Clinical chemistry最新文献

{"title":"B-208 Implementation of Genomic Surveillance of Epidemic Viruses in a Clinical Laboratory in Brazil: Outcomes from Public-Private Collaborative Efforts","authors":"Miguel Andrade, Lucas Silva, Aline Belmok, Thais Sena, Bruno Milhomem, Lara Velasco, Rafael Jacomo, Lidia Nery","doi":"10.1093/clinchem/hvaf086.597","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf086.597","url":null,"abstract":"Background Genomic surveillance has been widely implemented in various countries during and after the COVID-19 pandemic. In this context, nanopore sequencing technology gained prominence, enabling the development of multiple protocols based on multiplex PCR product sequencing. In Brazil, private laboratories are responsible for a significant portion of laboratory testing, making them potential allies in genomic surveillance. In this context, we submitted a research project to a public funding agency in the Federal District of Brazil, aiming to sequence the genomes of epidemiologically relevant viruses. This work describes the main results obtained. Methods This study was approved by the appropriate ethics and research committee. Between 2023 and 2024, positive samples previously identified by real time PCR (qPCR) for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Monkeypox virus (MPXV), Chikungunya virus (CHIKV), Dengue virus (DENV) were selected. DNA and RNA were extracted using the Starlet or Maxwell extractor. RNA samples were subjected to cDNA synthesis using LunaScript RT SuperMix. Multiplex PCR was performed using specific primer pools for SARS-CoV-2 and CHIKV. The amplified products were quantified by fluorimetry, normalized, and sequencing libraries were prepared using the Sequencing chemistry V14 (SQK-LSK114, SQK-NBD114.24 or SQK-RBK114.96. Sequencing experiments were conducted on the MinION sequencer using R10 flowcells (FLO-MIN114) or Flongles R10 (FLO-FLG114). Raw signal data (.pod5) were processed using Dorado software with the super-accuracy protocol for basecalling and demultiplexing. The resulting reads (.fastq) were used for genome assembly with virus-specific pipelines in the Epi2Me software. The MPXV genome was sequenced directly from total extracted nucleic acid using a shotgun approach (without PCR amplification). The genotypes of DENV samples were determined by serotype-specific qPCR primers and probes. Results Between 2023 and 2024, a total of 163 SARS-CoV-2 genomes were sequenced, the most frequently identified variant in 2023 being XBB.1.5 (n = 43) and in 2024 BA.2 (n = 115). During the same period, 17 CHIKV genomes were obtained with an average coverage of 82,88% (range: 54,18% – 95,04%), all belonging to East/Central/South African genotype. Regarding MPXV, only one genome was successfully sequenced by shotgun approach resulting in 3,082,296 reads, from which 28,230 (0,9%) mapped in the MPXV genome, with 99,95% coverage and average depth of 110. The analysis classified this genome within clade IIb, consistent with previous reports in the region. For DENV, 21 positive samples were genotyped by RT-qPCR, identifying three samples of serotype 1, 17 of serotype 2, and one of serotype 4. All generated sequences were deposited in public databases, ensuring accessibility for further epidemiological studies. Conclusion The use of samples from routine diagnostic testing in private laboratories proved to be a viable ","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"19 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145203209","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A-093 Study of Hemoglobin Variants Interference to Enzymatic HbA1c Assay on Mindray BS-2800M Analyzer","authors":"Jian Dai, Anping Xu, Houlong Luo, Jin Li, Xiuting Xu, Xian Wang","doi":"10.1093/clinchem/hvaf086.092","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf086.092","url":null,"abstract":"Background HbA1c reflects the average blood glucose level during the preceding 2 to 3 months. It is an important analyte for screening and diagnosing diabetes, and monitoring the diabetes progression. Hemoglobin variants are common interference factors for the HbA1c assay. This study aims to assess the analytical performance of Mindray enzymatic assay for HbA1c measurement on Mindray BS-2800M autoanalyzer, and also, in particular, to evaluate the measurement accurate in the presence of interference of hemoglobin variants (HbE, Hb NewYork, Hb G, Hb G-Honolulu, and Hb Q-Thailand) by four commonly used methods for measuring HbA1c in clinical laboratories. Methods Analytical performance evaluation included precision and accuracy. Total precision was assessed according to the