Optimization and validation of a neutralizing antibody assay for HIV-1 in A3R5 cells

Journal of Immunological Methods

Volumn 409, Issue , 2014, Pages 147-160

  Sarzotti Kelsoe, Marcella ^a,c   Daniell, Xiaoju ^a   Todd, Christopher A ^a   Bilska, Miroslawa ^a   Martelli, Amanda ^a   LaBranche, Celia ^a   Perez, Lautaro G ^a   Ochsenbauer, Christina ^b   Kappes, John C ^b   Rountree, Wes ^c   Denny, Thomas N ^c   Montefiori, David C ^a  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

^b and Clinical Center   (United States)

^c DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

A3R5 cells; Assay validation; HIV; Neutralizing antibody

Indexed keywords

HUMAN IMMUNODEFICIENCY VIRUS VACCINE; NEUTRALIZING ANTIBODY; RENILLA LUCIFERIN 2 MONOOXYGENASE;

ANTIBODY TITER; ARTICLE; BLOOD SAMPLING; CD4+ T LYMPHOCYTE; CELL LINE; CONTROLLED STUDY; DIAGNOSTIC TEST ACCURACY STUDY; GENE EXPRESSION; HUMAN; HUMAN CELL; HUMAN CELL CULTURE; HUMAN IMMUNODEFICIENCY VIRUS 1; IMMUNOASSAY; IMMUNOGENICITY; IN VITRO STUDY; INFECTIOUS MOLECULAR CLONE; LIMIT OF DETECTION; LIMIT OF QUANTITATION; LYMPHOBLASTOID CELL LINE; MOLECULAR CLONING; PLASMA; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROCESS OPTIMIZATION; SENSITIVITY AND SPECIFICITY; SERUM; VALIDATION STUDY; VIRUS REPLICATION; VIRUS STRAIN;

HUMAN IMMUNODEFICIENCY VIRUS 1; RENILLA LUCIFERASE;

A3R5 CELLS; ASSAY VALIDATION; HIV; NEUTRALIZING ANTIBODY;

ANTIBODIES, NEUTRALIZING; AUTOMATION, LABORATORY; BIOLOGICAL MARKERS; CELL LINE; GUIDELINE ADHERENCE; HIGH-THROUGHPUT SCREENING ASSAYS; HIV ANTIBODIES; HIV INFECTIONS; HIV-1; HUMANS; LIMIT OF DETECTION; NEUTRALIZATION TESTS; OBSERVER VARIATION; PRACTICE GUIDELINES AS TOPIC; PREDICTIVE VALUE OF TESTS; QUALITY CONTROL; REPRODUCIBILITY OF RESULTS; TIME FACTORS; TRANSFECTION;

EID: 84906078736     PISSN: 00221759     EISSN: 18727905     Source Type: Journal    
DOI: 10.1016/j.jim.2014.02.013     Document Type: Article

References (28)

