Summary of the study protocol for the Multicentre Evaluation of HIV viral load technologies as part of the WHO Prequalification of Diagnostics Programme

HIV viral load testing is critical for monitoring antiretroviral treatment, allowing for an early detection of virological failure. Earlier detection of treatment failure allows a better preservation of the efficacy of second-line regimens. In its effort to assist Member States in their decision-making process related to implementation of HIV viral load testing, WHO will be conducting a multi-centre evaluation of HIV virological technologies as part of its Prequalification of Diagnostics programme. Results from this assessment will provide unbiased scientific evidence of the performance and operational characteristics of currently available technologies.

The laboratory evaluation protocol was developed in collaboration with worldwide laboratory experts and in accordance with international best practice. The assessment will be carried out retrospectively using a staged approach and will take place in four different centres over three different WHO regions.

The specific objectives of the laboratory evaluation are to assess:

• Intra-laboratory repeatability (within-run and between-run variability)
• Linearity
• Robustness
• Inter-laboratory reproducibility
• Subtype detection (sensitivity)*
• Specificity*
• Agreement between the different technologies
• Operational characteristics

The analysed data resulting from this laboratory evaluation will be shared with manufacturers and will be made publicly available.

* using locally constructed, clinically derived plasma specimens