Journal of Applied Laboratory Medicine最新文献_第2页

Commentary on Caught in the Gap: A Case of Unexpected Lactate Elevation. 评论夹在缺口：一个意外的乳酸升高的案例。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2026-05-05 DOI: 10.1093/jalm/jfag022

Emily L Ryan

引用次数: 0

Clinical Evaluation of a Syphilis Treponemal Immunoassay for Use in United States Patient Populations. 梅毒螺旋体免疫测定在美国患者群体中的临床评价。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2026-05-05 DOI: 10.1093/jalm/jfag005

Rebecca A Lillis, Zhaoyi M Masucci, Meredith J Pensak, Robert H Christenson

{"title":"Clinical Evaluation of a Syphilis Treponemal Immunoassay for Use in United States Patient Populations.","authors":"Rebecca A Lillis, Zhaoyi M Masucci, Meredith J Pensak, Robert H Christenson","doi":"10.1093/jalm/jfag005","DOIUrl":"10.1093/jalm/jfag005","url":null,"abstract":"Background: The clinical performance of the VITROS® Immunodiagnostic Products Syphilis Assay was evaluated by comparison with composite results obtained with widely used lipoidal antigen (nontreponemal) and T. pallidum (treponemal) tests.Methods: Serum samples were tested from patients presenting for syphilis screening, and in relevant subpopulations including pregnant women, people living with HIV, known serologically positive for syphilis, and medically diagnosed with syphilis. Samples originated from 1710 and 113 patients in the United States and South America, respectively. Results were also compared for VITROS vs the Roche Elecsys® Syphilis immunoassay alone.Results: Positive percentage agreement was ≥98.81% for VITROS and the comparator composite results within and across populations, with a 95% Wilson Score confidence interval of 98.01%-99.94% across the entire intended use population. Negative agreement was ≥90.63%, with 95% Wilson Score confidence interval of 96.93%-98.67% for the entire population. Method comparison between VITROS and Elecsys assays found 99.09% total agreement and a Cohen's kappa coefficient of 0.97. In separate analyses, nonreactivity was observed for VITROS in 197 of 201 (98%) apparently healthy individuals, and positive reactivity was observed in 151/151 (100%) serum samples preselected from patients with medically diagnosed syphilis, indicating high clinical sensitivity of the VITROS Syphilis assay. In addition, specimens preselected as serologically positive showed 100% reactivity with VITROS.Conclusions: These findings support strong clinical performance of the VITROS Syphilis assay for aiding in diagnosis of syphilis, and excellent concordance with the well-established Elecsys Syphilis test.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"579-591"},"PeriodicalIF":1.9,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146182956","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Why Metrological Traceability Matters in Medical Laboratory Diagnostics. 计量溯源在医学实验室诊断中的重要性

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2026-05-05 DOI: 10.1093/jalm/jfaf203

Marith van Schrojenstein Lantman, Christa Cobbaert, Mauro Panteghini, Miranda van Berkel, Ruben L Smeets, Jaap J van Hellemond, Marc H M Thelen

{"title":"Why Metrological Traceability Matters in Medical Laboratory Diagnostics.","authors":"Marith van Schrojenstein Lantman, Christa Cobbaert, Mauro Panteghini, Miranda van Berkel, Ruben L Smeets, Jaap J van Hellemond, Marc H M Thelen","doi":"10.1093/jalm/jfaf203","DOIUrl":"10.1093/jalm/jfaf203","url":null,"abstract":"Application of the results provided by medical laboratories plays an essential role in medical decision-making. This is not limited to diagnosis and monitoring of disease but also involves its use in other phases of the health continuum, e.g., predisposition, risk stratification, screening, staging, prognosis, and surveillance. With the growing importance of precision medicine, the importance of requirements related to clinical performance, and consequently analytical performance of laboratory tests, also grows. To allow the community of laboratory medicine to translate clinical need into a test arsenal with adequate performance, the application of metrology concepts is essential. This paper summarizes, for all steps in the examination process from test development to clinical interpretation, why and how metrological traceability is a fundamental requirement for adequate medical decision-making and is critical for correct use of test results in algorithms and artificial intelligence-led approaches. This includes the importance of metrology concepts and their correct implementation for obtaining equivalence of test results upon cross-facility result exchange for primary or secondary use in healthcare and research. This is not limited to biochemistry and hematology but is also of importance to other areas of laboratory medicine, including microbiology. This paper provides an overview of the purposes of the underappreciated science of metrology in modern laboratory medicine and its importance to patients and caregivers.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"632-646"},"PeriodicalIF":1.9,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146031307","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A Sensitive Method for Quantitative Profiling of Estrogens, Progesterone, Androgens, and Corticosteroids in Human Serum by LC-MS/MS. LC-MS/MS快速定量分析人血清中雌激素、孕酮、雄激素和皮质激素的方法