Clinical and Laboratory Standards Institute (CLSI) EP05-A2 guidelines by using quality control materials and fresh whole blood samples, 8 samples from IFCC was assessed for accuracy. The sigma metric for HbA1c was calculated using the formula s=(TEa-|bias|)/CV. Furthermore, a large number (n=156) of 5 different hemoglobin variants samples were collected and HbA1c results was compared between enzymatic method (Mindray BS-2800M), cation-exchange high-performance liquid chromatography (HPLC) method (D-100), capillary electrophoresis method (Capillarys 3 TERA, C3), boronate affinity method (Premier Hb9210). Results When calculated in NGSP units and sample concentrations ranged from 4.9% to 10.2%, the coefficients of variation (CV) for total precision were between 0.31% to 0.51%. The results of enzymatic assay of whole blood samples of glycosylated hemoglobin assigned by IFCC calibrators were correlated with their target values with slope of 0.998, and the relative biases were all within ±5%. 6.0% was used as the total allowable error for HbA1c, sigma metrics of HbA1c measured by enzymatic assay varied from 11.99 to 19.49 with “world class” quality while sample concentrations ranged from 4.9% to 10.2%. A total of 5 hemoglobin variants types were identified in 156 patients. The most common variant was Hb E(n=85), followed by Hb G(n=30), Hb Q-Thailand (n=17), Hb NewYork (n=12), Hb G-Honolulu(n=12). Mindray enzymatic assay showed great correlation and agreement with D-100,C3,Hb9210. The correlation coefficients were greater than 0.96 and the relative deviations were within 10%? Conclusion Enzymatic HbA1c assay is an economical, efficient and accurate detection method, which shows good anti-interference capability from hemoglobin variants (HbE, Hb NewYork, Hb G, HB G-Honolulu, and Hb Q-Thailand) and can provide accurate HbA1c results for clinical laboratories. It is suitable for routine use in large, medium, and small clinical laboratories.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"3 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145203359","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A-106 Albumin-corrected Calcium: Should we use it or not?","authors":"Bibek Poudel, Shishir Adhikari, Ray Zhang, Jyoti Balani, Alagarraju Muthukumar","doi":"10.1093/clinchem/hvaf086.104","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf086.104","url":null,"abstract":"Background Accurate assessment of calcium (Ca) level is important for proper classification of Ca status. Biologically active ionized Ca (iCa) is the best marker for precisely estimating functional Ca levels. However, the cost and pre-analytical challenges limit wide use of this test. As an alternative, many facilities like ours report albumin-corrected Ca (ACa) and uncorrected total Ca (TCa) results concurrently with every metabolic panel order. This has led to frequent calls from our clinicians, specifically when a substantial difference is noted between the two results. Recent studies have challenged the widespread use of ACa in clinical practice, underscoring its potential inaccuracies in determining Ca status, especially in hospitalized patients needing frequent Ca level monitoring. Importantly, a subset of these investigations has affirmed the continued reliability of TCa in Ca assessment. Our study aims to evaluate the effectiveness of reporting ACa and TCa in our large urban academic medical center while exploring their selective utilization. Methods In this retrospective study, we analyzed 12,899 samples collected from 4,264 adult patients at our university hospital between January 2016 and December 2024. TCa, iCa, and ACa results reported from the same blood draw were included in the data analysis. The simplified Payne formula was employed for ACa calculation, with iCa serving as the reference method. Our facility*s reference ranges are 3.5-5.2 g/dl for albumin, 4.4-5.2 mg/dL for iCa and 8.4-10.2 mg/dL for TCa/ACa. Severe (critical) hypocalcemia and hypercalcemia were defined as <3.1 mg/dL and >6.3 mg/dL for iCa, and <6.0 mg/dL and >14.0 mg/dL for TCa/ACa, respectively. Statistical analysis was conducted using GraphPad Prism 9, with p<0.05 considered statistically significant. Results Among 4,264 patients, the majority (70%) had low albumin levels (<3.5 g/dl) and were inpatients (91%). ACa underestimated hypocalcemia and overestimated hypercalcemia significantly compared to iCa. In contrast, TCa overestimated hypocalcemia, particularly by several fold in severe hypocalcemia. In hypoalbuminemia, there was pronounced underestimation of hypocalcemia and overestimation of normocalcemia and hypercalcemia by ACa, while TCa showed