Statistical positivity criteria for the analysis of ELISpot assay data in HIV-1 vaccine trials
Abstract
The enzyme-linked immunospot (ELISpot) assay is one of the leading technologies used to measure cellular responses in many settings including HIV vaccine clinical trials. HIV-1-specific effector T lymphocyte responses are considered necessary in the control of infection. Accurate measurement and summary of cellular immune responses are critical to HIV research. ELISpot assay readout is often dichotomized into positive/negative responses according to some pre-specified criteria. Given the increase in the number of replicates used for each stimulation with current assay configurations in the HIV Vaccine Trials Network (HVTN) laboratories, a new approach is now possible. We propose an objective criteria based on a hypothesis-driven method that controls the false positive rate while maintaining sensitivity to each of the antigen-specific responses under study. The new approach is compared to other commonly employed criteria using real and simulated data.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
With sera from individuals who had recovered from COVID-19, the fluorescent neutralization assay gave results comparable to the conventional plaque reduction neutralization assay.
“With sera from patients who had recovered from COVID-19, the fluorescent neutralization assay produced comparable results to the conventional plaque reduction neutralization assay 43 .”
From BNT162b2 vaccine induces neutralizing antibodies and poly-specific T cells in humans (2021) · cites this paper as [43]
Cites
Gentleman R: R: A language for data analysis and graphics
Ihaka, R., & Gentleman, R. (1996) · Journal of Computational and Graphical Statistics · doi:10.1080/10618600.1996.10474713 · Cited by 11,747 · see citing works
R: A Language for Data Analysis and Graphics
Ihaka, R., & Gentleman, R. C. (1996) · Journal of Computational and Graphical Statistics · doi:10.2307/1390807 · Cited by 4,245 · see citing works
Resampling-Based Multiple Testing: Examples and Methods for p-Value Adjustment
Martín, M. A., Westfall, P. H., & Young, S. (1993) · Biometrics · doi:10.2307/2533464 · Cited by 2,308 · see citing works
Analysis of Successful Immune Responses in Persons Infected with Hepatitis C Virus
Lechner, F., Wong, D., Dunbar, P. R., Chapman, R. W., Chung, R. T., Dohrenwend, P. B., Robbins, G. K., Phillips, R., Klenerman, P., & Walker, B. D. (2000) · The Journal of Experimental Medicine · doi:10.1084/jem.191.9.1499 · Cited by 1,269 · see citing works
Multiple Hypothesis Testing in Microarray Experiments
Dudoit, S., Shaffer, J. P., & Boldrick, J. C. (2003) · Statistical Science · doi:10.1214/ss/1056397487 · Cited by 1,054 · see citing works
Resampling-Based Multiple Testing: Examples and Methods for p-Value Adjustment
Chaubey, Y. P., Westfall, P. H., & Young, S. S. (1993) · Technometrics · doi:10.2307/1270279 · Cited by 943 · see citing works
Zinkernagel, R. M., & Doherty, P. C. (1974) · Nature · doi:10.1038/251547a0 · Cited by 854 · see citing works
(1999) · Choice Reviews Online · doi:10.5860/choice.36-3094 · Cited by 569 · see citing works
Czerkinsky, C. C., Andersson, G., Ekre, H.-P. T., Nilsson, L., Klareskog, L., & Ouchterlony, Ö. (1988) · Journal of Immunological Methods · doi:10.1016/0022-1759(88)90079-8 · Cited by 495 · see citing works
