Malaria RDT Harmonization. Co chairs: Jan Jacobs, Institute of Tropical Medicine (ITM) Theodoor Visser, Clinton Health Access Initiative (CHAI)

Transcription

1 Malaria RDT Harmonization Co chairs: Jan Jacobs, Institute of Tropical Medicine (ITM) Theodoor Visser, Clinton Health Access Initiative (CHAI) WHO / UNICEF / UNFPA meeting with manufacturers and suppliers: September 2014

2 Despite their robustness and apparent simplicity, RDTs significantly differ from one to another RDTs vary in Components (e.g. shape of cassette, number of wells, specimen transfer devices, lancets) Procedure (e.g. specimen volume, numbers of buffer drops, reading time). Labeling and terminology for the RDT box and device Cassette packaging Buffer vials Accessories (e.g. type of blood transfer device, lancet) Instructions For Use (e.g. content, order, clarity) The differences can contribute to Performance challenges when end users switch from RDT to another; Additional training requirements for healthcare workers when new RDTs are used or Non-competitive public tenders when product specifications are such that only one or few manufacturers can participate 1

3 Variations in cassette shape and function Large variations in shape of buffer and sample well and reading window. Evaporation holes may resemble sample wells 2

4 Variations and problems with accessories Variety of Lancets Some poorly packed Variable specimen transfer devices. Some with inherent safety concerns (glass) Some with no data supporting performance 3

5 Incorrect or non existing use of international symbols Other errors found include IFU Inconsistencies between text and diagrams - eg. test line order, buffer drops or reading time ; incorrect results interpretation Irregularities in packaging and labelling of RDTs: incorrect labelling of the device, inaccurate instructions, poorly marked RDT boxes missing lot numbers or expiry dates, manual corrections to markings on boxes 4

6 An initial comparative assessment showed many differences and irregularities List of components displayed All Part of the NO components included components included Box 42 (73.7%) 4 (7.0%) 11 (19.3%) IFU 21 (36.8%) 35 (61.4%)* 1 (1.8%) IFU included pictures/drawings in the following categories: Nr of products Nr of manufacturers Sampling 35 (61.4%) 13 Procedure 43 (75.4%) 16 Interpretation 57 (100%) 22 All of the above 34 (59.6%) 12 Pictures/drawings only for interpretation 13 (22.8%) 5 A S W1 Identification of sample well: No identification Nr of products 14/49 (28.6%) 26/49 (53.1%) 1/49 (2.0%) 8/49 (16.3%) Nr of manufact urers

7 Enhanced harmonization of malaria RDT features could contribute to cost savings and reduce end user errors Expected benefits of harmonization could include: Improved procurement and supply management; Reduced training/re-training and supervision requirements; Improved adherence to international standards and manufacturer s and regulators recommended protocols; Increased performance through uniform, easy to follow and consistent labeling and instructions for use (IFU) As a result, harmonization can contribute to Cost savings in procurement through more competitive tenders and fewer trainings Improved health outcomes through fewer end user errors 6

8 An effort by the PSM WG RDT workstream is underway to harmonize RDTs In July 2012, the Diagnostics Work Stream of the RBM PSM WG commissioned the Institute of Tropical Medicine in Antwerp to Assess the current level of similarities and differences between commercially available malaria RDTs, and To identify opportunities and challenges for enhanced and rational harmonization of malaria RDT product characteristics. The results were discussed during a RBM Stakeholder Consultation meeting in early December 2013 with 81 participant including RDT manufacturers, regulators, program implementers and end users (lab trainers and technicians) In January 2014, a Harmonization Taskforce (HarT) comprised of implementers (n = 8), manufacturers (n = 4) and regulatory experts (n = 13) kicked off 7

9 Status of HarT to date (as of Sept ) Out of 66 harmonization proposals suggested by ITM, the Taskforce recommends 54 proposals to be implemented: These proposals mainly relate to harmonizing the labelling of the Instructions For Use (IFU) Labelling of device (e.g. what symbol is used for control line) Labelling of the pouch (e.g. what storage symbols should be included) Labelling of the box (e.g. print a list of components included and required to perform the test) Labelling of accessories (e.g. volume mark on specimen transfer device) => In August 2014, the RBM chairs approved the recommendations 8

10 Recommended labelling requirements 9

11 Recommended labelling requirements Distal Short axis Left Long axis Right Proximal 10

12 Status of HarT to date (as of Sept ) 12 proposals are still outstanding and require additional evidence and could increase the cost of the RDT: Choice of specimen transfer device (e.g. preference for inverted cup) Choice of lancet (e.g. auto retractable vs. simple flat lancet) Requirement to include additional buffer bottle Requirement to include additional accessories (e.g. swab) Desiccant specifications HarT decided not to harmonize procedural items: Reading time Test line order Buffer and blood volumes 11

13 Immediate next steps Publication on HarT recommendations (submission at end of October) Comparative assessment of commercially available RDTs to HarT recommendations Discuss implementation & timeline with regulators and major procurers (October 20 th ) Organize 2 nd consultation ((TBD- Q4 2014/Q1 2015) to Present the recommendations and implementation timeline Develop recommendations on outstanding proposals Discuss applicability (impact, utility) of this harmonization effort for other RDTs 12

14 Thank you 13