opposite trends. ACa performed poorly compared to TCa in chronic kidney disease (CKD) patients with eGFR <60 and <30 ml/min/1.73m2. Importantly, both ACa and TCa overestimated severe hypocalcemia and hypercalcemia in patients with normal albumin levels. ACa and TCa showed comparable performance to iCa only when both albumin and Ca levels were within normal ranges. Conclusion ACa is unreliable for classifying clinical Ca status, especially in hypoalbuminemia. ACa performs worse than TCa in CKD patients. Contrary to previous literature, TCa is as unreliable as ACa unless both albumin and TCa levels are normal. We recommend iCa as the sole accurate test for monitor","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"6 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145202927","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A-397 Creatinine Chaos: When Numbers Fail, Imaging Freezes","authors":"Madhusudhanan Narasimhan, Kibibi Smith, Shishir Adhikari, Alagarraju Muthukumar","doi":"10.1093/clinchem/hvaf086.381","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf086.381","url":null,"abstract":"Background: As chronic disease rates rise, intravenous (IV) contrast usage for diagnostic imaging is increasing steadily. While IV procedures are largely safe, patients at risk of contrast-induced neuropathy (CIN) due to predisposing factors like renal disease, albuminuria, diabetes, or nephrotic medications need pre-IV renal assessments. Widely used frontline point-of-care creatinine (POC) screening tests can yield ambiguous results, leading to retests, delays, patient distress, and healthcare burdens. This case study illustrates the consequences of unexpected elevation in initial POC creatinine (Cr) result on IV contrast plans, and examines how a holistic, patient-centric approach can alleviate renal concerns and enable timely imaging procedures Case Presentation: A diabetic, hypertensive, and chronic kidney diseased Caucasian male, aged 61, presented for a scheduled intravenous contrast-enhanced computed tomography scan. His initial POC-based Cr result of 1.20 mg/dL narrowly exceeded the reference interval (RI) (0.67 - 1.17 mg/dL). Given the patient’s pre-existing conditions, this increment raised the patient’s anxiety and laboratory-based Cr test was performed to reassure his renal function. The new result was found to be 0.95 mg/dL (RI: 0.72 -1.25 mg/dL), which fell within the normal RI. The 0.25 mg/dL (20.8%) disparity between Cr tests, which delayed the IV procedure, led the clinician to request a thorough laboratory investigation to assess the clinical significance of these fluctuations. Diagnostic Challenge: This case is notable for its distinctive presentation. Despite the patient*s underlying conditions, his Cr levels remained within normal range over the past 12 years, with only slight decrease observed on occasion. The recent pre-IV contrast renal assessment marked the first unexpected rise in Cr levels, making it an interesting case for in-depth analysis. Our examination of Cr results and its curvilinear relationship with kidney function limited the relevance of using population-based reference intervals (PBRI) in this patient. Results/Investigation and Outcome: Subject-based reference intervals (SBRI) were calculated using the index of individuality (IOI) and relative change value (RCV). The laboratory-based Cr assay showed an IOI of 0.271 and RCV of 17.3%, while the POC device yielded an IOI of 0.49 and RCV of 31.4%. The resulting SBRI ranges were 0.67-0.95 mg/dL for the laboratory method and 0.56-1.07 mg/dL for the POC assay. The latest lab-based Cr result (0.95 mg/dL) was within the SBRI range, while the POC result (1.2 mg/dL) exceeded the upper limit by 12%. Although the 20.8% discrepancy between methods exceeded the 15% total allowable error (TAE), the absolute difference of 0.25 mg/dL remained within the 0.3 mg/dL regulatory guideline. Conclusions/Clinical Implications: This case underscores the challenges of unexpected overestimation of POC Cr results, which can lead to patient distress and procedural delays during pre-IV co","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"101 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145203213","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A-130 Evaluation of the potential benefits of reticulocytes integrated in the CBC routine on sthemA 801 analyzer","authors":"Joffrey Feriel, Sylvain Barreau, Marie Gapihan","doi":"10.1093/clinchem/hvaf086.126","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf086.126","url":null,"abstract":"Background Reticulocyte (RET) count is a key parameter to assess the bone marrow’s ability to