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NAATOS Project Overview

The Diagnostics Gap in Primary Health Care

Health systems based on primary health care (PHC) have better population health, health equity, health care quality, and lower health expenditure.1 However, access to accurate and affordable diagnostics remains the weakest link in primary care worldwide.2 Without accurate and timely diagnosis many people with treatable diseases (e.g., TB, HIV/AIDS, malaria, pneumonia, hepatitis C, etc.) go undetected, impacting health and economic outcomes for much of the world's population.

Low- and middle-income countries (LMICs) in particular need scalable and regionally produced diagnostic solutions to ensure inclusive and equitable responses to global health threats and local health needs. International resolutions, like the World Health Assembly Resolution 76.5,3 and initiatives, like the Africa Collaborative Initiative to Advance Diagnostics (AFCAD),4 aim to strengthen diagnostic capacity, promote local manufacturing, and harmonize regulatory processes, particularly in low-income countries5. But to realize these targets globally, a sustainable and resilient ecosystem of regional research and product development must exist in LMICs to ensure health priorities are met locally.6 This approach is essential to build resilience in healthcare systems and to foster a responsive and self-sufficient local industry capable of addressing global health threats.

Global Health Labs (GHL) was a non-profit organization that from 2020 to 2025 created and de-risked innovative health technologies with the ultimate goal of enabling manufacturing and commercialization partners to make them available at the point of need. One product of GHL is NAATOS, Nucleic Acid Amplification Test On a Strip. NAATOS is a novel diagnostic platform conceived at GHL that integrates Nucleic Acid Amplification Test (NAAT) and Lateral Flow Assay (LFA) technologies to empower primary health care and diagnostic ecosystems with tests that are sensitive, specific, affordable, easy-to-use, and available.

NAATs are the gold standard for sensitivity and specificity in diagnostics, but their success depends on expensive lab infrastructure (e.g., reliable power, environmental controls, equipment maintenance) that is cost-prohibitive for PHC settings, most of which have only basic lab capabilities. LFAs bridge this gap by offering a low-cost and easy-to-use alternative that can be locally produced and readily deployed at the point of care in PHC, but LFAs lack the sensitivity and specificity of NAATs. NAATOS is a blueprint for obtaining the best characteristics of these technologies without their drawbacks.

NAATOS TB V1

The United Nations Sustainable Development Goal 3.3 targets an end to the global tuberculosis epidemic by 2030.7 Unfortunately, poor diagnostic access and low utilization of TB testing has allowed large-scale treatment delays and disease transmission. However, these issues can be addressed with an accurate, affordable, and accessible diagnostic tool that meets the performance criteria of high sensitivity, specificity (95% specificity), and affordability ($4.5 USD all-inclusive) set out by the WHO.8

The first demonstrated application of NAATOS is as an aid in diagnosis for tuberculosis (TB) in individuals 15 years of age and older with signs and symptoms of pulmonary TB. This version of NAATOS, TB V1, is a modular, instrumented-but-portable diagnostic system that returns genetic confirmation of Mycobacterium tuberculosis in a dorsal tongue swab specimen and accommodates variable patient volumes in near-point-of-care settings.

NAATOS V2

The next generation of NAATOS is a fully disposable, non-instrumented diagnostic platform. This version of NAATOS, V2, combines the core consumable technology of NAATOS TB V1 with a disposable power and control component that replaces the modular instrumentation of NAATOS TB V1. NAATOS V2 is intended as a blueprint for tests without difficult sample preparation requirements in true point-of-care settings. As an example, the design for a multiplexed HPV test is provided.

The Future of NAATOS

The goal of this documentation is to dedicate the NAATOS TB V1 and NAATOS V2 technology to the public domain as a global good, in the hopes that it informs the creation of new and needed diagnostic tools that are accurate, affordable, and accessible.

  1. Stange KC, Miller WL, Etz RS (2023). The Role of Primary Care in Improving Population Health. Milbank Quarterly, 101:795-840. ↩

  2. Think Global Health (accessed Oct 2025). Diagnostic Gaps in Global Health. ↩

  3. World Health Assembly (accessed Oct 2025). Strengthening diagnostics capacity. PDF. ↩

  4. Africa CDC (accessed Oct 2025). Africa Collaborative Initiative to Advance Diagnostics. ↩

  5. Yimer SA, Booij BB, Tobert G, Hebbeler A, Oloo P, Brangel P, et al. (2024). Rapid diagnostic test: a critical need for outbreak preparedness and response for high priority pathogens. BMJ Global Health, 9:e014386. ↩

  6. FIND and Unitaid (13-14 Apr 2023). Building for sustainability: accelerating regional manufacturing for diagnostics. PDF. ↩

  7. WHO (accessed 2025). Incidence of tuberculosis (per 100 000 population per year). ↩

  8. Brümmer LE, Thompson RR, Malhotra A, Shrestha S, Kendall EA, Andrews JR, Phillips P, Nahid P, Cattamanchi A, Marx FM, Denkinger CM, Dowdy DW (25 Jan 2024). Cost-effectiveness of Low-complexity Screening Tests in Community-based Case-finding for Tuberculosis. Clin Infect Dis. 78(1):154-163. ↩