In vitro diagnostics and laboratory technology

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

EMERGENCY USE ASSESSMENT AND LISTING (EUAL) PROCEDURE


Request for Proposals

22 MARCH 2017

The Prequalification Team is publishing a request for proposals for consultancy services relating to - developing and maintaining the Quality Management Systems (QMS) and assuming the responsibility for on-going system maintenance and effectiveness of operations within the Prequalification Team.

The services required by the World Health Organization (WHO) are more fully described in the below attached Terms of Reference and Request for Proposals.

Proposals should be submitted to WHO in writing no later than 5 April 2017 at 17:00 hours Geneva time ("the closing date"), by email at the following address: mubangizid@who.int

ESSENTIAL MEDICINES AND HEALTH PRODUCTS


Contact us

Prequalification Team - Diagnostics
Regulation of Medicines and other Health Technologies
Department of Essential Medicines and Health Products
(HIS/EMP/RHT/PQT)
World Health Organization
20 Avenue Appia
1211, Geneva 27
Switzerland
diagnostics@who.int