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

9

Recommended labelling requirements

10

Recommended labelling requirements

Proximal

Left Right

Lon

g a

xis

Short axis

Distal

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

13

Thank you