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QASI: A collaboration for implementation of an independent quality assessment programme in India
Adrienne F A Meyers1,2,3, Michèle Bergeron1, Madhuri Thakar4
1National HIV & Retrovirology Laboratories, Public Health Agency of Canada, JC Wilt Infectious Diseases Research Centre, Winnipeg, Canada.
Insights
Quality Assessment and Standardization programme for Immunological measures relevant to HIV/AIDS (QASI) training improved CD4 testing quality in India. This enhanced CD4 enumeration performance, crucial for effective HIV care management.
Area of Science:
- Immunology
- Public Health
- HIV/AIDS Research
Background:
- The HIV pandemic necessitates accurate CD4+ T-cell counts for patient management.
- Reliable CD4 enumeration is critical for assessing immune status in HIV-infected individuals.
- The Quality Assessment and Standardization programme for Immunological measures relevant to HIV/AIDS (QASI) supports quality improvement in resource-limited settings.
Purpose of the Study:
- To describe how the QASI program facilitated the development of a sustainable national External Quality Assessment (EQA) program for CD4 testing in India.
- To assess the impact of QASI-supported training on CD4 testing quality and inter-laboratory variation.
Main Methods:
- QASI collaborated with India's National AIDS Control Organization and National AIDS Research Institute for technology transfer.
- Training focused on corrective actions and improving the quality of CD4 testing.
- Inter-laboratory variation in CD4 EQA surveys was compared before and after skill development.
Main Results:
- Inter-laboratory variation (coefficient of variation) for CD4 testing was significantly reduced post-training.
- Variation decreased from 14.7% to 10.3% for mid-level CD4 controls.
- Variation decreased from 39.0% to 20.0% for low-level CD4 controls.
Conclusions:
- QASI training equipped Indian institutions with the knowledge to manage a national CD4 EQA program.
- The program established a foundation for providing corrective actions to improve CD4 enumeration quality.
- This initiative demonstrated a significant improvement in CD4 testing accuracy, enhancing HIV care in India.
Objective:
The 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.
Design:
Supported 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.
Results:
Prior 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.
Conclusion:
This 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.
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