HIV avidity index performance using a modified fourth-generation immunoassay to detect recent HIV infections

B. Suligoi, V. Regine, M. Raimondo, A. Rodella, L. Terlenghi, A. Caruso, P. Bagnarelli, M.R. Capobianchi, N. Zanchetta, V. Ghisetti, C. Galli

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Detecting recent HIV infections is important to evaluate incidence and monitor epidemic trends. We aimed to evaluate the diagnostic performance and accuracy of the avidity index (AI) for discriminating for recent HIV infections. We collected serum samples from HIV-1 positive individuals: A) with known date of infection (midpoint in time between last HIV-negative and first HIV-positive test); B) infected for >1 year. Samples were divided into two aliquots: one diluted with phosphate buffered saline (PBS) and the other with 1 M guanidine. Both aliquots were assayed by the Architect HIV Ag/Ab Combo 4th generation assay (Abbott). We compared AI found in recent (RI=
Original languageEnglish
Pages (from-to)2010-2019
Number of pages10
JournalClinical Chemistry and Laboratory Medicine
Volume55
Issue number12
DOIs
Publication statusPublished - 2017

Fingerprint

Guanidine
Immunoassay
HIV Infections
Assays
Phosphates
HIV
HIV-1
Incidence
Infection
Serum

Keywords

  • avidity
  • enzyme immunoassay
  • epidemiology
  • HIV
  • incidence
  • recent infection
  • anti human immunodeficiency virus agent
  • antigen p24
  • Human immunodeficiency virus antibody
  • Human immunodeficiency virus antigen
  • virus RNA
  • adolescent
  • adult
  • aged
  • antiretroviral therapy
  • Article
  • CD4 lymphocyte count
  • cohort analysis
  • comparative study
  • controlled study
  • diagnostic accuracy
  • disease classification
  • female
  • human
  • Human immunodeficiency virus 1 infection
  • Human immunodeficiency virus avidity index immunoassay
  • Human immunodeficiency virus infected patient
  • immunoassay
  • major clinical study
  • male
  • middle aged
  • multicenter study
  • observational study
  • open study
  • priority journal
  • receiver operating characteristic
  • seroconversion
  • validation study
  • virus load
  • antibody affinity
  • blood
  • clinical trial
  • Human immunodeficiency virus
  • Human immunodeficiency virus infection
  • immunology
  • isolation and purification
  • young adult
  • Adolescent
  • Adult
  • Antibody Affinity
  • Cohort Studies
  • Female
  • HIV Infections
  • Humans
  • Immunoassay
  • Male
  • Middle Aged
  • Young Adult

Cite this

HIV avidity index performance using a modified fourth-generation immunoassay to detect recent HIV infections. / Suligoi, B.; Regine, V.; Raimondo, M.; Rodella, A.; Terlenghi, L.; Caruso, A.; Bagnarelli, P.; Capobianchi, M.R.; Zanchetta, N.; Ghisetti, V.; Galli, C.

In: Clinical Chemistry and Laboratory Medicine, Vol. 55, No. 12, 2017, p. 2010-2019.

