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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: 22‒25 September 2014
1
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
2
Variations in cassette shape and function
Large variations in shape of buffer and sample well and reading window.
Evaporation holes may resemble sample wells
3
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
4
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
5
An initial comparative assessment showed many differences and irregularities
List of components displayed
All
components
included
Part of the
components
included
NO
Box 42 (73.7%) 4 (7.0%)11
(19.3%)
IFU 21 (36.8%) 35 (61.4%)* 1 (1.8%)
Identification of
sample well:
Nr of
products
Nr of
manufact
urers
A 14/49
(28.6%)5
S26/49
(53.1%)11
W11/49
(2.0%)1
No identification8/49
(16.3%)3
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 interpretation13 (22.8%) 5
6
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
7
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
8
Status of HarT to date (as of Sept 20 2014)
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
11
• 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
Status of HarT to date (as of Sept 20 2014)
12
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 20th )
• Organize 2nd 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