- All > Quality and Safety: Medicines > Quality Assurance
- All > WHO Prequalification of Medical Products > WHO-UNICEF-UN Project
- All > Diagnostics and Laboratory Technology > Evaluation of Diagnostics
- Keywords > good quality in vitro diagnostics (IVDs)
- Keywords > guidelines and standards
- Keywords > labelling
- Keywords > prequalification - In Vitro Diagnostics assessment
- Keywords > prequalification – diagnostic assessment
- Keywords > procurement - RDTs for malaria
- Keywords > product testing - malaria RDTs
- Keywords > rapid diagnostic test (RDT)
- Keywords > in vitro Diagnostic (IVD)
(2015; 45 pages)
Over the past 2 years, the WHO Global Malaria Programme (GMP) has been working with the Roll Back Malaria Secretariat, the Roll Back Malaria Procurement and Supply Management and Case Management working groups and partners and the Institute of Tropical Medicine, Antwerp, to review the comparability of malaria rapid diagnostics tests (RDTs) and their compliance with international standards and best practice for labelling and instructions for use (IFU).
The objective was to determine how malaria RDTs could be harmonized to increase their inter-changeability and ease of use and to reduce the burden of retraining and the risk of operator errors when products are replaced or switched in health care settings. This review covers design, packaging, labelling, IFU and the main procedural characteristics (including blood volume, buffer volume, interpretation, reading time). International standards, regulatory documents and published literature were reviewed to identify best practices in these areas.
The initial outputs of the exercise were reviewed and discussed by a large group of stakeholders, including manufacturers, “implementers” and regulatory experts, in December 2013, and subsequently amended, refined and recently published by a “harmonization task force”. To complement the review, additional analyses were conducted to determine variation and similarities in the procedural characteristics4 of RDTs submitted to rounds 1–5 of the WHO malaria RDT product testing programme.
The stakeholders and the subsequent harmonization task force recommended harmonization of the labelling of the device, boxes and accessories and of the language and format of the IFU. The task force did not make any recommendations about procedural characteristics, such as RDT buffer volume or reading time, but classified these as “outstanding”, for further discussion on specifications and feasibility.
WHO recognizes that building on this comprehensive work could promote compliance with best practices in product labelling and packaging, and thus facilitate RDT procurement, deployment and ease of use. To this end, WHO/GMP held a stakeholder consultation to: review the outputs of the harmonization task force, to make recommendations on requirements for labelling and IFU and to discuss how to encourage compliance with best practices. Items classified as outstanding by the task force were also discussed.
The purpose of the report is to provide a succinct summary of the meeting and the recommendations on RDT terminology, packaging and labelling. Verbal and written feedback on the IFU was obtained from participants outside the plenary sessions because of time restrictions.