Rowland‐Jones, S., Dong, T., Fowke, K. R., Kimani, J., Krausa, P., Newell, H., Blanchard, T., Ariyoshi, K., Oyugi, J. O., NGUGI, E. N., et al. (1998) · Journal of Clinical Investigation · doi:10.1172/jci4314 · Cited by 419 · see citing works
Olsson, T. P., Zhi, W. W., Höjeberg, B., Kostulas, V., Jiang, Y., Anderson, G., Ekre, H. P., & Link, H. (1990) · Journal of Clinical Investigation · doi:10.1172/jci114800 · Cited by 370 · see citing works
Currier, J. R., Kuta, E. G., Turk, E., Earhart, L. B., Loomis-Price, L. D., Janetzki, S., Ferrari, G., Birx, D. L., & Cox, J. H. (2002) · Journal of Immunological Methods · doi:10.1016/s0022-1759(01)00535-x · Cited by 320 · see citing works
Lechner, F., Gruener, N. H., Urbani, S., Uggeri, J., Santantonio, T. A., Kammer, A. R., Cerny, A., Phillips, R., Ferrari, C. I., Pape, G. R., et al. (2000) · European Journal of Immunology · doi:10.1002/1521-4141(200009)30:9 · Cited by 311 · see citing works
Enhanced: The Need for a Global HIV Vaccine Enterprise
Klausner, R. D., Fauci, A. S., Corey, L., Nabel, G. J., Gayle, H. D., Berkley, S., Haynes, B. F., Baltimore, D., Collins, C., Douglas, R. G., et al. (2003) · Science · doi:10.1126/science.1086916 · Cited by 197 · see citing works
Rahman, F., Dahmen, A., Herzog‐Hauff, S., Böcher, W. O., Galle, P. R., & Löhr, H. F. (2000) · Hepatology · doi:10.1002/hep.510310237 · Cited by 153 · see citing works
Gandhi, R. T., & Walker, B. D. (2002) · Annual Review of Medicine · doi:10.1146/annurev.med.53.082901.104011 · Cited by 145 · see citing works
Nylander, K., Coates, P. J., & Hall, P. A. (2000) · International Journal of Cancer · doi:10.1002/1097-0215(20000801)87:3 · Cited by 142 · see citing works
Nagorsen, D., Keilholz, U., Rivoltini, L., Schmittel, A. H., Letsch, A., Asemissen, A. M., Berger, G., Buhr, H. J., Thiel, E., & Scheibenbogen, C. (2000) · PubMed · Cited by 137 · see citing works
Russell, N. D., Hudgens, M. G., Ha, R., Havenar‐Daughton, C., & McElrath, M. J. (2003) · The Journal of Infectious Diseases · doi:10.1086/367702 · Cited by 118 · see citing works
Pelfrey, C. M., Rudick, R. A., Cotleur, A. C., Lee, J.-C., Tary‐Lehmann, M., & Lehmann, P. (2000) · The Journal of Immunology · doi:10.4049/jimmunol.165.3.1641 · Cited by 116 · see citing works
Goulder, P., Brander, C., Annamalai, K., Mngqundaniso, N., Govender, U., Tang, Y., He, S., Hartman, K. E., O’Callaghan, C. A., Ogg, G. S., et al. (2000) · Journal of Virology · doi:10.1128/jvi.74.12.5679-5690.2000 · Cited by 114 · see citing works
Acetylcholine receptor-reactive T and B cells in myasthenia gravis and controls.
Link, H., Olsson, O., Sun, J., Wang, W. Z., Andersson, G., Ekre, H. P., Brenner, T., Abramsky, O., & Olsson, T. P. (1991) · Journal of Clinical Investigation · doi:10.1172/jci115253 · Cited by 113 · see citing works
Parallel regulation of IL-4 and IL-5 in human helminth infections
Mahanty, S., Abrams, J. S., King, C. L., Limaye, A. P., & Nutman, T. B. (1992) · The Journal of Immunology · doi:10.4049/jimmunol.148.11.3567 · Cited by 106 · see citing works
Altfeld, M. A., Piechocka‐Trocha, A., Eldridge, R. L., Rosenberg, E. S., Phillips, M. N., Addo, M. M., Sékaly, R., Kalams, S. A., Burchett, S. K., McIntosh, K., et al. (2000) · Journal of Virology · doi:10.1128/jvi.74.18.8541-8549.2000 · Cited by 98 · see citing works
