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      Development and Validation of the First Point-of-Care Assay to Objectively Monitor Adherence to HIV Treatment and Prevention in Real-Time in Routine Settings

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          Abstract

          Objective:

          HIV prevention and treatment studies demonstrate that pharmacologic adherence metrics are more accurate than self-report. Currently-available metrics use liquid-chromatography/tandem-mass-spectrometry (LC-MS/MS), which is expensive and laboratory-based. We developed a specific and sensitive antibody against tenofovir, the backbone of treatment and prevention, but conversion to a lateral flow assay (LFA) –analogous to a urine pregnancy test- is required for point-of-care testing. We describe the development of the first LFA to measure antiretroviral adherence in real-time.

          Methods:

          Previous work in a directly-observed therapy study of providing tenofovir-disoproxil fumarate (TDF) to HIV-noninfected volunteers at various simulated adherence patterns defined the appropriate cut-off for the LFA (1500ng tenofovir/ml urine). We developed the LFA using a sample pad for urine; a conjugate pad coated with TFV-specific antibodies conjugated to colloidal gold nanoparticles; a nitrocellulose membrane striped with tenofovir-antigen (test line) and a control line; with an absorbent pad to draw urine across the reaction membrane.

          Results:

          We tested 300 urine samples collected from the directly-observed therapy study by this LFA and the gold-standard method of LC-MS/MS. The LFA demonstrated 97% specificity (95% CI: 93% to 99%) and 99% sensitivity (94% to 100%) compared to LC-MS/MS. The LFA accurately classified 98% of patients who took a dose within 24 hours as adherent.

          Conclusion:

          We describe the development and validation of the first point-of-care assay to measure short-term adherence to HIV prevention and treatment in routine settings. The assay is low-cost, easy-to-perform and measures the breakdown product (tenofovir) of both TDF and tenofovir alafenamide (TAF). This assay has the potential to improve HIV and PrEP outcomes worldwide by triggering differentiated service delivery with further study merited.

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          Author and article information

          Journal
          8710219
          1493
          AIDS
          AIDS
          AIDS (London, England)
          0269-9370
          1473-5571
          7 February 2020
          01 February 2020
          01 February 2021
          : 34
          : 2
          : 255-260
          Affiliations
          [a. ]Division of HIV, Infectious Disease, and Global Medicine, Department of Medicine, University of California, San Francisco (UCSF), San Francisco, CA
          [b. ]Alere Rapid Diagnostics/Abbott Rapid Diagnostics Division (ARDx), Pomona, CA
          [c. ]Department of Epidemiology and Biostatistics, UCSF, San Francisco, CA
          [d. ]Department of Medicine, Chiang Mai University, Chiang Mai, Thailand; Department of Immunology & Infectious Diseases, Boston, Harvard T.H Chan School of Public Health, MA, USA; Department of Molecular & Clinical Pharmacology, University of Liverpool, UK
          [e. ]Sanpatong Hospital, Sanpatong, Chiang Mai, Thailand
          [f. ]Centre for Clinical Research , Kenya Medical Research Institute (KEMRI), Thika, Kenya
          [g. ]Departments of Global Health, Medicine and Epidemiology, University of Washington, Seattle, WA
          [h. ]Department of Community Health, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya
          Author notes
          Corresponding author: Monica Gandhi MD, MPH, Professor of Medicine, Division of HIV, Infectious Diseases, and Global Medicine, 995 Potrero Avenue, 4 th floor, Room 423D, San Francisco, CA 94110, Phone: 415-476-4082 ext 138; Fax 415-476-9653, monica.gandhi@ 123456ucsf.edu
          Article
          PMC7021226 PMC7021226 7021226 nihpa1556274
          10.1097/QAD.0000000000002395
          7021226
          31634188
          a2c63daa-9597-4435-ba70-1036ff8e65d1
          Categories
          Article

          PrEP,urine,point-of-care,lateral flow assay,tenofovir,adherence,Antiretroviral treatment

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