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2026-05-05 DOI: 10.1093/jalm/jfaf198

Ersilia Bifulco, Kai Triebner, Francisco Gómez Real, Bénédicte Leynaert, Steinar Hustad

{"title":"A Sensitive Method for Quantitative Profiling of Estrogens, Progesterone, Androgens, and Corticosteroids in Human Serum by LC-MS/MS.","authors":"Ersilia Bifulco, Kai Triebner, Francisco Gómez Real, Bénédicte Leynaert, Steinar Hustad","doi":"10.1093/jalm/jfaf198","DOIUrl":"10.1093/jalm/jfaf198","url":null,"abstract":"Background: Determination of steroid hormones by mass spectrometry (MS) offers several advantages over immunoassays. Modern MS instruments have high selectivity and sensitivity and permit measurements of several compounds at picomolar concentrations in one sample volume, which is advantageous when conducting biobank studies.Methods: We developed a LC-MS/MS method for the determination of 17β-estradiol, 17α-ethinylestradiol, estrone, estrone 3-sulfate, estriol, progesterone, testosterone, dehydroepiandrosterone sulfate, aldosterone, cortisone, and cortisol in 300 μL human serum. Samples were subjected to robotized protein precipitation with acetonitrile and liquid-liquid extraction with ethyl acetate/heptane, and the aqueous and organic phases were used to determine conjugated and unconjugated steroids, respectively. The steroids were separated from isobars and compounds with similar mass (M + 2) on a C18 reversed phase column. Ammonium hydroxide was infused post-column to enhance ionization, and ions were measured in multiple reaction monitoring negative and positive mode.Results: The lower limits of quantification for 17β-estradiol and estrone were 3.6 (0.98 pg/mL) and 2.1 pmol/L (0.57 pg/mL), respectively. For medium concentrations of steroid hormones, total CVs were in the range 2.3% to 10.5%, and accuracies were 97% to 109%. The method was validated in terms of linearity (r2 ≥ 0.9779) and assay recovery (83%-114%), and certified control sera were analyzed. Steroid profiles were obtained in 921 women with a mean age of 56 years (range 44-66 years) from the European Community Respiratory Health Survey.Conclusions: We developed a selective and sensitive LC-MS/MS method for 11 steroids in human serum. It is suitable for biobank studies.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"504-517"},"PeriodicalIF":1.9,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145918860","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Commentary on A Diagnostic Journey through a Rare Hemostatic Disorder. 评述一种罕见的止血疾病的诊断之旅。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2026-05-05 DOI: 10.1093/jalm/jfag027

LaShanta Brice

引用次数: 0

Analytical Validation of Dried Blood Spot Cards for Assessing COVID-19 Seropositivity. 用于评估COVID-19血清阳性的干血卡片的分析验证。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2026-05-05 DOI: 10.1093/jalm/jfag013

Claire Auger, Imad Tarhoni, Grant Lewin, Cristina Fhied, Akanksha Sharma, Kelly Cagin, Radhika Patel, Hita Moudgalya, David Gerard, Darin Bagar, Jeffrey A Borgia

