Journal of Applied Laboratory Medicine最新文献

{"title":"Commentary on From Suspicion of Intravenous Immunoglobin Interference to Diagnosis of Rare Syndrome.","authors":"Mary Kathryn Bohn","doi":"10.1093/jalm/jfaf142","DOIUrl":"https://doi.org/10.1093/jalm/jfaf142","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145092579","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 Hook Effect in Immunoglobulin A (IgA) Measurements: A Diagnostic Challenge-A Case Series.","authors":"Aya Almashad, Hoda Hagrass","doi":"10.1093/jalm/jfaf132","DOIUrl":"https://doi.org/10.1093/jalm/jfaf132","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145092685","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":"Commentary on The Hook Effect in Immunoglobulin A Measurements: A Diagnostic Challenge-A Case Series.","authors":"David N Alter","doi":"10.1093/jalm/jfaf138","DOIUrl":"https://doi.org/10.1093/jalm/jfaf138","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145092595","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":"Using Aggregated Proficiency Testing Results to Identify Systematic Error.","authors":"Uzay Kırbıyık, J Rex Astles","doi":"10.1093/jalm/jfaf126","DOIUrl":"https://doi.org/10.1093/jalm/jfaf126","url":null,"abstract":"<p><strong>Background: </strong>Proficiency testing (PT) should identify systematic errors, which are likely to recur. The Clinical Laboratory Improvement Amendments of 1988 (CLIA) acceptance limits (ALs) include 3 standard deviations (3SD) and concentration limits. We investigated the ability of PT to detect systematic error, especially as affected by the different AL types.</p><p><strong>Methods: </strong>We removed any ungradable, duplicate, and irregular scores from CLIA laboratory PT data from 2008 to 2018. We calculated the overall miss rate, unsatisfactory event rate, i.e., score <80 (4 of 5 correct), and event rates for score 100 to 0. We used paired t-tests and the Wilcoxon signed-rank test to compare miss rates and unsatisfactory event rates between short- and long-term PT participants. We used the binomial distribution to estimate the expected event scores under the assumption that all misses were independent (random). We compared observed event scores with their expected values as a ratio.</p><p><strong>Results: </strong>Forty thousand five hundred ninety-six laboratories produced 15 140 128 event scores for 75 analytes. The distribution of event scores was skewed toward multiple event misses (score 0-60) compared to the predicted distribution. Miss rates and unsatisfactory rates were significantly higher for short-term laboratories. Plotting the log ratio of observed vs expected rates for event scores showed that the degree of systematic effect was substantial. The magnitude of the effect was less for 3SD ALs.</p><p><strong>Conclusions: </strong>In an event, PT misses are often dependent. All ALs detected systematic error. Expressing systematic error using PT data could help to identify and remediate analytical issues.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145092636","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 Transformative Role of Mass Spectrometry in Diagnosing and Monitoring Monoclonal Gammopathies and Plasma Cell Disorders.","authors":"Gema García de la Rosa, Silvia de Las Heras Flórez, Mercedes Carretero Pérez, Jorge Nuevo García","doi":"10.1093/jalm/jfaf133","DOIUrl":"https://doi.org/10.1093/jalm/jfaf133","url":null,"abstract":"<p><strong>Background: </strong>Mass spectrometry (MS) is emerging as a transformative diagnostic tool for plasma cell disorders, including multiple myeloma, Waldenström macroglobulinemia, and light chain amyloidosis. Traditional diagnostic methods such as serum protein electrophoresis, immunofixation electrophoresis, and serum free light chain assays, though effective, have limitations in sensitivity and specificity. These techniques may miss small monoclonal proteins or be affected by therapeutic antibody interference.</p><p><strong>Content: </strong>Recent advances focus on top-down MS techniques, particularly matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) and monoclonal immunoglobulin rapid accurate mass measurement (miRAMM). These methods analyze intact monoclonal proteins to enhance detection sensitivity and specificity. MALDI-TOF offers a streamlined workflow suitable for clinical laboratories, while miRAMM provides highly precise mass measurements, albeit requiring more sophisticated instrumentation.MS has demonstrated superior capabilities in detecting monoclonal proteins, including the ability to distinguish them from therapeutic antibodies. Additionally, MS enables structural characterization of monoclonal proteins, such as glycosylation patterns linked to amyloidosis. Notably, emerging evidence indicates that MS may match or surpass the sensitivity of molecular techniques. These include next-generation sequencing and next-generation flow cytometry, which are commonly applied to bone marrow biopsy for minimal residual disease detection, providing a less invasive alternative for disease monitoring.