ANNOUNCEMENT Conference on Guidelines for Laboratories Performing HIV-related CD4 T-Cell Determinations November 14-15, 2001 Disney Coronado Springs Hotel Orlando, FL SPONSOR: Centers for Disease Control and Prevention JOINT Association of Public Health Laboratories SPONSORS: Clinical Cytometry Society PURPOSE: Obtain input from the clinical cytometry community with regard to possible revision of the "1997 Revised Guidelines for Performing CD4+ T-Cell Determinations in Persons Infected with Human Immunodeficiency Virus (HIV)" MMWR 46:RR-2, January 10, 1997. TARGET Laboratorians, health scientists, physicians, and other AUDIENCE: members of the health care team who have responsibility for or an interest in assuring the quality of CD4 T-cell testing services. ISSUES: * Need to revise the current CD4 T-cell testing guidelines * Inter- and intralaboratory variability in CD4 and CD8 T-cell determinations * Absolute vs. percentage T-cell subset values, which is better as a clinical tool and why? * Gating strategies: use of light scatter and CD45 * Absolute CD4 and CD8 cell counts using flow cytometry: inter- and intralaboratory variability * 3- and 4-color panels for CD4 T-cell determinations: antibody combinations, number of tubes needed for a panel, QA and QC issues * Approaches to validation of new methods * Quality control and quality assurance ABSTRACTS: The areas of interest and instructions for submitting abstracts for oral presentations are located at: http://www.phppo.cdc.gov/mlp/cd4.asp COMMENTS: Comments/suggestions related to the meeting and issues to be discussed may be submitted at: http://www.phppo.cdc.gov/mlp/cd4_mailform.asp COST: There is no registration cost for participants. No accommodations or meals are provided. REGISTRATION: Meeting registration may be completed online at: http://www.phppo.cdc.gov/mlp/cd4_registration.asp or, alternatively, hard copies of the program and registration form may be obtained by contacting: G. David Cross, M.S. Centers for Disease Control and Prevention 4770 Buford Highway, N.E., Mailstop G-23 Atlanta, GA 30341-3717 (770) 488-8091 gcross@cdc.gov This meeting will be held in the same conference hotel and will begin the day following the 16th Annual Clinical Applications of Cytometry (CAC) meeting. +++++++++++++++++++++MEETING SCHEDULE++++++++++++++++++++++++++ The CD4 T-cell Guidelines Consensus Meeting November 14-15, Orlando, Florida TENTATIVE SCHEDULE 8:30-9:00 Introduction: Jan Nicholson Where we have been, where we are now, where we are going in CD4 cell testing. History of CDC guideline development and their impact. The process for revision for year 2002. Moderator: Frank Mandy 9:00-9:30 Quality Assurance Programs (MPEP): Barbara Slade What do we know about how well laboratories in the US are performing CD4 and CD8 cell testing? 9:30-10:00 Gating Strategies for T-cell Subsets have Evolved: Frank Mandy Concepts of gating and selection criteria have changed: Pros and cons of homogeneous vs. heterogeneous gating. 10:00-10:30 BREAK Moderator: Carol Schnizlein-Bick 10:30-11:00 One platform for absolute counting (Part One) Mo O'Gorman Absolute cell counting using Flow Count beads; 2- vs. 3- vs. 4-color immunophenotyping: intra and interlaboratory variability. 11:00-11:30 One platform for absolute counting (Part Two) Carol Schnizlein-Bick Absolute cell counting TruCount beads; 3- vs. 4-color immunophenotyping: intra and interlaboratory variability. 11:30-12:00 Quality Assurance Programs for CD4 T-cells for ACTG Becky Gelman What have we learned from the ACTG QAP about CD4 T-cell testing? What value does CD45 gating bring to laboratory results? 12:00-12:30 QUESTION AND ANSWERS SESSION FOR ALL MORNING SPEAKERS 12:30-2:00 LUNCH 2:00-3:45 PARALLEL WORKSHOPS Workshop Group A Absolute cell counting using FlowCount fluorospheres Beckman Coulter Workshop Group B Absolute cell counting using TruCount fluorospheres Becton Dickinson Moderator: Chris Tsoukas 3:45-4:15 T-cell subset analysis from a clinician's perspective Chris Tsoukas The CD4 T-cell legend is not the full story. 