Clinical chemistry最新文献

{"title":"B-052 Automation of sample preparation workflow for trace elements testing by ICP-MS/MS","authors":"Difei Sun, Donna Sealy, Dorothy Truong, Danijela Konforte","doi":"10.1093/clinchem/hvag086.379","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.379","url":null,"abstract":"Background Inductively coupled plasma–tandem mass spectrometry (ICP-MS/MS) is a gold standard for testing of trace elements. Despite its wide adoption within the clinical laboratories, sample preparation workflow is largely manual, time consuming, and prone to environmental contamination. Our clinical laboratory processes hundreds of serum samples daily and automation is needed for efficiency improvement. The objective of this study was to automate and validate a sample preparation procedure for quantitation of zinc (Zn), copper (Cu) and selenium (Se) in human serum by ICP-MS/MS. Methods We worked with the vendor to customize the Revvity Janus G3 expanded liquid handling workstation for trace elements testing to 1. scan barcodes on specimen collection (primary) tubes and sample preparation (secondary) tubes to verify sample matching; 2. add diluent with internal standards to secondary tubes; 3. aliquot blanks, calibrators, quality controls and human serum samples from the standard rack or primary tubes to secondary tubes. Zn, Cu and Se in human serum samples were quantified by an Agilent 8900 Triple Quadrupole ICP-MS/MS equipped with an SPS 4 autosampler. An in-house developed middleware was used to support sample preparation, automate data analysis and reporting. Results Linear regression results for the method comparison between the automated sample preparation method (y) and the manual sample preparation method (x) were y = 1.04x - 0.14 (R2=0.999, n=264) for serum Zn, y = 1.04x - 0.22 (R2=0.998, n=264) for serum Cu, and y = 1.03x + 0.00 (R2=0.994, n=264) for serum Se. A blank batch test with 96 blank samples was performed to determine environmental contamination during automated pipetting. It was demonstrated that the Janus workstation with enclosure, HEPA filter and a custom-made plastic cover on the barcode scanning arm are needed to minimize contamination. Additional control measures implemented to mitigate the risks of sample prep contamination include: a daily Janus deck cleaning, a weekly Janus workstation cleaning, and a monthly blank test. The results of other validation studies: calibration preparation verification, accuracy, precision, stability of standards (metal standards, QCs and 1% nitric acid), and storage caps for royal blue top tubes (without additive) all met the acceptable performance limits. Conclusion An automated sample preparation method using Revvity Janus G3 expanded liquid handling workstation has been successfully developed and validated for quantitation of Zn, Cu and Se in human serum samples by ICP-MS/MS. Since its implementation in February 2025, the automation method has resulted in 38%±9% (n=3) of hands-on time savings compared to the manual approach. Similar methods with minor modifications could be applied to other ICP-MS/MS applications for trace elements testing in human serum matrices.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"465 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086525","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-194 Development of candidate Standard Reference Material® 1950a Metabolites in Frozen Human Plasma","authors":"Johanna Camara, Yee-Yin Choong, Clay Davis, Tracey Schock, Elena Wood, Benjamin Neely, Katherine Shaw, Benjamin Place, Lisa Kilpatrick, Caitlin Berry","doi":"10.1093/clinchem/hvag086.155","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.155","url":null,"abstract":"Background Standard Reference Material® (SRM) 1950 Metabolites in Frozen Human Plasma was first made available in 2011 with the intended purpose of validating methods for determining a variety of metabolites, including fatty acids, vitamins, hormones, and amino acids, as well as comparison of measurement technologies used in metabolomic studies. Given the continued demand for SRM 1950, a user survey was conducted in 2023 to inform the design of the SRM 1950a renewal material. The specifications of the renewal material and measurands for priority value assignment were based on user survey feedback. Value assignments by NIST will be based on measurements from a variety of Joint Committee for Traceability in Laboratory Medicine (JCTLM)-listed Reference Measurement