1. Joseph Perriëns World Health Organization Geneva
Update on the June 6 and 7, WHO Treatment Optimization Diagnostics Workstream meeting
Joseph Perriëns
World Health Organization
Geneva

2. LABORATORY MONITORING OF ART IN ADULTS WHO 2010 "GUIDING PRINCIPLES"
Laboratory monitoring is not a prerequisite for the initiation of ART.
CD4 and viral load testing are not essential for monitoring patients on ART.
Symptom-directed laboratory monitoring for safety and toxicity is recommended for those on ART.
If resources permit, use viral load in a targeted approach to confirm suspected treatment failure based on immunological and/or clinical criteria.
If resources permit, use viral load in a routine approach, measured every 6 months, with the objective of detecting failure earlier than would be the case if immunological and/or clinical criteria were used to define failure.
These recommendations are being re-assessed as part of the development of WHO's 2013 consolidated guidelines on ART
4/18/2019
International AIDS Conference 2012

3. International AIDS Conference 2012
DIAGNOSIS OF HIV INFECTION AND MONITORING ART IN INFANTS AND YOUNG CHILDREN – WHO 2010
It is strongly recommended that all HIV-exposed infants have HIV virological testing at 4 – 6 weeks of age or at the earliest opportunity thereafter.
The following assays (and respective specimen types) are strongly recommended for use: HIV DNA on whole blood specimen or DBS, HIV RNA on plasma or DBS, Up24 Ag on plasma or DBS. "Exercise caution in interpreting negative results when using HIV RNA or Up24 if infant is established on ART."
In infants with an initial positive virological test result, it is strongly recommended that …/…a second specimen be collected to confirm the initial positive virological test result.
HIV VL measurement in monitoring treatment: "As required or symptom directed"
These recommendations are being re-assessed as part of the development of WHO's 2013 consolidated guidelines on ART
4/18/2019
International AIDS Conference 2012

4. Objectives of the meeting
To articulate consensus on technologies which need to be deployed now in HIV programs
To identify which technologies need to be developed in short, medium and longer term
4/18/2019
International AIDS Conference 2012

5. Technology deployment levels
4 - National
Senior lab specialists
3 - Regional/provincial
Lab Specialists/senior technicians
2 - District
Lab Technicians and assistants
1 - Primary care
No laboratory staff – first level trained health care workers
0 - Community outreach
No laboratory staff – outreach workers
4/18/2019
International AIDS Conference 2012

6. Viral load and Early diagnosis in infants (EID)
SAMPLE COLLECTION
Community
Health centre/office
District hospital/first referral centre lab
Provincial/higher level labs
EARLY DIAGNOSIS IN INFANTS
DBS collection for quantitative and qualitative DNA/RNA/TNA
Bundle sample collection materials in one package
Heel stick WB collection if feasible
Venous WB collection for DBS/plasma prep if feasible (VB preferred if laboratory close)
VIRAL LOAD TESTING
DBS collection for quantitative RNA
Mention of any product or manufacturer in this presentation cannot
should not be interpreted as their endorsement by WHO
International AIDS Conference 2012

7. Early diagnosis in infants (EID)
Community
Health centre/office
District hospital/first referral centre lab
Provincial/higher level labs
Ultrasensitive p24 Ag (Perkin Elmer)
But research use only…
Abbott RealTime Qualitative HIV-1(Abbott)
COBAS® AmpliPrep / COBAS® TaqMan® (CAP/CTM) HIV-1 Qual Test v1.0 (RUO) (Roche)
AMPLICOR HIV-1 DNA Test v1.5 (RUO)
( Roche)
Aptima (Gen-Probe) – qualitative
International AIDS Conference 2012
Mention of any product or manufacturer in this presentation should not be interpreted as their endorsement by WHO

