Background Adequate testing is critically important for control of the SARS-CoV-2 pandemic. Antibody testing is an option for case management and epidemiologic studies, with high specificity and variable sensitivity. However, characteristics of local populations may affect performance of these tests. For this reason, the National Institute of Health (INS) and regulatory agencies in Colombia require verification of diagnostic accuracy of tests introduced to the Colombian market. Methods We conducted a validation study of the Abbott SARS-CoV-2 test for qualitative detection of IgG using the Abbott Architect i2000SR. Participants and retrospective samples were included from patients with suspected SARS-CoV-2 infection, age ≥18 years, and ≥8 days elapsed since initiation of symptoms. Pre-pandemic plasma samples (taken before October 2019) were used as controls. We estimated the sensitivity, specificity and agreement (kappa) of the Abbott IgG test compared to the gold standard (RT-PCR). Results The overall sensitivity was 83.1% (95% CI: 75.4–100). Sensitivity among patients with ≥14 days since the start of symptoms was 85.7%, reaching 88% in samples collected from patients with COVID-19 symptoms onset >60 days. Specificity was 100% and the kappa index of agreement was 0.804 (95% CI: 0.642–0.965). Conclusions Our findings show high sensitivity and specificity of the Abbott IgG test in a Colombian population, which meet the criteria set by the Colombian INS to aid in the diagnosis of COVID-19. Data from our patient groups also suggest that IgG response is detectable in a high proportion of individuals (88.1%) during the first two months following onset of symptoms.
ABSTRACT Objective: To assess an instrument’s psychometric properties to evaluate compliance with institutional tuberculosis infection control measures of Healthcare Providers in the city of Cali. Methods: A cross-sectional study (psychometric type, instrument validation). The development of instrument considered sections from the Guidelines for the preventing of transmission of Mycobacterium tuberculosis in health care settings (CDC), Guidelines for implementation of infection control of tuberculosis in the Americas and Evaluation Control Tools for Hospital-Acquired Infections. The construction of final instrument was carried out with the support of seven experts according to Delphi method, obtaining an instrument comprising three domains and a final number of 65 questions; each item was evaluated, usefulness, format, and validity of the instrument. Contents were assessed with the Aiken coefficient and reliability with Bangdiwala concordance coefficient. R version 3.2.0 application was used. Results: The instrument was made up by 65 items referring to questions regarding administrative, environmental and respiratory measures. It holds acceptable psychometric properties, including good internal structure and suitable reliability. Conclusions: A valid and reliable instrument was obtained to evaluate compliance with institutional measures on tuberculosis infection control in Healthcare Institutions in the city of Cali. Key Words: Tuberculosis; Validation Studies; Delphi Technique. RESUMEN Objetivo: El estudio tuvo como objetivo construir y establecer las propiedades psicométricas de un instrumento para evaluar el cumplimiento de las medidas institucionales de control de infecciones para la tuberculosis en las Instituciones Prestadoras de Salud de la ciudad de Cali. Métodos: El estudio fue de corte transversal (tipo psicométrico, validación de un instrumento). El desarrollo del instrumento consideró secciones de las Guidelines for the preventing of transmission of Mycobacterium tuberculosis in health care settings (CDC), Guidelines for implementation of infecti
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