Update on EID testing: Global Progress & Emerging Challenges - Shaffiq Essajee - May, 2013
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Update on EID testing:
Global Progress & Emerging Challenges
Shaffiq Essajee - May, 2013
Lab testing is important all along the pediatric HIV prevention
and treatment continuum, but EID is a critical component
HIV Ab CD4 for Infant ART monitoring
test ART Diagnosis in mothers and
eligibility children
HIV - pregnant woman
HIV + pregnant woman
Infant diagnosis is important for PMTCT program
monitoring but essential for identification of infected
infants for ART
However, there are challenges to scaling up the service
and translating that service to better outcomes
Challenge: Over 75% of exposed infants never even receive an
EID test
EID has been scaled up from around 80K in 2007 to >1.2m in 2011. ~24% of need
The remaining 76% represent HIV+ mothers that were never tested, infants known to
be HIV exposed but LTFU or incident maternal HIV infection during pregnancy and BF
- Number of EID Tests - - Global coverage of EID testing -
1,400,000
1,200,000 Total Need
1,200,000
15x increase Tests Performed
24%
1,000,000
800,000
600,000
400,000
80,000
200,000
76%
-
tests 2007 2008 2009 2010 2011
~1.4 million HIV-exposed babies
Solution: Build maternal HIV testing and exposed infant EID testing
into the entire care continuum
1 Promote 2 Offer birth HIV 4 Delivery of EID
HIV testing testing to women results at 10
uptake at who never tested week EPI visit
ANC before or who
tested neg in ANC
Pregnancy Birth 6-week 10-week
3
Repeat offer of HIV test to women who never tested before or who tested neg
in ANC
Identification of mothers needing prophylaxis/treatment: prevents transmission
to HIV-exposed (but still negative) infant and improves her health and survival
Provide EID testing for all exposed infants
Identified HIV-positive infants can be immediately referred for pediatric ART
Source: CHAI Zambia
Challenge: For the 24% that DO get a test, a large proportion are lost
along the continuum of care
EID test DBS sample sent Results returned to Referral for Confirmatory
performed to laboratory facility + mother ART Test/ART
1 2 3 4 5
High loss High loss
point point
6 7
Ongoing Final HIV
follow-up status
of exposed High loss
infant
point
The highest points of loss continue to be in getting positive results
returned to mothers [50%], getting infants referred for ART [40%] and
following infants for confirmatory testing if initially negative
5
Solution: In Kenya, a partnership with HP has helped to create a
national automated results return system linked to SMS printers
Safaricom
Auto SMS to
Sample supports
clinic
information
entered into
confirming the auto
receipt and SMS
data terminal
providing
batch number
function
EID sample
received at
lab
Info Sample
HP provided enters processed and
data result entered
& supports into data
servers “cloud” terminal
Paper result
dispatched to
clinic
Auto SMS
sent to clinic
with result
Results are posted in real time into an online database
Solution: In Uganda, establishing an EID care point has helped to
ensure that exposed infants receive adequate care and follow-up
• Each site chooses the
Central lab location of EID care point
• The EID care point is
Site lab
equipped with a
PERSON, MEDS, TEST
EID Care Point EQUIPMENT and TOOLS
(within existing clinic)
• Caregivers return to EID
care point for every
MCH/PMTCT follow-up visit until no
ART Clinic longer exposed
Ped Ward OPDA range of complementary tools and aides simplifies work at the EID care point Visit Schedule Exposed Infant Clinical Chart Exposed Infant Care Guidelines Exposed infant registers Triplicate referral forms
Results of the pilot suggest significant improvement in a number of
areas
1 Exposed infants now
being picked up
earlier and from
many health
departments, not
just PMTCT program
DBS testing volumes 4
2 Retention of HIV-Positive Infants
have increased by Soroti and Serere Health Centers
almost 50%
The percentage of
3
exposed infants
initiated on CTX
75% received results and 96%
increased to 99%
of positive infants were
enrolled at an ART clinicSolution: PoC testing enables same day results and so may
reduce LTFU
Product Test Type Turnaround Max
Name Time Throughput
• Qualitative EID
• Gag p24 antigen • 40 minutes • 16 tests per
Northwestern
detection per test day
• Heel-prick blood
• Qualitative EID,
Quantitative VL
• 60 minutes • 5-10 tests
Alere NAT • NAT-based test
per test per day
• Finger-stick or
venous blood
• Qualitative EID,
Semi-quantitative
SAMBA EID VL • 60 minutes • 25-30 tests
and VL • Isothermal per test per day
amplification
• Blood or plasmaIn Mozambique CHAI with MoH evaluated Alere NAT PoC against
traditional PCR for EID
~8% MTCT
Transmission
60% were
under 2 m
Jani et al. Abs 607 CROI 2013PoC testing performs as well as conventional DNA PCR
Jani et al. Abs 607 CROI 2013Challenge: Infants that get a test are getting it late
http://www.nascop.org/eid
14The peak of infant mortality due to HIV is well before median age
at testing
Focus
As we get better at preventing
perinatal transmission so
proportionally more infants
are infected in utero, and the
peak of mortality is getting
earlier
Source: Emergence of a peak in early infant mortality
due to HIV/AIDS in South Africa, Bourne et al 2009In the age of maternal ART and infant prophylaxis we may have
lower sensitivity than we think, especially at 2 weeks
A v e r a g e s e n s i ti v i ty o f E ID a s s a y s
100
i n i d e n ti fy i n g H IV + i n fa n ts
75
50
25
0
Birth 2 weeks 4 weeks 6 weeks
Ti m e o f v i s i t a n d te s t p e r fo r m e d
Source: Lilian et al. J Clin Microbiol, 2012Solution: A possible change to the EID testing algorithm?
2010 Guidelines
Birth 6 wk PCR 10 wk result 12 wk ART start
Possible new recommendations
Birth PCR 4 wk 6 wk ART 10 wk 2nd PCR 14 wk result
resultTake Home Messages • Given the complexity – we have made huge progress and established new paradigms for sample transport/ result return • We are missing many many opportunities to identify HEI and need to expand access to screening and EID – not just at PMTCT but also at EPI and other clinical settings • There is poor retention across the continuum – in fact, most children are lost. Simple approaches such as identifying focal points, improving tools for follow up, and PoC EID need to studied • The peak of mortality is earlier than when we are testing….should there be a change in the guidance? • Money is a problem. Much of the progress and scale up has happened because of UNITAID’s commodity and programmatic funding – what happens next?
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