8. Viral load testing Community Health centre/office
District hospital/first referral centre lab
Provincial/higher level labs
Abbot m2000RealTime HIV-1 (Abbott)
NucliSENS EasyQ (bioMerieux)
AMPLICOR HIV-1 MONITOR UltraSensitive / Standard Test, v1.5 (Roche)
COBAS® AmpliPrep / COBAS® TaqMan® (CAP/CTM) HIV-1 Test v2.0(Roche)
COBAS® TaqMan® HIV-1 Test, version 2.0 For Use With The High Pure System (manual extraction) (Roche)
VERSANT®HIV RNA 1.0 (kPCR) Siemens
VERSANTHIV RNA 3.0 (bDNA) Siemens
LTR-based HIV-1 RNA RT-PCR (Biocentric)
REVERSE TRANSCRIPTASE
Exavir RT Assay (Cavidi)
International AIDS Conference 2012
Mention of any product or manufacturer in this presentation should not be interpreted as their endorsement by WHO

9. Viral load and Early diagnosis in infants (EID)
Short term needs
POC EID and VL tests for use in health centre/office and first referral lab settings
Medium/longer term needs
Instrument free POC test for use in community
Combo tests (CD4/VL)
Semi-automated devices for deployment at level 2 and up.
International AIDS Conference 2012
Mention of any product or manufacturer in this presentation should not be interpreted as their endorsement by WHO

10. International AIDS Conference 2012
HIV Drug Resistance
NOW
Technology: Only sophisticated technology (TruGene, Viroseq, in house assays) for use at central labs.
Sample collection: Plasma + cold chain or processing within 24 hours. DBS ready – use recommended for countries without cold chain transportation and storage
The current recommendation is to use HIV Drug Resistance testing mainly in surveys to monitor the emergence of resistance at programme level.
FUTURE
Simpler technology needs to be developed – e.g. point mutation assays
The use of HIV Drug Resistance testing in treatment optimization for individual patients might become cost effective – when this will be the case needs to be explored.
4/18/2019 Mention of any product or manufacturer in this presentation should not be interpreted as their endorsement by WHO
International AIDS Conference 2012

11. HIV Serology Community Health centre/office
District hospital/first referral centre lab
Provincial/higher level labs
Rapid HIV serology test – blood, serum, oral fluid
Assess readers for RDT - with communication capability
Develop RDT for HIV and syphilis and HIV and Hepatitis B
Secure access to confirmatory test
Manual ELISA and simple immunoanalyser
Automated immunoanalyser
Mention of any product or manufacturer in this presentation should not be interpreted as their endorsement by WHO
International AIDS Conference 2012

12. Medium and longer term needs
 CD4 Cell Counts
Community
Health centre/office
District hospital/first referral centre lab
Provincial/higher level labs
Sample collection
Venous blood collection in EDTA
Preservatives (ex. Streck, Cytomark, BD) allow testing to be extended up to 7 days
Capillary blood collection by finger prick
Testing technologies 
Manual methods (ex. Coulter beads, Dynabeads)
Phase out as new technology becomes available
POC cytometer (ex. PIMA, miniPOC)
Accelerate pipeline products to increase choice and fit to greater variety of settings
Instrument free POC for Health centre/office use
Dedicated Flow Cytometer (e.g. FACSCount, Cyflow, Guava, PointcareNow, Apogée)
Classical Flow Cytometer (e.g. FACScalibur, Epix, PLG)
Medium and longer term needs
Combo tests (CD4/VL)
Home sample collection tools
Mention of any product or manufacturer in this presentation should not be interpreted as their endorsement by WHO
International AIDS Conference 2012

13. Acknowledgements Participants ASLM CHAI GLI ESTHER MSF CDC GNP+
National Programme managers
UNICEF
Pangaea Foundation
Bill and Melinda Gates Foundation
Global Scientific Solutions for Health
UNITAID
The Murtagh Group
Columbia University
FIND
OGAC/PEPFAR
i+solutions
USAID/DELIVER
UNDP
WHO (HQ, AFRO, CO)
This work was supported by the Bill & Melinda Gates Foundation.
Pangaea Global Health Foundation
provided technical assistance.
International AIDS Conference 2012
Mention of any product or manufacturer in this presentation should not be interpreted as their endorsement by WHO