ElGhazali, G. E., Paulie, S., Andersson, G., Hansson, Y., Holmquist, G., Sun, J., Olsson, T. P., Ekre, H. P., & Troye‐Blomberg, M. (1993) · European Journal of Immunology · doi:10.1002/eji.1830231103 · Cited by 96 · see citing works
Multiple Comparisons by Rerandomization Tests
Petrondas, D. A., & Gabriel, K. R. (1983) · Journal of the American Statistical Association · doi:10.1080/01621459.1983.10477045 · Cited by 64 · see citing works
Joel, T., Burny, W., Dahmani, S., Zhou, L., Stordeur, P., Byl, B., & Groote, D. D. (2005) · Journal of Immunological Methods · doi:10.1016/j.jim.2005.07.014 · Cited by 62 · see citing works
Herr, W., Protzer, U., Lohse, A. W., Gerken, G., Büschenfelde, K. M. Z., & Wölfel, T. (1998) · The Journal of Infectious Diseases · doi:10.1086/517449 · Cited by 52 · see citing works
Statistical considerations for the design and analysis of the ELISpot assay in HIV-1 vaccine trials
Hudgens, M. G., Self, S. G., Chiu, Y.-L., Russell, N. D., Horton, H., & McElrath, M. J. (2004) · Journal of Immunological Methods · doi:10.1016/j.jim.2004.01.018 · Cited by 42 · see citing works
Self-citationMoss, R. B., Webb, E., Giermakowska, W., Jensen, F. C., Savary, J. R., Wallace, M. R., & Carlo, D. J. (2000) · JAIDS Journal of Acquired Immune Deficiency Syndromes · doi:10.1097/00126334-200007010-00012 · Cited by 33 · see citing works
Multiple Comparisons by Rerandomization Tests
Petrondas, D. A., & Gabriel, K. R. (1983) · Journal of the American Statistical Association · doi:10.2307/2288209 · Cited by 26 · see citing works
Slyker, J. A., Lohman, B. L., Mbori‐Ngacha, D., Reilly, M., Wee, E. G., Dong, T., McMichael, A. J., Rowland‐Jones, S., Hanke, T., & John-Stewart, G. C. (2005) · Vaccine · doi:10.1016/j.vaccine.2005.01.145 · Cited by 22 · see citing works
Eyeson, J., King, D. F. L., Boaz, M. J., Sefia, E., Tomkins, S., Waters, A., Easterbrook, P., & Vyakarnam, A. (2003) · AIDS · doi:10.1097/00002030-200311070-00004 · Cited by 16 · see citing works
Statistical evaluation of HIV vaccines in early clinical trials
Moodie, Z., Rossini, A. J., Hudgens, M. G., Gilbert, P. B., Self, S. G., & Russell, N. D. (2006) · Contemporary Clinical Trials · doi:10.1016/j.cct.2005.11.008 · Cited by 15 · see citing works
Self-citationUse of Interferon-γ ELISPOT in Monitoring Immune Responses in Humans
Matijevic, M., & Urban, R. G. (2005) · Humana Press eBooks · doi:10.1385/1-59259-903-6:237 · Cited by 6 · see citing works
Flagged first, then by citations
Cited by
Sorted by citations
COVID-19 vaccine BNT162b1 elicits human antibody and TH1 T cell responses
Sahin, U., Muik, A., Derhovanessian, E., Vogler, I., Kranz, L. M., Vormehr, M., Baum, A., Pascal, K., Quandt, J., Maurus, D., et al. (2020) · Nature · doi:10.1038/s41586-020-2814-7 · Cited by 1,977 · see citing works
Personalized RNA neoantigen vaccines stimulate T cells in pancreatic cancer
Rojas, L. A., Sethna, Z., Soares, K. C., Olcese, C., Pang, N., Patterson, E., Lihm, J., Ceglia, N., Guasp, P., Chu, A., et al. (2023) · Nature · doi:10.1038/s41586-023-06063-y · Cited by 1,432 · see citing works
BNT162b2 vaccine induces neutralizing antibodies and poly-specific T cells in humans
