Clinical chemistry最新文献

{"title":"B-157 Analytical evaluation of a fully automated multiplex microarray immunoassay for simultaneous detection of anti-MPO, anti-PR3, and anti-GBM autoantibodies in a reference laboratory in Southern France","authors":"Gerber Gomez, Guillaume Nardella, Claire Monat","doi":"10.1093/clinchem/hvag086.461","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.461","url":null,"abstract":"Background Accurate detection of disease associated autoantibodies is essential for evaluating anti-glomerular basement membrane (GBM) disease and ANCA-associated vasculitides (AAV). Clinical assessment often requires measurement of various serological targets, including antibodies to myeloperoxidase (MPO), proteinase 3 (PR3), and GBM. This study evaluated the analytical performance of a fully automated multiplex microarray immunoassay (MosaiQ AiPlex® VAS; AliveDx, Switzerland; investigational device) for simultaneous detection of IgG antibodies to MPO, PR3, and GBM, compared with a routinely used method in a reference clinical laboratory in Southern France. Methods De-identified, remnant human sera with known MPO, and GBM IgG antibody status were tested using the multiplex microarray assay. Results were compared with the laboratory’s routine method, an addressable laser bead immunoassay (ALBIA). Agreement was assessed using positive percent agreement (PPA), negative percent agreement (NPA), overall percent agreement (OPA), and Cohen’s kappa. Immunofluorescence (IF) results were reviewed for discrepant samples when available but were not included in the primary analysis (Table 1). Results A total of 387 results were included, comprising 100 antibody positive samples (anti-MPO: 52; anti-PR3: 48; anti-GBM: 0) and 287 antibody negative samples (anti-MPO: 122; anti-PR3: 126; anti-GBM: 39). For anti-GBM, comparison was limited to negative samples because no positive specimens were available. Across markers, the investigational device showed high concordance with the comparator, with an overall percent agreement of 97.9% and a Cohen’s kappa of 0.94. PPA and NPA were:Anti-MPO: 92% and 99.2% (excluding equivocal results)Anti-PR3: 95.8% and 99.2%Anti-GBM: not applicable and 100% Three equivocal results (all anti-MPO) were observed (1.7% of MPO positive samples; 0.8% overall). When treated as positive, anti-MPO’s PPA and NPA were 92.3% and 98.4%; when treated as negative, 88.5% and 99.2%. No invalid results occurred. Additional details are summarized in Table 1. Discordant result review:Anti-MPO: Four samples were negative on the investigational device but positive on ALBIA. All showed a perinuclear-ANCA pattern by IF, with titers from borderline (1:20) in two samples, to strongly positive (1:160–1:320) in the remaining two. One additional sample was borderline positive on the investigational device but negative on ALBIA.Anti-PR3: Two samples were negative on the investigational device but positive on ALBIA. One showed a high titer (1:320) cytoplasmic-ANCA pattern by IF. The other had a low positive ALBIA value, a perinuclear-ANCA IF pattern (1:320), and concurrent MPO positivity, on both compared platforms suggesting a potential false positive PR3 result on ALBIA. Finally, one sample was positive on the investigational device but negative on ALBIA; it showed a high titer (1:320) cytoplasmic-ANCA IF pattern, consistent with a possible false negative PR3 re","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"1 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086477","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-234 Histopathological Changes in Some Organs of Diabetic Rats Administered Aqueous Extract of Beetroot or Glibenclamide","authors":"Fidelis Olumese, Henrietta Oboh, Felix Omoruyi","doi":"10.1093/clinchem/hvag086.528","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.528","url":null,"abstract":"Background Red beetroot (Beta vulgaris) is a traditional medicinal plant that contains bioactive compounds such as nitrates, phenolics, ascorbic acid, carotenoids, and betalains. Although raw beetroot consumption has been associated with potential benefits in diabetes, its safety and histopathological effects require further investigation. This study evaluated the effects of aqueous beetroot extract on histopathological changes in the heart, pancreas, liver, and kidney of normal and streptozotocin-induced diabetic rats, compared with glibenclamide