Research output: Contribution to journalArticle

Suligoi, B. ; Regine, V. ; Raimondo, M. ; Rodella, A. ; Terlenghi, L. ; Caruso, A. ; Bagnarelli, P. ; Capobianchi, M.R. ; Zanchetta, N. ; Ghisetti, V. ; Galli, C. / HIV avidity index performance using a modified fourth-generation immunoassay to detect recent HIV infections. In: Clinical Chemistry and Laboratory Medicine. 2017 ; Vol. 55, No. 12. pp. 2010-2019.
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abstract = "Detecting recent HIV infections is important to evaluate incidence and monitor epidemic trends. We aimed to evaluate the diagnostic performance and accuracy of the avidity index (AI) for discriminating for recent HIV infections. We collected serum samples from HIV-1 positive individuals: A) with known date of infection (midpoint in time between last HIV-negative and first HIV-positive test); B) infected for >1 year. Samples were divided into two aliquots: one diluted with phosphate buffered saline (PBS) and the other with 1 M guanidine. Both aliquots were assayed by the Architect HIV Ag/Ab Combo 4th generation assay (Abbott). We compared AI found in recent (RI=",
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author = "B. Suligoi and V. Regine and M. Raimondo and A. Rodella and L. Terlenghi and A. Caruso and P. Bagnarelli and M.R. Capobianchi and N. Zanchetta and V. Ghisetti and C. Galli",
note = "Export Date: 24 April 2018 CODEN: CCLMF Correspondence Address: Suligoi, B.; Department of Infectious Diseases, Istituto Superiore di Sanit{\`a}, Viale Regina Elena 299, Italy; email: barbara.suligoi@iss.it Tradenames: Architect HIV Ag/Ab Combo, Abbott Diagnostics, Germany; AxSYM HIV 1/2 gO, Abbott Diagnostics, Germany; New LAV Blot HIV1, Biorad, France; Vitros Anti-HIV frac1/2, Ortho, United States Manufacturers: Abbott Diagnostics, Germany; Biorad, France; Ortho, United States References: Smith, M.K., Rutstein, S.E., Powers, K.A., Fidler, S., Miller, W.C., Eron, J.J., The detection and management of early HIV infection: A clinical and public health emergency (2013) J Acquir Immune Defic Syndr, 63, pp. S187-S199; (2011) When and How to Use Assays for Recent Infection to Estimate HIV Incidence at A Population Level, , http://www.who.int/diagnostics, UNAIDS/WHO Working Group on Global HIV/AIDS and STI Surveillance; Murphy, G., Parry, J.V., Assays for the detection of recent infections with human immunodeficiency virus type 1 (2008) Eurosurveillance, 13, pp. 4-10; Cole, K.S., Murphey-Corb, M., Narayan, O., Joag, S.V., Shaw, G.M., Montelaro, R.C., Common themes of antibody maturation to simian immunodeficiency virus, simian-human immunodeficiency virus and human immunodeficiency virus type 1 infections (1998) J Virol, 72, pp. 7852-7859; Curdt, I., Praast, G., Sickinger, E., Schultess, J., Herold, I., Braun, H.B., Development of fully automated determination of markerspecific immunoglobulin G (IgG) avidity based on the avidity competition assay format: Application for the Abbott Architect cytomegalovirus and Toxo IgG avidity assays (2009) J Clin Microbiol, 47, pp. 603-613; Suligoi, B., Massi, M., Galli, C., Sciandra, M., Di Sora, F., Pezzotti, P., Identifying recent HIV infections using the avidity index and an automated enzyme immunoassay (2003) J Acquir Immune Defic Syndr, 32, pp. 424-428; Suligoi, B., Butto, S., Galli, C., Bernasconi, D., Salata, R.A., Tavoschi, L., Detection of recent HIV infections in African individuals infected by HIV-1 non-B subtypes using HIV antibody avidity (2008) J Clin Virol, 41, pp. 288-292; Suligoi, B., Raimondo, M., Regine, V., Rodella, A., Terlenghi, L., Bagnarelli, P., HIV avidity index for identifying recent HIV infections: Factors associated with false recent classification (2015) Clin Chem Lab Med, 53, p. S1323; Suligoi, B., Rodella, A., Raimondo, M., Regine, V., Terlenghi, L., Manca, N., Avidity Index for anti-HIV antibodies: Comparison between third-and fourth-generation automated immunoassays (2011) J Clin Microbiol, 49, pp. 