Sahin, U., Muik, A., Vogler, I., Derhovanessian, E., Kranz, L. M., Vormehr, M., Quandt, J., Bidmon, N., Ulges, A., Baum, A., et al. (2021) · Nature · doi:10.1038/s41586-021-03653-6 · Cited by 845 · see citing works
Catanzaro, A. T., Koup, R. A., Roederer, M., Bailer, R. T., Enama, M. E., Moodie, Z., Gu, L., Martin, J. E., Novik, L., Chakrabarti, B. K., et al. (2006) · The Journal of Infectious Diseases · doi:10.1086/509258 · Cited by 319 · see citing works
Self-citationResponse definition criteria for ELISPOT assays revisited
Moodie, Z., Price, L. S., Gouttefangeas, C., Mander, A., Janetzki, S., Löwer, M., Welters, M. J. P., Ottensmeier, C. H. H., van der Burg, S. H., & Britten, C. M. (2010) · Cancer Immunology Immunotherapy · doi:10.1007/s00262-010-0875-4 · Cited by 225 · see citing works
Self-citationPhase I clinical evaluation of a six-plasmid multiclade HIV-1 DNA candidate vaccine
Catanzaro, A. T., Roederer, M., Koup, R. A., Bailer, R. T., Enama, M. E., Nason, M., Martin, J. E., Rucker, S., Andrews, C. A., Gomez, P. L., et al. (2007) · Vaccine · doi:10.1016/j.vaccine.2007.02.050 · Cited by 151 · see citing works
Koup, R. A., Roederer, M., Lamoreaux, L., Fischer, J., Novik, L., Nason, M., Larkin, B. D., Enama, M. E., Ledgerwood, J. E., Bailer, R. T., et al. (2010) · PLoS ONE · doi:10.1371/journal.pone.0009015 · Cited by 133 · see citing works
Disis, M. L., Guthrie, K. A., Liu, Y., Coveler, A. L., Higgins, D. M., Childs, J. S., Dang, Y., & Salazar, L. G. (2022) · JAMA Oncology · doi:10.1001/jamaoncol.2022.5143 · Cited by 100 · see citing works
Graham, B. S., Enama, M. E., Nason, M., Gordon, I. J., Peel, S. A., Ledgerwood, J. E., Plummer, S. A., Mascola, J. R., Bailer, R. T., Roederer, M., et al. (2013) · PLoS ONE · doi:10.1371/journal.pone.0059340 · Cited by 85 · see citing works
Wecker, M. T., Gilbert, P. B., Russell, N. D., Hural, J., Allen, M., Pensiero, M. N., Chulay, J. D., Chiu, Y.-L., Karim, S. S. A., & Burke, D. S. (2012) · Clinical and Vaccine Immunology · doi:10.1128/cvi.00258-12 · Cited by 70 · see citing works
Self-citationSpearman, P. W., Kalams, S. A., Elizaga, M. L., Metch, B. J., Chiu, Y.-L., Allen, M., Weinhold, K. J., Ferrari, G., Parker, S., McElrath, M. J., et al. (2008) · Vaccine · doi:10.1016/j.vaccine.2008.10.051 · Cited by 62 · see citing works
Ramanathan, V. D., Kumar, M., Mahalingam, J., Pattabiraman, S., Narayanan, P. R., Solomon, S., Panicali, D., Chakrabarty, S., Cox, J. H., Sayeed, E., et al. (2009) · AIDS Research and Human Retroviruses · doi:10.1089/aid.2009.0096 · Cited by 58 · see citing works
Gasser, O., SHARPLES, K. J., Barrow, C., Williams, G. M., Bauer, E., Wood, C. E., Mester, B., Dzhelali, M., Caygill, G., Jones, J., et al. (2017) · Cancer Immunology Immunotherapy · doi:10.1007/s00262-017-2085-9 · Cited by 58 · see citing works
Moodie, Z., Price, L. S., Janetzki, S., & Britten, C. M. (2011) · Methods in molecular biology · doi:10.1007/978-1-61779-325-7_15 · Cited by 52 · see citing works
Self-citationIndividualized mRNA vaccines evoke durable T cell immunity in adjuvant TNBC
Şahin, U., Schmidt, M., Derhovanessian, E., Cortini, A., Vogler, I., Omokoko, T., Godehardt, E., Attig, S., Newrzela, S., GRUTZNER, J., et al. (2026) · Nature · doi:10.1038/s41586-025-10004-2 · Cited by 50 · see citing works
