Oral Fluid Test HIV evaluation proposal

1. HIV Oral Fluid Test

2. Background – Global Review
• OraQuick test, was granted US FDA approval for testing on oral fluid,
plasma, for HIV-1 and HIV-2 antibody test in 2004
• Independent study during 2007-2015 in 11 countries (USA, Canada, Spain,
Singapore, Brazil, China, Peru, South Africa, Kenya, Uganda and Malawi) found1:
• Median sensitivity and specificity for the self-test kit: 93.6% and 99.9%
• Concordance results read by participant vs. by the HCW: 93,9% - 100%
• Perceptions & attitudes: Mostly considered to be easy to perform
• Risk Compensation: More associated with positive changes in behavior
• Counseling: Most participants felt counseling was necessary
• Linkage to Care: 44.6% - 100%
• Willingness to pay: $0 - $17
• A 2014 review of the harms of self-testing concluded that there was
little evidence of harms resulting from HST or other self-tests in the
literature2

3. Background – OFT in Indonesia
• PPK-UI, Jabodetabek 2007:
• Sensitivity: 99,7% and Specificity 98,4%
• NGO view was good, but prices must be adjusted
• There were concerns for confusion of HIV transmission through saliva
• Didn’t agree if it is sold freely
• MoH, Jakarta and Papua, 2008:
• Sensitivity: 70%
• Specivicity: 99,97%
• Wulandari et al. BMC Public Health, Bali, 2020:
• Uptake among men who purchase sex in brothels: 64,6%
• 98.9% who accepted a HIV self-test preferred assisted HIV self-testing
• The findings support the introduction of an HIV self-testing strategy among this group to
improve access to HIV testing
• Study HATI, Jakarta, Bandung, Bali, and Yogyakarta, 2020
• Effective at improving HIV testing uptake among MSM, FSW, Transgender and PWID who
did not want to take HIV testing at health facility
• Increase ART initiation (70% to >85%), and immediate ART initiation (3% to 37%)
• Operational study, 15 districts?
Comparison of OFT results with EIA, MoH 2008

4. Background – Regulation Framework
• Registration
• MoH Decree 62/2017 (Izin Edar Alat Kesehatan, Alat Kesehatan Diagnostik In Vitro Dan
Perbekalan Kesehatan Rumah Tangga)
• MoH Decree 15/2015 (Pelayanan Laboratorium Pemeriksa HIV dan Infeksi Oportunistik)
• Distribution
• MoH Decree 1191/2010 (Penyaluran Alat Kesehatan)
• Utilization
• MoH Decree 370/2007 (Standar Profesi ATLM)
• MoH Decree 411/2010 (Laboratorium Klinik)
• MoH Decree 37/2012 (Penyelenggaraan Laboratorium PKM)
• MoH Decree 21/2013 (Penanggulangan HIV dan AIDS)
• MoH Decree 15/2015 (Pelayanan Laboratorium Pemeriksa HIV dan Infeksi Oportunistik)

5. Background- Registration
• The laboratory evaluation to determine the accuracy of HIV assays in
comparison with established performance criteria is a mandatory for
registering HIV antibody test kit in Indonesia.
• Characteristics include: sensitivity, specificity, negative and positive
predictive values to assess the suitability for use in various testing
objectives (Screening, Surveillance and Diagnostic).
• The Laboratory evaluation procedure for HIV antibody test kit with oral
fluid specimen haven’t been established yet in Indonesia.
• Oral fluid specimen couldn’t be preserved for HIV antibody test.

6. Objective
To find and agree on feasible scenario for evaluating:
• The sensitivity and specificity of currently available HIV RDTs for
the detection of HIV-1/2 antibodies in oral fluid samples as
compared to a reference result (one antibody detection enzyme
immunoassay (EIA), one antibody/antigen EIA and/or one HIV
nucleic acid testing (NAT), performed on a matched plasma
specimen).
• To evaluate the operational characteristics of HIV oral fluid RDTs,
e.g. ease of performance, inter-reader variability, reaction
endpoint stability, rate of invalid runs/devices, and suitability for
various testing objectives

7. Scenario - 1
Recruitment of Respondent (100 PLHIV [75 ART Naive and 25 On-ART] +
200 non PLHIV) by NGO Providing PLHIV Psychosocial Support in Greater
Jakarta
10-20 Respondents come (organized by the NGO) to NRL per day (agreed
time) for giving their oral fluid and blood specimen
NRL collect and test oral fluid specimens immediately, as per the
manufacturer IFU. A matched EDTA whole blood specimen is collected
from the same individual for test with EIA (or other method)
NRL evaluate performance of the HIV antibody test kit from oral fluid
specimen by comparing the same individual test result from plasma with
EIA (or other method)

8. Scenario - 2
NRL train Field Team to collect and send a matched EDTA whole blood
specimen from the OFT Operational Research Respondent (100 OFT reactive
[75 ART Naive and 25 On-ART] + 200 non Reactive) in Greater Jakarta
The OFT Operational Research collect and test oral fluid specimens in the field
and send the result with a matched EDTA whole blood specimen collected
from the same individual
NRL conduct HIV antibody test with EIA (or other method) from plasma
specimen
NRL evaluate performance of the HIV antibody test kit from oral fluid
specimen by comparing the same individual test result from plasma specimen
with EIA (or other method)

9. Scenario - 3
Recruitment of Respondent (200 PLHIV [150 ART Naive and 50 On-ART] + 350
non PLHIV) by NGO Providing PLHIV Psychosocial Support in Medan, Jakarta,
Denpasar and Makassar
10-20 Respondents come (organized by the NGO) to appointed laboratory in each
city per day (agreed time) for giving their oral fluid and blood specimen
Appointed laboratory collect and test oral fluid specimens immediately, as per the
manufacturer IFU. A matched EDTA whole blood specimen is collected from the
same individual for test with EIA (or other method)
Appointed laboratory send HIV antibody test result from oral fluid and plasma
specimen to NRL
NRL evaluate performance of the HIV antibody test kit from oral fluid specimen by
comparing the same individual test result from plasma with EIA (or other
method)

10. Scenario - 4
NRL train Field Team to collect and send a matched EDTA whole blood specimen
from the OFT Operational Research Respondent (200 OFT reactive [150 ART Naive
and 50 On-ART] + 350 non Reactive) in Medan, Jakarta, Denpasar and Makassar
The OFT Operational Research team in Medan, Jakarta, Denpasar and Makassar
collect and test oral fluid specimens in the field and send the result with a
matched EDTA whole blood specimen collected from the same individual
NRL conduct HIV antibody test with EIA (or other method) from plasma specimen
NRL evaluate performance of the HIV antibody test kit from oral fluid specimen by
comparing the same individual test result from plasma specimen with EIA (or other
method)

11. Thanks