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In-country deployment depends on integration in the national laboratory network.ĭiscussion/Conclusion: Despite these limitations, successful implementation models in triage, contact tracing, and surveillance have been proposed, in particular for COVID-19 Ab RDTs. Integration in the healthcare setting requires a target product profile, landscape overview of technologies, certified manufacturing capacity, a sustainable market, and a stringent but timely regulation. Stability: storage temperature was ≤ 30☌ for all but one RDT, in-use and result stability were maximal at 1 h and 30 min, respectively. Shortcomings were reported for buffer vials (spills, air bubbles) and their instructions for use. Usability and Robustness: some COVID-19 Ab RDTs showed high proportions of faint lines (>40%) or invalid results (>20%).
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Kit configuration: For COVID-19 Ag RDTs, flocked swabs should be added to the kit for COVID-19 Ab RDTs, finger prick sampling materials, transfer devices, and controls should be added (currently only supplied in 15, 5, and 1/20 products). Reported specificity was high but has not yet been assessed against tropical pathogens. Sensitivity-Specificity: sensitivity of COVID-19 Ag and Ab RDTs depend on viral load (antigen) and timeframe (antibody), respectively COVID-19 Ab tests have lower sensitivity compared to laboratory test platforms and the kinetics of IgM and IgG are very similar. plasma/serum needs further validation (assessed for only eight (14.8%) products). Sampling: Challenges for COVID-19 Ag RDTs include nasopharyngeal sampling (technique, biosafety) and sample stability for COVID-19 Ab RDTs equivalence of whole blood vs. Only five COVID-19 Ab RDTs (9.3%) were assessed with capillary blood sampling at the point-of-care none of the studies were conducted in sub-Saharan Africa. Results: In total 47 articles on two COVID-19 Ag RDTs and 54 COVID-19 Ab RDTs and IFUs of 20 COVID-19 Ab RDTs were retrieved. Methods: Review of PubMed-published articles assessing COVID-19 RDTs complemented with Instructions for Use (IFU) of products. The present review assesses requirements for implementation of COVID-19 RDTs in sub-Saharan Africa. Introduction: For the COVID-19 (SARS-CoV-2) response, COVID-19 antigen (Ag), and antibody (Ab) rapid diagnostic tests (RDTs) are expected to complement central molecular testing particularly in low-resource settings. 8Division of Infection and Immunity, Faculty of Medical Sciences, University College London, London, United Kingdom.7Innovation and Business Development Unit, Laboratoire Hospitalier Universitaire de Bruxelles - Universitair Laboratorium Brussel (LHUB-ULB), ULB, Brussels, Belgium.6Center for Environmental Health and Occupational Health, School of Public Health, Université Libre de Bruxelles (ULB), Brussels, Belgium.5Clinical Microbiology, Centre National Hospitalier et Universitaire Hubert Koutoukou MAGA, Cotonou, Benin.4Microbiology Unit, Department of Clinical Biology, University Hospital of Kinshasa, Kinshasa, Democratic Republic of Congo.3Department of Clinical Microbiology, National Institute of Biomedical Research, Kinshasa, Democratic Republic of Congo.2Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium.1Department of Clinical Sciences, Institute of Tropical Medicine Antwerp, Antwerp, Belgium.Jan Jacobs 1,2 *, Vera Kühne 1, Octavie Lunguya 3,4, Dissou Affolabi 5, Liselotte Hardy 1 and Olivier Vandenberg 6,7,8