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ALL BELGIAN AIDS REFERENCE LABORATORIESKAROLIEN STOFFELS (ARL VUB STP) & FIEN VANROYE (ARL ITM)
NEW CHALLENGES FOR ACCURATE
HIV-1 DIAGNOSIS
30 NOVEMBER 2018, BRUGGE0
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ALL BELGIAN AIDS REFERENCE LABORATORIESKAROLIEN STOFFELS (ARL VUB STP) & FIEN VANROYE (ARL ITM)
NEW CHALLENGES FOR ACCURATE
HIV-1 DIAGNOSIS
30 NOVEMBER 2018, BRUGGE2
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3Nom de la présentation
1st serology screen test for HIV reactif (Ag+Ab)
2nd serology screen test for HIV (Ag+Ab)
confirmation test (Ab)
- Immunoblot (INNO-LIA HIV I/II - FujiRebio)- Immunochromatography (Geenius HIV 1/2 - BioRad)- Western Blot (HIV Blot 2.2 - MP Biomedicals)
additional tests (Ag p24, VL) if confirmation is negative or indeterminate
Very sensitive but less specific
Very specific but less sensitive
DIAGNOSIS HIV IN BELGIUM
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4Nom de la présentation
INNO-LIA HIV I/II Score Geenius HIV 1/2 HIV Blot 2.2
NEG
gp120
gp41
p31
p24
p17
gp105
gp36
gp1
60
gp1
20
p6
6p
55
p5
1
gp4
1
p3
9
p3
1
p2
4
p1
7
Seru
mco
ntr
ol
HIV
-2
IND
HIV-1
HIV-1 + 2
HIV-1HIV-2
HIV-2 HIV-1
HIV-1 HIV-2
controlsC
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DIAGNOSIS IN RESOURCE-CONSTRAINT SETTINGS:RAPID TESTS
5
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6Nom de la présentation
BM Branson, Acquir Immune Defic Syndr 2010,vol 54th
TEST WINDOW PERIOD
RAPIDS
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7Nom de la présentation
DIAGNOSIS HIV IN CASE OF ART?
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8Nom de la présentation
DIAGNOSIS HIV IN CASE OF ART?
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9Nom de la présentation
DIAGNOSIS HIV IN CASE OF ART?
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10Nom de la présentation
CASE: BRAZILIAN PATIENT 2006 : HIV diagnosis in Brasil
2007: start treatment
2009: follow-up in ARC STP
Date SCREENING INNO-LIA VL (cp/ml)
28/09/2009 POS IND <40
06/12/2011 POS IND <20
06/06/2012 POS IND <20
04/2012 : STOP TREATMENT
28/09/2012 POS HIV-1 54600
10/2012 : RESTART TREATMENT Atripla
14/03/2013 23
18/07/2013 <20
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7.2% (386/5331) of requested confirmations are not performed
because the patients are already known as HIV infected in the corresponding ARL (2017)
11
Taking any treatment?
No...
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12Nom de la présentation
INFLUENCE OF ART ON HIV DIAGNOSISIN BELGIUM?
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13Nom de la présentation
GROUP 1: CHRONIC GROUP 2: ACUTE
Treatment for >10 years Start treatment during acute infection
Standard confirmation testsused in Belgium
Rapid tests used in resource-constrained settings
EFFICIENT TREATMENT
ARL STUDY ON HIV DIAGNOSTIC TESTS IN BELGIUM
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RAPID TESTS
First Response
Assay Manufacturer CE WHO
Abon HIV1/2/O Tri-Line Rapid Test Device Abon, China No Yes
Determine HIV 1/2 Alere Health, Japan Yes Yes
First Response HIV 1.2.O Card TestPremier MedicalCoorporation, India
Yes Yes
INSTI HIV TestBiolytical Laboratories, Canada
Yes Yes
SD Bioline HIV 1/2 Alere Health, Japan Yes Yes
HIV 1/2 STAT PAK Chembio, USA Yes Yes
Rapid test for Ab to HIV (colloidal gold) Wantai, Shanghai No Yes
Abon
SD Bioline
STAT PAK
Determine
Wantai
First Response
14
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15Nom de la présentation
Inclusion criteria:
- Patients with HIV-1 VL <50 cp/ml for at least 10 years with a maximum interval between 2 consecutive VL determinations of 18 monthsno blips allowed
- With documented results at least uptill end 2016
388 patients, undetectable VL for 14 years in average [10y ; 21y]
GROUP 1: chronic, treatment >10 years
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16Nom de la présentation
1.5% (6/388) was not confirmed to be HIV-1 positive
98.5% HIV-1(382)
1.3% IND (5)0.2% NEG (1)
CONFIRMATION REFERENCE TESTING ON MOST RECENT SAMPLE: GEENIUS OR INNO-LIA OR WB
GROUP 1: chronic, treatment >10 years
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98.5% HIV-1(382)
1.3% IND (5)0.2% NEG (1)
Reference tests
96.3%
(368)
3.7% (14)
GROUP 1: chronic, treatment >10 years (388 patients)
All (7) Rapid Tests Reactive
≥1/7 Rapid Test Non Reactive
17
17% (1)
83% (5)
Rapid testsRapid tests
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GROUP 1: chronic, treatment >10 years
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19Nom de la présentation
DIAGNOSIS HIV IN CASE OF ART?