treatment. Methods Twenty-five Sprague Dawley rats (mean body weight 187.16 ± 7.20 g) were randomized into five groups (n=5/group): healthy control (deionized water), healthy + aqueous extract, diabetic control (deionized water), diabetic + aqueous extract, and diabetic + glibenclamide. Diabetes was induced by a single intraperitoneal injection of streptozotocin (60 mg/kg in 0.05 M citrate buffer, pH 4.5). For 30 days, treated groups received aqueous beetroot extract (500 mg/kg/day) or glibenclamide (5 mg/kg/day). After euthanasia by decapitation, blood was collected for glucose measurement, and the heart, and kidney were harvested for histopathological evaluation following fixation in 10% buffered formalin Results Diabetic rats treated with aqueous extract or glibenclamide demonstrated a significant reduction in blood glucose compared with diabetic controls (p<0.05). In the heart, diabetic controls exhibited severe vascular stenosis, myocardial degeneration, vascular ulceration, and inflammatory infiltrates. These changes were markedly attenuated in extract- and glibenclamide-treated diabetic rats, which showed largely preserved vascular architecture with mild congestion. Pancreatic sections from diabetic controls showed vascular stenosis, hypoplasia, lymphoid aggregates, ulceration, and reduced islets of Langerhans. Treatment with the aqueous extract restored islet architecture and vasculature, comparable to that achieved with glibenclamide. In the liver, diabetic controls demonstrated portal vascular congestion, and periportal inflammatory infiltrates. Diabetic groups treated with the extract or glibenclamide showed preserved hepatocyte morphology with only mild vascular congestion. Renal histology in diabetic controls revealed glomerular abnormalities, including shrunken vascular meshwork (Kimmelstiel–Wilson–like nodules), vascular hypertrophy, stenosis, and focal tubular necrosis. Extract-treated diabetic rats showed improved vascular architecture with only focal glomerular damage, while glibenclamide-treated rats demonstrated persistent glomerular changes relative to diabetic controls. Conclusion Aqueous beetroot extract significantly reduced hyperglycemia and attenuated diabetes-associated histopathological damage in the heart, and kidney. Restoration of vascular architecture and pancreatic islet structure suggests a potential protective role against diabetic complications. These findings ","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"53 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086500","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-042 Performance evaluation of Atellica IM infectious disease assays with dried blood spot sample","authors":"Sai Patibandla, Krishna Singh, Katie Ann Paden","doi":"10.1093/clinchem/hvag086.371","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.371","url":null,"abstract":"Background Dried Blood Spots (DBS) have been used for screening of inherited metabolic disorders in newborns and infectious disease in key populations (intravenous drug users, homeless, and sex workers) due to ease of blood collection and transportation. Siemens Healthineers Atellica IM CHIV, HBsII, and HBcT2 assays are commercially available fully automated assays for the diagnosis of HIV and HBV infection in serum and plasma. To enhance widespread detection of HIV and HBV infected individuals, performance of Atellica IM CHIV, and HBcT2 assays is evaluated with DBS. Methods To determine optimal conditions for use of DBS, blood spot drying time, punch size, and elution conditions (buffer, time, and mixing method) studies were conducted. The initial studies were conducted with dried plasma spots and subsequently verified with blood spots. For Atellica IM assays performance evaluation with DBS, blood was collected from normal donors and spiked with respective analytes. The Whatman 903 filter card was spotted with 50 ul of spiked or unspiked blood from each donor. The remaining blood was centrifuged to obtain plasma. For DBS elution, the punched spots were eluted in selected elution buffer. The DBS eluates and matched plasma were tested with Atellica IM CHIV, and HBcT2 assays using standard assay parameters. The results were analyzed using assay cut-off as per IFU. The results were also analyzed with DBS specific cut-off derived from results obtained with unspiked DBS samples. Results DBS drying time >2 hours did not show