Confirmed diagnosis of chronic Chagas disease (CD) requires positive results by two different IgG serology tests. Variable sensitivity has been reported among tests and in different endemic regions. Inadequate specificity presents a particular challenge in low prevalence settings such as the United States. This study provides a direct comparison of the latest-generation IgG serology assays with four previously assessed FDA-cleared tests. Seven hundred and ten blood donor plasma specimens were evaluated by Wiener Lisado and Wiener v.4.0 enzyme-linked immunosorbent assays (ELISAs) and Abbott PRISM Chagas chemiluminescent assay (ChLIA). Sensitivity and specificity were assessed relative to infection status as determined by the original blood donation testing algorithm. All three latest-generation assays demonstrated 100% specificity (95% confidence interval [CI]: 98.6, 100.0). Wiener Lisado, Wiener v.4.0 and Abbott PRISM had sensitivities of 97.1% (95% CI: 95.1, 98.4), 98.9% (95% CI: 97.4, 99.6) and 95.5% (95% CI: 93.2, 97.3), respectively. As with previously evaluated FDA-cleared tests, all three assays had the highest reactivity and sensitivity in samples from donors born in South America and lowest reactivity and sensitivity in specimens from those born in Mexico, with intermediate results in specimens from Central American donors. Wiener v.4.0 had the highest diagnostic sensitivity in all comparisons. Our findings suggest that the latest-generation CD serology tests could improve diagnostic sensitivity without affecting specificity.
Background Chagas disease (CD) is a neglected parasitic disease that affects >6 million people in the Americas, including >200,000 people in the United States (US). Medical provider knowledge of CD is key to decreasing morbidity and transmission; however, few studies have assessed diagnostic practices in US health systems serving at-risk patients. Our study aimed to describe existing provider approaches to diagnosing CD in California and Texas. Methods Site-based research teams at four hospital systems (the University of California [UC] San Francisco [UCSF], San Diego [UCSD], Irvine [UCI], and the Harris Health System [HHS] in Houston, TX) retrospectively identified patients ≥18 years old tested for CD between 2016-2019 and systematically extracted electronic medical record data using complementary electronic data entry forms. Specifically, eligible patients were identified using laboratory orders at UCSF and UCI, while the remaining sites employed SlicerDicer (Epic Systems). This study was approved by institutional review boards at each site. Results We identified 333 patients tested for CD, including 109 from UCSF, 88 from UCSD, 25 from UCI, and 111 from HHS. These patients had 125, 99, 31, and 181 tests sent to commercial laboratories, respectively. Test reactivity varied by system with the greatest percent reactivity among tests ordered at UCI (23%) followed by UCSD (16%), HHS (15%), and UCSF (10%). Among patients who screened positive for CD by commercial assays, confirmatory testing through the Centers for Disease Control and Prevention was sought for 100% at UCI; 59% at HHS, 55% at UCSF, and 40% at UCSD. The medical specialty that most often ordered CD testing was Cardiology at all UC sites (UCSF, 50%; UCSF, 55%; UCI, 35%) and Internal Medicine at HHS (46%; Cardiology ordered 13%). Only one recorded CD test was ordered by an Obstetrics/Gynecology service at any site. Conclusion These early results report positivity rates between our healthcare systems and demonstrate inconsistency in attaining recommended confirmatory testing, as well as a paucity of CD testing ordered through Obstetrics/Gynecology despite risk of congenital transmission. These findings suggest areas of opportunity to improve provider awareness and lay a foundation for standardizing CD diagnostic practices in the US. Disclosures Caryn Bern, MD, MPH, UpToDate (Wolters Kluwer) (Other Financial or Material Support, Author Royalties)
BACKGROUND: As health profession schools implement addiction curricula, they need survey instruments to evaluate the impact of the educational interventions. However, existing measures do not use current non-stigmatizing language and fail to capture core concepts. OBJECTIVE: To develop a brief measure of health profession student readiness to work with people who use drugs (PWUDs) and establish its content validity. METHODS: We conducted a literature review of existing instruments and desired clinical competencies related to providing care to PWUD and used results and expert feedback to create and revise a pool of 72 items. We conducted cognitive interviews with ten pre-clinical health profession students from various US schools of nursing, pharmacy, and medicine to ensure the items were easy to understand. Finally, we used a modified Delphi process with twenty-four health professions educators and addiction experts (eight each from nursing, pharmacy, and medicine) to select items for inclusion in the final scale. We analyzed expert ratings of individual items and interdisciplinary agreement on ratings to decide how to prioritize items. We ultimately selected 12 attitudes and 12 confidence items to include in the REadiness to Discuss Use, Common Effects, and HArm Reduction Measure (RE-DUCE-HARM). Experts rated their overall assessment of the final scale. RESULTS: Twenty-two of twenty-four experts agreed or strongly agreed that the attitudes scale measures student attitudes that impact readiness to work with PWUDs. Twenty-three of twenty-four experts agreed or strongly agreed that the confidence scale measures student selfefficacy in competencies that impact readiness to work with PWUDs. Seven of 72 initial items and none of the 24 selected items had statistically significant differences between disciplines. CONCLUSIONS:The REDUCE-HARM instrument has strong content validity and may serve as a useful tool in evaluating addiction education. Additional research is needed to establish its reliability, construct validity, and responsiveness to change.
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