Sourcing & Management of Health Products

Viral Load & Early Infant Diagnosis

The 2013 World Health Organization consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection and recommends quantitative viral load testing as the preferred monitoring tool for diagnosing and confirming the failure of antiretroviral therapy.

Qualitative viral load is also the recommended approach to early infant diagnosis of HIV. It is necessary to consider planning and procurement jointly as testing for viral load and early infant diagnosis sometimes uses the same technologies, albeit with different reagents and consumables.

The purchase of viral load and/or early infant diagnosis machines can cost more than US$150,000. Reagents and other consumables needed to produce a test results may vary significantly in price, with a range of US$10-85 per test for the reagents alone.

Analysis by partners demonstrates that high and variable costs associated with the testing technologies, low utilization of machines, frequent test malfunctions, and other challenges significantly limit the impact of these investments. Expanding viral load and early infant diagnosis testing can be complex and requires, in addition to the cost of the products, significant investments in infrastructure such as sample transport networks and people.

A 2015 Global Fund tender established framework agreements with diagnostic manufacturers and aims to make the market for HIV viral load testing more transparent and competitive.

Procurement strategy

The Global Fund’s procurement strategy for viral load and early infant diagnosis focuses on both optimizing existing equipment and investments as well as supporting scale-up. The prime focus of the procurement strategy is to achieve simple, transparent and affordable pricing with optimal contracting models for analyzers and/or reagents for both existing and new investments. The strategy emphasizes maintaining a sustainable, competitive market through:

  • Benchmarking both terms and pricing for Principal Recipients to leverage in the selection and acquisition of these technologies and/or reagents.
  • Providing Principal Recipients with clear information on different contracting modalities across the various platforms and technical options. This includes providing clear, itemized visibility on the total cost of ownership including freight, distributor markups, maintenance and more.
  • Supporting the introduction and up-take of new technologies for new manufacturers whose products do not yet meet the Global Fund Quality Assurance Policy for Diagnostics.
  • Enabling other public health partners to enter into agreements and access the negotiated benchmark prices.

Selection and procurement tool

Our interactive HIV Viral Load and Early Infant Diagnosis Selection and Procurement Information tool provides guidance and clarity for partners procuring these technologies.

  • HIV Viral Load and Early Infant Diagnosis Selection and Procurement Information Tool
    download in English
  • HIV Viral Load and Early Infant Diagnosis Selection and Procurement Information Tool Frequently Asked Questions
    download in English

The tool is continually updated and covers high-level topics including:

  • Country scenarios
  • Programming and funding
  • Request for proposal process and outcomes
  • Platform/technology selection
  • Pricing options
  • Contracting options

We welcome feedback and can provide additional information. Please contact .

Prequalified suppliers

A 2015 tender led to the prequalification of suppliers that provide relevant laboratory technical support services. Our list includes those suppliers.

  • List of Prequalified Viral Load and Early Infant Diagnosis Suppliers
    download in English | Français

Additional resources are available below to download and access.