Journal of Applied Laboratory Medicine最新文献

{"title":"Price Variability of Eight Common Laboratory Tests across All Licensed Tennessee Hospitals.","authors":"Stephanie A Hart, Ayesha Khan, Garrett S Booth, Joesph R Wiencek","doi":"10.1093/jalm/jfae167","DOIUrl":"https://doi.org/10.1093/jalm/jfae167","url":null,"abstract":"<p><strong>Background: </strong>In 2021, the United States implemented a federal price transparency mandate to help combat price variability across the country. Initial studies conducted within several months of the mandate showed persistent price variability.</p><p><strong>Methods: </strong>To assess continued price variability for laboratory tests and factors associated with prices across all licensed hospitals in Tennessee approximately 2.5 years since the mandate, hospital websites were queried for gross, cash, and Blue Cross Blue Shield (BCBS) prices for common laboratory tests (n = 8). Hospital ownership and county demographic data including income, region, and population density were also collected.</p><p><strong>Results: </strong>All tests showed considerable price variability. Gross price was set higher than cash and BCBS prices. For the majority (n = 6) of tests, cash was higher than BCBS price. Maximum to minimum price ratios for each test ranged from 29 to 114 for gross, 57 to 243 for cash, and 25 to 115 for BCBS prices. Gross and cash prices were associated with median household income of the hospital's county while BCBS prices were not. Overall, prices were associated with hospital county income, for-profit status, and region.</p><p><strong>Conclusions: </strong>Our study shows continued price variability in Tennessee 2.5 years after the federal price transparency mandate.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143366203","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}

{"title":"High-Sensitivity Cardiac Troponin Assays: From Implementation to Resource Utilization and Cost Effectiveness.","authors":"Hong-Kee Lee, Cian P McCarthy, Allan S Jaffe, Richard Body, Ahmed Alotaibi, Yader Sandoval, James L Januzzi","doi":"10.1093/jalm/jfae161","DOIUrl":"https://doi.org/10.1093/jalm/jfae161","url":null,"abstract":"<p><strong>Background: </strong>Cardiac troponin is the gold-standard biomarker for the evaluation of patients with suspected acute myocardial infarction (MI). Improvements in assay technology have led to high-sensitivity cardiac troponin assays that, when incorporated into accelerated diagnostic pathways, may rapidly diagnose or exclude acute MI more efficiently than conventional troponin assays.</p><p><strong>Content: </strong>In this narrative review, we provide practical suggestions for implementing high-sensitivity cardiac troponin assays, review accelerated diagnostic pathways incorporating these assays, and review the impact of these assays on resource utilization and cost-effectiveness in relation to the evaluation of individuals with possible acute MI.</p><p><strong>Summary: </strong>An increasing number of hospitals are transitioning to high-sensitivity cardiac troponin assays. This narrative review provides an overview of the potential benefits of this transition.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143190313","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}

{"title":"Recommendations for Improved Clinical Practices for Total Thyroxine (T4) Assay.","authors":"Ericka Berthe, Salim Bencheqroun, Romuald Mentaverri","doi":"10.1093/jalm/jfaf003","DOIUrl":"https://doi.org/10.1093/jalm/jfaf003","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143190441","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}

{"title":"Detection of Crystals in Gram-Stained Synovial Fluid.","authors":"Steven J Szlembarski, William A Agger, Sarah R Pendley, Stephen J Bloechl, Christopher H Cogbill, Arick P Sabin, Cathy Mikkelson Fischer, Douglas W White","doi":"10.1093/jalm/jfae162","DOIUrl":"https://doi.org/10.1093/jalm/jfae162","url":null,"abstract":"<p><strong>Background: </strong>Gout and calcium pyrophosphate deposition (CPPD) disease are common crystalline arthropathies. Identification of crystals in synovial fluid using polarized light microscopy (PLM) aids diagnosis. In routine clinical practice, the volume of synovial fluid available for PLM is frequently insufficient, especially when fluid is also needed for other analyses, such as Gram stain and culture. Few studies have investigated the reliability of microscopic examination for crystals, with or without polarization, using Gram-stained synovial fluid specimens. This study estimated the sensitivity and specificity of microscopy with and without polarization on Gram-stained specimens for identification of crystals compared with standard PLM on unstained samples.</p><p><strong>Methods: </strong>In total, 105 unstained synovial and bursal fluid samples were processed and examined by laboratory personnel using routine PLM procedures. Gram-stained samples of the same fluid were independently interpreted by microbiologists trained in examining fluid for crystals using standard light microscopy, followed by at least 2 pathologists using PLM.</p><p><strong>Results: </strong>Compared with standard PLM on unstained samples, the sensitivity and specificity of crystal examination by microbiologists on Gram-stained samples were 16% and 98%, respectively. Pathologists, using PLM on these Gram-stained samples, achieved slightly better sensitivity (24.5% and 96%, respectively). Concordance regarding crystal type was 100% and unaffected by Gram stain.</p><p><strong>Conclusions: </strong>Crystal examination of Gram-stained synovial and bursal fluid by trained personnel has low sensitivity but high specificity compared with standard evaluation of unstained samples. Examination of Gram-stained samples with PLM may be helpful when sample volumes are limited and, when positive, has sufficient specificity to support crystalline arthropathy diagnoses.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143189952","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}