Fiore-Gartland, A. J., Manso, B. A., Friedrich, D. P., Gabriel, E. E., Finak, G., Moodie, Z., Hertz, T., Rosa, S. C. D., Frahm, N., Gilbert, P. B., et al. (2016) · PLoS ONE · doi:10.1371/journal.pone.0147812 · Cited by 48 · see citing works
Self-citationEquivalence of ELISpot Assays Demonstrated between Major HIV Network Laboratories
Gill, D. K., Huang, Y., Levine, G. L., Sambor, A., Carter, D. K., Sato, A., Kopycinski, J. T., Hayes, P., Hahn, B., Birungi, J., et al. (2010) · PLoS ONE · doi:10.1371/journal.pone.0014330 · Cited by 44 · see citing works
Self-citationFellay, J., Frahm, N., Shianna, K. V., Cirulli, E. T., Casimiro, D. R., Robertson, M. N., Haynes, B. F., Geraghty, D. E., McElrath, M. J., & Goldstein, D. B. (2011) · The Journal of Infectious Diseases · doi:10.1093/infdis/jiq125 · Cited by 43 · see citing works
Epitope specific T‐cell responses against influenza A in a healthy population
Savić, M., Dembinski, J. L., Kim, Y., Tunheim, G., Cox, R. J., Oftung, F., Peters, B., & Mjaaland, S. (2015) · Immunology · doi:10.1111/imm.12548 · Cited by 42 · see citing works
Koblin, B. A., Casapía, M., Morgan, C. A., Li, Q., Wang, Z. M., Defawe, O., Baden, L. R., Goepfert, P., Tomaras, G. D., Montefiori, D. C., et al. (2011) · PLoS ONE · doi:10.1371/journal.pone.0024517 · Cited by 42 · see citing works
Quandt, J., Schlude, C., Bartoschek, M., Will, R. D., Cid-Arregui, Á., Schölch, S., Reißfelder, C., Weitz, J., Schneider, M. A., Wiemann, S., et al. (2018) · OncoImmunology · doi:10.1080/2162402x.2018.1500671 · Cited by 42 · see citing works
Multiple factors affect immunogenicity of DNA plasmid HIV vaccines in human clinical trials
Jin, X., Morgan, C. A., Yu, X., Rosa, S. C. D., Tomaras, G. D., Montefiori, D. C., Kublin, J. G., Corey, L., & Keefer, M. C. (2015) · Vaccine · doi:10.1016/j.vaccine.2015.03.036 · Cited by 38 · see citing works
Patton, K. S., Harrison, M. T., Long, B. R., Lau, K., Holcomb, J., Owen, R. E., Kasprzyk, T., Janetzki, S., Zoog, S. J., & Vettermann, C. (2021) · Molecular Therapy — Methods & Clinical Development · doi:10.1016/j.omtm.2021.05.012 · Cited by 37 · see citing works
Persistence of mucosal T-cell responses to herpes simplex virus type 2 in the female genital tract
Posavad, C. M., Zhao, L., Mueller, D. E., Stevens, C. E., Huang, M. L., Wald, A., & Corey, L. (2014) · Mucosal Immunology · doi:10.1038/mi.2014.47 · Cited by 34 · see citing works
Currier, J. R., Galley, L. M., Wenschuh, H., Morafo, V., Ratto‐Kim, S., Gray, C. M., Maboko, L., Höelscher, M., Marovich, M., & Cox, J. H. (2007) · Clinical and Vaccine Immunology · doi:10.1128/cvi.00284-07 · Cited by 33 · see citing works
Santos, R. G., Buying, A., Sabri, N., Yu, J. S., Gringeri, A. J., BENDER, J. G., Janetzki, S., Pinilla, C., & Judkowski, V. A. (2014) · Cells · doi:10.3390/cells4010001 · Cited by 32 · see citing works
Cleghorn, F. R., Pape, J. W., Schechter, M., Bartholomew, C., Sanchez, J., Jack, N., Metch, B. J., Hansen, M., Allen, M., Cao, H., et al. (2007) · JAIDS Journal of Acquired Immune Deficiency Syndromes · doi:10.1097/qai.0b013e318149297d · Cited by 31 · see citing works
Karulin, A. Y., Caspell, R., Dittrich, M. T., & Lehmann, P. (2015) · Cells · doi:10.3390/cells4010096 · Cited by 27 · see citing works
Xu, W., Pang, C., Song, C., Qian, J., Feola, S., Cerullo, V., Li, F., Yu, H., & Lehto, V. (2022) · Acta Biomaterialia · doi:10.1016/j.actbio.2022.08.073 · Cited by 25 · see citing works