produce red blood cells (RBC) in response to physiological challenges. While not mandatory part of the complete blood count, clinicians can request this test as needed. Laboratory can also add it as reflex testing based on hemoglobin (HGB) levels for example. This study aimed to evaluate the medical value of systematically performing reticulocyte counts alongside complete blood counts (CBC) on all samples enabled by the sthemA 801 analyzer. Methods We randomly collected 1004 samples in a French center over a 2-month period. The sthemA 801 was used as a reference for data collection and statistical analysis. We identified the number and percentage of samples for which RET was requested by clinicians, those without prescription and RET >150 G/L (a commonly accepted threshold for reticulocytosis) and those with in addition HGB =10 g/dL (the threshold proposed by the French Group of Cellular Hematology (GFHC) for RET reflex testing). A chi-square test was used to define whether the notion of prescription and HGB levels had an impact on the percentage of positive RETs. Finally, we reviewed medical records of samples with incidental findings of RET > 150 G/L associated with HGB = 10 g/dL to identify the most likely causes of reticulocytosis. Results Among the 1004 samples included in the study, 74 (7.4%) had a prescription for RET and 123 (12.3%) had a RET > 150 G/L. Prescription status did not affect the percentage of positive RET (p=0.2058) and 89.4% (110/123) of samples with reticulocytosis went missed. HGB levels had a significant impact on the percentage of positive RET identified (p<0.0001). Using an HGB threshold of 10 g/dL allowed the detection of 69.1% (76/110) of samples with positive RET. Finally, 34 samples with RET > 150 G/L remained undetected. Among them, 12 were related to road traffic accident or postoperative bleeding, 9 were multifactorial (resolution of inflammation or immunosuppressants combined with another cause), 4 involved iron supplementation for iron deficiency anemia, and 2 had a known constitutional RBC disorder (one sickle cell disease and one hereditary spherocytosis). The absence of clinical data for three patients prevented a definitive conclusion. Interestingly, one patient had compensated hemolysis of undetermined cause. She was a 46-year-old woman who had been followed for more than 20 years and had multiple comorbidities, but none of them could explain the chronic compensated hemolysis. An inherited RBC disorder was suspected and will be further explored. Conclusion We found that over 3% of samples with RET > 150 G/L might go unnoticed in daily hospital practice, despite clinicians having the option to request them and the use of GFHC expertise rules in the laboratory. Reticulocytes being part of the CBC routine on sthemA801 analyzer could benefit patients receiving iron supplementa","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"75 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145203319","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A-301 Using a host-protein test (based on TRAIL/IP-10/CRP) to assess the likelihood of bacterial infection in patients with suspected sepsis","authors":"Roy Navon, Alon Angel, Boris Lebedenko, Lior Kellerman, Tanya Gottlieb, Eran Eden","doi":"10.1093/clinchem/hvaf086.290","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf086.290","url":null,"abstract":"Background Sepsis is a life-threatening syndrome requiring rapid identification and appropriate management, including timely treatment of bacterial infections. Biomarker-based tests aid in determining infection etiology and guiding clinical decisions for patients with suspected sepsis. MeMed BV (MMBV), a host-protein test for differentiating between bacterial and viral infection, is based on computational integration of the circulating levels of three biomarkers (TRAIL, IP-10, CRP). This study evaluates MMBV’s accuracy in identifying bacterial versus viral infections in hemodynamically stable patients with suspected sepsis. Methods A post-hoc analysis of patients recruited prospectively in three studies (Apollo NCT04690569, Observer NCT03011515, Curiosity NCT01917461). Patients were recruited in urgent care centers, emergency departments or internal wards. Patients meeting the eligibility criteria of the parent studies, aged =18 years and with suspected sepsis (defined as at least two SIRS criteria) were included in this analysis. Reference standard infection etiology was determined based on the parent studies, where three independent adjudicators, blinded to MMBV results, assigned bacterial or viral labels after reviewing comprehensive patient data. A unanimous label with =90% confidence was required. MMBV scores (0-100) were interpreted as bacterial/viral/equivocal according to manufacturer’s instructions. MMBV results were compared to the reference standard infection etiologies. Area under the receiver operating characteristic curve (ROC-AUC) was calculated including patients with equivocal results across all possible thresholds. When calculating other diagnostic accuracy parameters, equivocal cases were removed. Results Out of 527 potentially eligible patients, 134 were included (Figure 1A). Median age was 42 years (interquartile range (IQR): 30-65); 69 (52%) were female. 