no statistical difference in the results between the three reagents of brand f, brand c and others at low and medium levels. In the classification of methods, there was no statistically significant difference in the robust CV and pass rate of CA15-3 among the five inter-laboratory quality assessments from 2023 to 2025. At low and medium levels, there was no significant difference between the results of some methods. At high levels, there were significant differences between any two groups except D - C and A - B.</p><p><strong>Conclusions: </strong>The pass rate of CA15-3 was increasing, and the robust coefficient of variation was decreasing. There are differences among different detection reagents and methods, so different reference intervals and treatment cut-off values should be used to provide more accurate clinical service.</p>","PeriodicalId":10384,"journal":{"name":"Clinical laboratory","volume":"72 10","pages":"2285-2292"},"PeriodicalIF":0.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149135049","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Detecting the TNF-α -308G/A Polymorphism by Quantitative PCR and its Correlation with Therapeutic Efficacy in Ankylosing Spondylitis. 定量PCR检测强直性脊柱炎患者TNF-α -308G/A多态性及其与疗效的相关性
IF 0.7 4区 医学
Clinical laboratory Pub Date : 2026-10-01 DOI: 10.7754/Clin.Lab.2025.250918
Ya L Dou, Ling J Kong, Xia T Zhao, Fu B Wang, Hong X Cheng
{"title":"Detecting the TNF-α -308G/A Polymorphism by Quantitative PCR and its Correlation with Therapeutic Efficacy in Ankylosing Spondylitis.","authors":"Ya L Dou, Ling J Kong, Xia T Zhao, Fu B Wang, Hong X Cheng","doi":"10.7754/Clin.Lab.2025.250918","DOIUrl":"10.7754/Clin.Lab.2025.250918","url":null,"abstract":"<p><strong>Background: </strong>The tumor necrosis factor-alpha (TNF-α) -308GA polymorphism (rs1800629) may affect TNF-α expression and the effectiveness of TNF-α inhibitors in autoimmune conditions such as ankylosing spondylitis (AS). For clinical use, it is very important to have fast and accurate genotyping methods. This study aimed to comprehensively evaluate a fluorescence quantitative polymerase chain reaction (PCR) method based on TaqMan minor groove binder (MGB) probe technology in detecting the TNF-α rs1800629 polymorphism and investigate the correlation between this SNP and the efficacy of TNF-α inhibitor therapy in patients with AS.</p><p><strong>Methods: </strong>A TaqMan-MGB FQ-PCR detection system was constructed for the detection of the TNF-α single nucleotide polymorphism (SNP) (-308G>A). The limit of detection, accuracy, precision, specificity, sensitivity, and stability were assessed. A multicenter clinical trial was conducted to assess the detection system using a double-blind method involving 1,045 patients with immune diseases. The genotypes of TNF-α -308G/A from 20 patients with hyperlipidemia or jaundice were tested using the detection systems to evaluate the influence of interference. The correlation between the clinical response to TNF-α inhibitors and TNF-α -308G/A SNP was investigated using the 32 patients with ankylosing spondylitis.</p><p><strong>Results: </strong>The detection range limit was 151.4 ng/μL - 0.5 ng/μL. The genotype detected using the research detection system and Sanger sequencing was 100%, with a Kappa 1.00 > 0.75, p = 0 < 0.001. The coefficient of variation of precision was less than 8%. Interfering substances did not affect the detection system. The follow-up trial indicated that the patients with the GA genotype, three out of the four cases, had no response for TNF-α inhibitors. In contrast, all patients with the GG genotypes experienced better treatment efficacy with TNF-α inhibitors.</p><p><strong>Conclusions: </strong>The detection system utilizing the TaqMan-MGB probe for TNF-α polymorphism - 308G/A demonstrated high reliability. TNF-α -308G/A polymorphisms are potential biomarkers for predicting the treatment efficacy of TNF-α inhibitors for patients with ankylosing spondylitis.</p>","PeriodicalId":10384,"journal":{"name":"Clinical laboratory","volume":"72 10","pages":"2152-2163"},"PeriodicalIF":0.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149135316","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Molecular Profiling and Clinical Characteristics of Breast Cancer in the Asir Region: a Retrospective Analysis. 阿西尔地区乳腺癌的分子特征和临床特征:回顾性分析。
