Vincent Habiyambere & Paula Fernandes

WHO AMDS, Sep 2014

• Tests for each tiered network level defined

• Importance of standardization recognized

Maputo 2008

• TWG 1 Goal: Standardization and case studies

• TWG 2 Goal: Specifications to facilitate (a) procurement HIV

diagnostic tests in adults and children (b) monitor treatment

outcomes in patients on ART

Geneva 2008 (AMDS/EHT meeting)

• Tool revised from meeting outcomes

• Released Jan 2014

Geneva 2012 (AMDS/EHT meeting)

ASLM

CDC

CHAI

CPS

Crown Agents

FIND

Global Fund

GSSHealth

SCMS

STB

UNDP

UNICEF

USAID

USAID/Deliver, JSI

USAID/SIAPS, MSH

WHO/HIV/TAC

WHO/HIV/TCO (AMDS)

WHO AFRO

WHO/EHT/DLT

Enable purchasers and suppliers to understand end user requirements;

Provide detailed specifications to improve procurement;

Itemize commodities by test;

Approximate quantities of commodities by test;

List required and optional accessories;

List other relevant data e.g. shelf life, installation.

Buyers, logisticians and

national program officers

•Develop correct specifications

•List required accessories

•List optional accessories

• Identify installation and

training requirements

• Identify quality standards

Staff responsible for laboratory

logistics, supply chain

management, service planning

and scale-up

•Determine appropriate

laboratory network level

• Identify required additional

equipment

•Determine required quantities

• Identify shipping and storage

conditions

•Approximate shelf-life

Laboratory managers,

supervisors and technical staff

• Identify suitable equipment

for the laboratory network

level

•Determine need for

equipment installation,

training, calibration and

regular servicing

•Understand equipment

operating conditions

•Recognize required quality

standards

• Identify items required by test

to assist in work flow

planning

Training of laboratory, program and logistics managers – approx. 60

All 5 ROs and Country Offices

Positive feedback from procurement staff

Useful input for updates

Surveys planned

Table re-organization and additional information on tests required

RDTs/EIAs not updated in January 2014 edition

Technologies obsolete or removed from WHO and GF lists for quality issues

New technologies WHO PQ’d and/or included on the GF/other partner lists

New technologies added

Obsolete technologies removed

Catalogue numbers, shelf life, storage conditions, accessories updated

Performance characteristics for NA-based test analyzers and CD4 enumerating instruments significantly expanded

Division of Section I adapted

Current version Name of analyzer

Catalog number

Description

Pre-installation requirements & Operating conditions

Items supplied with analyzer & Required accessories & Optional accessories

Throughput

Installation & Training

Maintenance/calibration

URL

2014 revision Name of analyzer

Name of test

Catalog number

Description

Pre-installation requirements & Operating conditions

Items supplied with analyzer & Required accessories & Optional accessories

Turnaround time & Capacity per run

Throughput

Sample needed and stability

Sample preparation and protocol complexity

Reagent stability and storage requirements

Cost/test & Cost/instrument

Installation & Training

Maintenance/calibration

Internal QC & External QA

URL

New technologies (PQ & partner lists) ◦ 31 added (more pq’d items expected)

◦ 26 deleted

Test table revision ◦ Specimen type, Eligibility Criteria, Regulatory Status

◦ No. of tests, UN hazard code deleted

Revised structure of specification tables ◦ Columns “Manufacturer”, “Price range” added

Separated RDTs and EIAs

Alphabetical order by technology, not manufacturer

Updates: catalog nos., shelf life, storage conditions,

accessories, items required to perform test

Price range of lab commodities

Overall input on the draft which will be circulated for review before publication (technical and non-technical)

Contact information (to ensure tool info is up to date)

Joint publication Possible online version Dissemination through workshops and field

visit (actively collect feedback as the tool is used)