Journal of Applied Laboratory Medicine最新文献_第10页

ADLM Guidance Document on Laboratory Testing for Drugs of Misuse to Support the Emergency Department. ADLM实验室检测误用药物以支持急诊科的指导文件。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2026-01-05 DOI: 10.1093/jalm/jfaf172

Christine L H Snozek, Matthew D Krasowski, Jennifer M Colby, Kamisha L Johnson-Davis, Rebecca E Bruccoleri, Stacy E Melanson

{"title":"ADLM Guidance Document on Laboratory Testing for Drugs of Misuse to Support the Emergency Department.","authors":"Christine L H Snozek, Matthew D Krasowski, Jennifer M Colby, Kamisha L Johnson-Davis, Rebecca E Bruccoleri, Stacy E Melanson","doi":"10.1093/jalm/jfaf172","DOIUrl":"https://doi.org/10.1093/jalm/jfaf172","url":null,"abstract":"Toxicology testing for drugs associated with scenarios such as recreational use or substance use disorder can be performed in support of the emergency department (ED) for specific patient populations such as pediatrics and trauma. These compounds were historically referred to as drugs of abuse (DOA); although the word \"abuse\" is recognized as potentially stigmatizing, no replacement terminology for DOA has emerged in current guidelines. This document refers to these compounds as drugs or substances of misuse, and acknowledges the need for less-stigmatizing language that more fully encompasses the range of uses for these drugs. This literature-driven, consensus guidance document provides recommendations primarily targeted to US hospital-based laboratories performing urine drug testing (UDT) in support of the ED. Indications for ordering UDT and related testing in both pediatric and adult populations are summarized. Further, recommendations are made for testing that should be available at all facilities with rapid turnaround, and how to perform and report testing. The advantages and disadvantages of immunoassays and mass spectrometry, as well as common challenges, are reviewed. Indications for mass-spectrometry assays and more extensive testing (e.g., novel psychoactive substances) are also provided. Future directions for improvements in laboratory technology to improve the utility of this testing are outlined. All laboratories should collaborate with ED leadership, medical toxicologists and poison control centers to optimize and update test menus to reflect local drug use patterns, ensure test methodologies and results meet clinical needs, and educate clinical staff regarding assay limitations and accurate test interpretation.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":"11 1","pages":"155-180"},"PeriodicalIF":1.9,"publicationDate":"2026-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145906801","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

Analytical Interference in Alanine Aminotransferase Determination in Patients with Monoclonal Gammopathy. 单克隆γ病患者丙氨酸转氨酶测定的分析干扰。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2026-01-05 DOI: 10.1093/jalm/jfaf115

Sara Martínez-Rodríguez, Alberto Izquierdo-Martínez, Juan Miguel Guerrero Montávez, Ricardo Rubio-Sánchez

{"title":"Analytical Interference in Alanine Aminotransferase Determination in Patients with Monoclonal Gammopathy.","authors":"Sara Martínez-Rodríguez, Alberto Izquierdo-Martínez, Juan Miguel Guerrero Montávez, Ricardo Rubio-Sánchez","doi":"10.1093/jalm/jfaf115","DOIUrl":"10.1093/jalm/jfaf115","url":null,"abstract":"Background: Analytical interferences are very common in clinical laboratories, so professionals must develop strategies for their detection, avoiding incorrect results that can lead to inappropriate diagnoses and treatments.Methods: An isolated 1040 error (absorbance-related) in the Alanine Aminotransferase2 (ALT2) assay performed on the Abbott Alinity c that occurred in 158 samples over 7 months was investigated. Highly lipemic or hemolyzed samples were excluded, and an error due to an increased concentration of total proteins was ruled out, all of which are documented analytical interferences.Results: We isolated immunoglobulin (Ig) with an increased concentration (monoclonal components: 149 IgM, 7 IgG, and 2 IgA) from all analyzed samples, so the presence of this error solely in the alanine aminotransferase (ALT) assay had a 100% positive predictive value for monoclonal gammopathy. Serum viscosity was elevated in all cases, which is the reason for the detected interference. Treatment of IgM samples with dithiothreitol confirmed that dissociation of the pentamers eliminates the error in ALT determination.Conclusions: The detection of this interference in samples from patients without recent immunoglobulin determinations indicates the presence of a significant and isolated increase in the concentration of one of them, potentially leading to the diagnosis of a previously unknown monoclonal gammopathy.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"120-124"},"PeriodicalIF":1.9,"publicationDate":"2026-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144973823","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 Incidental Detection of a Hemoglobin Variant Reveals the Cause of Chronic Dyspnea. 偶然发现的血红蛋白变异揭示了慢性呼吸困难的原因。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2026-01-05 DOI: 10.1093/jalm/jfaf162