IF 0.7 4区 医学
Clinical laboratory Pub Date : 2026-10-01 DOI: 10.7754/Clin.Lab.2025.251034
Majed S Al Fayi, Abdullah A Alghamdi, Yahya M M Elqahtani, Irfan Ahmad, Mohammad M Alam, Ali G Alkhathami, Hossam M Kamli, Adil A M Yousif, Hatem M A Asiri
{"title":"Molecular Profiling and Clinical Characteristics of Breast Cancer in the Asir Region: a Retrospective Analysis.","authors":"Majed S Al Fayi, Abdullah A Alghamdi, Yahya M M Elqahtani, Irfan Ahmad, Mohammad M Alam, Ali G Alkhathami, Hossam M Kamli, Adil A M Yousif, Hatem M A Asiri","doi":"10.7754/Clin.Lab.2025.251034","DOIUrl":"https://doi.org/10.7754/Clin.Lab.2025.251034","url":null,"abstract":"<p><strong>Background: </strong>Breast cancer is a major health issue in the Asir region of Saudi Arabia and is characterized by diverse molecular subtypes and varying clinicopathological features. This study focuses on analyzing the molecular subtypes of breast cancer, investigating associated clinical and pathological factors, and assessing the role of im-munohistochemistry (IHC) in subtype classification.</p><p><strong>Methods: </strong>A retrospective analysis was conducted on 385 patients with breast cancer from Asir Central Hospital. Clinicopathological data, including tumor size and molecular subtype distribution, were collected. IHC was performed to determine the expression of the estrogen receptors (ER), progesterone receptors (PR), and HER2.</p><p><strong>Results: </strong>The average patient age was 44.69 years (standard deviation [SD], 15.983), ranging from 4 to 93 years. The majority of cases were in women aged 31 - 60 years (60%), with fewer cases in individuals aged > 60 years (17.4%). Invasive ductal carcinoma (IDC) was the most common histological type (37.9%), followed by fibroadenoma (35.8%) and other benign tumors (14.5%). Most tumors were > 2 cm in size (2.6%), indicating a delayed diagnosis. Luminal A was the most frequent molecular subtype (67.3%), followed by triple-negative (19.23%) and luminal B (13.46%). Strong positivity for PR, ER, and HER2 was predominantly observed in IDC cases, with luminal A subtype showing the highest positivity rate.</p><p><strong>Conclusions: </strong>This study emphasizes the predominance of the IDC and luminal A subtypes in the Asir region, underscoring the importance of tailored treatment strategies based on molecular profiles. These findings highlight the need for improved early detection and screening programs to address delayed diagnosis of breast cancer. Enhanced awareness and education about breast cancer, coupled with better access to screening, are crucial for improving patient outcomes in this region. IHC analysis has proven to be a reliable tool for identifying breast cancer subtypes and aiding precise treatment decisions.</p>","PeriodicalId":10384,"journal":{"name":"Clinical laboratory","volume":"72 10","pages":"2251-2261"},"PeriodicalIF":0.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149134500","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Precision and Trueness Verification of Routine Biochemistry Tests using CLSI EP15-A3. CLSI EP15-A3常规生化检测的精密度和准确性验证
IF 0.7 4区 医学
Clinical laboratory Pub Date : 2026-10-01 DOI: 10.7754/Clin.Lab.2026.260350
Meltem Yardim, Levent Deniz
{"title":"Precision and Trueness Verification of Routine Biochemistry Tests using CLSI EP15-A3.","authors":"Meltem Yardim, Levent Deniz","doi":"10.7754/Clin.Lab.2026.260350","DOIUrl":"https://doi.org/10.7754/Clin.Lab.2026.260350","url":null,"abstract":"<p><strong>Background: </strong>Method verification is a fundamental requirement to ensure reliable test results in diagnostic and therapeutic processes. This study aimed to verify the precision and trueness of routine biochemistry assays on the Beckman Coulter AU680 analyzer according to the Clinical and Laboratory Standards Institute (CLSI) EP15-A3 and to evaluate analytical performance based on biological variation (BV)-derived specifications.