Accelerate Access to Innovative Point of Care (PoC) HIV Diagnostics: CD4, Early Infant Diagnosis, and Viral Loadchallenges-chat

Access to HIV prevention and treatment has improved significantly over the past years; nevertheless, major gaps remain between need and access to diagnostic tests in resource-limited settings.

This Innovation project is looking to address market shortcomings by accelerating access to high-quality Point-of-Care (PoC) products and overcoming barriers to entry and uptake for new diagnostics, in order to maximize the impact of these technologies on patient outcomes.

Accelerate Access to Innovative Point of Care (PoC) HIV Diagnostics: CD4, Early Infant Diagnosis, and Viral Load

QUICK FACTS

Start Date: 2012-11

Status:

Focus Areas:

Country: , , , , , ,

Keywords: PoC, diagnostics, EID, CD4, VL...

Overview

CURRENT SITUATION

Despite the progress that has been made in recent years in the fight against HIV/AIDS, there are still 1.8 million AIDS-related deaths and 2.7 million new infections every year. Access to HIV prevention and treatment has improved significantly over the past years; nevertheless, major gaps remain between need and access. Effective initiation and management of Antiretroviral Therapy (ART) for HIV/AIDS is delayed due to several reasons, such as limited access to diagnostic tests in resource-limited settings, leading to poorer health outcomes, higher treatment costs, and further spread of diseases.

 

THE CHALLENGE

Three main obstacles to opportune initiation and appropriate management of treatment are:

  • Late initiation in adults due to limited access to CD4 testing to determine ART eligibility.
  • Late initiation in infants due to limited access to Early Infant Diagnosis (EID) testing to determine HIV status of the child.
  • Late switching to second line treatment due to limited access to Viral Load (VL) testing to identify first line treatment failure.

The existing global market for HIV diagnostics does not meet the needs of the 34 million people living with HIV. The sophisticated technologies that are dominating the market are ill-suited to most resource-limited settings, as they are expensive; require complex laboratory infrastructure, stable electricity supply, highly trained laboratory technicians and have limited geographical access. Consequently, even with growing demand for HIV testing and ART programmes are scaled up; the coverage for HIV diagnostic testing remains low: 61% for CD4, 26% for EID and 25% for VL.

 

PROJECT PURPOSE

The overarching goals of the Project are:

  • To enable earlier initiation of patients onto life-saving antiretroviral therapies and facilitating timelier switching of patients onto more effective second line antiretroviral therapy regimens by reducing loss to follow-up and test turn-around time, ultimately reducing mortality and improving patient outcomes.
  • To accelerate global access to a new generation of high-quality PoC HIV diagnostic products and create a healthy, dynamic and sustainable market with affordable prices for PoC Products.

 

TECHNOLOGY

HIV PoC technologies can be transported and operated by non-laboratory technicians at the community level in the health system. This will increase access to diagnostic tests, access to HIV prevention and treatment centers, decrease the loss to follow-up amongst patients, ultimately improving equity by reaching all vulnerable groups. It is expected that new PoC technologies will be simpler with no or minimum training requirements, with much faster test results and potentially lower prices per test.

The project focuses on the following HIV PoC technologies:

  • CD4 testing, which is used for staging and monitoring HIV patients prior to initiation onto antiretroviral therapy (ART).
  • Early Infant Diagnosis (EID) testing for infants less than 18 months of age (this technology can be performed on viral load platforms).
  • Viral Load (VL) testing, which is mainly used for monitoring HIV patients following initiation to ART.

Meet The Team

  • Ignacio Giménez
    UNICEF Supply
    Supply Division, Health Technology Centre
    Project Officer
  • Bibiana Zambrano
    UNICEF Supply
    Supply Division
    Technical Specialist

Partners/Organizations

UNITAID

UNITAID is an international facility established in 2006 for the purchase of treatments and diagnostics for HIV/AIDS, Malaria and Tuberculosis. 

Clinton Health Access Initiative

CHAI  is a global health organization committed to strengthening integrated health systems in the developing world and expanding access to care and treatment for HIV/AIDS, malaria and tuberculosis.

Ministries of Health
World Health Organization (WHO)

WHO is the directing and coordinating authority for health within the United Nations system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries and monitoring and assessing health trends.

Médecins Sans Frontières (MSF)

MSF is an international, independent, medical humanitarian organisation that delivers emergency aid to people affected by armed conflict, epidemics, natural disasters and exclusion from healthcare. 