Catherine L Omosule

引用次数: 0

Commentary on A Pediatric Case of Recurrent Dehydration and Shock Revealing an Endocrine Disorder. 小儿反复脱水及休克1例提示内分泌紊乱。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2026-01-05 DOI: 10.1093/jalm/jfaf163

Kyle P McNerney

引用次数: 0

Regulatory Framework for In Vitro Diagnostic Devices in India: Current Landscape, Challenges, and Future Perspectives. 印度体外诊断设备的监管框架：现状、挑战和未来展望。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2026-01-05 DOI: 10.1093/jalm/jfaf164

Mahima Ramesh, Harsh Sah, Amrutha C

{"title":"Regulatory Framework for In Vitro Diagnostic Devices in India: Current Landscape, Challenges, and Future Perspectives.","authors":"Mahima Ramesh, Harsh Sah, Amrutha C","doi":"10.1093/jalm/jfaf164","DOIUrl":"10.1093/jalm/jfaf164","url":null,"abstract":"Background: In vitro diagnostic (IVD) devices are essential for disease detection and clinical decision-making. India's IVD market has grown rapidly, but regulatory oversight has lagged. Although the Indian Medical Device Rules introduced a risk-based framework in 2017, persistent gaps in enforcement, quality standards, and post-market surveillance undermine diagnostic reliability.Content: This review examines India's IVD regulatory framework, focusing on device classification, approval pathways, quality management requirements, and post-market mechanisms. Particular attention is given to challenges such as enforcement issues, inconsistent compliance among small and medium enterprises, adoption barriers for national/international standards, weak post-market surveillance systems, and the absence of transparent public databases. Comparative analysis highlights India's shortfalls relative to the European and US systems, especially in mandatory clinical evidence, structured post-market surveillance, and stakeholder engagement.Summary: Despite progress, India's IVD ecosystem remains constrained by fragmented oversight and weak harmonization with global standards. Strengthening regulatory capacity, mandating evidence-based evaluation, and fostering digital health readiness are critical to ensure patient safety and global competitiveness.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"125-142"},"PeriodicalIF":1.9,"publicationDate":"2026-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145490594","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

Changing Chemistry Instruments? Don't Forget to Ask These Questions. 改变化学仪器？别忘了问这些问题。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2026-01-05 DOI: 10.1093/jalm/jfaf158

Nicholas E Larkey, Derek C Waggoner, Erica M Fatica

引用次数: 0

Copeptin as a Marker for Vasopressin Dysregulation and Diagnosis. Copeptin作为抗利尿激素失调的标志物及其诊断。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2026-01-05 DOI: 10.1093/jalm/jfaf153

Seema Khattri Bhandari, Shu-Ling Fan

{"title":"Copeptin as a Marker for Vasopressin Dysregulation and Diagnosis.","authors":"Seema Khattri Bhandari, Shu-Ling Fan","doi":"10.1093/jalm/jfaf153","DOIUrl":"10.1093/jalm/jfaf153","url":null,"abstract":"Background: Arginine vasopressin (AVP) is a neuroendocrine hormone essential for fluid balance, vascular tone, and the endocrine stress response. However, its clinical measurement is limited by instability and technical challenges. Copeptin, the C-terminal segment of the AVP precursor, is secreted in equimolar amounts with AVP and serves as a stable, measurable surrogate.Content: This mini-review outlines the synthesis, release, and physiological roles of AVP and copeptin, emphasizing their relevance in endocrine regulation. It highlights copeptin's diagnostic utility in differentiating AVP-deficiency (AVP-D), AVP-resistance (AVP-R), and primary polydipsia (PP): conditions that share overlapping clinical features. Traditional diagnostic methods such as the water deprivation test (WDT) are contrasted with copeptin-based approaches, which offer improved accuracy and patient tolerability. The review summarizes diagnostic thresholds for baseline and stimulated copeptin levels using stimulation, such as hypertonic saline or arginine, and discusses their integration into clinical algorithms.Summary: Copeptin has emerged as a reliable endocrine biomarker for AVP secretion and is increasingly used in the diagnostic evaluation of polyuria-polydipsia syndromes. Its stability, accessibility, and diagnostic performance support its adoption as a first-line tool in endocrine diagnostics.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"143-154"},"PeriodicalIF":1.9,"publicationDate":"2026-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145276156","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