</p><p><strong>Summary: </strong>MS, particularly MALDI-TOF and miRAMM, represents a promising advancement in the diagnosis and monitoring of plasma cell disorders. Its high sensitivity, efficiency, and noninvasive nature support its potential to complement or replace existing diagnostic methods, improving patient care and clinical outcomes as the technology continues to evolve.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145092705","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 Proteinuria in Plasma Cell Disorders: Shortcomings of Measurements Based on 24-Hour Collections and Alternative Approaches.","authors":"Glen L Hortin, John M Koomen","doi":"10.1093/jalm/jfaf130","DOIUrl":"https://doi.org/10.1093/jalm/jfaf130","url":null,"abstract":"<p><strong>Background: </strong>Clonal plasma cell disorders, such as multiple myeloma (MM), often cause excretion of monoclonal free light chains (MFLC) into urine that serve as diagnostic markers and can cause renal injury.</p><p><strong>Content: </strong>Measures of urinary protein excretion (PEx) and MFLC excretion are parameters for diagnosing and managing plasma cell disorders, although the roles are evolving as new diagnostic tools are applied. Current guidelines dictate measuring PEx and MFLC excretion using 24-hour urine specimens, which have multiple shortcomings that compromise the quality of testing, delay results, and are burdensome for patients. These problems raise consideration of alternatives to the 24-hour PEx (24-hPEx). Such changes in practice have occurred for evaluating proteinuria in many other disorders. Calculating an estimated 24-hPEx based on urine protein/creatinine ratios on spot specimens is one option that overcomes many shortcomings of the measured 24-hPEx. Random urine specimens also probably are preferable for qualitative testing (absence or presence of MFLC) for diagnostic applications and MM response monitoring.</p><p><strong>Summary: </strong>Measurement of PEx and MFLC excretion using 24-hour collections is unreliable, inconvenient, and delays evaluation of plasma cell disorders. Estimated 24-hPEx based on protein assays of spot urine specimens overcomes many of these problems and should be evaluated by further studies. Changing routine practice requires guideline and protocol modification and action by laboratories to increase availability of testing and calculated values. Issues described here also have relevance to evaluating proteinuria in other disorders.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145034360","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":"A Rapid Approach for Assessing Body Fluid Matrix Effects.","authors":"Mengyuan Ge, Spencer Seely, Michael J Kelner, Robert L Fitzgerald, Raymond T Suhandynata","doi":"10.1093/jalm/jfaf109","DOIUrl":"https://doi.org/10.1093/jalm/jfaf109","url":null,"abstract":"<p><strong>Background: </strong>While clinical laboratories routinely perform automated chemistry assays on approved specimens (e.g., plasma and serum), the FDA has not evaluated the validity of these assays for nonapproved specimens (e.g., various body fluids). To meet College of American Pathologists' regulatory requirements, clinical laboratories must evaluate body fluid matrix effects. However, full validation studies are challenging due to time and labor demands. Therefore, a rapid and practical approach for validating body fluids benefits clinical laboratories by improving efficiency and minimizing resources utilized.</p><p><strong>Methods: </strong>Excess body fluids and plasma specimens were collected and frozen until testing was performed. Pooled body fluid specimens were spiked with a 10% spike solution (pooled plasma) containing analyte mixtures with measured concentrations. Matrix interference studies and dilution studies were performed on the Roche cobas automated (6000/8000) analyzers.</p><p><strong>Results: </strong>The matrix effects for albumin, amylase, blood urea nitrogen, cholesterol, creatinine, glucose, lactate, lactate dehydrogenase, lipase, potassium, sodium, total bilirubin, total protein, triglycerides, and uric acid were all within acceptable limits (±20% of full recovery). However, lipase was observed to be unstable in peritoneal fluid. Dilution linearity was confirmed for all analytes in pleural, peritoneal, ascites, and synovial fluids (R2 > 0.90).