Procedures (RMPs) and other higher-order methods. Methods The SRM 1950 user survey was developed in collaboration between laboratory and survey experts at NIST and administered via an online tool. Initial acceptance screening of candidate SRM 1950a was performed using an Abaxis Piccolo Xpress chemistry analyzer with Basic Metabolic Panel Plus rotors. Value assignment measurements for cholesterol, creatinine, total glycerides, urea, uric acid, homocysteine, and glucose use a combination of RMPs based on either isotope-dilution liquid chromatography-mass spectrometry (ID-LC-MS) or isotope-dilution gas chromatography-mass spectrometry (ID-GC-MS). Value assignment measurements for amino acids and fatty acids use higher-order ID-LC-tandem mass spectrometry (MS/MS) and ID-GC-MS methods, respectively. Measurement campaigns are designed to capture batch homogeneity, within-vial variation, between-vial variation, and method variation. Results Based on feedback from the SRM 1950 user survey, candidate SRM 1950a was designed with specifications similar to the original material. SRM 1950a is a pool of normal human plasma from 100 donors (50 % male, 50 % female) with a racial and ethnic distribution that approximates the current United States population. The plasma was prepared with lithium heparin anticoagulant and stored in 1 mL aliquots. Based on the chemistry analyzer results from 10 vials selected in a random stratified manner across the SRM 1950a batch, the material displayed homogeneity for urea, and glucose in addition to several other analytes not intended for value assignment. The values were within normal ranges and similar to the SRM 1950 control. Preliminary value assignment campaign data also support the overall homogeneity of SRM 1950a and target analyte values similar to the original SRM 1950. Conclusion Candidate SRM 1950a will provide a renewal batch of pooled human plasma with values assigned for priority metabolites to support validation and comparison of methods. Based on user feedback, the renewal material is designed similarly to the original SRM 1950 and will allow NIST to continue to support a variety of metabolomics measurements through a reference material once SRM 1950 is de","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"9 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086566","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-155 Establishing a Liquid Chromatography Mass Spectrometry Reference Measurement Procedure for the Accurate Quantification of Parathyroid Hormone 1-84","authors":"Grace Lee, William Perry, David Brumley, Karie Behm, C André Lagoueyte, Hubert Vesper, Alicia Lyle","doi":"10.1093/clinchem/hvag086.124","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.124","url":null,"abstract":"Background Parathyroid hormone (PTH) is a widely accepted diagnostic biomarker for Chronic Kidney Disease-Mineral and Bone Disorder (CKD), as well as hypo- and hyperparathyroidism.[1] Current clinical immunoassays measuring PTH(1-84) yield variable results, which limits the clinical utility of PTH as a diagnostic biomarker and can lead to patient misclassification, underscoring the need for standardization to improve assay measurement agreement.[2, 3] The Centers for Disease Control is developing a novel liquid chromatography mass spectrometry (LC-MS) reference measurement procedure (RMP) to accurately quantify PTH(1-84) in human specimens. Methods A LC-MS method was developed to accurately quantify PTH (1-84). To effectively isolate and enrich PTH(1-84) from human specimens, an immunoprecipitation (IP) method that uses magnetic beads coated with N- and C-terminal epitope antibodies was established. Beads are added to samples, mixed for 1 hour, washed 4 times, and then PTH is eluted for analysis by LC-MS. LC separations are conducted at a capillary flow rate of 3 µL/min and reverse phase trap-elute and analytical reverse-phase chromatography approaches are employed. MS measurements use multiple reaction monitoring with a triple quadrupole instrument. Endogenous PTH(1-84) is quantified relative to a stable isotope labeled (SIL) internal standard. Results A calibration curve spanning a concentration range of 0.74-2,200 pg/mL was established for the PTH RMP. The IP method was optimized to capture PTH(1-84), and the corresponding SIL, with 99.5% average recovery. Linear regression analysis yielded R² values of = 0.99. The estimated limit of detection for the PTH(1-84) LC-MS method is 0.74–1.84 pg/mL with 3–8% average