1. Bonsignori M., Hwang K.K., Chen X., Tsao C.Y., Morris L., Gray E., Marshall D.J., Crump J.A., Kapiga S.H., Sam N.E., Sinangil F., Pancera M., Yongping Y., Zhang B., Zhu J., Kwong P.D., O'Dell S., Mascola J.R., Wu L., Nabel G.J., Phogat S., Seaman M.S., Whitesides J.F., Moody M.A., Kelsoe G., Yang X., Sodroski J., Shaw G.M., Montefiori D.C., Kepler T.B., Tomaras G.D., Alam S.M., Liao H.X., Haynes B.F. Analysis of a clonal lineage of HIV-1 envelope V2/V3 conformational epitope-specific broadly neutralizing antibodies and their inferred unmutated common ancestors. J. Virol. 2011, 85:9998.
2. Bonsignori M., Montefiori D.C., Wu X., Chen X., Hwang K.K., Tsao C.Y., Kozink D.M., Parks R.J., Tomaras G.D., Crump J.A., Kapiga S.H., Sam N.E., Kwong P.D., Kepler T.B., Liao H.X., Mascola J.R., Haynes B.F. Two distinct broadly neutralizing antibody specificities of different clonal lineages in a single HIV-1-infected donor: implications for vaccine design. J. Virol. 2012, 86:4688.
3. DeCamp A., Hraber P., Bailer R.T., Seaman M.S., Ochsenbauer C., Kappes J., Gottardo R., Edlefsen P., Self S., Tang H., Greene K., Gao H., Daniell X., Sarzotti-Kelsoe M., Gorny M.K., Zolla-Pazner S., Labranche C.C., Mascola J.R., Korber B.T., Montefiori D.C. Global panel of HIV-1 Env reference strains for standardized assessments of vaccine-elicited neutralizing antibodies. J. Virol. 2014, 88(5):2489-2507. http://dx.doi.org/10.1128/JVI.02853-13 (Epub 2013 Dec 18).
4. Edmonds T.G., Ding H., Yuan X., Wei Q., Smith K.S., Conway J.A., Wieczorek L., Brown B., Polonis V., West J.T., Montefiori D.C., Kappes J.C., Ochsenbauer C. Replication competent molecular clones of HIV-1 expressing Renilla luciferase facilitate the analysis of antibody inhibition in PBMC. Virology 2010, 408:1.
5. Ezzelle J., Rodriguez-Chavez I., Darden J., Stirewalt M., Kunwar N., Hitchcock R., Walter T., D'souza M. Guidelines on good clinical laboratory practice: bridging operations between research and clinical research laboratories. J. Pharm. Biomed. Anal. 2008, 46:18.
6. Fenyo E.M., Heath A., Dispinseri S., Holmes H., Lusso P., Zolla-Pazner S., Donners H., Heyndrickx L., Alcami J., Bongertz V., Jassoy C., Malnati M., Montefiori D., Moog C., Morris L., Osmanov S., Polonis V., Sattentau Q., Schuitemaker H., Sutthent R., Wrin T., Scarlatti G. International network for comparison of HIV neutralization assays: the NeutNet report. PloS ONE 2009, 4:e4505.
7. Folks T., Benn S., Rabson A., Theodore T., Hoggan M.D., Martin M., Lightfoote M., Sell K. Characterization of a continuous T-cell line susceptible to the cytopathic effects of the acquired immunodeficiency syndrome (AIDS)-associated retrovirus. Proc. Natl. Acad. Sci. U. S. A. 1985, 82:4539.
8. I.C.H.Guideline, Schwager T. Validation of Analytical Procedures: Text and Methodology Q2 (R1) (2005) 2005, Website http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf.
9. Mascola J.R., D'Souza P., Gilbert P., Hahn B.H., Haigwood N.L., Morris L., Petropoulos C.J., Polonis V.R., Sarzotti M., Montefiori D.C. Recommendations for the design and use of standard virus panels to assess neutralizing antibody responses elicited by candidate human immunodeficiency virus type 1 vaccines. J. Virol. 2005, 79:10103.
10. McLinden R.J.L., Chenine C.C., A.L., Polonis V.R., Eller M.A., Wieczorek L., Ochsenbauer C., Kappes J.C., Perfetto S., Montefiori D.C., Michael N.L., Kim J.H. Detection of HIV-1 neutralizing antibodies in a human CD4+/CXCR4+/CCR5+ T-lymphoblastoid cell assay system. PloS 2013, 8(11):e77756. (Nov 28). 10.1371/journal.pone.0077756.
11. Montefiori D.C. Measuring HIV neutralization in a luciferase reporter gene assay. Methods Mol. Virol, HIV Protocols 2009, vol. 485:395. Humana Press. Second edition. G.V.K. Vinayaka, R. Prasad (Eds.).
12. Montefiori D.C., Karnasuta C., Huang Y., Ahmed H., Gilbert P., de Souza M.S., McLinden R., Tovanabutra S., Laurence-Chenine A., Sanders-Buell E., Moody M.A., Bonsignori M., Ochsenbauer C., Kappes J., Tang H., Greene K., Gao H., LaBranche C.C., Andrews C., Polonis V.R., Rerks-Ngarm S., Pitisuttithum P., Nitayaphan S., Kaewkungwal J., Self S.G., Berman P.W., Francis D., Sinangil F., Lee C., Tartaglia J., Robb M.L., Haynes B.F., Michael N.L., Kim J.H. Magnitude and breadth of the neutralizing antibody response in the RV144 and Vax003 HIV-1 vaccine efficacy trials. J. Infect. Dis. 2012, 206:431.
13. Ochsenbauer C., Kappes J.C. New virologic reagents for neutralizing antibody assays. Curr. Opin. HIV AIDS 2009, 4:418.
