30 40 50 60 70 80 90 1 00 0 1 0 20 Days Since Infection HIV RNA plasma HIV Antibody HIV p24 Ag IgM IgG FIGURE 1 LABORATORY MARKERS OF HIV INFECTION ID: 744126
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Slide1
INTEGRATING
HIV AND HCV
TESTINGSlide2
30
40
50
60
70
80
90
100
0 10
20Days Since
InfectionHIV RNA
(plasma)HIV
AntibodyHIV p24 Ag
IgMIgG
FIGURE
1: LABORATORY
MARKERS
OF HIV
INFECTION
Figure
adapted
from
Delaney et al., CID 2017:64 and provided by M. Owen,
NCHHSTP,
CDC.
HIV
TEST
PERFORMANCESlide3
HIV
TEST PERFORMANCE
HIV
TESTS:MEDIAN WINDOW PERIOD IN
DAYS BASED ON PLASMA
Laboratory-Based
Tests
POC
Rapid
Tests
Ag/Ab
17.8
19.2
IgM/IgG
23.1
29.3
IgG
30.6
31.1
Test
sensitivity is highest
when used with
plasma
and serum samples
.
Test
sensitivity
is
lower
with
whole
blood
.
Test
sensitivity
is
lowest
when used on
oral
fluid.Slide4
HCV
TEST PERFORMANCE
HCV
RNA
HCV core Ag
Anti-HCV
FIGURE
2:
LABORATORY
MARKERS
OF
HCV
INFECTION
Window
Phase
0
1
0
2
0
3
0
4
0
5
0
6
0
7
0
8
0
9
0
1
00
days
Days
Since
Infection
Figure
provided by
S. Kamili,
DVH,
CDC.Slide5
TESTING
STRATEGIES
Laboratory-Based
Testing
Specimen sent to
laboratory
for
testing Sequence
of
tests
performed
Laboratory
Testing
for the
Diagnosis of HIV
Infection
Testing
for
HCV
Infection: An
Update of
Guidance for
Clinicians and
Laboratorians
Earlier
detection
than
possible with
POC
Point-of-Care
Rapid
Testing
Testing
where
client
receives
services
Various
supplemental testing
methodsSlide6
COMPARISON
OFTESTING
STRATEGIES
C
omparison
Categories
Laboratory-Based
Testing
(using CDC-recommended serum/plasma algorithms)
Point-of-Care Rapid
Testing
(using CLIA-waived
tests)
HIV
HCV
HIV
HCV
Window
period
2-3
weeks
8–11
weeks
3-5
weeks
8–11
weeks
Detect
acute infection
Yes
Yes
No
Yes
Final
results
From
a single
specimen
Negative results from single specimen;
Positive
results second
specimen
Testing
for
multiple infections
Yes,
multiple
tests
may
be
performed
on
single
specimen
No, additional specimens
needed
for
other
tests
Timeframe
for delivering
results
Several
hours
to days to
final
Negative results
delivered
same
visit/day. Positive results, several hours
to days to final
FDA-approved specimen
types
Serum or plasma
Whole
blood, serum, or oral mucosal transudate
(HIV only)
Specimen
collection
Venipuncture
Varies by
test
(venipuncture, finger
stick,
or
oral
fluid).
Quality
assurance
Limited QA
assurance
by
providers.
Extensive
QA
by
testing
providersSlide7
SELECTING
A
TESTING STRATEGY
HIV and HCV
Prevalence
HIV and HCV
Incidence
HIV-2
prevalence
Co-morbidity of HIV and
HCV,
and/
or with other
conditions such
as
STDs
and hepatitis
B virus
(HBV)
Staff
capabilities to conduct
testing
Staff perceptions and attitudes about
strategy
Feasibility
of introducing
strategy
into existing
workflow
Laboratory
capacity to
implement required
tests,
including CDC- recommended
testing
algorithms
Delivery of related prevention and
treatment services such
as HIV
PrEP
Likelihood of acute HIV
infection
Likelihood of
current
HCV
infection
Likelihood
that clients will return for results/linkage
Understanding of the
accuracy tests
Acceptability of the testing
strategy
Appropriateness and relevance to client
needs
Cost to client for testing and
treatment
Readiness to engage in
treatment
Access to treatment
Population-Level
Factors
Program-Level Factors
Client-Level Factors