Analytical Validation of a Second-Generation Methotrexate Immunoassay. 第二代甲氨蝶呤免疫分析法的分析验证。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2026-01-05 DOI: 10.1093/jalm/jfaf166

Rebecca Wilson, Diane Yamaguchi, Jamie Garrett, Michael Schmeling, Erin Kuest, Andrew N Hoofnagle

{"title":"Analytical Validation of a Second-Generation Methotrexate Immunoassay.","authors":"Rebecca Wilson, Diane Yamaguchi, Jamie Garrett, Michael Schmeling, Erin Kuest, Andrew N Hoofnagle","doi":"10.1093/jalm/jfaf166","DOIUrl":"10.1093/jalm/jfaf166","url":null,"abstract":"Background: Methotrexate, an antifolate therapy, is used for the treatment of cancers, autoimmune disease, and transplant patients and needs to be carefully monitored for toxicity. Plasma measurement of methotrexate concentrations is problematic as a result of analytical interference of its metabolites. Immunoassays are widely used for monitoring therapeutic drug levels of methotrexate; however, chromatographic assays, LC-MS/MS most particularly, are preferentially used since they are less prone to metabolite interference.Methods: Analytical performance was evaluated in a second-generation methotrexate immunoassay (ARK, Inc.) by testing precision, accuracy, linearity, interference, and method comparison with LC-MS/MS. Cross-reactivity of the immunoassay with 4-deoxy-4-amino-N10-methylpteroic acid (DAMPA), 7-OH methotrexate, and folic acid was also measured.Results: Findings indicate that the within-run %CV ranged from 2.6% to 4.4% across control materials. The assay was linear across an analytical measuring range of 0.03 to 1.3 μM. The lower limit of the measuring interval and the lower limit of detection were established at 0.03 µM and 0.0067 μM, respectively. Notable interference from DAMPA was observed above 1 µM, whereas 7-OH methotrexate and folic acid showed no interference up to 5 µM and 1000 µM, respectively. Correlation studies showed an average 3% bias in DAMPA-free samples (R2 = 0.9935) and a significant bias and poorer correlation (R2 = 0.3241) in samples containing DAMPA.Conclusions: The assay performed well based on the validation experiments and is suitable for most clinical applications involving methotrexate. However, the significant interference with DAMPA highlights the necessity for careful assay selection and interpretation of glucarpidase-treated patients.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"73-82"},"PeriodicalIF":1.9,"publicationDate":"2026-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145379230","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

Assessing and Resolving Findings of Sex Chromosome Discordance in Genetic Testing. 基因检测中性染色体不一致发现的评估与解决。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2026-01-05 DOI: 10.1093/jalm/jfaf167

Kyle T Salsbery, Anna A Essendrup, Heather C Flynn Gilmer, Molly H Nelson-Holte, Lauren A Choate, Zhiyv Niu