improvement in analyte recovery. For DBS elution, testing of 1-3 spots in 500 µl elution buffer showed increase in recovery with increasing spots. When 6 mm and 12 mm punches from 2 spots were compared, the latter provided enhanced recovery. Among tested conditions, elution of 2 spots in 500 ul of Atellica IM Wash buffer at room temperature with shaking for 2 hours showed optimal recovery. Using these conditions, DBS and plasma of unspiked blood from 27–30 donors were tested with Atellica IM CHIV, and HBcT2 assays. All DBS samples and matched plasma were nonreactive with all 3 assays using respective commercial cut-off (1 index). When DBS and plasma of HIV-1, HIV-2, Group ‘O’ and p24 spiked blood were tested with CHIV assay, DBS showed 5 to 10-fold lower dilutional sensitivity compared to plasma using commercial cut-off. Reduced dilutional sensitivity was observed in DBS with HBsII assay (8-fold lower) and HBcT2 assay (20-fold lower) with commercial cut-offs. The results from unspiked donors were used to calculate a DBS specific cut-off (Avg + >=7SD). With DBS specific cut-offs (CHIV-0.51 index, HBsII-0.31 Index, HBcT2-0.46 Index), all the unspiked donor DBS samples were nonreactive with all 3 assays showing 100% specificity. DBS dilutional sensitivity was significantly improved with DBS specific cut-offs. The HBsII and HBcT2 assays showed dilutional sensitivity 2-fold lower and CHIV assay showed 2-5-fold lower compar","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"20 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086501","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-161 Clinical Application of Magnetic Particle Chemiluminescence Method for Detecting HBV PreS1 in Chronic HBV Infection","authors":"Renquan Jiang, Zhen Xun, Can Liu, Ou Qishui","doi":"10.1093/clinchem/hvag086.465","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.465","url":null,"abstract":"Background To detect the role of PreS1 in different stages of chronic HBV infection and to explore its potential as a predictor of HBsAg clearance. Methods Quantitative detection of HBV PreS1 was performed on serum samples from 594 patients with chronic HBV infection, chronic hepatitis B (CHB), liver cirrhosis (LC), and hepatocellular carcinoma (HCC). The cohort of HBeAg-negative patients receiving pegylated interferon (Peg-IFN) treatment was divided into the HBsAg seroclearance group and the HBsAg non-seroclearance group based on whether HBsAg was cleared at 48 weeks. The level of PreS1 was detected using magnetic particle chemiluminescence method. Results The level of PreS1 varied in different natural history periods and was correlated with HBV serum markers. The level of PreS1 had a high diagnostic value in the diagnosis of HBV infection stages. The baseline levels of PreS1 and HBsAg in the HBsAg seroclearance group were significantly lower than those in the HBsAg non-seroclearance group. The combination of baseline PreS1 and HBsAg levels had a better predictive value for HBsAg clearance. In the HBsAg seroclearance group, PreS1 disappeared before HBsAg; in the HBsAg non-seroclearance group, PreS1 partially disappeared. The rate of decline of PreS1 and HBsAg in the HBsAg seroclearance group was faster than that in the HBsAg non-seroclearance group. The level of PreS1 in CHB patients was significantly higher than that in LC and HCC patients. Conclusion The baseline level of PreS1 is not only an important biomarker for differentiating chronic HBV infection from CHB, but also can predict HBsAg clearance in HBeAg-negative patients after Peg-IFN treatment.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"8 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086530","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-030 Analytical Performance Evaluation of the Maccura Glycosylated Hemoglobin Analyzer G 02 (High-Performance Liquid Chromatography)","authors":"Jing Liu, Hailian Zhou, Yuxiang Qiu, Tianqi Yuan, Ting Hou, Qiuyang Guo, Jian Wan, Wen Zeng, Renlin Li","doi":"10.1093/clinchem/hvag086.361","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.361","url":null,"abstract":"Background The Glycosylated Hemoglobin Analyzer G 02 (High-Performance Liquid Chromatography) is a next-generation product independently developed by Maccura Biotechnology. It features two testing modes (Standard Mode/ Variant Mode) with the advantage of one-touch switching between modes without replacing