111 patients (82.8%) had two SIRS criteria; 22 (16.4%) had three; and one patient (0.7%) had four. The most common source of infection was the respiratory tract (73.9%). 53% of the patients were hospitalized with a median duration of 4 days (IQR: 3-7 days). Most patients (54%) had no microbiological confirmation in their medical record (even after the ED visit), 21% had a bacterial detection, 11% had viral detection and 14% had both bacterial and viral detections. Reference standard adjudication determined that 56% had a bacterial infection. MMBV results were viral for 53 (39.6%), bacterial for 72 (53.7%) patients, and equivocal for 9 (6.7%) patients. MMBV achieved AUC of 0.98 (95% confidence interval: 0.96-1.00). Among patients with non-equivocal MMBV results (Figure 1B), MMBV attained sensitivity of 97.2% (95%CI: 89.8-99.8), specificity of 96.2% (95%CI: 86.5-99.7), PPV of 97.2% (95%CI: 89.8-99.8) and NPV of 96.2% (95%CI: 86.5-99.7). Notably, the positive likelihood ratio of MMBV was 25.76 (95%CI: 6.61-100.39) and the negative likelihood ratio was 0.03 (95%CI: 0.01-0.11). C","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"32 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145203320","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A-226 Optimizing the laboratory workflow with healthcare informatics","authors":"George Wierschem","doi":"10.1093/clinchem/hvaf086.220","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf086.220","url":null,"abstract":"Background In healthcare informatics, technology is used to streamline processes to improve patient care and health outcomes. For example, informatics can help modern laboratories experiencing increased testing demands with fewer resources. Small- and medium-sized labs, including physician office labs, however, tend to have challenges with cost and availability of resources for installing informatics solutions. Our aim was to evaluate the QuidelOrtho® Results Manager™ System software for streamlining operations to improve overall laboratory performance in multiple sites. Methods The QuidelOrtho Results Manager System software is an informatics solution that focuses on four areas in the laboratory workflow: patient results, rules/standard configuration, quality control, and moving averages. The software was implemented at multiple sites globally, where pre- and post-implementation surveys were conducted. Questions on current tube workflow and informatics setup were asked in the pre-implementation portion, as well as time to complete tasks such as sample validation and quality control. The post-implementation survey included questions about installation and implementation time and ease of use. In addition, customer feedback was obtained for future improvements to the QuidelOrtho Results Manager System. Results All sites previously have not had middleware installed. Highlights from post-implementation survey responses from customers included seamless integration into current workflow, and overall ease of use and customization of software tools with an intuitive interface. Complex rules were set up without extensive training, and troubleshooting and decision-making processes were improved for more efficient patient care. The QuidelOrtho Results Manager System also facilitated standardization of result interpretation and management of abnormal results while also providing in-depth quality control (QC) review, which supported improvements to workflow and efficiency. Processes for updating ranges, adding assays, and storing samples were also improved. Installation time was relatively quick, and turnaround times were reduced compared to those collected pre-implementation. Conclusion In conclusion, the QuidelOrtho Results Manager System was shown to be an ideal solution for streamlining operations to improve overall laboratory performance at multiple sites located in different countries. This is supported by survey findings including reduction in turnaround time, efficiency in obtaining results more quickly, and ease of use and installation without coding expertise. Future improvements to the software will be incorporated in later stages with further implementation in more laboratories.