{"title":"Assessing and Resolving Findings of Sex Chromosome Discordance in Genetic Testing.","authors":"Kyle T Salsbery, Anna A Essendrup, Heather C Flynn Gilmer, Molly H Nelson-Holte, Lauren A Choate, Zhiyv Niu","doi":"10.1093/jalm/jfaf167","DOIUrl":"10.1093/jalm/jfaf167","url":null,"abstract":"Background: X and Y chromosome analysis is a critical component of genetic testing, used both diagnostically and as a quality control (QC) metric. Discordances between expected and observed sex chromosome data can arise due to mislabeling, demographic data errors, transplant history, or biological variations. Such discordances pose challenges to laboratories and affect patient care, particularly in marginalized populations and unique clinical contexts.Methods: We reviewed cases of sex chromosome discordance identified at our laboratory from January 2021 through August 2023. Cases spanned various testing methods and were categorized by the root cause, including mislabeling, sample mix-ups, transgender individuals, stem cell transplants, and unexplained causes. Case outcomes were assessed, and potential resolutions were analyzed.Results: Among 65 cases identified, the leading cause of discordance was mislabeling (n = 20, 31%), followed by other/not identified (n = 16, 25%), sample mix-ups (n = 13, 20%), transgender individuals (n = 9, 14%), and stem cell transplants (n = 7, 11%). Cases required additional QC processes such as reanalysis, clinician contact, and occasionally sample re-collection. The process extended turnaround times by up to 13 business days. Detailed case reviews highlighted the challenges and implications of managing these discordances, emphasizing the importance of accurate data transmission and inclusive practices.Conclusion: Using X and Y chromosome data as a QC metric can identify critical errors but also introduces limitations and bias. Improved standardization, inclusive practices, and alternative QC methods are necessary to ensure accuracy and equitable patient care. Collaborative efforts are required to address demographic complexities and reduce testing delays.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"4-14"},"PeriodicalIF":1.9,"publicationDate":"2026-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145446237","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

Performance of a Rapid, Highly Multiplexed Nucleic Acid Detection Assay for Identification of Viral and Bacterial Pathogens from Upper Respiratory Tract Specimens. 一种快速、高度复用的核酸检测方法用于鉴定上呼吸道标本中的病毒和细菌病原体。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2026-01-05 DOI: 10.1093/jalm/jfaf144

Coreen L Johnson, James J Dunn

{"title":"Performance of a Rapid, Highly Multiplexed Nucleic Acid Detection Assay for Identification of Viral and Bacterial Pathogens from Upper Respiratory Tract Specimens.","authors":"Coreen L Johnson, James J Dunn","doi":"10.1093/jalm/jfaf144","DOIUrl":"10.1093/jalm/jfaf144","url":null,"abstract":"Background: Accurate and timely identification of upper respiratory tract pathogens can improve patient management by decreasing unnecessary additional testing, reducing the cost of care, and informing antimicrobial stewardship. We evaluated the FDA-cleared Diasorin LIAISON PLEX® Respiratory Flex (RSP Flex), a highly multiplexed, rapid nucleic acid detection assay that can identify 14 viral and 5 bacterial respiratory pathogens.Methods: In total, 215 residual patient upper respiratory tract specimens were tested using the RSP Flex assay and results compared to standard-of-care (SOC) molecular testing.Results: Positive percentage agreement (PPA) was 100% for the following targets: adenovirus, human coronavirus, Bordetella pertussis, Bordetella parapertussis, Mycoplasma pneumoniae, and Chlamydia pneumoniae. Performance for the remaining panel targets were: human enterovirus/rhinovirus PPA = 97.5% (39/40), influenza A virus PPA = 92.3% (12/13), human metapneumovirus PPA = 87.5% (14/16), influenza B virus PPA = 92.9% (13/14), parainfluenza 1 virus PPA = 85.7% (6/7), parainfluenza 2 virus PPA = 80% (4/5), parainfluenza 3 virus PPA = 85.7% (12/14), parainfluenza 4 virus PPA = 87.5% (7/8), respiratory syncytial virus (RSV) PPA = 92.9% (13/14), and SARS-CoV-2 PPA = 95.0% (19/20). The negative percentage agreement (NPA) for all targets was 100% except adenovirus NPA = 98.4% (180/183), enterovirus/rhinovirus NPA = 96.9% (155/160), and M. pneumoniae NPA = 91.9% (34/37). For all targets, the RSP Flex assay had an overall PPA of 93.8%, NPA of 99.5% and complete concordance of 99.1% compared to SOC testing.Conclusions: The LIAISON PLEX RSP Flex assay is a fully automated, sample-to-customizable answer system that offers a wide range of bacterial and viral target testing with high accuracy.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"113-119"},"PeriodicalIF":1.9,"publicationDate":"2026-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145394049","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