This document proposes a clinical trial to evaluate the accuracy of the QikTech One-Step HIV I/II/O Saliva Test compared to a conventional blood test. The trial would enroll 250+ individuals across medical centers in Tijuana, Mexico. Participants would receive both tests, and positive results would undergo further confirmatory testing. If found to be accurate, the saliva test could provide a simpler alternative for HIV screening in Mexico and be commercialized in the country. The proposed trial outlines inclusion criteria, sample collection processes, testing procedures, statistical analysis plans, and anticipated outcomes of increased access to rapid and flexible HIV detection tools.

1. Evaluation of accuracy of rapid point-of-care
HIV test with oral fluid versus the conventional
blood by fingerstick test
Marco Velazco Rivera
Octavio Romo Fewell
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2. HIV Statistics
• Human immunodeficiency virus (HIV) is a lentivirus that
causes acquired immunodeficiency syndrome (AIDS)
• World Health Organization (WHO) estimates (end 2012):
 34 million people living with HIV in the world
 1.2 million in US (Joint United Nations Program on HIV/AIDS)
 More than 220000 people (15-49 years) in Mexico (CENSIDA)
 26 million are eligible for antiretroviral therapy
 9.7 million people had access to antiretroviral therapy
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3. HIV testing
• Many HIV-positive people are unaware that they
are infected with the virus.
• Less than 1% of the urban population of Africa had
been tested for HIV
• Plasma testing by ELISA and Western Blot are used
to detect antibodies to HIV-1, which are accurate
but also complex and expensive.
Needles, samples need storage equipment and a
suitable environment, transportation*, centrifuge,
ELISA kit, spectrophotometer, people, lab, permits, etc
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4. Practical HIV test
• High Sensitivity and Specificity (high degree of
confidence)
• No False Positive or Negatives
• Point-of-care test
• Non-invasive
• Convenient and Inexpensive
• Positive results always require a confirmatory
test, regardless of the mean of testing
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5. Available tests
• Tests may detect antibodies, antigens, or RNA
from serum, urine or oral mucosal transudate
samples
• The OraQuick ADVANCE® Rapid HIV-1/2
Antibody Test detects antibodies to HIV-1/2
(OraSure Technologies, Inc)
• Approved for oral fluid, plasma, fingerstick or
venipuncture whole blood specimens.
• Greater than 99% agreement with
confirmatory Western blot.
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6. OraQuick ADVANCE® disadvantages
• Needs oral mucosal transudate samples (not
saliva)
• Chances of contamination (many steps)
• Saturation threshold at 400 mIU
• 20 to 40 minute period for results
• This product does not have approval for
marketing and selling in Mexico
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7. QikTech One-Step HIV I/II/O Saliva Test
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8. Government Permits
• Obtaining all documentation and permits Mexican
Department of Health and COFEPRIS (equivalent to
US FDA)
• Registration (Class II)
• JAJ International representative (POA)
• Permit of importation of product
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10. 10
PAYMENT METHOD:
APPLICATION FOR
AUTHORIZATION OF
PROTOCOL RESEARCH
INVOLVING HUMAN.

11. Medical Centers and Organizations
• Hospital General de Tijuana (500 register patient)
• Prevencasa A.C (aprox. 400 subjects get tested
per month)
• CENSIDA/CAPASITS (1700 register patient)
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15. Tentative Protocol
• Inclusion criteria males and females ages 18 to
64
Participating medical center and organization
personal and/or MEDEVISE personal trained to:
- To give and obtain inform consent from patient
- Guide patient with the correct use of the tests
- Collect samples and record results
- Provide guidance for further testing and for
medical/psychological support 15