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20Nom de la présentation
Inclusion criteria:- All patients diagnosed HIV-1 in 2010 or later
and not lost to follow-up after diagnosis 2010-2018
- With documented acute HIV-1 infection HIV confirmation test negative or indeterminate AND Ag p24 positive or RNA VL positive acute only
- AND started efficient treatment within 3 months no blips once undetectable viral load has been obtained treatment started between 0 and 88 days after diagnosis
83 patients included in study
GROUP 2: ART during acute infection
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21Nom de la présentation
90.4%HIV-1 (79)
9.6%IND(8)
routine confirmation test: (INNO-LIA OR Geenius OR MP Blot 2.2)
Most recentsample
time1st sample
HIV-1 acute infectionFollow-up
samples
9.6% (8/83) were not confirmed as HIV-1 positive
GROUP 2: ART during acute infection (83 patients)
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22Nom de la présentation
90.4%HIV-1(79)
9.6%IND(8)
routine confirmation test: (INNO-LIA OR Geenius OR MP Blot 2.2)
Start treatment after diagnosis
Q1 0 – 6 days
Q2 7 – 13 days
Q3 14 – 39 days
Q4 40 – 88 days
19
16
2119
1
5
02
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Q1 Q2 Q3 Q4
Start treatment after diagnosis
HIV-1 IND
timeFollow-up
samplesMost recent
sample
1st sample HIV-1 acute infection
GROUP 2: ART during acute infection (83 patients)
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23Nom de la présentation
90.4%HIV-1
9.6%IND
Evolution of the 9.6% IND results
Follow-up samples Most recent sample
NEG IND
HIV-1
IND
NEG / IND IND
INDNEG ?
time
3 patients
4 patients
1 patient
A1CRF36CRF01_AE
Time betweenfirst and recent sample
BBBCRF02_AG
1.7 years3.7 years3.1 years2.0 years
B 0.4 years
Start treatment after diagnosis
54 days
12 days12 days7 days47 days
Subtype
2.4 years1.8 years0.4 years
8 days7 days0 days
1st sample HIV-1 acute infection
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All (7) Rapid Tests Reactive
≥ 1/7 Rapid Test Non Reactive
90.4%HIV-1
(75)
9.6%IND (8)
Reference tests
GROUP 2: ART during acute infection
24
74,7% (56)
25,3% (19)
62,5% (5)
37,5% (3)
Rapid testsRapid tests
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GROUP 2: ART during acute infection
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Conclusion studyReference testing Rapid testsA
cute
Ch
ron
ic
98.5% HIV-1(382)
1.3% IND (5)0.2% NEG (1)
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27Nom de la présentation
DIAGNOSIS HIV IN CASE OF PREP?
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CASE: ITM PREP PATIENT Date Screening Antigen Confirmation
(Geenius)Inno- Lia HIV-1
Viral load (cp/ml)
HIV-1 DNA
CD4 Therapy
06/2017 NEG/NEG NEG / / / / / /
07/2017 START PREP TRUVADA
07/2017 NEG/POS NEG NEG / <60 / / TDF/FTC
09/2017 POS/POS NEG NEG / / / / TDF/FTC
12/2017 START TRITHERAPY STRIBILD
12/2017 POS/POS NEG IND (gp41) IND (gp41) <20 NEG 844 EVG/c/TAF/FTC
03/2018 POS/POS NEG IND (gp41) / <20 / 1029 EVG/c/TAF/FTC
Additional tests performed in Ghent: all tests are negative
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Conclusion: Do we need other markers for diagnosis?
Screening tests
Confirmation tests (blots)
Rapid tests
DNA detection
RNA viral load
Ag/Ab basedNAT
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30Nom de la présentation
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Thank you!
Any questions?
31