Niel T. Constantine, PhD

1. Hong, L., Ketema, F., Sill, A., Kreisel, K., Cleghorn, F.R., & Constantine, N.T. A simple and inexpensive particle agglutination test to distinguish recent and established HIV-1 infection. International Journal of Infectious Disease, 11:459-465, 2007.
2. Sill, A.M., Kreisel, K., Deeds, B.G., Wilson, C.M., Constantine, N.T., Peralta, L., & the Adolescent Trials Network (ATN) for HIV/AIDS Intervention. Calibration and validation of an oral fluid-based S/LS assay to distinguish recent from established HIV-1 infection. Journal of Clinical Laboratory Analysis, 21:40-45, 2007.
3. Constantine, N.T., Sill, A.M., Jack, N., Kreisel, K., Edwards, J., Cafarella, T., Smith, H., Bartholomew, C., Cleghorn, F., & Blattner, W.A. Improved classification of recent HIV-1 infection by employing a two-stage sensitive/less sensitive test strategy. Journal of AIDS, 32:94-103, 2003.
4. Constantine, N.T. & Lana, L. Immunoassays for the diagnosis of infectious diseases. In: Murray et al. (Eds), Manual of Clinical Microbiology, 8^th Edition, ASM Press, pp. 218-233, 2003.
5. Highsmith, W.E., Constantine, N.T., & Friedman, K.F. Molecular diagnostics, (Chapter 48). In: L. Kaplan, A. Pesche, & Kazmierszak (Eds), Clinical Chemistry, 4^rd Ed. NY: Mosby, pp. 937-959, 2003.
6. Nkeze, J, Constantine, NT, Zhao, R. Laboratory Testing for HIV Infection; In HIV Clinical Manual, 2^nd    Edition; Singh, N, Shafer, R, Swindells, S (editors); www.antimicrobe.org, 2009.
7. Sajadi, M.M., Constantine, N.T., Mann, D.L., Charurat, M., Dadzan, E., Kadlecik, P., Redfield, R.R.  Epidemiologic characteristics and natural history of HIV-1 natural viral suppressors; JAIDS, 50: 403-408, 2009.
8. Rosenberg, E, Brennan, C, Claessens, C, Constantine, N, Murphy, G, Owen, S, Werner, B, Yao, J, Yen-Lieberman, B, Branson, B, Garrett, P, Howell, R.  Criteria for laboratory testing and diagnosis of HIV infection.  CLSI, M53-P, Vol. 30, Number 21, ISBN: 1-56238-735-9, 2011.
9. Nkeze, J, Constantine, N, Zhao, RY.  Laboratory testing for HIV infection: advances after 27 years.  In Molecular Diagnostics: 14 Tests that changed everything;  A volume in the series: Molecular and Personalized Medicine; WB Coleman and GJ Tsongalis (Series Eds), W Highsmith (Ed); Springe, 2014.
10. Wei Luo, Silvina Masciotra, Kevin Delaney, Man Charurat, Taeleisha Croxton, Niel Constantine, Abdulsalami Nasidi, William Blattner, Laura Wesolowski, S. Michele Owen.  Comparison of HIV Oral Fluid and Plasma Testing during Early Infection in a Longitudinal Nigerian Cohort.  J Clin Virol; 58S 2013.

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Diagnostic test development, including highly sensitive molecular techniques, serologic assays, rapid tests, point of care tests, and biosensor assays; Clinical trials, quality assurance.

FDA Clinical Trials

9/22/05:  Innovator of the Year, The Daily Record

Constantine (PI), 4/1/17-3/31/18

Chembio Diagnostic Systems, Inc.

FDA PMA Clinical Trial of the DPP HIV / Syphilis Assay

This clinical trial assess the performance characteristics of a new combination rapid test for the ability to meet manufacturer's claims for the detection of HIV and Treponemal antigens simultaneously.  A novel reading device is used.

Constantine (PI), 10/25/15 -9/2/17

The USAID Global Health Supply Chain Quality Assurance Program

Proposal for Rapid Diagnostics (HIV and syphilis), and Other Laboratory Products (Point  of Care Products), USAID Global Health Supply Chain‐Quality Assurance Program (USAID | GHSC – QA), FHI360.

This is an effort to assess and evaluate a large number of infectious and chemistry tests for their suitability to meet manufacturers’ claims.  Test kits from over 15 resource-limited countries, and from manufacturers’ facilities are sent to our laboratory for determination of their accuracy and performance characteristics using panels of blood samples.

Constantine (PI), 8/1/16 -8/1/17

The USAID Global Health Supply Chain Quality Assurance Program, Supplement

This supplement to the above project includes provisions for international consultancy, extensive evaluation of select tests, establishing a test kit retention facility, determination of the causes of test kit failure, and providing training of individuals in resource-limited countries.

