Performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay in Detecting ""Recent"" HIV Infection and Calculating Population Incidence

Imagem de Miniatura
Arquivos
art_KEATING_Performance_of_the_BioRad_Geenius_HIV12_Supplemental_Assay_2016.PDF (553.81 KB)
Citações na Scopus
21
Tipo de produção
article
Data de publicação
2016
Editora
LIPPINCOTT WILLIAMS & WILKINS
Indexadores
Scopus
Web of Science
PubMed
Título da Revista
ISSN da Revista
Título do Volume
Autores
KEATING, Sheila M.
KASSANJEE, Reshma
LEBEDEVA, Mila
FACENTE, Shelley N.
MACARTHUR, Jeffrey C.
GREBE, Eduard
MURPHY, Gary
WELTE, Alex
MARTIN, Jeffrey N.
LITTLE, Susan
Autor de Grupo de pesquisa
Consortium Evaluation Performance
Editores
Coordenadores
Organizadores
Citação
JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES, v.73, n.5, p.581-588, 2016
Projetos de Pesquisa
Unidades Organizacionais
Fascículo
Resumo
Objective: HIV seroconversion biomarkers are being used in cross-sectional studies for HIV incidence estimation. Bio-Rad Geenius HIV-1/2 Supplemental Assay is an immunochromatographic single-use assay that measures antibodies (Ab) against multiple HIV-1/2 antigens. The objective of this study was to determine whether the Geenius assay could additionally be used for recency estimation. Design: This assay was developed for HIV-1/2 confirmation; however, quantitative data acquired give information on increasing concentration and diversity of antibody responses over time during seroconversion. A quantitative threshold of recent HIV infection was proposed to determine ""recent"" or ""nonrecent"" HIV infection; performance using this cutoff was evaluated. Methods: We tested 2500 highly characterized specimens from research subjects in the United States, Brazil, and Africa with well-defined durations of HIV infection. Regression and frequency estimation were used to estimate assay properties relevant to HIV incidence measurement: mean duration of recent infection (MDRI), false-recent rate, and assay reproducibility and robustness. Results: Using the manufacturer's proposed cutoff index of 1.5 to identify ""recent"" infection, the assay has an estimated false-recent rate of 4.1% (95% CI: 2.2 to 7.0) and MDRI of 179 days (155 to 201) in specimens from treatment-naive subjects, presenting performance challenges similar to other incidence assays. Lower index cutoffs associated with lower MDRI gave a lower rate of false-recent results. Conclusions: These data suggest that with additional interpretive analysis of the band intensities using an algorithm and cutoff, the Geenius HIV-1/2 Supplemental Assay can be used to identify recent HIV infection in addition to confirming the presence of HIV-1 and HIV-2 antibodies.
Palavras-chave
rapid turn-around time, recent HIV infection, HIV incidence
URI
https://observatorio.fm.usp.br/handle/OPI/17838
Referências
  1. Aghaizu A, 2014, EUROSURVEILLANCE, V19, P5, DOI 10.2807/1560-7917.ES2014.19.2.20673
  2. Ananworanich J, 2015, JAIDS-J ACQ IMM DEF, V68, P481, DOI 10.1097/QAI.0000000000000502
  3. Ananworanich J, 2015, CURR OPIN HIV AIDS, V10, P1, DOI 10.1097/COH.0000000000000125
  4. Bellan SE, 2015, PLOS MED, V12, DOI 10.1371/journal.pmed.1001801
  5. Branson BM, 1999, J ACQ IMMUN DEF SYND, V55, pS102
  6. Cardenas AM, 2013, J CLIN VIROL, V58, pE97, DOI 10.1016/j.jcv.2013.08.021
  7. CDC, 1989, MMWR-MORBID MORTAL W, V38, P1
  8. Cohen MS, 2011, NEW ENGL J MED, V365, P493, DOI 10.1056/NEJMoa1105243
  9. Eshleman SH, 2013, J INFECT DIS, V207, P223, DOI 10.1093/infdis/jis658
  10. Fiebig EW, 2003, AIDS, V17, P1871, DOI 10.1097/01.aids.0000076308.76477.b8
  11. Gokengin D, 2014, INT J STD AIDS, V25, P695, DOI 10.1177/0956462414531244
  12. Grijsen ML, 2012, PLOS MED, V9, DOI 10.1371/journal.pmed.1001196
  13. Hallen AH, 2014, CLIN VACCINE IMMUNOL, V21, P1192, DOI 10.1128/CVI.00153-14
  14. Hammett TM, 2012, PLOS ONE, V7, DOI 10.1371/journal.pone.0043141
  15. Hollingsworth TD, 2015, J INFECT DIS, V211, P1757, DOI 10.1093/infdis/jiu831
  16. Incidence Assay Critical Path Working G, 2011, PLOS MED, V8
  17. Kassanjee R, 2014, AIDS, V28, P2439, DOI 10.1097/QAD.0000000000000429
  18. Laeyendecker O, 2013, PLOS ONE, V8, DOI 10.1371/journal.pone.0078818
  19. Laeyendecker O, 2013, PLOS ONE, V8, DOI 10.1371/journal.pone.0068349
  20. Le Vu S, 2012, PLOS ONE, V7, DOI 10.1371/journal.pone.0039872
  21. Lee HY, 2009, J THEOR BIOL, V261, P341, DOI 10.1016/j.jtbi.2009.07.038
  22. Lissouba P, 2011, BMC INFECT DIS, V11, DOI 10.1186/1471-2334-11-253
  23. Masciotra S, 2011, J CLIN VIROL, V52, pS17, DOI 10.1016/j.jcv.2011.09.011
  24. Montesinos I, 2014, J CLIN VIROL, V60, P399, DOI 10.1016/j.jcv.2014.04.025
  25. Mor O, 2014, J CLIN MICROBIOL, V52, P2677, DOI 10.1128/JCM.01184-14
  26. Pilcher CD, 2005, NEW ENGL J MED, V352, P1873, DOI 10.1056/NEJMoa042291
  27. Reza-Paul S, 2008, AIDS, V22, pS91, DOI 10.1097/01.aids.0000343767.08197.18
  28. Rosenberg NE, 2015, CURR OPIN HIV AIDS, V10, P61, DOI 10.1097/COH.0000000000000121
  29. Schupbach J, 2012, BMC INFECT DIS, V12, DOI 10.1186/1471-2334-12-88
  30. Schuetz A, 2014, PLOS PATHOG, V10, DOI 10.1371/journal.ppat.1004543
  31. Selik RM, 2014, REVISED SURVEILLANCE
  32. Wawer MJ, 2005, J INFECT DIS, V191, P1403, DOI 10.1086/429411
  33. [Anonymous], 2009, GUIDELINES USING HIV
  34. [Anonymous], 2012, HIV SURVEILLANCE SUP, P17

Coleções
Artigos e Materiais de Revistas Científicas - FM/MCM
Artigos e Materiais de Revistas Científicas - HC/ICHC
Artigos e Materiais de Revistas Científicas - LIM/60
Artigos e Materiais de Revistas Científicas - ODS/03