Global Partnership to Deliver 120 Million Affordable, Quality COVID-19 Rapid Tests to LMICs

Recommendation: Expedite a diversified supply strategy with clear guidelines; submitted plans should include a proposed timeline and explicit requisitos near term, and recognize abbotts as a key provider within the industry.

Strategic engagement: Unite parceiros across the industry to widen access, with a diversified procurement pipeline and risk-sharing; mobilize concessional loans to support a mass rollout, and ensure providers meet strict performance criteria, including abbotts as a trusted supplier.

Standards-based assurance and trackability: Implement a standards-driven framework with pre-submission guidelines, conformity checks, and a robust track system to measure deliveries against commitments; emphasize critical milestones and a clear escalation path to emerge bottlenecks in near-real time.

Health-system integration: Highlights include a risk-managed approach to widen access in resource-limited regions, with particular attention to ventilators and vaccine coordination; it provides a stable backbone for the provider network and readiness for future emergencies.

Which LMICs are eligible and how coverage is determined

Recommendation: Prioritize economies in the World Bank’s low-income and lower-middle brackets and require a formal roadmaps and procurement document to verify readiness before inclusion.

Eligibility criteria

• Income classification: Countries listed as low-income or lower-middle by the latest World Bank classification; upper-middle and high-income economies are outside this tranche.
• Governance and transparency: Evidence of an accountable public procurement framework, plus discloses pricing and adherence to anti-corruption practices.
• Demand signals and priorities: National plans include the covid-19 response and other essential screening needs, with a forecast of quantities for the coming year.
• Supply readiness and manufacturing: Access to national or regional distribution networks, adequate storage, validated manufacturing capacity, or reliable import channels for diagnostic kits; emphasis on high-quality production standards and validated molecules in reagents.
• Past performance and continuity: Prior involvement in health initiatives is viewed positively as a signal of transformation and continuing prior initiatives.

How coverage is determined

1. Analytics-based demand alignment: Link national burden estimates to projected quantities; there should be a dozen metrics across use cases, delivery timelines and budget alignment.
2. Readiness assessment: Evaluate roadmaps, logistics capacity, workforce training, and existing distribution channels; timelines and milestones are checked against the documented plan.
3. Financial transparency: Countries discloses pricing practices, procurement routes, and any subsidies; ensure a clear approach to cost control and maintaining lower price points.
4. Risk and governance: Identify unclear data points; where data are unresolved, the country may be placed on a watchlist with additional investigative follow-ups.
5. Scale-up plan: Confirm a pragmatic, phased approach to deployment aligned with priorities and a long-term transformation strategy.

Documentation and evidence

• O pacote de documentos deve incluir roteiros nacionais, uma previsão da procura discriminada por trimestre e uma avaliação da capacidade de produção nacional ou dos canais de importação.
• Incluir resumos de análise, ensinamentos de projetos anteriores e uma abordagem clara ao acompanhamento, avaliação e correção de rumo ao longo do plano.
• Assegurar que o plano divulga potenciais estrangulamentos e apresenta uma estrutura de governação responsável; existe um requisito para publicar as práticas de governação e aquisição para escrutínio público.

Estratégia de preços: subsídios, preços escalonados e acesso acessível para utilizadores finais

Recomendação: implementar três abordagens de preços: (1) preços subsidiados financiados por doadores ou governos para contextos com orçamentos limitados, a fim de impulsionar a acessibilidade para utilizadores finais em todos os sistemas de saúde mundiais, (2) preços escalonados por nível de rendimento e tipo de instalação para garantir uma cobertura equitativa, (3) acordos de partilha de risco e garantia de volume com os fabricantes para garantir o armazenamento e a disponibilidade fiável durante os picos, com preparação de stocks antes dos eventos.

Objetivo geral: manter a acessibilidade, refletindo os custos reais dos artigos manufaturados; os preços devem ser previsíveis, mensuráveis e capazes de suportar a disponibilidade de stock antes dos eventos. As três abordagens devem ser avaliadas continuamente, com contributos extraídos de dados online, insights recolhidos e feedback dos fornecedores para fortalecer a resiliência a longo prazo.

Garantia da qualidade: normas, validação e procedimentos de libertação de lote

Recomendação: Estabelecer um quadro de garantia de qualidade baseado no risco que defina metas de desempenho mínimas para cada classe de diagnóstico e que incorpore critérios de libertação de lotes em SOP aprovadas. Construir um registo de dados centralizado que recolha registos de lotes, resultados e dados de cadeia de custódia para permitir que as autoridades aprovem decisões de libertação de lotes e para garantir a integridade dos dados durante a produção crescente e distribuída. Criar percursos claros para o tratamento de lotes não conformes, não deixando lacunas nos rastos de investigação e abordando os problemas na origem para apoiar uma ampliação mais rápida com risco mínimo. Em casos de exceção, o comité aprova critérios revistos para refletir a evolução das evidências. Manter ciclos de melhoria contínua para abordar pontos de discórdia e para garantir que o planeamento da capacidade se alinha com as exigências de longo prazo.