relative error in method serum calibrators. The PTH RMP was applied to 125 commercially sourced plasma samples, all of which were analyzed in duplicate. PTH concentrations in plasma ranged from 0.39–81.73 pg/mL, which are lower than concentrations typically measured by clinical immunoassays, suggesting the PTH LC-MS RMP is more selective. Conclusion This novel, sensitive, and selective PTH LC-MS RMP allows for effective enrichment and accurate quantification of PTH(1-84). The PTH RMP will serve as the basis of the CDC’s PTH Clinical Standardization Program and will be used to value assign reference materials used for PTH standardization, ultimately improving the analytical accuracy and reliability of PTH assays used in patient care.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"40 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086704","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-159 Specificity of beta hydroxybutyrate in the confirmation of insulin-induced hypoglycemia in post mortem cases","authors":"Stephen Morley, Christopher Milroy, Christopher McCudden, Jacqueline Parai","doi":"10.1093/clinchem/hvag086.128","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.128","url":null,"abstract":"Background In postmortem biochemical testing, hypoglycemia is most often attributed to postmortem glucose degradation. However, in some cases, administration of hypoglycemic agents may be involved. Physiologically, hypoglycemia should trigger lipolysis, leading to ketone body formation. Insulin or oral hypoglycemic agents inhibit lipolysis; therefore, ß-hydroxybutyrate (BHB) measurement may help assess whether insulin or hypoglycemic drugs contributed to hypoglycemia. Methods A retrospective cross-sectional analysis of complete medicolegal postmortem examinations over a two-year period was performed. From the 1,533 examinations conducted, 967 adult cases had vitreous humor biochemical testing performed. Vitreous humor samples were centrifuged, aliquoted and treated with hyaluronidase to reduce viscosity prior to analysis. Vitreous BHB concentrations were done through enzymatic quantitation by BHB dehydrogenase; the biochemical panel also included electrolytes, urea, creatinine, and glucose. Hemoglobin A1c was also performed on postmortem blood. Hypoglycemia was defined as vitreous glucose <2 mmol/L; cases with concurrent BHB measurement were included. For those with vitreous glucose <2 mmol/L and BHB <0.5 mmol/L, the recorded cause of death was reviewed. Results Fifty-one deaths met the criteria of vitreous glucose <2 mmol/L and BHB <0.5 mmol/L. The group consisted of 35 males, and 16 females. They had an average age of 55.6 years and average body mass index of 27.9 kg/m2. Nine decedents had a history of diabetes mellitus; the average HbA1c of the group was 5.72% (range: 3.8-8.9%). The vitreous glucose concentration ranged from not detectable (<0.1) up to 1.7 mmol/L; the vitreous BHB ranged from 0.15 to 0.5 mmol/L. None of the cases with concurrently low vitreous glucose and BHB were attributed to insulin excess or overdose. Causes of death varied widely in the group, with the most common being cardiovascular disease (20/51), trauma (12/51), and acute drug toxicity (8/51). Two deaths during the study time period were attributed to excess insulin, but failed to meet the selection criteria for the study group. They were both diabetic, had not detectable vitreous glucose (<0.1 mmol/L) and vitreous BHB of 1.55 and 1.78 mmol/L. Conclusion A suppressed BHB concentration demonstrates very poor specificity and should not be used to diagnose insulin excess in postmortem investigations. Additional biochemical and toxicological evidence remains essential for accurate interpretation.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"6 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086423","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-349 Improving identification of monoclonal IgM associated light chains by MASS-FIX","authors":"James Larkin, Mark Martinez, Mindy Kohlhagen, David Murray, Maria Alice Willrich","doi":"10.1093/clinchem/hvag086.620","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.620","url":null,"abstract":"Background Quantitative M-protein Study, Serum (QMPSS), a laboratory developed test, is used to identify and quantify monoclonal immunoglobulins by MALDI-TOF MS MASS-FIX. Monoclonal IgM proteins with glycosylated light chains (LC) are rare (5% of total M-proteins identified). In a given month