14. Ochsenbauer C., Edmonds T.G., Ding H., Keele B.F., Decker J., Salazar M.G., Salazar-Gonzalez J.F., Shattock R., Haynes B.F., Shaw G.M., Hahn B.H., Kappes J.C. Generation of transmitted/founder HIV-1 infectious molecular clones and characterization of their replication capacity in CD4 T lymphocytes and monocyte-derived macrophages. J. Virol. 2012, 86:2715.
15. Ozaki D.A., Gao H., Todd C.A., Greene K.M., Montefiori D.C., Sarzotti-Kelsoe M. International technology transfer of a GCLP-compliant HIV-1 neutralizing antibody assay for human clinical trials. PloS ONE 2012, 7:e30963.
16. Piehler B., Nelson E.K., Eckels J., Ramsay S., Lum K., Wood B., Greene K.M., Gao H., Seaman M.S., Montefiori D.C., Igra M. LabKey Server NAb: a tool for analyzing, visualizing and sharing results from neutralizing antibody assays. BMC Immunol. 2011, 12:33.
17. Platt E.J., Wehrly K., Kuhmann S.E., Chesebro B., Kabat D. Effects of CCR5 and CD4 cell surface concentrations on infections by macrophagetropic isolates of human immunodeficiency virus type 1. J. Virol. 1998, 72(1998):2855-2864.
18. Polonis V.R., Brown B.K., Rosa Borges A., Zolla-Pazner S., Dimitrov D.S., Zhang M.Y., Barnett S.W., Ruprecht R.M., Scarlatti G., Fenyo E.M., Montefiori D.C., McCutchan F.E., Michael N.L. Recent advances in the characterization of HIV-1 neutralization assays for standardized evaluation of the antibody response to infection and vaccination. Virology 2008, 375:315.
19. Sarzotti-Kelsoe M., Cox J., Cleland N., Denny T., Hural J., Needham L., Ozaki D., Rodriguez-Chavez I.R., Stevens G., Stiles T. Evaluation and recommendations on good clinical laboratory practice guidelines for phase I-III clinical trials. PLoS Med. 2009, 6:e1000067.
20. Sarzotti-Kelsoe M., Bailer R.T., Turk E., Lin C.L., Bilska M., Greene K.M., Gao H., Todd C.A., Ozaki D.A., Seaman M.S., Mascola J.R., Montefiori D.C. Optimization and validation of the TZM-bl assay for standardized assessments of neutralizing antibodies against HIV-1. J. Immunol. Methods 2014, 409:131-146. (in this issue).
21. Seaman M.S., Janes H., Hawkins N., Grandpre L.E., Devoy C., Giri A., Coffey R.T., Harris L., Wood B., Daniels M.G., Bhattacharya T., Lapedes A., Polonis V.R., McCutchan F.E., Gilbert P.B., Self S.G., Korber B.T., Montefiori D.C., Mascola J.R. Tiered categorization of a diverse panel of HIV-1 Env pseudoviruses for assessment of neutralizing antibodies. J. Virol. 2010, 84:1439.
22. Stiles T., Grant V., Mawby N. Good Clinical Laboratory Practice (GCLP): A Quality System for Laboratories That Undertake the Analyses of Samples from Clinical TrialsBARQA, Medical Laboratories 2003, 1-18.
23. Todd C.A., Greene K.M., Yu X., Ozaki D.A., Gao H., Huang Y., Wang M., Li G., Brown R., Wood B., D'Souza M.P., Gilbert P., Montefiori D.C., Sarzotti-Kelsoe M. Development and implementation of an international proficiency testing program for a neutralizing antibody assay for HIV-1 in TZM-bl cells. J. Immunol. Methods 2012, 375:57-67.
24. Todd C.A., Greene K.M., Yu X., Ozaki D.A., Gao H., Huang Y., Wang M., Li G., Brown R., Wood B., D'Souza M.P., Gilbert P., Montefiori D.C., Sarzotti-Kelsoe M. Development and implementation of an international proficiency testing program for a neutralizing antibody assay for HIV-1 in TZM-bl cells. J. Immunol. Methods 2012, 375:57-67.
25. Todd C.A., Sanchez A.M., Garcia A., Denny T.N., Sarzotti-Kelsoe M. Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL). J. Immunol. Methods 2014, 409:91-98. (in this issue).
26. Wei X., Decker J.M., Liu H., Zhang Z., Arani R.B., Kilby J.M., Saag M.S., Wu X., Shaw G.M., Kappes J.C. Emergence of resistant human immunodeficiency virus type 1 in patients receiving fusion inhibitor (T-20) monotherapy. Antimicrob. Agents Chemother. 2002, 46:1896.
27. Wei X., Decker J.M., Wang S., Hui H., Kappes J.C., Wu X., Salazar-Gonzalez J.F., Salazar M.G., Kilby J.M., Saag M.S., Komarova N.L., Nowak M.A., Hahn B.H., Kwong P.D., Shaw G.M. Antibody neutralization and escape by HIV-1. Nature 2003, 422:307.
28. Wu X., Zhou T., Zhu J., Zhang B., Georgiev I., Wang C., Chen X., Longo N.S., Louder M., McKee K., O'Dell S., Perfetto S., Schmidt S.D., Shi W., Wu L., Yang Y., Yang Z.Y., Yang Z., Zhang Z., Bonsignori M., Crump J.A., Kapiga S.H., Sam N.E., Haynes B.F., Simek M., Burton D.R., Koff W.C., Doria-Rose N.A., Connors M., Mullikin J.C., Nabel G.J., Roederer M., Shapiro L., Kwong P.D., Mascola J.R. Focused evolution of HIV-1 neutralizing antibodies revealed by structures and deep sequencing. Science 2011, 333:1593.