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Evaluation of accuracy of rapid point-of-care HIV test with oral fluid versus the conventional

blood by fingerstick test

Marco Velazco RiveraOctavio Romo Fewell

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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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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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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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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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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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QikTech One-Step HIV I/II/O Saliva Test

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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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PAYMENT METHOD: APPLICATION FOR AUTHORIZATION OF PROTOCOL RESEARCH INVOLVING HUMAN.

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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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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

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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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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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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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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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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 1500ONCE: APPLICATION, IMPORT PERMIT, WITHOUT TRAVEL EXPENSES

OUTSOURCING 1500CONTRIBUTIONS 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 ANALYSES40 DAYS SANITARY REG.

ROI GH GENERAL HOSPITAL1000 UNITS MONTHLY ONE G.H. 3.5 per unit $ 3,500

23 MONTHS 32 GENERAL HOSPITALS + OTC8000 UNITS MONTHLY 16 GH (500) MONTH

3.5 per unit$ 28,000

16,000 UNITS MONTHLY 16 (1K) MONTH $ 56,000PATIENTS BETWEEN 15 a 49 YRS OLD LIVING WITH HIV 220K

PREVALENCE 0.3% IN MEXICO ( 1 FOR EACH 1000)

Concentrated Epidemic

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.

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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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THANK YOU & TAKE A LOOK OF THE SAMPLE PRODUCT…

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