approximately 3 cases of the 71 reported IgM monoclonal proteins with glycosylated light chains present with indeterminate kappa or lambda LC. The structure of the intact IgM monoclonal protein may restrict access to the Ig-LC constant region resulting in inefficient isolation. The laboratory uses immunofixation electrophoresis (IFE, Sebia) to confirm the Ig-LC isotype in this scenario. This study evaluates a reduction step prior to LC isolation to enhance the detection of the IgM isotype. Methods For QMPSS analysis, serum is added to five immunoaffinity matrices that target IgG, IgA, IgM, Ig-K, and Ig-L (CaptureSelect). After a binding phase, the serum/bead mixtures are washed to remove unbound protein. Finally, Igs are eluted, and the disulfide bonds are reduced, resulting in purified Ig-components. This step is followed by MALDI-TOF MS (Bruker) analysis. M-protein isotypes are determined by pairing each monoclonal protein’s unique LC mass detected in both heavy chain and LC Ig isolates. Twenty de-identified, residual waste serum samples with IgM-M-proteins without clear LC isotype were collected over several months. The proof-of-concept method modification studied to decrease reliance on IFE included use of 2.5 mcL of 0.5M dithiothreitol (DTT) added to kappa and lambda affinity matrix beads prior to sample addition followed by the QMPSS pre-analytical processing. Results For the 20 IgM glycosylated M-proteins, M-spike concentrations ranged from 0.026 to 0.506 g/dL. Using QMPSS and IFE lab routine protocol, the IgM samples were reported as glyco MK (n=17), biclonal MK+ML (n=1), and 2 samples were reported as negative. 16 of the 20 samples used in the study had IgM kappa monoclonal proteins that were identifiable on IFE. 13 of these IgM kappa monoclonal proteins were also identifiable by QMPSS-DTT. Additionally, 1 IgM kappa monoclonal protein was identifiable on QMPSS-DTT but was reported as equivocal on IFE. Of the 6 samples that the DTT method could not resolve, IFE was positive for 3. As shown by the 3 samples in which the light chain was identified only by IFE, the need for IFE as a confirmatory assay is not fully eliminated. The 3 false negative samples had M-quant values of 0.036g/dL, 0.043g/dL, and 0.117g/dL. More extensive testing would be required to determine the cause and prevalence of the observed discrepancy between IFE and QMPSS-DTT. Conclusion The use of the alternative QMPSS-DTT method shows potential to improve the capabilities of the QMPSS assay to identifying IgM monoclonal proteins with glycosylated light chains and would effectively remove the need for IFE in 70% of cases, improving test turnaround time. Further experimentation and opti","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"35 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086528","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-406 Integration of a Rapid Real-time PCR Module into Point of Care Instruments","authors":"Damian Verdnik, Stuart Knowles, Scott Thomson, Tim Lee","doi":"10.1093/clinchem/hvag086.330","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.330","url":null,"abstract":"Background Polymerase chain reaction (PCR) and real-time PCR (qPCR) are widely regarded as gold-standard methods for nucleic acid amplification in diagnostic applications. Despite advances in PCR instrumentation, conventional systems can require more than 30 minutes to complete an assay, limiting their utility for point-of-care testing. Microfluidic PCR platforms offer the potential for faster amplification due to reduced thermal mass and improved heat transfer, but achieving ultra-rapid thermal cycling while maintaining sensitivity and real-time fluorescence detection remains a technical challenge. This work addresses this gap by developing and evaluating an ultra-rapid real-time microfluidic PCR module capable of amplifying DNA and RNA with dramatically reduced time to result, and suitable for incorporation into point-of-care or benchtop instruments. Methods A custom RT-PCR module was developed that integrates injection-molded polycarbonate microfluidic chips with a novel thermal cycling system. The microfluidic chip incorporates a small-volume amplification chamber sealed with thin polymeric films to promote efficient heat transfer. Two thermoelectric Peltier elements clamp the amplification chamber, enabling active heating and cooling, while a strategically positioned fluorescence detector allows real-time signal acquisition during continuous thermal