Two-phase Bayesian latent class analysis to assess diagnostic test performance in the absence of a gold standard: COVID-19 serological assays as a proof of concept.

Autor: Camirand Lemyre F; Faculté des sciences, Université de Sherbrooke, Sherbrooke, Quebec, Canada.; Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada., Honfo SH; Faculté de médecine et des sciences de la santé, Université de Sherbrooke, Sherbrooke, Quebec, Canada., Caya C; McGill Interdisciplinary Initiative in Infection and Immunity, Montreal, Quebec, Canada., Cheng MP; McGill Interdisciplinary Initiative in Infection and Immunity, Montreal, Quebec, Canada.; Division of Microbiology, Department of Clinical Laboratory Medicine, Optilab Montreal - McGill University Health Centre, Montreal, Quebec, Canada.; Division of Infectious Diseases, Department of Medicine, McGill University Health Centre, Montreal, Quebec, Canada., Colwill K; Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Sinai Health, Toronto, Ontario, Canada., Corsini R; McGill Interdisciplinary Initiative in Infection and Immunity, Montreal, Quebec, Canada., Gingras AC; Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Sinai Health, Toronto, Ontario, Canada.; Department of Molecular Genetics, University of Toronto, Toronto, Ontario, Canada., Jassem A; British Columbia Centre for Disease Control Public Health Laboratory, Vancouver, British Columbia, Canada., Krajden M; British Columbia Centre for Disease Control Public Health Laboratory, Vancouver, British Columbia, Canada., Márquez AC; British Columbia Centre for Disease Control Public Health Laboratory, Vancouver, British Columbia, Canada.; Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, British Columbia, Canada., Mazer BD; COVID-19 Immunity Task Force, Secretariat, McGill University, Montreal, Quebec, Canada.; Division of Allergy and Immunology, Montreal Children's Hospital, McGill University Health Centre, Montreal, Quebec, Canada., McLennan M; British Columbia Centre for Disease Control Public Health Laboratory, Vancouver, British Columbia, Canada., Renaud C; Affaires Médicales et Innovation, Héma-Québec, Montreal, Quebec, Canada., Yansouni CP; McGill Interdisciplinary Initiative in Infection and Immunity, Montreal, Quebec, Canada.; Division of Microbiology, Department of Clinical Laboratory Medicine, Optilab Montreal - McGill University Health Centre, Montreal, Quebec, Canada.; Division of Infectious Diseases, Department of Medicine, McGill University Health Centre, Montreal, Quebec, Canada.; J.D. MacLean Centre for Tropical Diseases, McGill University, Montreal, Quebec, Canada., Papenburg J; McGill Interdisciplinary Initiative in Infection and Immunity, Montreal, Quebec, Canada.; Division of Microbiology, Department of Clinical Laboratory Medicine, Optilab Montreal - McGill University Health Centre, Montreal, Quebec, Canada.; Division of Pediatric Infectious Diseases, Department of Pediatrics, Montreal Children's Hospital, Montreal, Quebec, Canada.; Department of Epidemiology, Biostatistics, and Occupational Health, School of Population and Global Health, McGill University, Montreal, Quebec, Canada., Lewin A; Faculté de médecine et des sciences de la santé, Université de Sherbrooke, Sherbrooke, Quebec, Canada.; Affaires Médicales et Innovation, Héma-Québec, Montreal, Quebec, Canada.
Jazyk: angličtina
Zdroj: Vox sanguinis [Vox Sang] 2023 Dec; Vol. 118 (12), pp. 1069-1077. Date of Electronic Publication: 2023 Oct 18.
DOI: 10.1111/vox.13545
Abstrakt: Background and Objectives: In this proof-of-concept study, which included blood donor samples, we aimed to demonstrate how Bayesian latent class models (BLCMs) could be used to estimate SARS-CoV-2 seroprevalence in the absence of a gold standard assay under a two-phase sampling design.
Materials and Methods: To this end, 6810 plasma samples from blood donors who resided in Québec (Canada) were collected from May to July 2020 and tested for anti-SARS-CoV-2 antibodies using seven serological assays (five commercial and two non-commercial).
Results: SARS-CoV-2 seroprevalence was estimated at 0.71% (95% credible interval [CrI] = 0.53%-0.92%). The cPass assay had the lowest sensitivity estimate (88.7%; 95% CrI = 80.6%-94.7%), while the Héma-Québec assay had the highest (98.7%; 95% CrI = 97.0%-99.6%).
Conclusion: The estimated low seroprevalence (which indicates a relatively limited spread of SARS-CoV-2 in Quebec) might change rapidly-and this tool, developed using blood donors, could enable a rapid update of the prevalence estimate in the absence of a gold standard. Further, the present analysis illustrates how a two-stage BLCM sampling design, along with blood donor samples, can be used to estimate the performance of new diagnostic tests and inform public health decisions regarding a new or emerging disease for which a perfect reference standard does not exist.
(© 2023 International Society of Blood Transfusion.)
Databáze: MEDLINE
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