The Global Fund

The Global Fund is an international financing institution that fights AIDS, tuberculosis and malaria with a 21st century approach: partnership, transparency, constant learning and results-based funding.

PEPFAR

The U.S. President's Emergency Plan for AIDS Relief (PEPFAR) is the U.S. Government initiative to help save the lives of those suffering from HIV/AIDS around the world. 

Project Updates

Request for Proposals (RFP) for implementation pilots and initial scale-up

A Request for Proposals (RFP) was launched on 7 April, with a closing date of 30 April. This tender exercise focuses on the procurement of POC CD4, VL and EID POC/Near POC technologies for implementation pilots and initial scale-up, with the objectives of (1) providing the project countries with a range of high quality HIV POC products to choose from; (2) opening the market entry of new manufacturers and suppliers and increasing competition of innovative HIV POC diagnostics. The tender is currently undergoing technical and commercial evaluations.

6 weeks 3 days ago by igimenez

Global Fund & UNITAID: Up-coming EoI for ERP Diagnostics

On 13 February 2014, The Global Fund to Fight AIDS, Tuberculosis and Malaria and UNITAID posted on their webpages a first Invitation to manufacturers of Diagnostic Technologies for HIV Early Infant Diagnosis to submit an Expression of Interest (EoI) for product evaluation by an Expert Review Panel for Diagnostics (ERPD).

From this pilot phase the ERPD processes and procedures have been fine-tuned and the lessons learned helped in designing the final framework for the consecutive EoI.

The Global Fund and UNITAID will issue the Round 1 of ERPD review in the week starting 23 June 2014.

The up-coming EoI will cover a wider range of diagnostic technologies including CD4, HIV viral load and HIV EID point-of-care technologies, including procedures for dried blood spot (DBS) for lab-based and point-of-care testing platforms.

For more information please visit: http://www.theglobalfund.org/en/procurement/information/ 

13 weeks 3 days ago by igimenez

CHAI-UNICEF Pre-Tender Industry Meeting

In an effort to make patient testing more accessible, UNICEF convened on 20 March 2014 at UNICEF Supply Division, Copenhagen, some of the leading manufacturers of cutting-edge POC HIV diagnostic technologies to announce the launch of a tender exercise in April 2014 for the procurement of POC HIV technologies. UNICEF, CHAI, UNITAID and global health partners and governments, expect that the tender will help to create a healthier POC diagnostics market, foster innovation and expand the supplier base.

The meeting agenda and presentations can be found here.

A press release on the meeting can be found here.

20 weeks 11 hours ago by igimenez

Phase 1 Summary

Request of Expression of Interest- 2012:

UNICEF, CHAI and UNITAID, launched at the end of 2012 a Request for Expression of Interest (REoI) calling upon the industry, academia and others engaged in the development of point of care products for CD4, EID and VL to express their interest in becoming a future supplier of these product categories and to provide information about their existing and future products, including instruments, reagents, consumables, and after-sale support for their products.

 

RFP for Field Evaluation- 2013:

UNICEF, in partnership also with Médecins Sans Frontières (MSF), opened in October 2013 a joint Request for Proposal (RFP) to the industry engaged in the development of PoC products for CD4, EID and VL. The purpose of the tender was to identify and procure, based on countries’ requests, limited quantities of the new PoC technologies for field evaluation purposes only and its outcome revealed there are several innovative technologies that could facilitate treatment initiation and monitoring at the PoC level.

 

Product selection

HIV POC/near POC equipment can be strategically placed and used at the primary and secondary levels of the health system, depending on patient load,  reagent stability (required refrigeration or not), instrument weight (portable vrs bench top) and  need for aditional equipment (centrifuge, etc.). The following graph describes the strengths and weaknesses of the HIV POC/near POC technology according to health system level: 

Health system level
 
Documents:
24 weeks 2 days ago by sblichfeldt

Resources

CD4 Technology performance characteristics Q1-2014

The following table provide details of the performance characteristics of the CD4 PoC technologies in Q1, 2014

UNICEF Quality Assurance Policy for procurement of IVDs

This Quality Assurance (QA) Policy outlines the principles of QA in relation to the selection and procurement of all In-Vitro Diagnostics (IVDs) by UNICEF Supply Division. It harmonises the UNICEF QA policy to the extent possible with the currently accepted global norms and standards for QA of HIV Point of Care (POC) technology.

EID-VL Technology performance characteristics Q1-2014

The following table provide details of the performance characteritics of the EID and viral load PoC and near PoC technologies in Q1, 2014