Journal of Applied Laboratory Medicine最新文献

{"title":"A Practical Approach to Validating, Integrating, and Reporting Z-Scores along with IGF-1 Results.","authors":"Ericka Olgaard, Juan Manuel Munoz, Kwaku Baryeh, Maximo Marin, Bremansu Osa-Andrews","doi":"10.1093/jalm/jfag108","DOIUrl":"https://doi.org/10.1093/jalm/jfag108","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":"11 5","pages":"1301-1305"},"PeriodicalIF":2.3,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148889127","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 Retrieval-Based Approach for Automatic Interpretation of Multi-Analyte Laboratory Profiles.","authors":"Thomas E Tavolara, Sarthak Khandelwal, Rachel Leger, Serena Navitskas, Rajiv Pruthi, Dong Chen, Jansen N Seheult","doi":"10.1093/jalm/jfag063","DOIUrl":"10.1093/jalm/jfag063","url":null,"abstract":"<p><strong>Background: </strong>Interpretation of multi-analyte laboratory profiles, such as lupus anticoagulant (LAC) testing, requires integration of numerous test results and clinical information. However, this process is time-consuming, requires domain knowledge, and has limited scalability. Given that rule-based systems are rigid and difficult to maintain and large language models pose risks of \"hallucinations,\" we developed and evaluated a novel retrieval-based approach to automate LAC profile interpretation to improve efficiency while maintaining fidelity and reliability for clinical use.</p><p><strong>Methods: </strong>Our method processes laboratory values through ensemble random forest (RF) models to retrieve the most similar expert interpretation from a curated database of 347 previously interpreted LAC profiles. The system's performance was assessed through technical accuracy metrics, a work flow efficiency timing study, and expert review of interpretation accuracy for held-out cases.</p><p><strong>Results: </strong>Technical validation demonstrated high accuracy in retrieving correct interpretative elements (median: 93% accuracy, interquartile range [IQR]: 67% to 100%). Retrieval accuracy was highly correlated with the prevalence of a given element (ρ = 0.8307). In a timing study of 93 consecutive LAC profiles, ensemble-assisted interpretation achieved a median time of 22 s per report (IQR: 16 s to 31 s), representing a 78.6% total reduction compared to manual interpretation (median: 118 s, IQR: 96 s to 172 s; t = 18.61, P < 0.001). Furthermore, 92.5% of AI-assisted interpretations were completed within 60 s, exceeding the target of 85%. Expert review confirmed 100% concordance for LAC presence/absence.</p><p><strong>Conclusions: </strong>The proposed approach significantly improves efficiency of complex laboratory interpretation for LAC profiles, while maintaining consistency and high fidelity. Future studies will explore the method's inherent extensibility to the interpretation of other multi-analyte laboratory profiles.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"1197-1211"},"PeriodicalIF":2.3,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148036409","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":"Development of a Low-Cost Spectrometer for Hemolysis Detection in Emergency Blood Gas Samples.","authors":"Qian Dai, Jia-Yin Tu, Kou-Qiong Wang, Bai-Shen Pan, Wei Guo, Bei-Li Wang","doi":"10.1093/jalm/jfag068","DOIUrl":"10.1093/jalm/jfag068","url":null,"abstract":"<p><strong>Background: </strong>Hemolysis is a major cause of sample rejection in blood gas analysis. We aimed to develop a low-cost spectrometer for hemolysis detection in emergency laboratories.</p><p><strong>Methods: </strong>The spectrometer was developed using a complementary metal-oxide-semiconductor (CMOS) sensor and DVD-ROM grating. We evaluated the linearity, precision, and interference resistance of the instrument in accordance with CLSI and China National Accreditation Service for Conformity Assessment (CNAS) guidelines. In 51 clinical blood gas samples subjected to mechanically simulated hemolysis, the correlation between absorbance at 540 nm (A540 nm) and the hemolysis index (H index) determined by the Cobas c701 biochemical analyzer was evaluated. We utilized the hemolysis absorbance value that causes a maximum ±10% deviation in potassium (K+) and calcium ion (Ca2+) results as a reference to establish the rejection criteria for hemolysis in blood gas samples.</p><p><strong>Results: </strong>The detection range of the spectrometer spanned 0.160< A540 nm <2.67, exhibiting a highly significant correlation with the H index (P < 0.01). The between-run coefficient of variation (CV) for the device was below 5%, while the within-laboratory CV remained below 10%. At interfering substance levels of 8.0 mg/dL (136.8 μmol/L) for unconjugated bilirubin, 13.3 mg/dL (226.7 μmol/L) for conjugated bilirubin, and 431.4 mg/dL (4.87 mmol/L) for triglycerides, detection bias stayed within 10%. Hemolysis significantly altered pH, partial pressure of oxygen (pO2), K+, and Ca2+ (P < 0.05). By calculating the bias caused by hemolysis on the test results, rejection criteria were established: A540nm >0.671 hemolysis will affect K+ results and A540nm >0.960 hemolysis will affect Ca2+ results.</p><p><strong>Conclusion: </strong>This low-cost spectrometer enables reliable pre-analysis hemolysis detection, improving accuracy in blood gas testing.