cycling. Thermal cycling parameters, including ramp rates and dwell times, were systematically optimized. The module was previously integrated into a point-of-care instrument and independently tested with standard, unmodified commercial RT-PCR chemistries, and then integrated into a second instrument design, demonstrating its modularity and flexibility. Results In benchtop testing, the RT-PCT module achieved heating and cooling rates of up to 12°C/s and 10°C/s, respectively, with accurate and reproducible temperature control inside the amplification chamber. Forty cycles of real-time PCR were completed in as little as 8 minutes, representing an 84% reduction in assay time compared with a standard ∼50-minute protocol. Once integrated into the first instrument, an optimized protocol completed amplification in under 15 minutes with minimal loss of efficiency. PCR efficiency for DNA amplification was measured at 99.5%, and sensitivity was comparable to that of a commercial instrument, detecting DNA concentrations down to 1pg/µL. Successful amplification was demonstrated for both forensic DNA targets and clinical SARS CoV 2 RNA. Similar performance was then demonstrated in a completely different instrument design and assay chemistry. Conclusion This study demonstrates an ultra-rapid real-time microfluidic PCR module that enables fast, reliable amplification of DNA and RNA without modifying standard assay chemistries. By combining efficient microfluidic chip design, dual Peltier-based thermal cycling, and simultaneous fluorescence detection, the module achieves substantial reductions in time to result ","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"11 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086399","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-185 Comparison of clinical and paraclinical features among NMOSD, MOGAD, and seronegative patients","authors":"Suong Nguyen","doi":"10.1093/clinchem/hvag086.486","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.486","url":null,"abstract":"Background Neuromyelitis optica spectrum disorders are autoimmune inflammatory diseases of the central nervous system, most commonly associated with anti-aquaporin-4 antibodies. A subset of patients with similar clinical presentations but negative for anti-aquaporin-4 antibodies has been identified with anti-myelin oligodendrocyte glycoprotein antibodies and classified as myelin oligodendrocyte glycoprotein antibody-associated disease. Additionally, some patients remain negative for both antibodies, creating diagnostic and therapeutic challenges. Methods A retrospective descriptive study was conducted on 75 patients with NMOSD-like clinical presentations diagnosed and treated at the University Medical Center Ho Chi Minh City from January 2022 to July 2024. Patients were stratified into three groups based on serostatus: anti-aquaporin-4 positive NMOSD, anti-myelin oligodendrocyte glycoprotein positive disease, and double-seronegative. Demographic characteristics, clinical manifestations, and paraclinical findings, including cerebrospinal fluid and serum immunological indices, were compared among the groups. Results The cohort had a mean age of 43.6 years with a strong female predominance, showing a female-to-male ratio of 6.5 to 1. Anti-aquaporin-4 antibodies were detected in 72 percent of patients, while 12 percent were classified as myelin oligodendrocyte glycoprotein antibody-associated disease and 16 percent were double-seronegative. The anti-aquaporin-4 positive group demonstrated the highest female predominance and significantly higher serum IgG levels (p < 0.001). Patients with myelin oligodendrocyte glycoprotein antibody-associated disease showed higher cerebrospinal fluid IgG levels (p = 0.019). Seronegative patients exhibited overlapping clinical and paraclinical features. Conclusion Antibody-based stratification revealed distinct clinical and paraclinical profiles among NMOSD, myelin oligodendrocyte glycoprotein antibody-associated disease, and seronegative patients. Anti-aquaporin-4 positivity accounted for the majority of cases in this cohort. In patients negative for anti-aquaporin-4 antibodies, additional anti-myelin oligodendrocyte glycoprotein testing and close clinical follow-up are essential to support accurate diagnosis and appropriate management.