Harmonization of Real-World Data for Vaccine-Preventable Infectious Diseases: Integration of SARS-CoV-2 Diagnostic and Serologic Data from Multiple Sources

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ID: 322587
2026
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Abstract
Abstract Background The COVID-19 Real World Data infrastructure (CRWDi) was established to study the impact of COVID-19 on patients with immunocompromising conditions. A key challenge was harmonizing SARS-CoV-2 laboratory test results. Methods. There were 27 different test names for SARS-CoV-2 nucleic acid amplification tests (NAAT); and 34 and 26 for SARS-CoV-2 qualitative and semi-quantitative serologic tests, respectively. We validated a strategy to eliminate the multiplicity of test names and results, and harmonized SARS-CoV-2 semi-quantitative serology test results by target antigen and antibody; using published conversion factors to report Binding Arbitrary Units (BAU) on a uniform scale. Results For 5,200,000 patients, the number of unique SARS-CoV-2 test events were: 4,865,431 NAAT; 3,092,198 qualitative; and 834,487 semi-quantitative serology tests, of which 378 522 were anti-spike (S) semi-quantitative serology. In achieving harmonization of semi-quantitative serologic results, semi-log cumulative ordinal plots demonstrated that test results from patients with transplantation exhibited a significantly higher proportion of negative-and-submaximal SARS-CoV-2 anti-S BAU values, when compared to patients with cancer or systemic autoimmune or rheumatic diseases (SARDs), or to a general non-immunocompromised population. Conclusions Complex and heterogeneous test name and result conventions can represent a significant barrier to understanding the clinical relevance of real-world laboratory data. The generalizable methodology described herein permitted successful harmonization of SARS-CoV-2 diagnostic and serologic test data from multiple laboratory sources with administrative claims data, vital status data, and structured data on cancer diagnostics and treatment. This methodology supports exploration of the clinical utility of semi-quantitative serologic data, especially in patients with immunocompromising conditions.
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Authors Yonah Ziemba, Suhyeon Yoon, Harvey W. Kaufman, William A. Meyer, Laura Gillim, Nkemakonam Okoye, Cheryl B. Schleicher, Shahidul Islam, Cristina Sison, Lígia A. Pinto, Lynne Penberthy, James M. Crawford
Journal Open forum infectious diseases
Year 2026
DOI
10.1093/ofid/ofag454
URL
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