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"1078-1092"},"PeriodicalIF":2.3,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147989451","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":"Tribute to Robert Christenson, Ph.D., First and Emeritus Editor-in-Chief, The Journal of Applied Laboratory Medicine.","authors":"Alan H B Wu, Dennis Dietzen, Paul Collinson, John Toffaletti","doi":"10.1093/jalm/jfag103","DOIUrl":"10.1093/jalm/jfag103","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":"11 5","pages":"1311-1313"},"PeriodicalIF":2.3,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148889167","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":"When the Reference Is Not a Reference: Hidden Substitution Bias in LDL-C Measurement and Its Implications for Electronic Health Record-Based Research and Risk Prediction.","authors":"Paola A Ramos, Jeffrey W Meeusen","doi":"10.1093/jalm/jfag136","DOIUrl":"https://doi.org/10.1093/jalm/jfag136","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148882208","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 a One-Step Serological Test for Lyme Disease.","authors":"Kirsten Fagan, Marta Urban, P Rocco LaSala, Charles R Caso, James W Needham, Anu S Maharjan","doi":"10.1093/jalm/jfag133","DOIUrl":"https://doi.org/10.1093/jalm/jfag133","url":null,"abstract":"<p><strong>Background: </strong>Lyme disease, a vector-borne zoonosis caused by Borrelia species, is classified into early localized and late disseminated infection. Left untreated, infected patients face multisystem pathology involving the joints, heart, and peripheral and central nervous system, making early antibiotic therapy essential. Lyme diagnosis with standard 2-tier test (STTT) and a modified 2-tier test utilize sequential serological assays. In this study, we evaluated the InBios Lyme Detect™ Multiplex ELISA (RUO) (InBios ELISA), a one-step method that combines screening and confirmatory tests. While a recent publication (Curr. Issues Mol. Biol. 2021;42:333-84.) demonstrated good performance of the InBios ELISA during early stages of Lyme disease, this study aimed to assess assay performance relative to STTT and to characterize IgG and IgM reactivity compared to standard immunoblot.</p><p><strong>Methods: </strong>A convenience sampling of 119 residual sera previously characterized by STTT were analyzed for Lyme antibodies using the InBios ELISA. The evaluation quantified antigen reactivity using imaging and machine-learning analysis, which triggered simultaneous confirmatory analysis to provide an inclusive final interpretation.</p><p><strong>Results: </strong>Among the 119 serum samples, InBios ELISA demonstrated 99.2% concordance with STTT. A single discordant result was observed for one STTT-positive sample with IgM confirmation. Concordance between second-tier immunoblots (IgM or IgG) and InBios IgM or IgG index was 76.2% for both.</p><p><strong>Conclusions: </strong>This study shows that the InBios ELISA can (with minimal discordance) interpret both screen and confirmatory results in one step. Overall, there is a potential to replace the 2-tier test with one-step InBios ELISA to enable rapid turnaround and improve diagnosis of Lyme.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148867241","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 High-Sensitivity Cardiac Troponin Measurement to Rule-out/Rule-in Myocardial Infarction in the Emergency Department.","authors":"Anne Marie Dupuy, Yanis Gueche, Anne Sophie Bargnoux, Marion Morena, Bruno Lehodey, François Roubille, Jean Paul Cristol","doi":"10.1093/jalm/jfag130","DOIUrl":"https://doi.org/10.1093/jalm/jfag130","url":null,"abstract":"<p><strong>Background: </strong>Point-of-care (POC) testing and triage liaison physicians could help alleviate the impact of emergency department (ED) overcrowding. The aim of our study was to evaluate the diagnostic performance of the TriageTrue POC assay for the rapid rule-out of myocardial infarction based on a single measurement of high-sensitivity cardiac troponin I (hs-CTnI). The diagnostic performance was compared to measurements obtained with the Vitros 3600 assay, taking into account the cutoffs recommended by the European Society of Cardiology.</p><p><strong>Methods: </strong>The study compared results of troponin obtained simultaneously on the TriageMeterPro device from whole blood and plasma samples (n = 139) and the hs-cTnI assay on the Vitros 3600 instrument from EDTA plasma samples (n = 225). The diagnostic performance of the 3 methods was compared, including negative predictive value and sensitivity as well as positive predictive value and specificity. Concordance between the methods with disease state samples was then assessed using the Cohen kappa test.</p><p><strong>Results: </strong>An excellent correlation between plasma and whole blood samples was achieved with the TriageTrue with a coefficient of correlation >0.99 and a bias of +8.2 (±45, with 95% CI 0.4 to 16.0) ng/L. A significant overestimation (around 47%) of the values obtained with the TriageTrue compared with those of the Vitros was also observed. Our results confirmed the acceptable and comparable diagnostic accuracy to the established hs-cTnI-Vitros assay, with a negative predictive value of 100% to rule-out myocardial infarction.