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"168 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086404","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-130 The role of laboratory diagnostics in breast cancer screening disparities","authors":"Daisy Zaragoza, Aneta Szczesniak","doi":"10.1093/clinchem/hvag086.438","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.438","url":null,"abstract":"Background Breast cancer continues to be one of the main causes of cancer-related morbidity in the United States, with remaining disparities in diagnostic access and clinical treatment among underserved communities. Even though lab diagnostic tests like estrogen and progesterone receptor testing, HER2 analysis, BRCA genetic tests, and genetic assays like Oncotype DX have revolutionized breast cancer care, equal use of these tests remain limited. This study investigates how access to advanced laboratory testing influences disparities in breast cancer screening, diagnosis, and treatment among underserved populations. Methods An evaluation study was conducted to assess how access to advanced laboratory testing influences breast cancer screening, and treatment planning across diverse populations. Evidence from peer-reviewed studies, public health databases, and clinical practice guidelines was synthesized to examine testing availability, turnaround times, healthcare coverage, laboratory workflow capacity, and resource limitations in underfunded healthcare settings. Findings were examined with emphasis on diagnostic access, operational barriers, and their impact on timely and equitable patient care. Results Results demonstrated that minority and low-income populations experience significantly reduced access to timely molecular and biomarker testing, leading to delays in treatment initiation and poorer prognoses. Financial barriers, limited laboratory infrastructure, and inconsistent testing protocols were identified as primary contributors to inequitable care. Healthcare establishments serving under-resourced communities frequently lacked the resources to provide advanced testing within optimal clinical timeframes. Conclusion Expanding insurance coverage for essential diagnostic testing, strengthening laboratory infrastructure, and standardizing testing protocols are vital strategies for reducing breast cancer disparities. Strengthening laboratory access and operational capacity may greatly improve early detection, personalized treatment planning, and equitable patient outcomes.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"4 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086406","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-170 Prevalence and risk factors in obesity phenotypes in a rural-urban population in a developing country","authors":"Billy Sanchez-Jacinto, Alexandra Palomino Andia","doi":"10.1093/clinchem/hvag086.138","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.138","url":null,"abstract":"Background Obesity is a chronic disease strongly associated with cardiovascular disease and type 2 diabetes; its prevalence has increased in recent years due to changes in diet and lifestyle. Currently, there are different obesity phenotypes related to the amount of body fat and the presence or absence of metabolic abnormalities. These are classified as: metabolically healthy normal weight (MHNW), metabolically unhealthy normal weight (MUNW), metabolically healthy obesity (MHO), and metabolically unhealthy obesity (MUO). On the other hand, the PERU MIGRANT study is a cohort of 989 subjects over 30 years of age living in rural or urban areas. The aim of study is to determine the prevalence and risk factors of the obesity phenotypic profile in a rural-urban population using data from the PERU MIGRANT study. Methods Secondary data analysis was performed using a cross-sectional, retrospective design. Subjects with complete sociodemographic and metabolic data were included, while those with diabetes and/or hypertension were excluded. The sample size consisted of 820 subjects, and the outcome variable was obesity phenotype, defined according to the Adult Treatment Panel III (ATP III) criteria and body mass index. Descriptive and inferential analyses were performed using the Chi-square, Kruskal-Wallis, and Dunn's post-hoc tests. Additionally, a robust multinomial regression with standard errors, adjusted for sex and urbanization, was conducted to obtain the relative risk ratio (RRR) with its respective 95% confidence intervals (95% CI). The analysis was performed using Stata version 16. Results A total of 820 subjects were included, of whom 53.05% (n = 435) were female, 78.66% (n = 