4:15-5:00 ORAL PRESENTATIONS (ten minutes each) Selected from submitted abstracts (4 or 5) Day Two Moderator: Mo O'Gorman 8:00-8:30 Issues of compensation, how to succeed with 3 or 4 colors? Mario Roederer Software versus hardware compensation in the 21st century 8:30-9:00 Has the single tube assay arrived? Mo O'Gorman Can one get the same results from 1 tube as from multiple tubes? Considerations for increasing the number of antibodies per tube: technical requirements for antibody combinations; quality control issues. Are isotype controls needed for CD4 and CD8 T-cell determinations? 9:00-9:30 Percentage and absolute T-cell subsets are no longer two solitudes Michael Lederman During clinical evaluation of HIV infection the benefits of using CD4 and CD8 percentages and absolute number values. 9:30-10:00 BREAK Moderator: Howard Shapiro 10:00-10:30 Quality control systems for immunophenotyping Katharine Muirhead Methods available for quality control and quality assurance. How are these applied in single-platform technologies and multicolor panels? 10:30-11:00 Quality Assessment issues in the Global Village Michele Bergeron We have the tools, are we implementing them where they are needed the most? 11:00-11:30 Clinical cytometers moved from the floor to the desktop where next? Howard Shapiro Emerging new technologies that will improve or replace current clinical diagnostic tools to fight HIV disease. 11:30-12:00 QUESTIONS AND ANSWER SESSION FOR ALL MORNING SPEAKERS 12:00-12:15 Closing remarks Jan Nicholson ++++++++++++++++++++++++++++CALL FOR ABSTRACTS+++++++++++++++++++++++++++++ The National Conference on Guidelines for Laboratories Performing HIV-related CD4 T-cell Determinations, held in Orlando, FL, November 14 and 15, 2001 is seeking data for oral presentations. We will select a limited number of abstracts for oral presentation, based in the scope of the study, the completeness of the data, and how well it addresses one of the questions posed below. 1. What is the minimum number of tubes required for accurate and reliable CD4 and CD8 cell determinations? 2. Which provides the most accurate and reproducible results: CD45 gating or light scatter gating? 3. Is the inclusion of isotype controls in a monoclonal antibody panel for CD4 and CD8 determinations necessary? 4. Which provides the most accurate and reproducible results: 4-color, 3-color, or 2-color panels? 5. Which provides the most accurate and reproducible results for CD4 and CD8 cell counts: single-platform methods or multi-platform methods? The abstract may not exceed 250 words, should be submitted in English, and must be received no later than Oct. 15, 2001. It is preferred that the abstract be submitted as a word processing file attached to an e-mail (phpdls@cdc.gov). Otherwise, the abstract should be submitted as text in the body of an e-mail or conventionally delivered hard copy. Abstracts will be included in the program book. Notification of acceptance for oral presentation will be sent by Nov. 1, 2001. Instructions about abstract submission are also available on our website (http://www.phppo.cdc.gov/mlp/cd4.asp). Please address all non-electronic inquiries or abstract submissions to: David Cross Division of Laboratory Systems Public Health Practice Program Office Centers for Disease Control and Prevention Mailing address: Overnight/Priority delivery address 4770 Buford Hwy. N.E., (FedEx, United Parcel Service etc.) Mailstop G-23 CDC/Williams Building Atlanta GA, USA 30341-3717 2877 Brandywine Road, Room #2009 Atlanta, GA 30341 Mr. Cross may also be contacted at: Phone: (01) 770-488-8091 FAX: (01) 770-488-8275
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