</p><p><strong>Conclusion: </strong>Our results demonstrated that the TriageTrue hs-cTnI whole blood test could serve as an alternative method for ruling out or confirming non-ST-elevation myocardial infarction in the prehospital setting using a single POC troponin measurement.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148867212","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 Update on State-of-the-Art Performance for Precision in Medical Laboratories.","authors":"Jeremie M Gras, Delphine A Collin-Chavagnac, Florian Scherrer, Jean-Baptiste Raimbourg, Cyrille Biette, Michel Vaubourdolle, Anne J Vassault","doi":"10.1093/jalm/jfag125","DOIUrl":"https://doi.org/10.1093/jalm/jfag125","url":null,"abstract":"<p><strong>Background: </strong>The European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has established a three-stage model of criteria to set analytical performance specifications (APS). The third model is based on state-of-the-art (SoA), which has been described as the highest level of analytical performance with currently available methods. However, an up-to-date, comprehensive, easily usable SoA database does not currently exist.</p><p><strong>Methods: </strong>Data mining was performed using a data management package (Unity Real Time) for Internal quality control (IQC) and interlaboratory comparisons (ILC). For each analyte, the coefficient of variation (CV) values reported by the 50th, 90th, and 95th percentiles of laboratories were extracted and then the median intralaboratory CV50, CV90, and CV95 values were calculated.</p><p><strong>Results: </strong>Using >775 million quality control (QC) measurements, an updated SoA database includes >100 analytes commonly performed in the fields of clinical biochemistry, hematology, hemostasis, therapeutic drug monitoring (TDM), and serology. The number of QC measurements of each analysis, for 3 specific levels of concentration, ranged from 1090 to 9 163 824 to evaluate the impact of concentration level on the method precision for each analysis.</p><p><strong>Conclusions: </strong>This study provides an updated SoA database for precision that is of particular importance in circumstances where EFLM Biological Variation Database-derived APS do not exist, cannot be generated with current methods, or are inappropriate for pathophysiologic states. The impact of concentration level on precision data is also reported.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148841533","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":"Comparison of Target Detection Rates of Broad Multiplex Gastrointestinal PCR Panels to Inform Utilization of a Midplex Panel Approach: A Systematic Literature Review and Meta-Analysis.","authors":"Jordan Chase, Darsh Devani, Bridget Manning, Anita Mohandas, Lucas Schulz, Thomas F Goss, D Jane Hata, Ping Ren","doi":"10.1093/jalm/jfag132","DOIUrl":"https://doi.org/10.1093/jalm/jfag132","url":null,"abstract":"<p><strong>Background: </strong>Multiplex gastrointestinal panels (GIPs) allow rapid detection of infectious gastroenteritis pathogens. Broader 15- or 22-target (15t and 22t, respectively) panels also detect colonizing or nonetiologic organisms, increasing diagnostic uncertainty. We performed a systematic literature review and meta-analysis to estimate relative detection frequency (RDF) with an 11-target (11t) GIP compared with larger panels.</p><p><strong>Methods: </strong>We searched PubMed and EMBASE (January 1, 2010-October 31, 2024) for studies reporting target-specific positivity in patients suspected of infectious gastroenteritis using 15t and 22t GIPs. Pooled detection rates were estimated via random-effects meta-analysis. Estimated RDF for the 11t panel was modeled using pooled target-specific positivity rates from 15t and 22t panels. RDF co-detection-adjusted positivity for the 11t panel was compared with the 15t and 22t GIPs. Twenty-five studies were included: 18 and 8 evaluating the 22t and 15t GIPs, respectively (one study included both).</p><p><strong>Results: </strong>Adjusted pooled detection frequency rates were 32.94% (15t) and 50.01% (22t). Adjusted for co-detection, the 11t panel captured 57.3% of targets relative to 15t GIPs and 39.7% relative to 22t GIPs. The targets excluded from the 11t panel included Clostridioides difficile and certain Escherichia coli strains frequently identified in broader GIPs due to colonization. Larger multiplex GIPs yield more frequent positive results, offset by detecting organisms of questionable significance in asymptomatic patients or without risk factors.</p><p><strong>Conclusions: </strong>Modeled findings suggest that an 11t panel preserves a clinically meaningful diagnostic yield while reducing co-detections, aligning with Infectious Diseases Society of America and American Society for Microbiology recommendations favoring targeted testing to improve diagnostic stewardship.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148814327","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":"Stakeholder Preferences for Laboratory Result Reporting and Symptom Entry in Emerging Digital Diagnostics.","authors":"Fammi M Parokkaran, Henning Nillius, Carola A Huber, Sven Streit, Michael Nagler","doi":"10.1093/jalm/jfag134","DOIUrl":"https://doi.org/10.1093/jalm/jfag134","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148814302","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}