{"title":"Analytical Validation of Dried Blood Spot Cards for Assessing COVID-19 Seropositivity.","authors":"Claire Auger, Imad Tarhoni, Grant Lewin, Cristina Fhied, Akanksha Sharma, Kelly Cagin, Radhika Patel, Hita Moudgalya, David Gerard, Darin Bagar, Jeffrey A Borgia","doi":"10.1093/jalm/jfag013","DOIUrl":"10.1093/jalm/jfag013","url":null,"abstract":"Background: Serological testing frequently utilizes high-sensitivity assays, which are very amenable to microsampling. Herein, we describe the conversion of a COVID-19 immunobead assay from a plasma matrix to the dried blood spot (DBS) card matrix with key analytical parameters reported.Methods: Plasma samples were obtained for 96 seronegative patients and 97 seropositive patients and spotted onto Advanced Diagnostics 100 (ADx100) lateral-flow DBS cards. All cards were stored in opaque pouches with desiccant at room temperature, with extractions performed on days 1, 30, and 120 for analyte stability assessments. Luminex assays were used to measure antibody titers against the SARS CoV-2 Spike and Nucleocapsid glycoproteins in both plasma and matched DBS extracts. Optimal thresholds were established for seropositivity assessments. Agreement was assessed between timepoint analyte measurements. Robust linear models (RLM) were created to predict DBS levels from measured plasma and vice versa, with classification accuracy predictions determined.Results: Assay accuracy for the DBS matrix was calculated at 94.9%, which was <1% different from plasma and with limited observed proportional bias. Total IgG normalization improved extract level accuracy to 97.3%. Storage experiments revealed excellent agreement (>0.9) for both the Spike and Nucleocapsid titers when evaluated over a 120-day period. Finally, utilizing the RLM-predicted plasma and DBS levels, equivalent assay performance was observed in a test set for predicted vs measured value classification.Conclusions: DBS cards represent a convenient and cost-effective means of specimen delivery for serological testing with analyte stability documented for up to 4 months without loss of diagnostic performance.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"518-530"},"PeriodicalIF":1.9,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147291200","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Electronic Alerts for Acute Kidney Injury: Retrospective Comparison of KDIGO- and AACC-Based Criteria for In-Hospital Outcomes. 急性肾损伤的电子警报：基于KDIGO和aacc的住院预后标准的回顾性比较

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2026-05-05 DOI: 10.1093/jalm/jfag009

Sebastian Dietsch, Michael Kiehntopf, Boris Betz

{"title":"Electronic Alerts for Acute Kidney Injury: Retrospective Comparison of KDIGO- and AACC-Based Criteria for In-Hospital Outcomes.","authors":"Sebastian Dietsch, Michael Kiehntopf, Boris Betz","doi":"10.1093/jalm/jfag009","DOIUrl":"10.1093/jalm/jfag009","url":null,"abstract":"Background: Electronic alert systems (e-alerts) based on blood creatinine changes are used to detect acute kidney injury (AKI) in hospitalized patients. While most e-alerts follow the KDIGO (Kidney Disease: Improving Global Outcomes) definition for AKI, the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) has proposed alternative AACC criteria. This study directly compares e-alerts using both AKI definitions in relation to in-hospital outcomes.Methods: E-alerts based on KDIGO and AACC criteria were retrospectively assessed over 1 year in hospitalized patients at a tertiary care hospital. Adverse outcomes included in-hospital death, initiation of dialysis, and renal function decline at hospital discharge according to acute kidney disease criteria.Results: Among 14 719 patients, 1304 had adverse outcomes. KDIGO-based e-alerts were fired in 2598 patients of whom 2554 also met AACC criteria, 1138 were detected by AACC-based e-alert alone. AACC-based alerts were more sensitive (81.4% vs 74.0%) but less specific (80.4% vs 87.8%) for the composite adverse outcome. KDIGO but not AACC-based e-alerts showed reduced sensitivity in female patients and patients without chronic kidney disease. AACC-based alerts triggered earlier than KDIGO-based e-alerts in 22% of dual-alert cases. This subgroup had a higher rate of adverse outcomes (42.7%) than those with e-alerts firing simultaneously (35.1%).Conclusion: AACC-based e-alerts improve early AKI detection and reduce bias, potentially enhancing risk stratification. However, they also increase alert burden. These findings provide a basis for future prospective comparative studies.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"433-445"},"PeriodicalIF":1.9,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147370220","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Investigating Elevated Glutaric Acid in Early Infancy. 婴儿早期戊二酸升高的研究。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2026-05-05 DOI: 10.1093/jalm/jfaf207

Shubhnita Singh, Caitlin Menello, Xinying Hong, Miao He, Rebecca D Ganetzky

引用次数: 0

Caught in the Gap: A Case of Unexpected Lactate Elevation. 夹在缝隙中：一个意外乳酸升高的案例。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2026-05-05 DOI: 10.1093/jalm/jfaf185

Meshach Asare-Werehene, Emily Austin, Daniel R Beriault, Sarah R Delaney

引用次数: 0

Sherlock Holmes Meets Dr. Watson. 夏洛克·福尔摩斯遇见华生医生。