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"63 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145203353","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A-186 Performance Evaluation of Selected Biochemical Tests Using Sigma Metrics and the Quality Goal Index","authors":"Rajendra Bhatt","doi":"10.1093/clinchem/hvaf086.180","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf086.180","url":null,"abstract":"Background Quality reporting is a critical global concern, necessitating the implementation and evaluation of quality indicators to ensure reliable outcomes. While developed countries have established benchmarks through national policies and significantly minimized errors, developing nations like Nepal remain in the early stages of adopting such practices. Sigma metrics approach provide a robust framework for performance evaluation, while the Quality Goal Index (QGI) aids in identifying causes of low sigma values. The integration of Westgard rules with Sigma metrics enables tailored quality control strategies, ensuring compliance with stringent standards and reducing errors effectively. This study aimed to analyze the performance of a selected biochemical tests using Sigma metrics and the Quality Goal Index. Methods A cross-sectional study was conducted in the Clinical Biochemistry Laboratory of Dhulikhel Hospital-Kathmandu University Hospital, Nepal, from April to June 2024. Twenty routine biochemical tests were analyzed using the Vitros 5600 analyzer. Sigma metrics and Quality Goal Index (QGI) were derived from internal and external quality control data. Method Decision Charts were employed for visual performance evaluation. Statistical analysis was conducted using MS Excel and STATA to calculate and interpret the results. Results Tests with high Sigma Metrics, such as Triacylglycerol and Alkaline phosphatase (ALP), exhibited excellent performance, indicating optimal accuracy and precision. Conversely, tests with low Sigma Metrics, including Alanine transaminase (ALT) and albumin, showed unacceptable performance, with QGI analysis identifying significant inaccuracies and imprecision. Conclusion This study emphasizes the application of Sigma metrics and the Quality Goal Index (QGI) to evaluate test performance and the implementation of Westgard rules to enhance Quality Control (QC) strategies. It recommends refining QC protocols, conducting long-term performance monitoring, and assessing performance across analyzers to drive continuous quality improvement.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"115 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145203762","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"B-341 Effect of chemokine CXCL13-induced tertiary lymphoid structure formation on pathological features and prognosis of non-small cell lung cancer","authors":"H U A Geng, Mengli Xue, Shixiong Li, Meilin Xu","doi":"10.1093/clinchem/hvaf086.728","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf086.728","url":null,"abstract":"Background The prognosis of patients with non-small cell lung cancer (NSCLC) is closely related to the tumor microenvironment. Studies have shown that the status of tertiary lymphoid structures (TLS) is an important factor affecting the tumor microenvironment. B cell cluster is the main component of TLS, and the C-X-C motif chemokine ligand 13 (CXCL13) is a selective attractant for B cells. However, the relationship between CXCL13 and the formation of TLS remains to be explored. Methods A hundred NSCLC patients who underwent surgical resection in Tianjin Chest Hospital in 2018 were retrospectively recruited. TLS number and maturity were assessed by HE staining and immunohistochemical staining, respectively. The relationship between TLS in tumor tissue and clinicopathological characteristics and prognosis of NSCLC patients was analyzed. The CXCL13 mRNA and protein expression levels were detected by RT-PCR and immunohistochemical staining, respectively. The correlation between CXCL13 in tumor tissue and TLS in tumor microenvironment was analyzed by Spearman correlation.COX regression analysis and Kaplan-Meier survival curve were used to analyze the prognostic effects of TLS and CXCL13 on patients. Results There was no correlation between TLS number or maturity and gender, age, smoking history, histological type, differentiation, pleural invasion, or TNM stage. TLS number and maturity were positively correlated with CD8+ T cell infiltration in tumor tissue (P < 0.05). Kaplan-Meier