{"title":"The Prevalence of Xylazine in Patient Urine Samples That Were Positive for Fentanyl in Western New York.","authors":"Brandy L Young, Putuma P Gqamana, Yinghua Qiu, Nicholas E Nacca, Y Victoria Zhang","doi":"10.1093/jalm/jfae158","DOIUrl":"https://doi.org/10.1093/jalm/jfae158","url":null,"abstract":"<p><strong>Background: </strong>Xylazine, a veterinary sedative, is increasingly being discovered in the illegal drug supply across the United States and is associated with overdose fatalities. Not approved for human use, xylazine poses life-threatening risks, particularly when used in conjunction with opioids such as fentanyl. This study evaluates the prevalence of xylazine in urine samples that screened positive for fentanyl. The evaluation involved measuring the parent drug xylazine and its metabolites, xylazine glucuronide and hydroxy-xylazine, as well as finding their correlation with fentanyl and norfentanyl concentrations in patient samples.</p><p><strong>Methods: </strong>Samples were collected over a one-month period. Urine samples were analyzed for fentanyl, norfentanyl, and 3 xylazine-specific analytes (i.e., xylazine, xylazine glucuronide, and hydroxy-xylazine). Briefly, reverse-phase chromatographic separation was performed on a Bonshell Phenyl-Hexyl column utilizing a binary mobile phase gradient. The eluents were detected through positive electrospray ionization and multiple reaction monitoring analysis on a triple quadrupole mass spectrometer.</p><p><strong>Results: </strong>Out of a total of 230 urine samples, 184 were confirmed positive for fentanyl. Xylazine was detected in 56 out of the 184 fentanyl-positive samples, accounting for 30% of the fentanyl-positive confirmatory test. Xylazine (or its metabolites) was not observed in fentanyl-negative samples. Furthermore, the parent xylazine drug was detected in all 56 samples, whereas the metabolite glucuronide and hydroxy forms were only detected in 28 and 6 samples, respectively.</p><p><strong>Conclusions: </strong>This study estimated a xylazine prevalence of 30% in fentanyl-positive urine samples within our local Western New York population. This study represents the first report within our clinical population.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143190475","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}

{"title":"Evaluation of Immunoassay Performance for the Detection of Opioids in Urine.","authors":"Michael E Walsh, Michael T Kelliher, Jacqueline A Hubbard, Mark A Cervinski","doi":"10.1093/jalm/jfae169","DOIUrl":"https://doi.org/10.1093/jalm/jfae169","url":null,"abstract":"<p><strong>Background: </strong>Immunoassay drug screens provide rapid analysis of urine for the presence of therapeutics and drugs of abuse. Compared to definitive (confirmatory) methods, immunoassays are prone to false-positive and -negative results. Laboratories generally rely on manufacturers' claims regarding method sensitivity and specificity; few have the resources to independently verify performance. In this study, we review the performance of our opioid immunoassay drug screens in comparison to a definitive method.</p><p><strong>Methods: </strong>Results of 859 urine samples tested via opioid immunoassay screens for buprenorphine, fentanyl, methadone metabolite (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine; EDDP), opiates, and oxycodone were compared to definitive results obtained via liquid chromatography-tandem mass spectrometry (LC-MS/MS). The data examined here included multiple samples from individual patients. Our quantitative LC-MS/MS method includes 19 opioid compounds (parent drugs plus metabolites).</p><p><strong>Results: </strong>Immunoassay sensitivity and specificity ranged from 96% to 100% and 84% to 99%, respectively. The sensitivity and specificity of these screens were similar to manufacturers' claims with some exceptions. The opiates immunoassay had poor performance when limiting the comparison to its target compound, morphine, but improved when including all compounds listed in the manufacturer's instructions for use (IFU). While demonstrating good sensitivity, the buprenorphine immunoassay demonstrated lower specificity than stated in the IFU.</p><p><strong>Conclusions: </strong>The opioid immunoassay screens in use at our facility compared favorably to a definitive LC-MS/MS method. The urine fentanyl screen had the lowest sensitivity (96%) and had a specificity of 97%. The urine buprenorphine assay was the least specific (84%) and had a sensitivity of 99%.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143190369","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}

{"title":"The Therapeutic Monoclonal Antibody Pemivibart Causes Persistent Interference in Immunofixation Electrophoresis.","authors":"Susan L Fink, Rebecca S Treger","doi":"10.1093/jalm/jfaf002","DOIUrl":"https://doi.org/10.1093/jalm/jfaf002","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143190567","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}