2610-2613; CDC: Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents, US Department of Health and Human Services (2016) AIDSinfo, , https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf; WHO/UNAIDS Annual Meeting of the Technical Working Group on HIV Incidence Assays, October 2014, , http://apps.who.int/iris/bitstream/10665/162156/1/WHO_HIV_2015.11_eng.pdf?ua=1&ua=1, WHO/HIV/2015.11; Butto, S., Raimondo, M., Fanales-Belasio, E., Suligoi, B., Suggested strategies for the laboratory diagnosis of HIV infection in Italy (2010) Ann Ist Super Sanita, 46, pp. 34-41; (2004) Evaluation of Precision Performance of Quantitative Measurement Methods, , NCCLS; Approved Guideline-Second Edition; Selleri, M., Orchi, N., Zaniratti, M.S., Bellagamba, R., Corpolongo, A., Angeletti, C., Effective highly active antiretroviral therapy in patients with primary HIV-1 infection prevents the evolution of the avidity of HIV-1-specific antibodies (2007) J Acquir Immune Defic Syndr, 46, pp. 145-150; Binley, J.M., Trkola, A., Ketas, T., Schiller, D., Clas, B., Little, S., The effect of highly active antiretroviral therapy on binding and neutralizing antibody responses to human immunodeficiency virus type 1 infection (2000) Journal of Infectious Diseases, 182, pp. 945-949; Kassanjee, R., Pilcher, C.D., Keating, S.M., Facente, S.N., McKinney, E., Price, M.A., Independent assessment of candidate HIV incidence assays on specimens in the CEPHIA repository (2014) AIDS, 28, pp. 2439-2449; Kirkpatrick, A.R., Patel, E.U., Celum, C.L., Moore, R.D., Blankson, J.M., Mehta, S.H., Development and evaluation of a modified fourth-generation human immunodeficiency virus enzyme immunoassay for cross-sectional incidence estimation in clade B populations (2016) AIDS Res Hum Retroviruses, 32, pp. 756-762; Kassanjee, R., Pilcher, C.D., Busch, M.P., Murphy, G., Facente, S.N., Keating, S.M., Viral load criteria and threshold optimization to improve HIV incidence assay characteristics (2016) AIDS, 30, pp. 2361-2371; Curtis, K.A., Hanson, D.L., Kennedy, M.S., Owen, M., Evaluation of a multiplex assay for estimation of HIV-1 incidence (2013) PLoS One, 8, p. e64201; Laeyendecker, O., Brookmeyer, R., Oliver, A.E., Mullis, C.E., Eaton, K.P., Mueller, A.C., Factors associated with incorrect identification of recent HIV infection using the BED capture immunoassay (2012) AIDS Res Hum Retroviruses, 28, pp. 816-822; Jafarzadeh, S.R., Johnson, W.O., Gardner, I.A., Bayesian modelling and inference for diagnostic accuracy and probability of disease based on multiple diagnostic biomarkers with and without a perfect reference standard (2016) Stat Med, 35, pp. 859-876; Hanson, D.L., Song, R., Masciotra, S., Hernandez, A., Dobbs, T.L., Parekh, B., Mean recency period for estimation of HIV-1 incidence by the BED-capture EIA and Bio-Rad avidity in persons diagnosed in the United States with subtype B (2016) PLoS One, 11, p. e0152327; Sweeting, M.J., De Angelis, D., Parry, J., Suligoi, B., Estimating the distribution of the window period for recent HIV infections: A comparison of statistical methods (2010) Stat Med, 29, pp. 3194-3202; Shepherd, S.J., McAllister, G., Kean, J., Wallace, L.A., Templeton, K.E., Goldberg, D.J., Development of an avidity assay for detection of recent HIV infections (2015) J Virol Methods, 217, pp. 42-49; (2014) HIV/AIDS Surveillance in Europe 2013, , European Centre for Disease Prevention and Control/WHO Regional Office for Europe. Stockholm: ECDC; (2015) Linee Guida Italiane Sull'utilizzo Dei Farmaci Antiretrovirali e sulla Gestione Diagnostico-clinica Delle Persone Con Infezione da HIV-1, , http://www.simit.org/medias/852-lg-hiv-2015-c17pubblicazioni2442allegato.pdf, Ministero della Salute, Sezioni L ed M del Comitato Tecnico Sanitario. 17 Dicembre; (2015) EACS: European AIDS Clinical Society. Guidelines, , http://www.eacsociety.org/guidelines/eacs-guidelines/eacs-guidelines.html, version 8.0, October",
year = "2017",
doi = "10.1515/cclm-2016-1192",
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TY - JOUR