</p><p><strong>Methods: </strong>Twelve routine biochemical analytes, including albumin, alkaline phosphatase (ALP), alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase (LDH), amylase, glucose, total cholesterol, total protein, triglycerides, urea, and uric acid, were evaluated. Two levels of Bio-Rad Lyphochek Assayed Chemistry Controls (lots 89701 and 89702) were analyzed using a 5 × 5 experimental design. Repeatability and within-laboratory precision were estimated using one-way ANOVA and compared with the manufacturer's claims and CLSI EP15-A3 upper verification limits (UVL). Trueness was assessed using Unity Real Time peer group means as the target values. The results falling outside the verification intervals were further evaluated against the BV-based allowable bias limits. The total analytical error (TAE) was calculated by combining the bias and within-laboratory imprecision estimates derived from the CLSI EP15-A3 verification protocol, and was subsequently evaluated against BV-based specifications.</p><p><strong>Results: </strong>Repeatability CV values ranged from 0.37% to 1.51%, and within-laboratory CV values ranged from 0.56% to 3.70%. Although several observed CV values exceeded the manufacturer's claims, all remained below the CLSI EP15-A3 UVL, confirming acceptable analytical precision. Trueness was verified by compliance with verification intervals or by bias values remaining within the allowable BV-based limits. Optimal bias performance was achieved for ALP, LDH, total protein, triglycerides, and urea at both control levels, whereas the remaining analytes met the desirable bias specifications. All analytes fulfilled either the optimal or desirable BV-based total error specifications, and none exceeded the desirable allowable limits.</p><p><strong>Conclusions: </strong>All evaluated assays demonstrated satisfactory analytical performance and successfully met the CLSI EP15-A3 verification criteria. Furthermore, this integrated verification approach may assist laboratories in generating objective evidence to support quality assurance activities and comply with ISO 15189:2022 accreditation requirements.</p>","PeriodicalId":10384,"journal":{"name":"Clinical laboratory","volume":"72 10","pages":"2301-2313"},"PeriodicalIF":0.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149134745","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Spontaneous Postpartum Hematomas Revealing Acquired Hemophilia A with Extreme Inhibitor Interference: a Case Report and Literature Review. 产后自发性血肿显示获得性血友病A伴极端抑制剂干扰:1例报告及文献复习。
IF 0.7 4区 医学
Clinical laboratory Pub Date : 2026-10-01 DOI: 10.7754/Clin.Lab.2025.251045
Rhazali Aida, Mamad Hassane, Zirar Jalila, Benkirane Souad, Masrar Azlarab
{"title":"Spontaneous Postpartum Hematomas Revealing Acquired Hemophilia A with Extreme Inhibitor Interference: a Case Report and Literature Review.","authors":"Rhazali Aida, Mamad Hassane, Zirar Jalila, Benkirane Souad, Masrar Azlarab","doi":"10.7754/Clin.Lab.2025.251045","DOIUrl":"https://doi.org/10.7754/Clin.Lab.2025.251045","url":null,"abstract":"<p><strong>Background: </strong>Acquired hemophilia A (AHA) is a rare autoimmune bleeding disorder caused by autoantibodies against factor VIII. Extremely high-titer inhibitors may cause laboratory interference patterns mimicking com-bined factor deficiencies.</p><p><strong>Methods: </strong>We report a 28-year-old woman with extensive postpartum hematomas. Investigations included coagulation screening, factor assays, serial dilution studies (undiluted to 1:16), and anti-factor VIII antibody quantification using the Nijmegen method. Factor VIII activity was measured by both one-stage clot-based and chromogenic assays. Immunological workup excluded associated autoimmune conditions. Treatment consisted of first-line immunosuppression with rituximab and prednisone followed by emicizumab (for refractory disease).</p><p><strong>Results: </strong>Initial testing showed isolated aPTT prolongation (ratio 3.82) with apparent deficiency of factors VIII, IX, XI, XII (all 0%). Serial dilutions revealed differential recovery with factors IX, XI, XII progressively normalized while factor VIII remained at 0%. Anti-factor VIII antibodies exceeded 256 BU/mL. At one-year follow-up, factor VIII activity reached 54% and inhibitor titer 2.1 BU/mL.