the reagent chromatography column. This study aimed to evaluate the analytical performance of the G 02 analyzer to determine whether it meets the requirements for clinical application. Methods In accordance with the Clinical and Laboratory Standards Institute (CLSI) EP09-A3 guidelines and other relevant specifications, the accuracy, precision, and other analytical performance indicators of the G 02 were assessed. Additionally, the analyzing performance of the G 02 analyzer was compared with that of Tosoh HLC-723 G11 system in 143 clinical samples, and the consistency between the two systems was evaluated. Results In Standard Mode, the within-laboratory precision coefficient of variation (CV) ranged from 0.3% to 0.9%, and the relative bias for accuracy ranged from -2.48% to -0.14%. For clinical comparison, the expected relative biases at medical decision levels (MDLs) of 6.5%, 7.0%, and 10.0% were -0.19% (95% CI: -0.53% to 0.32%), -0.21% (95% CI: -0.54% to 0.18%), and -0.31% (95% CI: -0.92% to 0.30%), respectively. In Variant Mode, the within-laboratory precision CV ranged from 0.4% to 0.7%, and the relative bias for accuracy ranged from -1.96% to 0.00%. For clinical comparison, the expected relative biases at medical decision levels of 6.5%, and 10.0% were -1.25% (95% CI: -1.52% to -0.78%), -0.90% (95% CI: -1.13% to -0.50%), and 0.45% (95% CI: 0.074% to 0.84%), respectively. In both modes, the within-run repeatability met the requirement of CV < 0.5%. Conclusion The Maccura G 02 analyzer offers high-speed detection, with each test taking 30 seconds in Standard Mode and 50 seconds in Variant Mode. Both testing modes demonstrate excellent fundamental performance and show high consistency with the clinical results from the Tosoh G11. These characteristics meet the requirements for clinical laboratory use.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"32 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086535","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-103 Cultural detection of C. auris: compatibility study on a selective and enrichment broth and a new chromogenic, selective and differential agar medium.","authors":"Francesco Bonometti, Matteo Miriani","doi":"10.1093/clinchem/hvag086.079","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.079","url":null,"abstract":"Background Candidozyma auris is now recognized as one of the most significant global fungal threats, classified as a critical pathogen by the WHO due to its rapid spread, ability to persist in healthcare settings, and marked multi-resistance to major antifungals. Diagnostic challenges and the clinical impact on critically ill patients urgently require the development of more accurate, sensitive, and standardized diagnostic and screening methods: the use of enrichment and selection broths combined with chromogenic agar plates may represent a valid option for achieving precise identification of C. auris. This abstract illustrates the compatibility test conducted on Copan CABroth™, a specific enrichment and selection broth for C. auris, and Thermo Fisher’s Candida Brilliance 2, a new chromogenic and selective agar plates. Methods CABroth™ was tested for its enrichment capacity with 5 different ATCC and CDC strains representing Clades I-V, using a medium (˜10^3 CFU/mL) and a low (˜10^2 CFU/mL) concentration C. auris suspension to inoculate the broth’s tubes. C. auris concentration was checked by seeding 100 µL of the inoculated CABroth™ onto 2 different agar plates:Thermo Fisher Scientific Brilliance™ Candida Agar 2 (CAND)Thermo Fisher Scientific Sabouraud Glucose Agar (SAB) Seeded plates at this timepoint (T0) and inoculated CABroth™ tubes were then incubated at 35±2°C for 48 hours. After incubation, T0 plates were checked for C. auris growth and seeding was repeated (T48). C. auris growth on plates was checked again after 48 hours at 35±2°C and CFU counts were averaged. Results For each of the tested C. auris strains CABroth™ ensured growth at T0 and enrichment by increasing CFU counts after 48 hours of incubation at 35±2°C. Growth was obtained on both the tested agar media, but CAND plates demonstrated an increased size of the colonies after incubation if compared to SAB. Conclusion The performed analysis showed that enrichment and growth of different strains of C. auris can be obtained using the combination of Copan CABroth™ and Thermo Fisher Scientific Brilliance™ Candida Agar 2. This cultural setting can increase the testing sensitivity and improve clinical lab’s capacity to detect C. auris infections.