QASI: A collaboration for implementation of an independent quality assessment programme in India.

Adrienne F.A Meyers,Paul Sandstorm,Madhuri Thakar,Philip Abraham,Trevor Peter,Alexandre Martel,Bharati Mahajan,Tao Ding,Michèle Bergeron,Terry B Ball,Namita Singh,Sandhya Kabra

doi:10.4102/ajlm.v5i2.442

Abstract

ObjectiveThe HIV pandemic remains a significant global health concern. Accurate determination of CD4+ T-cells in patient samples relies on reliable CD4 enumeration. The Quality Assessment and Standardization programme for Immunological measures relevant to HIV/AIDS (QASI) programme of the Public Health Agency of Canada provides clinical laboratories from resource-limited countries with a mechanism to evaluate the quality of CD4 testing and develop the implementation of an independent national External Quality Assessment (EQA) programme. This study describes how QASI helped develop the capacity for managing a sustainable national CD4 EQA programme in India.DesignSupported by the Public Health Agency of Canada and Clinton Foundation HIV/AIDS Initiative, QASI engaged with the National AIDS Control Organization and the Indian National AIDS Research Institute to assist in technology transfer in preparation for the implementation/management of an independent CD4 EQA programme. Technology transfer training was provided to support corrective actions and to improve the quality of CD4 testing. Inter-laboratory variation of EQA surveys between pre- and post-skill development was compared.ResultsPrior to training, coefficient of variation values were 14.7% (mid-level CD4 count controls) and 39.0% (low-level). Following training, variation was reduced to 10.3% for mid-level controls and 20.0% for low-level controls.ConclusionThis training assisted the National AIDS Control Organization and the Indian National AIDS Research Institute in identifying the information necessary for management of an EQA programme, and developed the foundation for India to provide corrective actions for sites with challenges in achieving reliable results for CD4 enumeration. This led to a demonstrable improvement in CD4 testing quality and illustrates how country-specific training significantly improved CD4 enumeration performance for better clinical management of HIV care in India.

Highlights

Infection by HIV and progression to death in the form of AIDS is responsible for significant morbidity and mortality worldwide, despite considerable efforts to prevent and/or treat the disease
New targeted efforts aimed at the HIV epidemic are focused on the 90-90-90 initiative proposed by UNAIDS that by 2020, 90% of individuals living with HIV will know their status, 90% of those infected with HIV will have access to ongoing antiretroviral therapy (ART) and 90% of those on ART will achieve suppression of HIV infection.[7]
QASI has more than 20 years of experience in assisting the implementation of activities for quality improvement and best practice for quality assurance in developing countries and, as a part of its overall objective, QASI is dedicated to capacity building and training for countries wishing to develop and implement their own national or regional quality assessment programmes for CD4 enumeration

Summary

Introduction

Infection by HIV and progression to death in the form of AIDS is responsible for significant morbidity and mortality worldwide, despite considerable efforts to prevent and/or treat the disease. Immune responses to HIV infection are largely mediated by CD4 T-lymphocytes – depletion of which reflects disease progression and AIDS.[3,4,5] While the latest World Health Organization Guidelines recommend treatment for all infected with HIV, irrespective of CD4 counts, many resource-limited countries have yet to adopt these recommendations due to constraints, and CD4 enumeration remains the hallmark for staging and monitoring patients on ART.[6] New targeted efforts aimed at the HIV epidemic are focused on the 90-90-90 initiative proposed by UNAIDS that by 2020, 90% of individuals living with HIV will know their status, 90% of those infected with HIV will have access to ongoing ART and 90% of those on ART will achieve suppression of HIV infection.[7] As such, it is critical to properly and rapidly detect HIV infection and responses to therapy. Reliable CD4 measurements are critical to clinical decision-making in situations where viral load data is unavailable.[8,9]

Methods

Results

Conclusion