{"title":"Measurement of Whole Blood Tacrolimus Concentrations by LC-MS/MS and Immunoassay Methods: Influence of Immediate-Release vs Extended-Release Tacrolimus Formulations.","authors":"Adekunle Alabi, Mengyuan Ge, Jeremiah D Momper, Shirley M Tsunoda, Michael J Kelner, Robert L Fitzgerald, Raymond T Suhandynata","doi":"10.1093/jalm/jfae156","DOIUrl":"https://doi.org/10.1093/jalm/jfae156","url":null,"abstract":"<p><strong>Background: </strong>Therapeutic drug monitoring of the immunosuppressant tacrolimus is commonly performed by immunoassay or LC-MS/MS. Measurement biases between these methodologies have been characterized for immediate-release tacrolimus (IR-tac; Prograf) but have not been performed for extended-release formulations such as Envarsus. These discrepancies can impact patient care, as appropriate dosing is required to maintain therapeutic concentrations and immunosuppression.</p><p><strong>Methods: </strong>Validation of a whole-blood LC-MS/MS method for the simultaneous quantification of tacrolimus and its major metabolite, desmethyl tacrolimus, was performed using traceable calibrators (tacrolimus, ERM-DA110a) and quality control (QC) material for tacrolimus and standard material for desmethyl tacrolimus. Tacrolimus concentrations were determined by LC-MS/MS and the ARCHITECT immunoassay in patients receiving either IR-tac or Envarsus for clinical care.</p><p><strong>Results: </strong>External calibration curves for both tacrolimus and desmethyl tacrolimus were linear (R2 > 0.995), and the analytical measurement range (AMR) for tacrolimus spanned from 1.1 to 31.6 ng/mL. Calibrator/QC biases were within 15% of their spiked concentrations throughout the AMR, and within-run imprecision was <10%, except at the lower limit of quantification (n = 25). Between-run imprecision for low, mid, and high QC levels was ≤11% over a 2-week period (n = 5 days). Comparative biases between immunoassay and LC-MS/MS were significantly lower (P = 0.0074) for patients receiving Envarsus (n = 20 specimens) relative to patients receiving IR-tac (n = 32 specimens).</p><p><strong>Conclusions: </strong>Biases between immunoassay and LC-MS/MS tacrolimus measurements in patients receiving immediate-release vs extended-release formulations indicate that their distinct pharmacokinetic profiles impact measurement accuracy. These assay biases should be considered when interpreting tacrolimus concentration measurements.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143068449","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}

{"title":"Adrenal Venous Sampling in the Investigation of Hyperaldosteronism: A Retrospective Practice Review from a Large Academic Medical Center.","authors":"Ariana Ishaq, Oksana Hamidi, Ibrahim A Hashim","doi":"10.1093/jalm/jfae150","DOIUrl":"https://doi.org/10.1093/jalm/jfae150","url":null,"abstract":"<p><strong>Background: </strong>Hyperaldosteronism involves complex, multidisciplinary management, including clinical testing, radiological exams, and adrenal venous sampling (AVS). This study assesses AVS outcomes at a large referral center, focusing on cannulation success, lateralization of aldosterone-producing adenomas, and correlation with radiological and surgical findings.</p><p><strong>Methods: </strong>A retrospective review of 153 patients who underwent AVS from September 2016 to January 2024 was conducted. Data included aldosterone and cortisol levels, procedural details, and outcomes. AVS success was determined by aldosterone-to-cortisol ratios and cortisol levels confirming adequate cannulation.</p><p><strong>Results: </strong>Of the 153 patients, 49.9% had lateralized adenomas (51.3% left, 48.7% right), while 39.9% had bilateral adrenal hyperplasia. In 10.8% of cases, AVS was inconclusive or unsuccessful. Right adrenal vein cannulation required more attempts due to anatomical challenges. Aldosterone levels were higher in right adrenal adenomas compared to left, though cortisol levels did not predict laterality or hyperplasia. There was strong concordance between AVS, radiological, and surgical findings, except for bilateral hyperplasia cases.</p><p><strong>Conclusions: </strong>This large series highlights AVS's central role in diagnosing hyperaldosteronism, with significant insights into cannulation challenges and biochemical correlations. The study underscores the importance of a multidisciplinary approach for accurate diagnosis and effective management.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143061037","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}

{"title":"An Introduction to the Complete Blood Count for Clinical Chemists: White Blood Cells.","authors":"Bremansu Osa-Andrews, Xander M R van Wijk, Normarie Herrera Rivera, Robert P Seifert, Neil S Harris, Maximo J Marin","doi":"10.1093/jalm/jfaf004","DOIUrl":"https://doi.org/10.1093/jalm/jfaf004","url":null,"abstract":"<p><strong>Background: </strong>The most frequently ordered laboratory test worldwide is the complete blood count (CBC). As clinical chemists are increasingly assigned to assist or direct laboratories outside of the traditional clinical chemistry sections, such as the automated hematology section, expertise must be established. This review article is a dedication to that ongoing effort.</p><p><strong>Content: </strong>In this primer, the white blood cell (WBC) test components of the CBC are introduced, followed by a discussion of the laboratory evaluation of leukopenia and leukocytosis.</p><p><strong>Summary: </strong>The laboratorian's approach to consult cases should be guided by the patient's clinical history and presentation while being able to provide key laboratory-based insights to assist in resolving result discrepancies that may otherwise go unnoticed.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143053850","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}