T1 - HIV avidity index performance using a modified fourth-generation immunoassay to detect recent HIV infections

AU - Suligoi, B.

AU - Regine, V.

AU - Raimondo, M.

AU - Rodella, A.

AU - Terlenghi, L.

AU - Caruso, A.

AU - Bagnarelli, P.

AU - Capobianchi, M.R.

AU - Zanchetta, N.

AU - Ghisetti, V.

AU - Galli, C.

N1 - Export Date: 24 April 2018 CODEN: CCLMF Correspondence Address: Suligoi, B.; Department of Infectious Diseases, Istituto Superiore di Sanità, Viale Regina Elena 299, Italy; email: barbara.suligoi@iss.it Tradenames: Architect HIV Ag/Ab Combo, Abbott Diagnostics, Germany; AxSYM HIV 1/2 gO, Abbott Diagnostics, Germany; New LAV Blot HIV1, Biorad, France; Vitros Anti-HIV frac1/2, Ortho, United States Manufacturers: Abbott Diagnostics, Germany; Biorad, France; Ortho, United States References: Smith, M.K., Rutstein, S.E., Powers, K.A., Fidler, S., Miller, W.C., Eron, J.J., The detection and management of early HIV infection: A clinical and public health emergency (2013) J Acquir Immune Defic Syndr, 63, pp. S187-S199; (2011) When and How to Use Assays for Recent Infection to Estimate HIV Incidence at A Population Level, , http://www.who.int/diagnostics, UNAIDS/WHO Working Group on Global HIV/AIDS and STI Surveillance; Murphy, G., Parry, J.V., Assays for the detection of recent infections with human immunodeficiency virus type 1 (2008) Eurosurveillance, 13, pp. 4-10; Cole, K.S., Murphey-Corb, M., Narayan, O., Joag, S.V., Shaw, G.M., Montelaro, R.C., Common themes of antibody maturation to simian immunodeficiency virus, simian-human immunodeficiency virus and human immunodeficiency virus type 1 infections (1998) J Virol, 72, pp. 7852-7859; Curdt, I., Praast, G., Sickinger, E., Schultess, J., Herold, I., Braun, H.B., Development of fully automated determination of markerspecific immunoglobulin G (IgG) avidity based on the avidity competition assay format: Application for the Abbott Architect cytomegalovirus and Toxo IgG avidity assays (2009) J Clin Microbiol, 47, pp. 603-613; Suligoi, B., Massi, M., Galli, C., Sciandra, M., Di Sora, F., Pezzotti, P., Identifying recent HIV infections using the avidity index and an automated enzyme immunoassay (2003) J Acquir Immune Defic Syndr, 32, pp. 424-428; Suligoi, B., Butto, S., Galli, C., Bernasconi, D., Salata, R.A., Tavoschi, L., Detection of recent HIV infections in African individuals infected by HIV-1 non-B subtypes using HIV antibody avidity (2008) J Clin Virol, 41, pp. 288-292; Suligoi, B., Raimondo, M., Regine, V., Rodella, A., Terlenghi, L., Bagnarelli, P., HIV avidity index for identifying recent HIV infections: Factors associated with false recent classification (2015) Clin Chem Lab Med, 53, p. S1323; Suligoi, B., Rodella, A., Raimondo, M., Regine, V., Terlenghi, L., Manca, N., Avidity Index for anti-HIV antibodies: Comparison between third-and fourth-generation automated immunoassays (2011) J Clin Microbiol, 49, pp. 2610-2613; CDC: Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents, US Department of Health and Human Services (2016) AIDSinfo, , https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf; WHO/UNAIDS Annual Meeting of the Technical Working Group on HIV Incidence Assays, October 2014, , http://apps.who.int/iris/bitstream/10665/162156/1/WHO_HIV_2015.11_eng.pdf?ua=1&ua=1, WHO/HIV/2015.11; Butto, S., Raimondo, M., Fanales-Belasio, E., Suligoi, B., Suggested strategies for the laboratory diagnosis of HIV infection in Italy (2010) Ann Ist Super Sanita, 46, pp. 34-41; (2004) Evaluation of Precision Performance of Quantitative Measurement Methods, , NCCLS; Approved Guideline-Second Edition; Selleri, M., Orchi, N., Zaniratti, M.S., Bellagamba, R., Corpolongo, A., Angeletti, C., Effective highly active antiretroviral therapy in patients with primary HIV-1 infection prevents the evolution of the avidity of HIV-1-specific antibodies (2007) J Acquir Immune Defic Syndr, 46, pp. 145-150; Binley, J.M., Trkola, A., Ketas, T., Schiller, D., Clas, B., Little, S., The effect of highly active antiretroviral therapy on binding and neutralizing antibody responses to human immunodeficiency virus type 1 infection (2000) Journal of Infectious Diseases, 182, pp. 945-949; Kassanjee, R., Pilcher, C.D., Keating, S.M., Facente, S.N., McKinney, E., Price, M.A., Independent assessment of candidate HIV incidence assays on specimens in the CEPHIA repository (2014) AIDS, 28, pp. 2439-2449; Kirkpatrick, A.R., Patel, E.U., Celum, C.L., Moore, R.D., Blankson, J.M., Mehta, S.H., Development and evaluation of a modified fourth-generation human immunodeficiency virus enzyme immunoassay for cross-sectional incidence estimation in clade B populations (2016) AIDS Res Hum Retroviruses, 32, pp. 756-762; Kassanjee, R., Pilcher, C.D., Busch, M.P., Murphy, G., Facente, S.N., Keating, S.M., Viral load criteria and threshold optimization to improve HIV incidence assay characteristics (2016) AIDS, 30, pp. 2361-2371; Curtis, K.A., Hanson, D.L., Kennedy, M.S., Owen, M., Evaluation of a multiplex assay for estimation of HIV-1 incidence (2013) PLoS One, 8, p. e64201; Laeyendecker, O., Brookmeyer, R., Oliver, A.E., Mullis, C.E., Eaton, K.P., Mueller, A.C., Factors associated with incorrect identification of recent HIV infection using the BED capture immunoassay (2012) AIDS Res Hum Retroviruses, 28, pp. 816-822; Jafarzadeh, S.R., Johnson, W.O., Gardner, I.A., Bayesian modelling and inference for diagnostic accuracy and probability of disease based on multiple diagnostic biomarkers with and without a perfect reference standard (2016) Stat Med, 35, pp. 859-876; Hanson, D.L., Song, R., Masciotra, S., Hernandez, A., Dobbs, T.L., Parekh, B., Mean recency period for estimation of HIV-1 incidence by the BED-capture EIA and Bio-Rad avidity in persons diagnosed in the United States with subtype B (2016) PLoS One, 11, p. e0152327; Sweeting, M.J., De Angelis, D., Parry, J., Suligoi, B., Estimating the distribution of the window period for recent HIV infections: A comparison of statistical methods (2010) Stat Med, 29, pp. 3194-3202; Shepherd, S.J., McAllister, G., Kean, J., Wallace, L.A., Templeton, K.E., Goldberg, D.J., Development of an avidity assay for detection of recent HIV infections (2015) J Virol Methods, 217, pp. 42-49; (2014) HIV/AIDS Surveillance in Europe 2013, , European Centre for Disease Prevention and Control/WHO Regional Office for Europe. Stockholm: ECDC; (2015) Linee Guida Italiane Sull'utilizzo Dei Farmaci Antiretrovirali e sulla Gestione Diagnostico-clinica Delle Persone Con Infezione da HIV-1, , http://www.simit.org/medias/852-lg-hiv-2015-c17pubblicazioni2442allegato.pdf, Ministero della Salute, Sezioni L ed M del Comitato Tecnico Sanitario. 17 Dicembre; (2015) EACS: European AIDS Clinical Society. Guidelines, , http://www.eacsociety.org/guidelines/eacs-guidelines/eacs-guidelines.html, version 8.0, October