Normas e validação

Normas e validação: Alinhar com a ISO/IEC 17025 para competência laboratorial, práticas tipo BPL e orientações da OMS adaptadas a ambientes com recursos limitados. Utilizar um método de referência padrão ouro para verificar um subconjunto de cada lote; realizar ensaios contínuos numa rede de laboratórios e locais de campo para compreender a dinâmica do desempenho durante as condições de utilização real. Quando relevante, avaliar os imunoensaios baseados em proteínas dentro da estrutura e documentar o desvio ao longo do tempo. Os dados recolhidos de diversos locais devem informar a otimização do limiar, permitindo melhorias na utilização e uma tomada de decisão mais rápida do que as verificações informais em websites. Para contextos de rendimento médio, incorporar matrizes locais e feedback dos utilizadores para reforçar a robustez e apoiar a expansão.

Libertação de lote, ciclo de vida e melhoria contínua

Libertação de lote e ciclo de vida: Defina critérios de aceitação com documentação rastreável: especificações de matérias-primas, desvios de processo, dados de estabilidade e decisões de libertação de lote. A autoridade emissora aprova a libertação do lote; assegure a rastreabilidade, ligando os números de lote aos dados recolhidos e ao registo mestre. Se ocorrerem desvios ou interrupções, trate-os através de CAPA e implemente, pelo menos, uma investigação mínima com ações corretivas. Mantenha o planeamento da capacidade e o stock de segurança para evitar lacunas no fornecimento; monitorize a utilização em todas as instalações e ajuste os planos de produção para uma resiliência a longo prazo. Incentive a colaboração contínua entre os programadores e os fabricantes, com esforços coletivos apoiados por dashboards em websites para monitorizar a adesão e otimizar o fluxo de trabalho de ponta a ponta.

Cronograma e alocação de aquisições: marcos, encomendas e prazos de entrega

Comece com um plano holístico e progressivo de 12 semanas para otimizar as quantidades alocadas, reduzir o fornecimento fragmentado e impulsionar o cumprimento. Avance para um centro de coordenação único para satisfazer rapidamente a procura, focando-se em manter um stock base completo em locais de alta prioridade, incluindo enfermeiros em equipas da linha da frente. Garanta acordos com fornecedores que melhorem a visibilidade das janelas de produção e cumprimento para reduzir alterações de última hora e melhorar a fiabilidade.

Marcos e sequenciação: Até ao final da 2ª semana, finalizar os acordos-quadro; até à 4ª semana, garantir as alocações iniciais; até à 6ª semana, iniciar os envios simultâneos a partir dos centros regionais; até à 8ª semana, verificar os níveis de stock e ajustar as alocações; até october, complete a primeira vaga de alocado encomendas que abrangem zonas prioritárias, visando um alcance de milhões de unidades. Tratar ingredients e núcleo inativado componentes como fluxos separados, com full rastreabilidade e acordos em vigor para cada fornecedor a apoiar entregando no prazo.

Encomenda de janelas e prazos de entrega: estabelecer janelas fixas para prevenir fragmentado de aquisição e manter uma cadência previsível. No caso de artigos standard, preveja 4 a 6 semanas desde a encomenda até à receção; para componentes de longo prazo ou da cadeia de frio, 8 a 12 semanas. Crie uma margem de segurança de 4 semanas para absorver os choques. Tire partido de loans ou linhas de crédito para sustentar o financiamento da linha da frente durante os períodos de pico de atividade. Garantir alocado as quantidades estejam alinhadas com a capacidade regional e recorram a dashboards para monitorizar projects across sites to meet demand, while keeping fulfillment pace steady.

Allocation strategy and fragmentation prevention: shift from dispersed distribution to regional pools and concurrent shipments, with clear rules for allocation by facility type, ensuring a base stock for hospitals, clinics, and mobile units. Use formal acordos to govern reallocation when needs shift, and continuously assess implications e effects on service coverage and staff workload, especially for nurses, to meet demand without compromising safety and quality.

Financing and risk management: mobilize loans to bridge cash flow gaps and maintain full coverage of priority items. Work with donors and lenders to secure multi-year acordos that support scale-up while preserving flexibility for shifting priorities. Schedule regular reviews to enhancing coordination between production, packaging, and distribution, and to address implications of any stockouts or supplier delays, moving moved shipments into adjusted allocations to keep fulfillment on track.