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"7 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086538","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-296 Quantitative Analysis of Creatinine and HbA1c from Dried Microsamples as a Patient Centered Approach for Value Based Care Programs","authors":"Ramona Seliger, Jens-Peter Brock, Michelle Wittmann, Mathias Karlsson, Johan Olausson, Mikael Ström","doi":"10.1093/clinchem/hvag086.579","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.579","url":null,"abstract":"Background Value based care (VBC) programs in the United States increasingly incentivize regular diabetes monitoring, supported by Centers for Medicare & Medicaid Services policies that now cover up to two diabetes screenings per year, including hemoglobin A1c (HbA1c) testing without coinsurance. These measures lower barriers to routine assessment. Clinical guidelines emphasize timely evaluation of HbA1c and kidney function to prevent diabetes related complications. However, traditional venous blood collection can limit access and adherence, especially in rural areas where traveling distances can exceed recommendations for appropriate access and people with impaired mobility. Microsampling solutions for dried blood enables simple, convenient, at home capillary blood collection, reducing the need for clinic visits and improving patient participation. By supporting decentralized, high frequency monitoring, microsampling technology helps providers meet VBC quality metrics related to glycemic control and early detection of kidney disease—key drivers of improved outcomes and reimbursement performance. Methods For creatinine analysis, fresh whole blood from 23 clinical leftover samples was pipetted onto Capitainer B50 Cards and cards were further processed according to the manufacturer’s instructions. Capitainer dried microsamples were subsequently eluted with an 80% methanol solution. Corresponding whole blood control samples were centrifuged to generate plasma. Eluates and liquid control plasma were analyzed with the Atellica CH Enzymatic Creatinine_3 assay. For HbA1c analysis, fresh whole blood from 57 healthy donors was pipetted onto Capitainer B Cards and cards were further processed according to the manufacturer’s instructions. Capitainer dried microsamples were subsequently eluted with HbA1c assay pretreatment solution. Eluates and liquid control whole blood were analyzed with the Atellica CH Enzymatic Hemoglobin A1c assay. For both assays, the instrument pipetting schemes were adapted to consider the dilution factor introduced by microsample elution. Results Creatinine concentrations measured from the microsamples show a linear association with the corresponding liquid control concentrations (R²=0.99). The absolute concentrations are approximately 65% lower compared to the liquid controls. Methanol at the concentration used does not significantly affect assay performance. HbA1c values in percentage show a linear association with the liquid control values as well (R²=0.85). Stability studies indicate a storage time–dependent increase in HbA1c values. For both analytes, the mean coefficient of variation between duplicates from one sample is below 1.5%. Conclusion Capitainer microsampling demonstrates strong potential as a practical alternative to conventional venous blood collection for HbA1c and creatinine measurement in decentralized or remote monitoring settings. Although the eluted microsamples results yield lower absolute concentrations ","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"30 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086540","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-412 A novel approach to detect synthetic urine simultaneously with drug confirmation by LC-MS/MS","authors":"Rojeet Shrestha, Kascion Outland, Binata Shrestha, Safedin Beqaj","doi":"10.1093/clinchem/hvag086.679","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.679","url":null,"abstract":"Background The widespread availability of affordable synthetic urine in the market that can pass traditional specimen validity criteria has been a rising issue of concern in recent days. These synthetic products visually appear natural and possess normal creatinine, pH, specific gravity, urea, uric acid, and