Statistical Analysis of ELISPOT Assays
Dittrich, M. T., & Lehmann, P. (2011) · Methods in molecular biology · doi:10.1007/978-1-61779-325-7_14 · Cited by 25 · see citing works
Baden, L. R., Blattner, W. A., Morgan, C. A., Huang, Y., Defawe, O., Sobieszczyk, M. E., Kochar, N. K., Tomaras, G. D., McElrath, M. J., Russell, N. D., et al. (2011) · The Journal of Infectious Diseases · doi:10.1093/infdis/jir615 · Cited by 25 · see citing works
Self-citationPala, P., Serwanga, J., Watera, C., Ritchie, A. J., Moodie, Z., Wang, M., Goonetilleke, N. P., Birabwa, E., Hughes, P. J., Senkaali, D., et al. (2013) · Journal of Virology · doi:10.1128/jvi.00721-13 · Cited by 20 · see citing works
Self-citationRountree, W., Vandergrift, N., Bainbridge, J., Sanchez, A. M., & Denny, T. N. (2014) · Journal of Immunological Methods · doi:10.1016/j.jim.2014.01.007 · Cited by 19 · see citing works
Carluccio, S., Delbue, S., Signorini, L., Setola, E., Bagliani, A., Valle, A. D., Galli, A., Ferrante, P., & Bregni, M. (2015) · Journal of Cellular Physiology · doi:10.1002/jcp.24886 · Cited by 16 · see citing works
Immunogenicity of ALVAC-HIV vCP1521 in Infants of HIV-1–Infected Women in Uganda (HPTN 027)
Kaleebu, P., Njai, H. F., Wang, L., Jones, N. G., Ssewanyana, I., Richardson, P., Kintu, K., Emel, L., Musoke, P., Fowler, M. G., et al. (2013) · JAIDS Journal of Acquired Immune Deficiency Syndromes · doi:10.1097/01.qai.0000435600.65845.31 · Cited by 16 · see citing works
Disis, M. L., Dang, Y., Coveler, A. L., Childs, J. S., Higgins, D. M., Liu, Y., Zhou, J., Mackay, S., & Salazar, L. G. (2023) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-22-3578 · Cited by 14 · see citing works
Murashev, B., Nazarenko, O. V., Akulova, E. B., Artemyeva, A. K., Verevochkin, S. V., Шаболтас, А. В., Skochilov, R. V., Toussova, O., & Kozlov, A. P. (2012) · AIDS Research and Human Retroviruses · doi:10.1089/aid.2011.0335 · Cited by 14 · see citing works
Development of an interferon-gamma ELISPOT assay to detect human T cell responses to HSV-2
Posavad, C. M., Magaret, A., Zhao, L., Mueller, D. E., Wald, A., & Corey, L. (2011) · Vaccine · doi:10.1016/j.vaccine.2011.07.028 · Cited by 13 · see citing works
Gilbert, P. B., Yu, X., & Rotnitzky, A. G. (2013) · Statistics in Medicine · doi:10.1002/sim.6006 · Cited by 13 · see citing works
Frey, S. E., Peiperl, L., McElrath, M. J., Kalams, S. A., Goepfert, P., Keefer, M. C., Baden, L. R., Lally, M., Mayer, K. H., Blattner, W. A., et al. (2014) · Clinical and Vaccine Immunology · doi:10.1128/cvi.00450-14 · Cited by 12 · see citing works
Self-citationCarri, I., Schwab, E., Triviño, J. C., von Euw, E. M., Nielsen, M., Mordoh, J., & Barrio, M. M. (2025) · Frontiers in Immunology · doi:10.3389/fimmu.2024.1496204 · Cited by 11 · see citing works
Recent developments in clinical trial designs for HIV vaccine research
Richert, L. E., Lhomme, É., Fagard, C., Lévy, Y., Chêne, G., & Thiébaut, R. (2015) · Human Vaccines & Immunotherapeutics · doi:10.1080/21645515.2015.1011974 · Cited by 11 · see citing works
Sources of diversity in T cell epitope discovery
Chang, C. X. L. (2011) · Frontiers in bioscience · doi:10.2741/3895 · Cited by 11 · see citing works