</p><p><strong>Conclusions: </strong>Extremely high-titer anti-factor VIII antibodies can cause spurious multi-factor deficiencies through assay interference rather than true multiple factor inhibition. Serial dilution studies are essential for accurate diagnosis. This interference phenomenon must be recognized in order to avoid misdiagnosis and ensure appropriate treatment of severe AHA.</p>","PeriodicalId":10384,"journal":{"name":"Clinical laboratory","volume":"72 10","pages":"2320-2325"},"PeriodicalIF":0.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149134968","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
The Role of Blood Parameters and Inflammatory Scoring Systems in Prognostic Prediction in Pediatric Pancreatitis Patients. 血液参数和炎症评分系统在小儿胰腺炎患者预后预测中的作用。
IF 0.7 4区 医学
Clinical laboratory Pub Date : 2026-10-01 DOI: 10.7754/Clin.Lab.2025.250914
Süleyman Nogay, Fatih Gönültaş, Turgut Dolanbay, Bilgehan Demir, Muhammed S Sinanoğlu, Asiye Özkan
{"title":"The Role of Blood Parameters and Inflammatory Scoring Systems in Prognostic Prediction in Pediatric Pancreatitis Patients.","authors":"Süleyman Nogay, Fatih Gönültaş, Turgut Dolanbay, Bilgehan Demir, Muhammed S Sinanoğlu, Asiye Özkan","doi":"10.7754/Clin.Lab.2025.250914","DOIUrl":"https://doi.org/10.7754/Clin.Lab.2025.250914","url":null,"abstract":"<p><strong>Background: </strong>Acute pancreatitis (AP) is an acute inflammatory disease primarily involving the pancreas and can affect all age groups. Acute recurrent pancreatitis (ARP) refers to two distinct episodes of AP. In children, pancreatitis typically presents as a single uncomplicated episode, but it can also manifest as ARP and progress to chronic pancreatitis. Pediatric AP differs clinically from adult AP and requires specific diagnostic and therapeutic approaches. Although pediatric AP has lower mortality rates compared to adult AP, it may still lead to significant morbidity and complications. This study aimed to evaluate the relationship of laboratory parameters and inflammatory scores with etiology, clinical features, and prognosis in pediatric pancreatitis.</p><p><strong>Methods: </strong>The Akgün database of Malatya Training and Research Hospital was retrospectively reviewed. Between January 2020 and December 2024, epicrisis reports of 46 hospitalized patients coded as ICD-10 K85 (acute pancreatitis) or K85.9 (unspecified acute pancreatitis) were examined. Patients were classified according to the INSPPIRE (International Study Group of Pediatric Pancreatitis: In Search for a Cure) criteria as acute pancreatitis (AP) or acute recurrent pancreatitis (ARP). Nine patients who did not meet inclusion criteria were ex-cluded, and the study was conducted with the remaining 37 cases.</p><p><strong>Results: </strong>Among the patients, 10 (27%) were diagnosed with ARP, while 27 (73%) presented with AP. The most common etiologies were idiopathic (n = 20, 54.1%), cholelithiasis (n = 10, 27%), and drug-induced pancreatitis (n = 7, 18.9%). Among drug-related cases, valproic acid was identified in 42.8% (3 patients), metronidazole in 28.6% (2 patients), and NSAIDs in 28.6% (2 patients). Laparoscopic cholecystectomy was performed in 5.4% (2 patients). All patients were monitored in the ward and discharged with full recovery.</p><p><strong>Conclusions: </strong>In our study, the increase in creatinine levels was associated with a higher risk of ARP, highlighting the importance of renal function markers in pancreatitis. Furthermore, the positive correlation between amylase, lipase, and the SIRI index with the length of hospital stay suggests that these parameters may be useful in predicting disease severity.</p>","PeriodicalId":10384,"journal":{"name":"Clinical laboratory","volume":"72 10","pages":"2143-2151"},"PeriodicalIF":0.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149135125","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
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