Browsing by Subject "Clinical laboratory techniques"

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    Evaluating Congruence Between Laboratory LOINC Value Sets for Quality Measures, Public Health Reporting, and Mapping Common Tests
    (American Medical Informatics Association, 2013-11-16) Wu, Jianmin; Finnell, John T.; Vreeman, Daniel J.; Emergency Medicine, School of Medicine
    Laboratory test results are important for secondary data uses like quality measures and public health reporting, but mapping local laboratory codes to LOINC is a challenge. We evaluated the congruence between laboratory LOINC value sets for quality measures, public health reporting, and mapping common tests. We found a modest proportion of the LOINC codes from the Value Set Authority Center (VSAC) were present in the LOINC Top 2000 Results (16%) and the Reportable Condition Mapping Table (52%), and only 25 terms (3%) were shared with the Notifiable Condition Detector Top 129. More than a third of the VSAC Quality LOINCs were unique to that value set. A relatively small proportion of the VSAC Quality LOINCs were used by our hospital laboratories. Our results illustrate how mapping based only on test frequency might hinder these secondary uses of laboratory test results.
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    Real-world performance of SARS-Cov-2 serology tests in the United States, 2020
    (Public Library of Science, 2023-02-03) Rodriguez-Watson, Carla V.; Louder, Anthony M.; Kabelac, Carly; Frederick, Christopher M.; Sheils, Natalie E.; Eldridge, Elizabeth H.; Lin, Nancy D.; Pollock, Benjamin D.; Gatz, Jennifer L.; Grannis, Shaun J.; Vashisht, Rohit; Ghauri, Kanwal; Knepper, Camille; Leonard, Sandy; Embi, Peter J.; Jenkinson, Garrett; Klesh, Reyna; Garner, Omai B.; Patel, Ayan; Dahm, Lisa; Barin, Aiden; Cooper, Dan M.; Andriola, Tom; Byington, Carrie L.; Crews, Bridgit O.; Butte, Atul J.; Allen, Jeff; Medicine, School of Medicine
    Background: Real-world performance of COVID-19 diagnostic tests under Emergency Use Authorization (EUA) must be assessed. We describe overall trends in the performance of serology tests in the context of real-world implementation. Methods: Six health systems estimated the odds of seropositivity and positive percent agreement (PPA) of serology test among people with confirmed SARS-CoV-2 infection by molecular test. In each dataset, we present the odds ratio and PPA, overall and by key clinical, demographic, and practice parameters. Results: A total of 15,615 people were observed to have at least one serology test 14-90 days after a positive molecular test for SARS-CoV-2. We observed higher PPA in Hispanic (PPA range: 79-96%) compared to non-Hispanic (60-89%) patients; in those presenting with at least one COVID-19 related symptom (69-93%) as compared to no such symptoms (63-91%); and in inpatient (70-97%) and emergency department (93-99%) compared to outpatient (63-92%) settings across datasets. PPA was highest in those with diabetes (75-94%) and kidney disease (83-95%); and lowest in those with auto-immune conditions or who are immunocompromised (56-93%). The odds ratios (OR) for seropositivity were higher in Hispanics compared to non-Hispanics (OR range: 2.59-3.86), patients with diabetes (1.49-1.56), and obesity (1.63-2.23); and lower in those with immunocompromised or autoimmune conditions (0.25-0.70), as compared to those without those comorbidities. In a subset of three datasets with robust information on serology test name, seven tests were used, two of which were used in multiple settings and met the EUA requirement of PPA ≥87%. Tests performed similarly across datasets. Conclusion: Although the EUA requirement was not consistently met, more investigation is needed to understand how serology and molecular tests are used, including indication and protocol fidelity. Improved data interoperability of test and clinical/demographic data are needed to enable rapid assessment of the real-world performance of in vitro diagnostic tests.