Theoretical and practical considerations for validating antigen-specific B cell ImmunoSpot assays
Lehmann, P., Karulin, A. Y., Becza, N., Yao, L., Liu, Z., Chepke, J., Maul‐Pavicic, A., Wolf, C., Köppert, S., Valente, A. V., et al. (2025) · Journal of Immunological Methods · doi:10.1016/j.jim.2025.113817 · Cited by 10 · see citing works
Defining ELISpot cut-offs from unreplicated test and control wells
Alexander, N. D. E., Fox, A., Lien, V. T. K., Dong, T., Lee, L. Y.-H., Hằng, N. L. K., Mai, L. Q., & Horby, P. (2013) · Journal of Immunological Methods · doi:10.1016/j.jim.2013.02.014 · Cited by 10 · see citing works
Sugumar, P., Veerasami, M., Appana, G., Chandran, D., Das, D., & Srinivasan, V. A. (2012) · Journal of Microbiological Methods · doi:10.1016/j.mimet.2012.06.001 · Cited by 9 · see citing works
Variability of the IFN-γ ELISpot assay in the context of proficiency testing and bridging studies
Rountree, W., Berrong, M., Sanchez, A. M., Denny, T. N., & Ferrari, G. (2016) · Journal of Immunological Methods · doi:10.1016/j.jim.2016.03.004 · Cited by 8 · see citing works
Sarwar, U. N., Novik, L., Enama, M. E., Plummer, S. A., Koup, R. A., Nason, M., Bailer, R. T., McDermott, A. B., Roederer, M., Mascola, J. R., et al. (2014) · PLoS ONE · doi:10.1371/journal.pone.0106240 · Cited by 5 · see citing works
Hersey, S., McGuire, K., Kholmanskikh, O., Bivi, N., Bandukwala, A., Gong, B., Irwin, C. R., Ray, S., Gunsior, M., Avanesov, A. S., et al. (2025) · Bioanalysis · doi:10.1080/17576180.2025.2599698 · Cited by 4 · see citing works
Shu, J., Shen, W. H., Liu, H., Zhou, Y., Li, J., Zhuang, Y., Huang, Z., Yin, S., Jiang, L., Sun, Y., et al. (2020) · Vaccine · doi:10.1016/j.vaccine.2020.02.069 · Cited by 4 · see citing works
Ranaivomanana, P. P., Raharimanga, V., Dubois, P. M., Richard, V., & Razanamparany, V. R. (2015) · PLoS ONE · doi:10.1371/journal.pone.0127590 · Cited by 4 · see citing works
Richert, L. E., & Thiébaut, R. (2013) · AIDS · doi:10.1097/qad.0b013e328360d52e · Cited by 3 · see citing works
Dintwe, O., Rosa, S. C. D., Huang, Y., Flach, B., Manso, B. A., Carter, D., Omar, F. L., Schwedhelm, K. V., Yu, C., Lu, H., et al. (2022) · Journal of Leukocyte Biology · doi:10.1002/jlb.5ma0522-668r · Cited by 3 · see citing works
Self-citationWu, J., Chen, G., Zhuang, F.-C., Gao, M. Q., Wu, C.-D., Zhan-long, H., Jiang, Y., Li, J.-B., Bao, J.-Y., & Mao, Z. (2018) · Europe PMC (PubMed Central) · Cited by 3 · see citing works
Ström, P., Støer, N. C., Borthwick, N., Dong, T., Hanke, T., & Reilly, M. (2016) · Journal of Immunological Methods · doi:10.1016/j.jim.2016.05.006 · Cited by 2 · see citing works
Personalized neoantigen-targeting cancer vaccines in ovarian cancer: a phase 1 trial
Sellars, M., Frank, J. A., Shim, B., Vanasse, A. P., Liu, R., Forman, C., Tu, C. R., Tabata, K. K., Kowelewski, A., Cheng, S.-C., et al. (2026) · Nature Medicine · doi:10.1038/s41591-026-04717-8 · Cited by 1 · see citing works
A New Statistical Method for Analyzing Elispot Data
Huang, S. (2017) · Biometrics & Biostatistics International Journal · doi:10.15406/bbij.2017.05.00131 · Cited by 1 · see citing works
Statistical Estimation & Inference of Cell Counts from ELISPOT Limiting Dilution Assays
Yang, H., Topham, D. J., Holden‐Wiltse, J., & Wu, H. (2013) · Journal of Biopharmaceutical Statistics · doi:10.1080/10543406.2013.790645 · Cited by 1 · see citing works