Monitoring and next steps: deploy an integrated dashboard to track projects, october milestones, and stock status, and to assess implications for coverage and transmission risk. Use findings to guide a phased creation of additional waves, focusing on optimizing ingredients, expanding capacity, and ensuring continued enhancing collaboration among procurement, warehousing, and clinical teams. Once initial waves are stabilized, begin expansion to higher-demand regions while keeping the base stock intact and continuing to deliver entregando value to frontline facilities.

Distribution and logistics: storage, cold chain (if applicable), and last-mile delivery

Recommendation: Build a tiered, auditable distribution network that pre-positions covid-19-related diagnostic kits at regional depots, maintains stockpiling logic, and uses a real-time sheet for batch, expiry, and throughput tracking. Execution depends on a clearly called bill-of-materials and instituted engagement with local distributors. This approach allows ongoing operations to move swiftly to sites, reducing waste, and targeting steady performance under changing circumstances. starting july, align with milestones and maintain readiness to scale in the coming months, representing a reality where best-practice routes can be implemented quickly with close collaboration among stakeholders and adopted policies that guide pricing and eligibility, and ensuring supplies are prioritized, representing the industry’s demand in planning cycles and emphasizing economic efficiency.

Storage and cold chain management

The storage solution must differentiate between items requiring refrigeration and those stable at ambient temperature. Maintain 2-8 C for refrigerated stock when applicable, and ensure validated packaging supports transport to non-refrigerated points in up to 25 C environments for short durations. Use FEFO (first-expiry-first-out) procedures and a temperature-monitoring system that logs readings on a real-time sheet; escalate any excursion within hours. For items like quickvue-ready kits, confirm compatibility with regional cold-chain capabilities and avoid prolonged exposure that could accelerate degradation. Keep a maintained inventory file that includes lot numbers, expiration dates, and current stock levels, and ensure the bill-of-materials is updated after each delivery.

Last-mile delivery and engagement

Plan routes to clinics, pharmacies, and community posts with a mix of direct shipments and partner-led drops, prioritizing priority regions with the highest need and lowest access. Engage local distributors, community health workers, and mobile units to reduce delays and improve uptake. Use a simple order flow that allows field teams to place requests in real time, and aim for expedited movement to sites while preserving supply integrity. The approach should be aligned with mandates and policies, and include medicare-like reimbursement considerations when relevant. Maintain transparency with a clear order target, and report progress on a monthly basis to a representative industry council.

Contributors: roles, data sharing, and attribution for partners

Recommendation: Establish a formal governance framework that assigns clear roles, specifies data-sharing rights, and defines attribution rules to accelerate access and accountability across developing regions.

Roles matrix: clear delineation of duties across development, quality, logistics, and field operations. The core team should include data steward, privacy officer, deployment lead, country focal pointe external evaluator. Engage john, jansen, and medtronic as advisory partners to participate in cross-functional teams. Build a longer-term roadmap that emphasizes develop capabilities, developing local capacities, and another cycle of training to enhance competencies. Align with local regulators, health bodies, and supply chain actors to ensure more resilient operations.

Data sharing and interoperability: adopt a harmonized model for diagnostics data, with standardized fields for test types, lot IDs, storage, and device interoperability. Implement a virtual workspace for secure collaboration, while ensuring validation and privacy controls. The policy requires that a partner discloses data through approved channels. Data-use agreements formalize access and ensure a traceable audit trail to support validation and accelerate learning across sites.

Attribution and recognitions: maintain an auditable log of contributions by party, time, and role to support milestone assessments. Use gatherings e virtual forums to participate in decision-making. Ensure clarity about recognition across bodies such as ethics boards, national health committees, and donor groups. The system should make evident who was responsible for key interventions and the decisions that followed.

Security and privacy: data processing should be afforded strong governance controls; implement role-based access, encryption, and least-privilege data views to reduce exposure. Use virtual workspaces to coordinate, increasing efficiency while keeping patient information protected. Ensure that all parties can participate in risk assessments and incident response drills to strengthen resilience.

Interventions and capacity-building: run joint trainings to enhance field capabilities; execute a collaborative transformation that reduces duplication and builds shared tooling. Pilot ventilator maintenance modules alongside diagnostics deployment to demonstrate cross-sector applicability. The approach aims to reduce waste, shorten cycles, and improve patient trajectories in the hardest-hit regions.

Monitoring and evaluation: establish visible milestone markers and evident progress signals; publish anonymized metrics that show increasing coverage, utilization, and quality improvements. Use a governance body to review validation results and adjust plans; this helps ensure that the mesmo standards are upheld across sites and bodies.

Next steps: ensure ongoing transparency, convene gatherings, and foster active participate across all partners to sustain longer-term momentum and digital readiness. The team should understand local contexts, and continue to develop more scalable diagnostics, and to accelerate adoption of evidence-based interventions in low-resource settings.