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Background Rapid diagnostic tests (RDTs) for coronavirus disease (COVID) are used in low- and middle-income countries (LMICs) to inform treatment decisions. However, to date, it is unclear when this use is cost-effective. Existing analyses are limited to a narrow set of countries and uses. The aim of this study is to assess the cost-effectiveness of COVID RDTs to inform the treatment of patients with severe illness in LMICs, considering real world practice. Methods and findings We assessed the cost-effectiveness of COVID testing across LMICs using a decision tree model, differentiating results by country income level, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) prevalence, and testing scenario (none, RDTs, polymerase chain reaction tests-PCRs and combinations). LMIC experts defined realistic care pathways and treatment options. Using a healthcare provider perspective and net monetary benefit approach, we assessed both intended (COVID symptom alleviation) and unintended (treatment side effects) health and economic impacts for each testing scenario. We included the side effects of corticosteroids, which are often the only available treatment for COVID. Because side effects depend both on the treatment and the patient's underlying illness (COVID or COVID-like illnesses, such as influenza), we considered the prevalence of COVID-like illnesses in our analyses. We found that SARS-CoV-2 testing of patients with severe COVID-like illness can be cost-effective in all LMICs, though only in some circumstances. High influenza prevalence among suspected COVID cases improves cost-effectiveness, since incorrectly provided corticosteroids may worsen influenza outcomes. In low- and some lower-middle-income countries, only patients with a high index of suspicion for COVID should be tested with RDTs, while other patients should be presumed to not have COVID. In some lower-middle-income and upper-middle-income countries, suspected severe COVID cases should almost always be tested. Further, in these settings, negative test results in patients with a high initial index of suspicion should be confirmed through PCR and, during influenza outbreaks, positive results in patients with a low initial index of suspicion should also be confirmed with a PCR. The use of interleukin-6 receptor blockers, when supported by testing, may also be cost-effective in higher-income LMICs. The cost at which they would be cost-effective in low-income countries ($162 to $406 per treatment course) is below current prices. The primary limitation of our analysis is substantial uncertainty around some of the parameters in our model due to limited data, most notably on current COVID mortality with standard of care, and insufficient evidence on the impact of corticosteroids on patients with severe influenza. Conclusions COVID testing can be cost-effective to inform treatment of LMIC patients with severe COVID-like disease. The optimal algorithm is driven by country income level and health budgets, the level of suspicion that the patient may have COVID, and influenza prevalence. Further research to better characterize the unintended effects of corticosteroids, particularly on influenza cases, could improve decision making around the treatment of those with COVID-like symptoms in LMICs., Author(s): Gabrielle Bonnet 1,*, John Bimba 2,3, Chancy Chavula 4, Harunavamwe N. Chifamba 5, Titus H. Divala 6, Andres G. Lescano 7, Mohammed Majam 8, Danjuma Mbo 9, Auliya A. [...]

During the COVID-19 pandemic, the need for making testing readily available was recognized as an important factor for individuals to help make informed decisions, including to isolate or seek care, and for policymakers to control transmission. Toward this end, FIND and the Access to COVID-19 Tools Accelerator funded 16 rapid operational research studies and one implementation project in Africa, the Caribbean, and Asia evaluating the utility, acceptability, and feasibility of different community-based SARS-CoV-2 testing approaches. Here, we discuss common factors and challenges encountered during study implementation. We note six key factors essential for success: 1) collaboration and partnerships; 2) buy-in of local stakeholders, including communities; 3) access to affordable supplies; 4) flexible financing; 5) effective approval systems; and 6) a skilled and motivated workforce. We also note various challenges that must be addressed to fully capitalize on these success factors. In particular, ethics committees are often not well equipped to assess operational research during outbreaks. Outbreaks, especially of novel pathogens, are unpredictable, and transmission dynamics are even more likely to change if the pathogen is prone to frequent mutations, such as SARS-CoV-2. Research that aims to evaluate strategies for curbing transmission must hence be easily and swiftly adaptable. This requires flexibility from researchers, funders, staff conducting the studies, and ethics and other approval committees. International guidelines for evaluating operational research protocols in outbreaks are needed to provide timely evidence to enable informed decisions by individuals, communities, and policymakers, thereby reducing both the human and the economic impact of outbreaks.

To expand access to testing beyond public health facilities and to strengthen surveillance efforts for COVID-19, community testing using COVID-19 antigen-based rapid diagnostic tests (Ag-RDTs) was identified as a major area of focus in Malawi and Zambia. This research aimed to gather evidence on the feasibility and acceptability of community testing in marketplaces. A cross-sectional study with a mixed-methods design was conducted in marketplaces in Malawi and Zambia to understand operational considerations for the implementation of Ag-RDTs for SARS-CoV-2 in a community setting. Programmatic data were collected prospectively as individuals were tested from June to September 2022. COVID-19 testing was done using Abbott Panbio nasal swab test kits. Semi-qualitative questionnaires were administered to individuals who tested, healthcare workers, and site-based personnel. Data were collected electronically via the SurveyCTO platform and analyzed using STATA. In Malawi, 2,348 participants were tested, and in Zambia, 1,723 people were tested for COVID-19. In Zambia, participants were 46% female, with a median age of 28 years, whereas in Malawi, participants were 69% female, with a median age of 37 years. In Malawi, 78 positive cases were reported (3.3% positivity rate), and in Zambia 10 positive cases were reported (0.5% positivity rate). In Zambia, 99% of 300 participants and in Malawi, 92% of 1,158 testers found the market testing experience and sample collection acceptable. Community testing is a feasible and acceptable intervention to increase testing access in Malawi and Zambia, especially when coupled with community awareness campaigns and mobilization.