645) resided in an urban area, and 45.58% (n = 371) had a high level of physical activity. Regarding obesity phenotypes, 15.73% (n = 129) presented a MUO phenotype, and 40.85% (n = 335) were MHO. In the bivariate analysis, obesity phenotypes were associated with sex (p<0.0001); women with the MUO phenotype represented 22.9% (n = 100), while males represented 7.53% (n = 29). Likewise, an association was found with the level of urbanization (p<0.001). In rural areas, the MHNW phenotype predominated at 78.29% (n = 137), while in urban areas, the MHO phenotype was more prevalent at 47.44% (n = 306) and 19.22%, respectively. Physical activity (p <0.001) and levels of high-sensitivity C-reactive protein (p <0.0001) were also associated with the phenotype. In the multinomial model, urbanization was found to be significantly associated with a higher risk of MHO phenotype (RRR = 7.25; 95% CI 4.68–11.23; p < 0.001) and MUO phenotype (RRR = 18.41; 95% CI 7.17–47.24; p < 0.001) compared to MHNW, and male sex was associated with a lower risk of MUO (RRR = 0.22; 95% CI 0.13–0.36; p < 0.001). Conclusion The predominant phenotype was MHO, and living in an urban area increases the risk of developing both the MHO and MUO phenotypes. On the other","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"16 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086433","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-099 Development of Human and Avian Influenza Analytical Reference Materials for Surveillance and Diagnostics","authors":"Leka Papazisi, Holly Asbury, Jason Bose, Victoria Victoria Knight-Connoni","doi":"10.1093/clinchem/hvag086.075","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.075","url":null,"abstract":"Development of Human and Avian Influenza Analytical Reference Materials for Surveillance and Diagnostics Holly Ann Asbury, BS; Jason Bose; Victoria Knight-Connoni, PhD; Leka Papazisi, DVM, PhD Background Human and highly pathogenic avian influenza (HPAI) viruses pose a significant public health threat, with the potential to cause widespread illness and economic losses. Early detection and control of outbreaks depend on effective surveillance and diagnostic testing. Method ATCC® developed a comprehensive suite of quantitative synthetic analytical reference materials (ARMs) for HPAI virus serotypes H5N1, H5N6, H7N7, H7N9, and H9N2; human influenza A virus serotypes H1N1, H3N2, and H1N1 2009 pandemic; and Influenza B virus strains. Each synthetic ARM contains the complete sequences from segments 4, 5, 6, 7, and 8, including the HA, NP, NA, M1, M2, NS1, and NEP/NS1 genes, covering 50% of the influenza genome. These segments are key diagnostic targets for molecular tests and provide sufficient genomic context for assessing assay specificity. These ARMs are manufactured using a highly reliable synthetic biology technology, verified by next-generation sequencing, and quantified via digital-based PCR. Further, they do not contain any viable material and can be handled in BSL-1 settings. As such, they are intended to serve as safe and reliable positive controls for molecular tests for surveillance and diagnostics. Results These synthetic ARMs were experimentally evaluated using several published quantitative PCR (qPCR) assays, including those from the Centers for Disease Control and Prevention (CDC), the World Health Organization (WHO), and the World Organization for Animal Health (WOAH). Additionally, the avian influenza ARMs were confirmed to be compatible with subtype-specific loop-mediated isothermal amplification (LAMP) assays and the BioFire Diagnostics FilmArray (bioMérieux) in vitro diagnostic device. We conducted an in silico assessment of ARM compatibility using over 250 published assays. The synthetic products performed as well as genomic RNA in all tests. Conclusions The data show that all synthetic ARMs for avian and human influenza are effectively designed and suitable for developing and validating molecular detection and quantification assays. Moreover, our findings indicate that the synthetic RNA ARMs are equivalent to their corresponding genomic RNA, making them a valuable BSL-1 alternative to BSL-3–derived materials. Our results suggest that these synthetic ARMs can serve as reliable and safe controls for molecular assays used in diagnostics and surveillance.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"6 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086467","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}