survival analysis showed that OS was significantly better in patients with greater TLS count, TLS maturity, and CXCL13 expression than those of relatively low values (P < 0.05). The results of multivariate COX regression analysis showed that TLS maturity (P = 0.002) and TNM stage (P < 0.001) were independent predictors of OS in NSCLC patients. Spearman correlation analysis showed that the number and maturity of TLS were positively correlated with CXCL13 mRNA and protein levels. Conclusion The large number of TLS, high TLS maturity, and high CXCL13 expression are associated with good prognosis of NSCLC patients. TLS maturity can be used as a predictor of patient prognosis. Moreover, CXCL13 mRNA and protein expression levels were significantly correlated with TLS number and maturity. CXCL13 may induce B cells to infiltrate the tumor immune microenvironment to promote the formation of TLS in tumor tissues.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"1 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145203002","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A-404 Evaluating the need for head CT in mild TBI patients using a whole blood point-of-care test within 24 hours of suspected head injury","authors":"James Smith, Swati Pradhan-Bhatt, Erica Wyse, Raj Chandran, Ksenia Musaelyan, Brandon Gentile, Paula Bernander, Jaime Marino, Susan Brophy, Manish Gupta, Beth McQuiston, Adam Moss","doi":"10.1093/clinchem/hvaf086.388","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf086.388","url":null,"abstract":"Background Approximately 69 million people worldwide experience a traumatic brain injury (TBI) annually. In the Emergency Department, over 80% of patients evaluated for TBI undergo head CT scans, but fewer than 10% of these scans reveal acute traumatic abnormalities. This highlights the need for objective, rapid, and accurate tools to help clinicians evaluate patients with suspected TBI, significantly improving patient care by reducing unnecessary radiation exposure, minimizing wait times, and optimizing resource utilization. The i-STAT® TBI test represents a significant advancement in TBI diagnostics. This point-of-care test measures two key brain injury biomarkers, glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1). Its recent regulatory clearance for clinical use with venous whole blood enhances its utility and accessibility in various environments, including bedside use. This study demonstrates the analytical and clinical performance of the whole blood TBI test. Methods The i-STAT TBI test is a panel of in vitro diagnostic immunoassays for the quantitative measurements of GFAP and UCH-L1 in 20 µL of venous whole blood. Performance characteristics such as detection limits, imprecision, linearity, measuring interval, and potential interference due to drugs of abuse were established following CLSI guidance. Clinical performance was evaluated in a prospective study across 20 U.S. sites. The study enrolled 970 adult patients with suspected mild TBI who presented with initial GCS scores of 13-15 within 24 hours of injury and had a head CT scan ordered as part of standard care. Results The reportable range of the GFAP assay extended from 47 pg/mL to 10,000 pg/mL. For UCH-L1, the range extended from 87 pg/mL to 3,200 pg/mL. Within-laboratory imprecision ranged from 3.98% to 24.62% CV for GFAP and 4.81% to 11.64% CV for UCH-L1. The linearity of GFAP and UCH-L1 assays was established using venous whole blood samples of varying antigen levels. Deviations from linearity were =15% for GFAP and =10% for UCH-L1. Additionally, drugs of abuse were tested and no interference was observed with TBI assays at concentrations up to 2.25 times the highest therapeutic drug concentration. In the clinical performance study, 283 had positive CT imaging showing acute traumatic intracranial lesions, while 687 had negative scans (no acute trauma-related findings). The TBI test correctly identified 273 of the 283 CT-positive patients as “Elevated,” resulting in a clinical sensitivity of 96.5%. All patients requiring neurosurgical intervention were classified as “Elevated.” Among the 687 patients with negative CT scans, 277 were identified as “Not Elevated,” reflecting a specificity of 40.3%. These metrics translated into an overall negative predictive value of 96.5%, indicating that most patients testing “Not Elevated” had no lesions on head CT. Conclusion The i-STAT TBI test allows for expanded utility and easier accessibility of T","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"18 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145203114","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}