Huang, D., Sansas, B., Jiang, J., Gong, Q., Jin, G.-D., Calais, V., Yu, D., Zhu, M. Y., Wei, D., Zhang, D. H., et al. (2017) · Journal of Viral Hepatitis · doi:10.1111/jvh.12791 · Cited by 1 · see citing works
Welner, S., Ruggli, N., Liniger, M., Summerfield, A., Larsen, L. E., & Jungersen, G. (2021) · Vaccines · doi:10.3390/vaccines9030208 · Cited by 1 · see citing works
Theoretical and practical considerations for validating antigen-specific B cell ImmunoSpot assaysPreprint
Lehmann, P., Karulin, A. Y., Becza, N., Yao, L., Liu, Z., Chepke, J., Maul‐Pavicic, A., Wolf, C., Köppert, S., Valente, A. V., et al. (2024) · Research Square · doi:10.21203/rs.3.rs-3994852/v1 · Cited by 1 · see citing works
Estimating individual peptide effects from grouped Elispot data
Ström, P. (2013)
Janetzki, S. (2016) · Techniques in life science and biomedicine for the non-expert · doi:10.1007/978-3-319-45295-1_7
Theoretical and Practical Considerations for Validating Antigen-Specific B Cell Immunospot AssaysPreprint
Lehmann, P., Karulin, A. Y., Becza, N., Yao, L., Liu, Z., Chepke, J., Maul‐Pavicic, A., Wolf, C., Köppert, S., Valente, A. V., et al. (2024) · SSRN Electronic Journal · doi:10.2139/ssrn.4776655
T-cell Response Induced by the BNT162b2 COVID-19 Vaccine in Children
Vogler, I., Renken, S., Hilker, R., Lui, B. G., Finlayson, A., Gurtman, A., Sabharwal, C., Kitchin, N. R. E., Lockhart, S. P., Gruber, W. C., et al. (2025) · Open Forum Infectious Diseases · doi:10.1093/ofid/ofaf699
Multi-antigen-targeting T cells in pediatric central nervous system tumors: a phase 1 trial
Gomez, S., DiCioccio, R. A., Geiger, A. E., Grant, M., Reynolds, E., Datar, A. A., McCann, C. D., Tanna, J., Kukadiya, D., Hoq, F., et al. (2026) · Nature Medicine · doi:10.1038/s41591-026-04449-9
- Authors
- Moodie, Z., Huang, Y., Gu, L., Hural, J., & Self, S. G.
- Affiliations
- Fred Hutch Cancer Center (US)
- Corresponding author
- Moodie, Zoe
- Venue
- Journal of Immunological Methods
- Publisher
- Elsevier BV
- Published
- 2006-08
- Volume
- 315
- Issue
- 1-2
- Pages
- 121-132
- ISSN
- 0022-1759 (ISSN-L)
- OpenAlex
- W1980497671
- Cited by
- 68
- References
- 35
- Citations by year
- 2026: 3 · 2025: 4 · 2024: 2 · 2023: 2 · 2022: 3 · 2021: 3 · 2020: 2 · 2018: 2 · 2017: 4 · 2016: 4 · 2015: 6 · 2014: 5 · 2013: 9 · 2012: 3
- FWCI
- 0.69
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Immunological Methods (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health
- National Institute of Allergy and Infectious Diseases (P30AI27757, R01-AI47086, R01 AI65328, U01 AI46725, U01AI046725, R37AI035605, P01 AI57005, R37AI35605, P01AI057005, R01AI065328, R01 AI48017, R01AI047086, P30AI027757)
- Topics
- Life Sciences › Immunology and Microbiology › Virology › HIV Research and Treatment
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
- Keywords
- ELISPOT assay, HIV-1-specific T cell responses, effector T cells, false positive rate control
- MeSH terms
- Clinical Trials as Topic, Computer Simulation, Data Interpretation, Statistical, Enzyme-Linked Immunosorbent Assay, False Positive Reactions, HIV Seropositivity, Humans, Sensitivity and Specificity, T-Lymphocytes, HIV-1, AIDS Vaccines
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review