Constantine (Investigator), 9/01/15 – 2-29/17;Fabio Romerio / Lichterfeld (Co-PIs)

NIH 1RO1AI120008-01, NIAID; Quantification of the HIV Reservoir by Immuno-PCR”, NIAID

This project aims to use Immuno-PCR to determine HIV latent reservoirs by increasing the sensitivity of detection

Constantine (PI) 7/30/15 – 12/31/15

Supply Chain Management System (SCMS)

Supplement to Proposal to Establish and Implement Procedures to Assure Suitability for

Intended Use of Laboratory Supplies, and HIV/AIDS, TB, Syphilis,

Hepatitis and Pregnancy Rapid Test Kits, “Evaluation of the SD Bioline syphilis 3.0

and the Chembio Syphilis Screen and Confirm.

This project involved evaluating 2 rapid syphilis tests appropriate for resource-limited countries for their suitability to rapidly diagnose syphilis.  A large panel of well-characterized samples were used and included assessment of accuracy, precision, reproducibility, lot-to lot variation, and high temperature studies.

Constantine (PI)          3/1/09-8/28/15

Supply Chain Management System (SCMS)

Proposal to Establish and Implement Procedures to Assure Suitability for Intended Use of Laboratory Supplies, and HIV/AIDS, TB, Syphilis, Hepatitis and Pregnancy Rapid Test Kits

This quality assurance project aims to evaluate 5 types of rapid tests for meeting specifications after they arrive at world-wide sites.  The kits will be shipped to the US for a series of experiments to determine suitability and compliance with manufacturers’ recommendations; investigations as to cause for poor performance are included.

Constantine (PI)          12/1/13 – 12/1/15

Chembio Diagnostics Systems, Inc.

This pre-clinical trial of the CHEMBIO DPP HIV-Syphilis Rapid Test, evaluates a novel multiplex rapid test to detect both HIV and syphilis simultaneously.  The trial has been successful and Chembio is planning a full FDA clinical trial before the end of 2015.

Constantine (PI)          01/01/15

Jacques Initiative, Institute of Human Virology

This effort, funded by Gilead, and known as FOCUS, aims to decrease turn-around time for HIV and HCV test results in a clinical setting (UMMC).  Patients in the Emergency Department and select medical floors are recruited for testing, results are returned within 2 hours, and they are linked to care before being released.  The effort includes IT support, laboratory stat testing, and result reporting.

Constantine (Investigator)                   10/08/13-9/30/14

Roche Diagnostics

This project was to prospectively collect up to 500 samples from high risk group subjects to evaluate tests for hepatitis A, B, C, and E.  The subjects included those at high risk (from methadone clinics) and those with symptoms compatible with hepatitis. Extensive questionnaires were used and 2-3 tubes of blood collected.  Samples were processed, aliquoted, transported, and stored within well-defined time limits.  All data were entered into an electronic database.

Constantine (PI)          12/1/13-11/30-14

Chembio Diagnostics

Evaluation of the DPP HIV/syphilis rapid test.

The FDA clinical trial evaluated a new and novel rapid test that can detect HIV-1/HIV-2 and syphilis simultaneously.  The assessment included prospectively-collected samples and archived samples.  The DPP experimental test was evaluated against reference tests.

Constantine (PI)          2/1/11-6/31/13

G & W Laboratories

Comparison of results of plasma and SMARTplasma (using SMARTube) for identifying HIV infection in a high risk population.

This effort involved the collection of blood from 400 high risk individuals, incubation of whole blood in the SMARTube, and comparing HIV test results on the resultant SMARTplasma as compared with those in routine plasma.  The SMARTube contains components that activate B lymphocytes to produce specific antibodies faster and in higher quantities.  Thus, this technology offers early HIV detection, and can be applied to measure HIV incidence.

Local Service

National Service

Editorial Tasks

International Service

Invited Chairman

Workshops

Current trainings:

• HIPAA training (101, 120, 125, 201).
• CITI Program in the Protection of Human Research Subjects Training.
• Good Clinical Practice and ICH.
• Blood Borne Pathogens Training.
• Biological Material and Dry Ice Shipping Training.
• Laboratory Safety Training.
• Environmental Management Training.
• DOT Infectious and Diagnostic Materials Shipping Training
• Overview of GLP and Human Subjects Protection
• Good Clinical Practices and Clinical Research Professionals
• Clinical Research billing Compliance Education
• BRAAN Training
•  UPI Compliance Training for Physicians
• Unanticipated Problems Involving Risk to Research Participants or Others
• Protecting Human Research Participants, HIH Web-based training
• Investigator Training for Financial Conflict of Interest (FCOI)
• Employee Sexual Harassment Awareness