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Immunology Core: Central Quality Assurance Unit
The Duke Center for AIDS Research (CFAR) Central Quality Assurance Unit (CQAU), (M. Sarzotti-Kelsoe, Director, D. Ozaki, Deputy Director) was created in 2002 to implement a quality system for the HVTN Endpoint Assay Laboratories. Today, the CQAU serves CFAR-GCLP-compliant AIDS Program (CFAR-GAP) laboratories at Duke complying with GCLP engaged in the following assays for phase I-III clinical trials immunogenicity endpoint assessment: Binding Antibody Multiplex Assays (BAMA), Enzyme-linked ImmunoSpot (ELISPOT) Assays, Neutralizing Antibody (NAb) Assays, Antibody-dependent Cell-mediated Cytotoxicity Assays (ADCC), Intracellular Cytokine Staining Assays (ICS), and Peripheral Blood Mononuclear Cell (PBMC) processing/isolation. Additionally, the CQAU has expanded its operations within the CFAR community and to its strategic partners. This has involved monitoring/managing quality and establishing proficiency testing programs for multiple HIV vaccine consortia associated with both Duke CFAR-GAP and Duke Human Vaccine Institute (DHVI) laboratories conducting immunogenicity endpoint assays for phase I-III clinical studies. The CQAU also assists laboratories conducting HIV viral isolation, culture, viral load, viral infectivity testing, sterility testing, and immunogen production.
The CFAR CQAU can assist the laboratory in the interpretation and application of various federal and international regulations/guidance necessary for compliance to Sponsor requirements.
The CFAR CQAU has extensive experience in advising on implementing quality into basic research and development laboratories. This typically involves a site-visit of the laboratory with a report of observations and recommendations as follow-up.
The CFAR CQAU can provide customized training on the applicable elements of Good Clinical Laboratory Practice as endorsed by the NIAID, RQA, and EMA.
The CFAR CQAU can assist laboratories in the creation and implementation of Standard Operating Procedures and in the development of mechanisms for document control.
The CFAR CQAU can assist laboratories in formal process of assay/method validation following ICH Q2(R1) guidance through training in validation, development of validation plans, planning the conduction of validation assays, and composing a validation final report. Additional information on the differences between standardized, qualified, and validated assays can be found here.
The CFAR CQAU can perform external facility and process audits to ensure compliance to applicable regulations/guidance. An audit report detailing observations and findings is generated as a deliverable and the CQAU can follow-up with the laboratory with an audit report response form (corrective action plan) to set a timetable to compliance.
This publication details the “harmonization” efforts between NIAID GCLP and RQA GCLP which was led by the CFAR CQAU.
Sarzotti-Kelsoe M., Cox J., Cleland N., Denny T., Hural J., Needham L., Ozaki D., Rodriguez-Chavez I.R., Stevens G., Stiles T., Tarragona-Fiol T., Simkins A. Evaluation and Recommendations on Good Clinical Laboratory Practice (GCLP) Guidelines for Phase I-III Immunol resClinical Trials. PLoS Medicine 2009, 6(5): e1000067. doi: 10.1371 /journal.pmed.10000675.
This publication details the establishment of an international proficiency testing program for the Neutralzing Antibody Assay for HIV-1 in TZM-bl Cells.
Todd C, Yu X, Ozaki DA, Greene KM, Gao H, Wood B, Wang M, Gilbert P, Montefiori DC, 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. 2011, Sep 22, 2012; 375 (1):57.
This publication details technology transfer of the Neutralizing Antibody Assay for HIV-1 in TZM-bl Cells to an international network of laboratories operating under GCLP compliance.
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(1):e30963. Epub 2012 Jan 27.
This publication details the steps taken to implement GCLP in domestic laboratories previously operating in a research and development environment, as part of an NIH-funded contract.
Todd CA, Sanchez AM, Garcia A, Denny TN, Sarzotti-Kelsoe M. Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL). J Immunol Methods. 2013 Oct 9. pii: S0022-1759(13)00268-8. doi: 10.1016/j.jim.2013.09.012. [Epub ahead of print]
This publication details the validation efforts led by the CFAR CQAU for the Neutralizing Antibody Assay for HIV-1 in A3R5 Cells.
Sarzotti-Kelsoe M, Daniell X, Todd CA, Bilska M, Martelli A, LaBranche C, Perez LG, Ochsenbauer C, Kappes JC, Rountree W, Denny TN, Montefiori DC, Optimization and validation of a neutralizing antibody assay for HIV-1 in A3R5 cells, J Immunol Methods, Available online 6 March 2014, ISSN 0022-1759, http://dx.doi.org/10.1016/j.jim.2014.02.013.
This publication details the validation efforts led by the CFAR CQAU for the Neutralizing Antibody Assay for HIV-1 in TZM-bl Cells.
Sarzotti-Kelsoe M, Bailer RT, Turk E, Lin C, Bilska M, Greene KM, Gao H, Todd CA, Ozaki DA, Seaman MS, Mascola JR, Montefiori DC, Optimization and validation of the TZM-bl assay for standardized assessments of neutralizing antibodies against HIV-1, J Immunol Methods, Available online 1 December 2013, ISSN 0022-1759, http://dx.doi.org/10.1016/j.jim.2013.11.022.
Core Staff Contact
Duke CFAR Central Quality Assurance Unit
2812 Erwin Rd. Erwin Terrace II
Durham, NC 27705
Marcella Sarzotti-Kelsoe, Ph.D.
CFAR CQAU Director
Dan Ozaki, MPH, RQAP-GLP
CFAR CQAU Deputy Director
Chris Todd, MPH
CFAR CQAU Manager
CFAR CQAU Coordinator