Elecsys HIV Signal-to-Cutoff
Description
Supplementary file 3: Data for 28,952 HIV screening tests on 24,556 unique patients using the Roche Diagnostics Elecsys HIV combi PT assay. All laboratory data involve analysis on serum or plasma. Specific data fields include: unique patient identification number (deidentified), whether result was first or only HIV screening test performed for the specific patient within the retrospective timeframe or a repeat test (further indicating days after initial testing), age in years, sex (as recorded in the electronic medical record), clinical location/unit at time of testing (emergency department, infectious disease clinic, obstetrics, inpatient, or outpatient), HIV screening result (negative or positive), and S/CO value. Supplementary file 4: Data for 163 positive HIV screening tests on 142 unique patients using the Roche Diagnostics Elecsys HIV combi PT assay. All laboratory data involve analysis on serum or plasma. Specific data fields include: unique patient identification number (deidentified), whether result was first or only HIV screening test performed for the specific patient within the retrospective timeframe or a repeat test (further indicating days after initial testing), age in years, sex (as recorded in the electronic medical record), clinical location/unit at time of testing (emergency department, infectious disease clinic, obstetrics, inpatient, or outpatient), S/CO value, result of antibody differentiation assay (Bio-Rad Geenius), results of HIV RNA PCR, days between HIV RNA PCR and the antecedent HIV screen, HIV results classification (Confirmed Positive, Confirmed Positive but Geenius Negative), False Positive/PCR negative, False Positive/PCR not done), and clinical notes.
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During the retrospective analysis period (July 17, 2018 through May 14, 2021), HIV screening was performed using the Roche Diagnostics Elecsys HIV combi PT (Roche Diagnostics, Indianapolis, IN) . A reporting tool within the electronic medical record, known as Epic Reporting Workbench, was used to identify all HIV screening tests performed in the retrospective timeframe. The Elecsys HIV combi PT is a 4th generation HIV assay that simultaneously detects HIV-1 p24 antigen along with antibody to HIV-1 and HIV-2 and outputs a single signal-to-cutoff (S/CO) ratio that translates into a reactive/nonreactive (referred to as positive/negative in this manuscript) qualitative result. An S/CO ratio of 1.00 or greater on the Elecsys assay is considered positive, with repeat testing to verify the result. For all samples with a positive HIV screen, antibody differentiation was performed with the Bio-Rad Geenius HIV-1/HIV-2 Antibody Differentiation assay (Bio-Rad Laboratories, Redmond, WA), an assay that can confirm HIV infection. Final confirmation of HIV infection utilized HIV RNA PCR, testing which required a new specimen from the patient. The data compile information from Epic Reporting Workbench along with chart review of infection status and testing performed outside of University of Iowa.