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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
ALL BELGIAN AIDS REFERENCE LABORATORIESKAROLIEN STOFFELS (ARL VUB STP) & FIEN VANROYE (ARL ITM)
NEW CHALLENGES FOR ACCURATE
HIV-1 DIAGNOSIS
30 NOVEMBER 2018, BRUGGE2
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
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
DIAGNOSIS IN RESOURCE-CONSTRAINT SETTINGS:RAPID TESTS
5
6Nom de la présentation
BM Branson, Acquir Immune Defic Syndr 2010,vol 54th
TEST WINDOW PERIOD
RAPIDS
7Nom de la présentation
DIAGNOSIS HIV IN CASE OF ART?
8Nom de la présentation
DIAGNOSIS HIV IN CASE OF ART?
9Nom de la présentation
DIAGNOSIS HIV IN CASE OF ART?
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
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...
12Nom de la présentation
INFLUENCE OF ART ON HIV DIAGNOSISIN BELGIUM?
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
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
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
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
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
GROUP 1: chronic, treatment >10 years
18
19Nom de la présentation
DIAGNOSIS HIV IN CASE OF ART?
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
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)
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)
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
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
GROUP 2: ART during acute infection
25
Conclusion studyReference testing Rapid testsA
cute
Ch
ron
ic
98.5% HIV-1(382)
1.3% IND (5)0.2% NEG (1)
26
27Nom de la présentation
DIAGNOSIS HIV IN CASE OF PREP?
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
28
Conclusion: Do we need other markers for diagnosis?
Screening tests
Confirmation tests (blots)
Rapid tests
DNA detection
RNA viral load
Ag/Ab basedNAT
29
30Nom de la présentation
Thank you!
Any questions?
31
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