PY - 2017

Y1 - 2017

N2 - Detecting recent HIV infections is important to evaluate incidence and monitor epidemic trends. We aimed to evaluate the diagnostic performance and accuracy of the avidity index (AI) for discriminating for recent HIV infections. We collected serum samples from HIV-1 positive individuals: A) with known date of infection (midpoint in time between last HIV-negative and first HIV-positive test); B) infected for >1 year. Samples were divided into two aliquots: one diluted with phosphate buffered saline (PBS) and the other with 1 M guanidine. Both aliquots were assayed by the Architect HIV Ag/Ab Combo 4th generation assay (Abbott). We compared AI found in recent (RI=

AB - Detecting recent HIV infections is important to evaluate incidence and monitor epidemic trends. We aimed to evaluate the diagnostic performance and accuracy of the avidity index (AI) for discriminating for recent HIV infections. We collected serum samples from HIV-1 positive individuals: A) with known date of infection (midpoint in time between last HIV-negative and first HIV-positive test); B) infected for >1 year. Samples were divided into two aliquots: one diluted with phosphate buffered saline (PBS) and the other with 1 M guanidine. Both aliquots were assayed by the Architect HIV Ag/Ab Combo 4th generation assay (Abbott). We compared AI found in recent (RI=

KW - avidity

KW - enzyme immunoassay

KW - epidemiology

KW - HIV

KW - incidence

KW - recent infection

KW - anti human immunodeficiency virus agent

KW - antigen p24

KW - Human immunodeficiency virus antibody

KW - Human immunodeficiency virus antigen

KW - virus RNA

KW - adolescent

KW - adult

KW - aged

KW - antiretroviral therapy

KW - Article

KW - CD4 lymphocyte count

KW - cohort analysis

KW - comparative study

KW - controlled study

KW - diagnostic accuracy

KW - disease classification

KW - female

KW - human

KW - Human immunodeficiency virus 1 infection

KW - Human immunodeficiency virus avidity index immunoassay

KW - Human immunodeficiency virus infected patient

KW - immunoassay

KW - major clinical study

KW - male

KW - middle aged

KW - multicenter study

KW - observational study

KW - open study

KW - priority journal

KW - receiver operating characteristic

KW - seroconversion

KW - validation study

KW - virus load

KW - antibody affinity

KW - blood

KW - clinical trial

KW - Human immunodeficiency virus

KW - Human immunodeficiency virus infection

KW - immunology

KW - isolation and purification

KW - young adult

KW - Adolescent

KW - Adult

KW - Antibody Affinity

KW - Cohort Studies

KW - Female

KW - HIV Infections

KW - Humans

KW - Immunoassay

KW - Male

KW - Middle Aged

KW - Young Adult

U2 - 10.1515/cclm-2016-1192

DO - 10.1515/cclm-2016-1192

M3 - Article

VL - 55

SP - 2010

EP - 2019

JO - Clinical Chemistry and Laboratory Medicine

JF - Clinical Chemistry and Laboratory Medicine

SN - 1434-6621

IS - 12

ER -