urobilinogen. Many of these products has artificial urinator that can be wrapped on the waist and has heat activators to mimic physiological temperature. Therefore, current specimen validity criteria are ineffective for detecting these synthetic urines needing novel approach. Methods We developed a tandem mass spectrometric assay for the simultaneous quantification of metabolites of catecholamines in urine along with drug confirmation. The presence of these substances in urine is a strong indicator of urine from biological sources and can be potentially used to differentiate fake synthetic urine. An algorithm based on the metabolites of catecholamines are used to identify synthetic urine (gnosis verified). A total of 12 different commercially available synthetic urine was evaluated to determine its efficiency along with 230 healthy human urine samples. Results All tested commercial synthetic urine pass conventional validity test including creatinine, pH and specific gravity but failed for gnosis verified while all samples from healthy urine sample passed. We identified a total of 54 synthetic urine over a period of year of which 30 samples were negative for all tested drugs including cotinine. Remaining samples were positive for various drugs including alprazolam, buprenorphine, oxycodone and hydrocodone apparently spiked directly into the synthetic urine as indicated by absence of metabolites. Conclusion Simultaneous identification of synthetic urine in LC-MS/MS run of drug confirmation is cost-effective, efficient and novel approach to detect adulteration of sample. Presence of metabolites of catecholamine in urine is a strong indicator of urine from biological source and can be potentially used to differentiate fake synthetic urine.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"53 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086546","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-075 Mixed Aspergillus fumigatus and Rhizomucor miehei infections in an immunocompromised patient diagnosed by FungiFlex® Mold Panel","authors":"Tiffany Huwe, Anton Evans, Jacob Panten, Hannah Sweet, Nicholas Shankey, Kendra Steine, Xiaoying Liu, Jo-Anne Young","doi":"10.1093/clinchem/hvag086.055","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.055","url":null,"abstract":"Background Invasive fungal infections are a major risk to immunocompromised patients. Existing diagnostics with limited sensitivity or specificity may fail to identify mixed fungal infections, which require special treatment considerations. Zepto’s FungiFlex® Mold Panel amplifies circulating pathogen cfDNA, using an ultra-sensitive giant magnetoresistance (GMR) biosensor to deliver actionable identification of 14 important mold pathogens from plasma. This case report describes the condition of an immunocompromised patient with mixed Aspergillus fumigatus and Rhizomucor miehei infections and the clinical value of the FungiFlex® Mold Panel. Methods The index patient was a 57-year-old female with B-cell acute lymphoblastic leukemia and extramedullary involvement who received Obecabtagene autoleucel chimeric antigen receptor T-cell therapy on day-56 and day-45. She developed pneumonia while taking yeast prophylaxis with fluconazole. Chest imaging showed right lung consolidations. Blood cultures, sputum Pneumocystis PCR, and urine Histoplasma antigen tests were negative. Invasive aspergillosis was diagnosed based on (1,3)-beta-D-glucan (BDG) >500 and serum Aspergillus Galactomannan index (GI) of 5.81. Treatment included Micafungin 150 mg day-29 through day-16, with Voriconazole day-27 through day+7. Following discharge from the hospital while neutropenic on day-19, Voriconazole blood level was therapeutic at 4.7 µg/mL on day-8. She was readmitted day+0 with neutropenic fever, COVID-19 infection, progressive hypoxia, and new pleural effusions. BDG >500 and serum Aspergillus GI 6.06 indicated persistent aspergillosis. Despite Voriconazole, resuming Micafungin, Remdesivir, and intravenous immunoglobulin treatment, her condition deteriorated. Antifungal medications were changed to AmBisome® on day+8 and Isavuconazole on day+10. Bronchoscopic lavage fluid from day+9 returned Aspergillus GI 6.29 without fungal growth in culture. She transitioned to comfort care on day+24 and passed away on day+25. Thirteen daily anticoagulated blood specimens were saved from day+2 through day+13, transported