Sourcing & Management of Health Products

COVID-19 Response: Antigen-Detection Diagnostic Test Procurement

15 September 2020

Following the World Health Organization’s interim guidance on antigen-detection in the diagnosis of COVID-19 from 11 September, the Global Fund anticipates being able to support countries in accessing high-performing antigen-detecting rapid diagnostic tests (Ag-RDTs) as soon the specific products receive WHO quality assurance approval, which is expected very soon.

Costing around US$5 per test, with results in 10 to 30 minutes, and with no need to rely on laboratory instruments, Ag-RDTs represent a significant step forward in reinforcing the effectiveness of COVID-19 response strategies.

Whereas automated polymerase chain reaction (PCR) tests still play an essential role in the COVID-19 response strategy per WHO’s guidance, the Global Fund encourages implementing countries to move swiftly and prepare to deploy Ag-RDTs as well. Countries should consider their own context when deciding on Ag-RDTs and carefully consult the interim WHO guidance on “appropriate scenarios” and “implementation considerations” for the use of these tests.

The use of Ag-RDTs in the diagnosis of COVID-19 can be supported by Global Fund grants when:

1. They are used as recommended in the WHO guidance.
2. They meet the quality assurance requirements as per the current Global Fund quality assurance policy supplemented by the Interim Quality Assurance Requirements for the Procurement of COVID-19 Diagnostic Products. The list of COVID-19 Ag-RDTs eligible for Global Fund support will be included in the next update of the List of SARS-CoV-2 Diagnostic Test Kits and Equipments Eligible for Procurement: COVID-19 [ download in English ] .

The Global Fund will support countries to access WHO-approved Ag-RDTs in three ways, once countries have accepted the use of these tests in their national COVID-19 testing strategies:

1. Through the COVID-19 Response Mechanism (C19RM)

• Countries which have already been awarded funds through C19RM for COVID-19 diagnostics, but have not yet spent the full amount, are encouraged to use the remainder for purchasing high-performing Ag-RDTs and automated PCR tests.
• Countries which are receiving C19RM “top-ups” are also encouraged to use a significant proportion of these funds for Ag-RDTs and automated PCR tests.
• Countries can reprogram current C19RM funding.
• Countries which have not yet submitted funding requests for C19RM are encouraged to incorporate these tests.

2. Through grant flexibilities

• Countries which have further scope to use grant flexibilities are encouraged to consider their use for Ag-RDTs.
• Countries should contact their Global Fund Country Team if they have further scope to use grant flexibilities to purchase Ag-RDTs without negative impact on HIV, TB and malaria programming, but have already exceeded the 10% limit across C19RM and grant flexibilities.

3. Using Global Fund and other sources of funding

Once the WHO recommendation is published, the Ag-RDTs will be listed in the Global Fund’s wambo.org platform as soon as they meet Global Fund’s quality assurance requirements.

As we anticipate significant demand for these tests, we encourage countries to move swiftly to confirm their needs with Country Teams and begin preparation to submit a request through wambo.org as soon as funding is confirmed. If not registered to wambo.org, countries may contact their Country Teams to start the order process. Lead times will be posted on the Global Fund website shortly in Category and Product-Level Procurement and Delivery Planning Guide: Indicative Lead Times [ download in English | Français ] .

The Global Fund will also support countries to access high-performing Ag-RDTs through its wambo.org platform even when countries are seeking to procure these using funding from other sources such as the World Bank or domestic resources. Further information is available from Country Teams.