</p><p><strong>Conclusions: </strong>Our study describes a rapid and practical approach for evaluating body fluid matrix effects in automated clinical chemistry assays. By streamlining the validation process, this approach can help laboratories maintain compliance while minimizing time and resources.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145024361","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":"Leveraging Hematologic Single-Cell Measurements for Patient Triage and Outcome Prediction.","authors":"Ya-Lin Chen, Fabienne Lucas, Brody H Foy","doi":"10.1093/jalm/jfaf127","DOIUrl":"https://doi.org/10.1093/jalm/jfaf127","url":null,"abstract":"<p><strong>Background: </strong>The complete blood count (CBC) is widely used across nearly all areas of medicine. While standard CBC markers reflect basic summaries of the blood cells, modern hematology analyzers generate many additional markers from the underlying data distributions-collectively referred to as cell population data (CPD). While CPD markers have been studied in targeted clinical settings, their value for general prognostic tasks has not yet been established. In this brief report, we assess whether CPD markers can provide additional prognostic information beyond CBC markers in general patient cohorts.</p><p><strong>Methods: </strong>We retrospectively analyzed CBC and CPD markers from over 10 000 patients at a large academic medical center between March 14, 2024, and October 23, 2024. Marker associations with general outcomes (inpatient admission from the emergency department, mortality, and length-of-stay) were analyzed in both univariate and multivariate models. Outcomes were also predicted using CBC- and CPD-based machine learning models.</p><p><strong>Results: </strong>Many CPD markers were strongly associated with patient mortality, length-of-stay, and inpatient admission from the emergency department. CPD markers showed consistent outcome associations after stratification by patient demographics and medical specialties, and many retained statistical significance after controlling for commonly used CBC markers. In machine learning modelling, inclusion of CPD markers enhanced predictive performance for mortality [area under the curve (AUC): 0.79] and inpatient admission (AUC: 0.81). Analysis of CPD markers revealed 2 phenotypes: an inflammatory phenotype associated with inpatient admission and a dysregulatory phenotype associated with mortality.</p><p><strong>Conclusions: </strong>These results highlight how routinely collected CPD markers may enhance the use of the CBC for evaluation of general patient cohorts.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145001605","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":"Commentary on Fluctuating Hyperparathyroidism after Surgery.","authors":"Lorin M Bachmann","doi":"10.1093/jalm/jfaf125","DOIUrl":"https://doi.org/10.1093/jalm/jfaf125","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145001648","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":"Single-Sample Confirmation of Positive Gonorrhea and Chlamydia Results Using the Roche Cobas CT/NG and Cepheid Xpert CT/NG Assays.","authors":"Kenneth P Smith, Nicole A Loeven, Jeffrey Fink, Michael Elkan, Kevin Weller, Rebecca M Harris","doi":"10.1093/jalm/jfaf120","DOIUrl":"https://doi.org/10.1093/jalm/jfaf120","url":null,"abstract":"<p><strong>Background: </strong>Testing for sexually transmitted infections (STIs) in preadolescent patients carries significant medical and legal implications. Guidelines from the Centers for Disease Control and Prevention (CDC) support the use of nucleic acid amplification testing (NAAT) for diagnosis of Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) in children. These guidelines also recommend confirmation of positive results by repeat testing of either the original specimen or a separately collected specimen to reduce the risk of false positives. Currently, no FDA-cleared NAATs have a specific indication for use in samples from prepubertal children or for the evaluation of suspected sexual assault. Further, if confirmation using a second assay is desired, manufacturer-specific collection kits may preclude this, necessitating a second specimen collection, which may not be feasible.</p><p><strong>Methods: </strong>Here, we evaluate the compatibility between the Cepheid Xpert CT/NG assay and the Roche cobas CT/NG assay on samples collected in cobas PCR media.</p><p><strong>Results: </strong>Our data suggest that the Xpert CT/NG assay is compatible with specimens collected in cobas collection medium.</p><p><strong>Conclusions: </strong>As such, laboratories may validate this work flow as a confirmatory test on specimens collected in cobas collection medium.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145001673","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}