to Zepto Life Technology, and screened using FungiFlex®. Testing was conducted as a research activity independent of patient care. Results FungiFlex® detected high Aspergillus fumigatus signals (GMR >1400) in samples each day from day+2 through day+7, suggesting treatment failure. After switching to AmBisome on day+8, the A. fumigatus signal decreased to a still-positive 844. Except for a positive signal (872) on day+12, A. fumigatus results were negative in samples from day+9 through day+13. Additionally, FungiFlex® detected Rhizomucor miehei (GMR >600) in samples from day+6 through day+8 that dropped to negative levels in the remaining tested samples (Figure). The decrease in GMR for both fungi suggests the infections responded to the new therapy. Conclusion Zepto’s FungiFlex® Mold Panel yielded more informative results than standard testin","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"12 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086655","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-008 Cardiovascular Risk Stratification in Pediatric Population Using ASCVD Risk Equations","authors":"Earnest Daniel, Maureen Sampson, Alan Remaley, Sridevi Devaraj","doi":"10.1093/clinchem/hvag086.008","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.008","url":null,"abstract":"Background Atherosclerotic cardiovascular disease (ASCVD) remains the leading cause of mortality worldwide. Contemporary risk prediction models, including the 2013 Pooled Cohort Equations (PCE), the 2022 estimated ASCVD (eASCVD), and the 2023 PREVENT equations, have been developed and validated exclusively in adult population. PCE incorporates age, sex, race, blood pressure, diabetes, smoking status, and lipids, while eASCVD simplifies lipid-based prediction and PREVENT adds kidney function, hemoglobin A1c, BMI, while intentionally excluding race. Despite widespread adult use, the performance of these equations in pediatric populations, where cardiometabolic risk emerges early, remains unclear. The objective of this study is to compare ASCVD risk estimation using PCE, PREVENT, and eASCVD equations in a large pediatric cohort and to evaluate associations with cardiometabolic risk factors, race and ethnicity. Methods We conducted a retrospective analysis of 32,000 patients aged 1 month–18 years at Texas Children’s Hospital. The cohort was ethnically diverse (39% Hispanic [non–African American], 25% African American, 36% non-Hispanic non–African American), with obesity in 20%, diabetes in 10%, and hypertension in 12%. ASCVD risk scores were calculated using PCE, and eASCVD. Risk categories were defined as <5% (low), 5–7.5% (borderline), 7.5–20% (high), and >20% (very high), with =7.5% considered statin-eligible. Associations with clinical variables were assessed using Pearson’s correlation. A risk-adjusted eASCVD was defined as positive for LDL-C >190 mg/dL or =3 risk factors regardless of score. Results Significant discordance in risk classification was observed. PREVENT identified more patients at very high-risk thresholds, classifying threefold more males in the >20% category than PCE or eASCVD. Risk-adjusted eASCVD was positive in ∼17% of patients overall. Ethnic differences were pronounced- PREVENT identified 20 Hispanic patients as very high risk vs none by PCE/eASCVD, and 80 patients statin-eligible at =7.5% risk category compared to 19 by PCE. In contrast, PCE assigned the highest =7.5% risk to African American patients (n=103 vs 42 by PREVENT). Overall, 4% Hispanic and 9.5% African American patients were ‘risk positive’ by adjusted eASCVD score. Age-stratified analyses showed PREVENT identified more 9–11-year-olds at =7.5% risk than PCE (19 vs 4) and categorized ∼2% of adolescents (12–18 years) as borderline risk. Among diabetic patients (1.4%, predominantly Hispanic), PREVENT classified most as very high risk, whereas PCE and ASCVD classified only 0.1-0.3% as very high and 2-4% as high risk. Similar patterns were observed in hypertension. In overweight patients (BMI >25), all equations classified <1% as =7.5% risk. Notably, non-HDL as an individual biomarker, particularly in Hispanic patients with positive eASCVD risk, correlated significantly with eASCVD score (r=0.71, p<0.00001), stronger ","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"13 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086656","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}