Introduction and Overview


The Consortium for the Evaluation and Performance of HIV Incidence Assays (CEPHIA) was formed in 2011, after members of an international Incidence Assay Critical Path Working Group meeting identified a need for cultivated HIV specimens to aid development of new HIV incidence assays. Following that meeting, the Bill and Melinda Gates Foundation provided funding to create CEPHIA to support the development of existing and new HIV incidence assays, improve data analysis and interpretation of incidence assay results, and bring consensus to the field. Importantly, the consortium was charged with creating a consolidated repository of over 30,000 highly-selected and well-characterized plasma specimens from around the world, along with setting standards and conducting independent evaluations of existing and new incidence assays, in order to remove real or perceived assay developer bias and allow direct, objective comparison of HIV incidence assays. A second round of funding (“CEPHIA 2”) in 2013 expanded the expensive repository of well-characterized plasma specimens to include prospectively collected serum, dried blood spots, urine, saliva, and stool. More information about the work of CEPHIA during this phase is available here, as well as in the Evaluation Reports and standard specimen panels detailed on this website.

CEPHIA is strengthened by its wide membership (see Membership, below), including close work with the World Health Organization/UNAIDS Technical Working Group on HIV Incidence Measurement and Data Use. More information about CEPHIA and the need for centralized specimen archives can be found here.



Evaluation Reports


CEPHIA has conducted independent evaluations of 11 assays designed to assess recency of HIV infection (i.e. useful for estimating HIV incidence). The methods and findings of these evaluations are available in each of the Evaluation Reports (colloquially known as "blue books"), which can be accessed below:

Ortho Avidity-VITROS ECi
Ortho Less Sensitive (LS)-VITROS ECi
SEDIA™ BED HIV-1 Incidence EIA
SEDIA™ HIV-1 LAg-Avidity EIA
Bio-Rad GS HIV-1/HIV-2 PLUS O EIA Avidity Assay
Asanté™ HIV-1 Rapid Recency® Assay
BioRad Geenius
Abbott Architect Avidity
Bio-Rad GS HIV-1/HIV-2 PLUS O EIA Avidity (Glasgow modification)
ANRS IDE-V3
Luminex (CDC multiplex)



Available Panels


All together, CEPHIA has distributed over 50 panels of well-characterized specimens to 19 investigators and groups since 2012. The table below provides more information about the five different panels available for access by external investigators, along with criteria for panel access.

Category

 

Discovery Panel (DP)

 

Proof of Concept (POC)-Mean Duration of Recent Infection (MDRI) panel

POC-False Recent Ratio (FRR) panel

 

Qualification Panel (QP)

Evaluation Panel (EP)

Panel description

-    50 specimens

-    15 recent, 35 non-recent

-    Clade B

-    All ARV naïve

 

-    100 specimens

-    All well-characterized estimated infection date

-    50 0-12 months from infection

-    50 12-24 months from infection

-    Mixed Clade

-    All ARV naïve

-    150 specimens

-    All >2 years from HIV infection date

-    Mixed Clade

-    All ARV naïve

-    250 specimens

-    50 recent (including 5 series of 5 specimens each)

-    125 non-recent

-    12 elite controller

-    13 ART-suppressed

-    50 reproducibility (10 blood donor specimens included as 5 replicates each)

-    All Clade B

-    3000 specimens

-    5 panels of 485 unique specimens and 15 controls

-    All blood plasma

-    Always blinded

Criteria for panel access

-    Plausible concept

-    Associated with HIV

-    Associated with recency

-    Can be reliably measured, tunable threshold

-    Useful as classifier

-    MDRI analysis plan approved by SACEMA

-    Threshold with plausible MDRI (4-24mo)

-    FRR analysis plan approved by SACEMA

-    Threshold with plausible MDRI (4-24mo)

-    Threshold with plausible FRR (<15%)

-    Consistent FRR between clades

-    Final protocol with proposed threshold

-    Potential advantages

-    MDRI 4-24mo

-    FRR not inferior to BED-CEIA

Request Panel Access:

If you would like to request access to one of the CEPHIA panels listed above, complete this request form and email it to us at sfacente [at] vitalant.org. Someone will be in touch with you shortly about your request.



Consortium Members


CEPHIA is staffed by the following core members:

    • Alex Welte, Joseph Sempa, formerly: David Matten, Hilmarié Brand, Trust Chibawara (South African Centre for Epidemiological Modelling and Analysis, Stellenbosch University)
    • Gary Murphy, Jake Hall, formerly: Elaine Mckinney (Public Health England)
    • Michael P. Busch, Eduard Grebe, Shelley Facente, formerly: Sheila Keating, Dylan Hampton, Mila Lebedeva (Vitalant Research Institute)
    • Christopher D. Pilcher, formerly: Kara Marson (University of California San Francisco)

Other members of CEPHIA include outstanding researchers from around the globe, including:

    • Reshma Kassanjee (University of Cape Town)
    • Oliver Laeyendecker, Thomas Quinn, David Burns (National Institutes of Health)
    • Susan Little (University of California San Diego)
    • Anita Sands (World Health Organization)
    • Tim Hallett (Imperial College London)
    • S. Michele Owen, Bharat Parekh, Connie Sexton (Centers for Disease Control and Prevention)
    • Matthew Price, Anatoli Kamali (International AIDS Vaccine Initiative)
    • Lisa Loeb (formerly of The Options Study - University of California San Francisco)
    • Jeffrey Martin, Steven Deeks, Rebecca Hoh (The SCOPE Study – University of California San Francisco)
    • Zelinda Bartolomei, Natalia Cerqueira (The AMPLIAR Cohort – University of São Paulo)
    • Breno Santos, Kellin Zabtoski, Rita de Cassia Alves Lira (The AMPLIAR Cohort Grupo Hospital Conceição)
    • Rosa Dea Sperhacke, Leonardo R Motta, Machline Paganella (The AMPLIAR Cohort – Universidade Caxias Do Sul)
    • Esper Kallas, Helena Tomiyama, Claudia Tomiyama, Priscilla Costa, Maria A Nunes, Gisele Reis, Mariana M Sauer, Natalia Cerqueira, Zelinda Nakagawa,
      Lilian Ferrari, Ana P Amaral, Karine Milani (The São Paulo Cohort University of São Paulo, Brazil)
    • Salim S Abdool Karim, Quarraisha Abdool Karim, Thumbi Ndungu, Nelisile Majola, Natasha Samsunder (CAPRISA, University of Kwazulu-Natal)
    • Denise Naniche (The GAMA Study – Barcelona Centre for International Health Research)
    • Inácio Mandomando, Eusebio V Macete (The GAMA Study – Fundacao Manhica)
    • Jorge Sanchez, Javier Lama (SABES Cohort – Asociación Civil Impacta Salud y Educación (IMPACTA))
    • Ann Duerr (The Fred Hutchinson Cancer Research Center)
    • Maria R Capobianchi (National Institute for Infectious Diseases “L. Spallanzani”, Rome)
    • Barbara Suligoi (Istituto Superiore di Sanità, Rome)
    • Susan Stramer (American Red Cross)
    • Phillip Williamson (Creative Testing Solutions / Vitalant Research Institute);
    • Marion Vermeulen (South African National Blood Service)
    • Ester Sabino (Hemocentro do São Paolo)