16. Tentative Protocol
• Collection of samples and data would take place at:
 The moment a subject get tested (in site testing)
 Inviting register patients to participate in the study
• Register patients can be invited to participate in the
study:
 At the moment of visit to physician for regular checks
 At the moment of visit to hospital for medication
 Can be invited to participate in the study by phone call
(gift cards incentives)
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17. Tentative Protocol
• QikTech One-Step HIV I/II/O Saliva Test results
can be compered to:
Neogen HIV-1/2 and syphilis (Treponema
pallidum) test (INTERBIOL S.A. de C.V.); blood
sample by fingerstick (In site testing)
Samples that test positive can be further
analyzed with ELISA and/or Western Blots and
results are going to compared again to
QikTech results
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18. Test comparison
• Goal: to collect 250 or more samples of test
that indicate positive and 250 or more
samples of test that specify negative of
QikTech for comparison of diagnosis accuracy
to those of Neogen kit.
• Proper Statistical analysis would be performed
on the data and a final report of results and
conclusions would be provided to JAJ
International
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19. Conclusion
• If QikTech One-Step HIV I/II/O Saliva Test
results are comparable and accurate to those
of Neogen HIV-1/2 and syphilis blood test
then we can:
Submit manuscript for publication
Submit application for commercialization of
QikTech One-Step HIV I/II/O Saliva Test in
Mexico
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20. Conclusion
• If product is approved for commercialization in
Mexico:
It would provide a rapid, flexible, simple and
accurate method for the detection of HIV,
overcoming the disadvantage and limitations of
current products in the market
Mexico can be a platform to sell the product to in
other countries
Promote early detection of HIV and early
treatment can be provided to patient, thus
improving quality of life
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RESOURCE / SERVICE COST DESCRIPTION
STUDY DESIGN 2500 ONCE: PATIENT SELECTION, PROTOCOL MODEL, FORMATS, CONSULTATIONS
HOSPITAL FEE 2500 ONCE: REVIEW BY AUTHORIZED BIOETHIC COMISSION (COFEPRIS)
PRINCIPAL
INVESTIGATOR 1000
MONTHLY OCTAVIO ROMO FEWELL
RESEARCH
COORDINATOR 1000
MONTHLY MARCO VELAZCO RIVERA
REGISTRATION 1500
ONCE: APPLICATION, IMPORT PERMIT, WITHOUT TRAVEL EXPENSES
OUTSOURCING 1500
CONTRIBUTIONS FOR CLINICIANS, LETTERS, DOCUMENTATION,
INFORMATIVE MATERIALS, PATIENT INCENTIVES, TRANSLATIONS,
BEFORE ALL OPEX MUST BE SUMMARIZED/COMMERCIAL INVOICES
20000
6 MONTHS OF CLINICAL TRIAL + MONTHLY REPORTS, OUTCOMES
ANALYSES
40 DAYS SANITARY REG.
ROI
GH GENERAL HOSPITAL1000 UNITS MONTHLY ONE G.H. 3.5 per unit $ 3,500
23 MONTHS 32 GENERAL HOSPITALS + OTC
8000 UNITS MONTHLY 16 GH (500) MONTH
3.5 per unit
$ 28,000
16,000 UNITS MONTHLY 16 (1K) MONTH $ 56,000
PATIENTS BETWEEN 15 a 49 YRS OLD LIVING WITH HIV 220K
PREVALENCE 0.3% IN MEXICO ( 1 FOR EACH 1000)
C o n c e n t r a t e d E p i d e m i c
CensidaCensida (2010a). «Estadísticas». Panorama epidemiológico del VIH/sida e ITS en México. Ciudad de México: Censida.
CensidaCensida (2010b). «Casos nuevos y acumulados de sida en jóvenes (15-29 años), por categoría de transmisión y sexo» (en español, PDF). Panorama epidemiológico del VIH/sida e ITS en México. Ciudad de México: Censida.

22. References
• http://www.who.int/hiv (World Health Organization)
• Kumaranayake L, Watts C (2001). "Resource allocation and priority setting of
HIV/AIDS interventions: addressing the generalized epidemic in sub-Saharan
Africa". Journal of International Development 13 (4): 451–466.
doi:10.1002/jid.797
• http://www.unaids.org/en/ (Joint United Nations Programme on HIV/AIDS)
• http://www.cdc.gov/hiv (Centers for Disease Control and Prevention )
• Pant Pai N, Balram B, Shivkumar S, Martinez-Cajas JL, Claessens C, Lambert
G, Peeling RW, Joseph L (2012) Head-to-head comparison of accuracy of a
rapid point-of-care HIV test with oral versus whole-blood specimens: a
systematic review and meta-analysis. The Lancet. DOI:10.1016/S1473-
3099(11)70368-1
• Leea SR, Yearwooda GD, Guillona GB, Kurtza LA, Fischla M, Frielb T, Bernec
CA, Kardosa KW (2010) Evaluation of a rapid, point-of-care test device for the
diagnosis of hepatitis C infection. Journal of Clinical Virology.
doi:10.1016/j.jcv.2010.02.018
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23. THANK YOU & TAKE A LOOK OF THE
SAMPLE PRODUCT…
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