01-ID-03 Committee: Infectious Disease Title: Improved laboratory surveillance for HIV. Statement of Problem: Not all states have implemented laboratory reporting of CD4 counts <200 cells/µL, as recommended by CSTE in 1996, or laboratory reporting of HIV nucleic acid (DNA or RNA) detection tests included as part of the revised HIV surveillance case definition (January 2000). New HIV tests offer opportunities for improved surveillance. A 1997 survey of HIV/AIDS surveillance coordinators indicated that only 27 states required laboratory reporting for CD4. The level of reportable CD4 counts varied by state. Some states with HIV infection reporting of CD4 counts greater than 200 cells/µL have found that this reporting practice enhances the reporting of HIV infection cases as well as of AIDS cases. Obtaining data on CD4 levels among persons diagnosed with HIV infection is important to monitor the impact of antiretroviral therapy, to evaluate new treatment guidelines, and to meet the increasing need for surveillance data on persons at all stages of HIV disease for targeting and evaluating treatment services and public health interventions. CD4 level at HIV diagnosis can be used in a “snapshot” method for estimating HIV incidence, and was recommended to CDC as an approach for estimating incidence of HIV infection a February, 2001 consultation on this subject.  Only a few states have instituted laboratory reporting of nucleic acid detection tests. Such reporting will be increasingly important to identify reportable HIV cases among previously diagnosed persons for the purposes of determining HIV prevalence. Standards for viral load reporting have been developed in collaboration with the FDA, the Association of Public Health Laboratories (APHL), the American College of Pathology (ACP) and other experts and will be published soon in the MMWR.  Two recently developed laboratory tests provide additional opportunities and challenges for surveillance of the HIV epidemic. The Serologic Testing Algorithm for Recent HIV Seroconversion (STARHS), the so-called “detuned” test, permits the identification of recently infected persons and was recommended as a primary approach for estimating incidence of HIV infection at the recent CDC consultation on estimating incidence of HIV infection in the U.S. Currently, the detuned test has only FDA IND approval for research purposes. Future routine surveillance methods utilizing detuned testing would have to address issues including obtaining informed consent, obtaining suitable laboratory specimens, ensuring the availability of laboratory testing services, and considering incorporating detuned testing into surveillance reporting requirements. Availability of detuned test results would be improved if such results had clinical utility, e.g. different treatments are recommended for newly infected persons.  Antiretroviral (ARV) resistance testing is a new laboratory testing technology that may have importance for public health programs. As resistance testing is incorporated as the standard of care for HIV infected persons, there will be increased need for surveillance data to describe the impact of drug resistance on the epidemic. Statement of desired action(s) to be taken: CSTE Recommends: 1) All states should implement laboratory reporting of CD4 test results. CDC should facilitate the management and use of such data by providing adequate funding and technical assistance, by developing standards for laboratory reporting, by promoting electronic laboratory reporting of CD4 test results, and by developing surveillance software systems to automate or improve efficiency of matching high volumes of CD4 reports. CDC should engage state partners in determining the recommended level for CD4 reportability. Until this recommendation is available, states should determine their reportable level based on the capacity of their surveillance programs, capabilities of currently available software, and their data needs.  2) States should implement laboratory reporting of HIV nucleic acid (DNA and RNA) detection tests. CDC and states should work with clinical laboratories to adopt the CDC reporting standards to be published in the MMWR.  3) CDC should host a consultation to determine the appropriate role in public health surveillance of detuned HIV and antiretroviral resistance test results, and to identify implementation issues, such as FDA approval, informed consent, and accessibility of laboratory testing. 4) CDC should provide guidance, technical assistance and adequate funding to states to implement electronic reporting procedures and enhance the capacity of state surveillance programs to manage electronic laboratory data. The goal of these activities should be to minimize the impact on surveillance programs of receipt large numbers of reportable laboratory results, by automating processing of results and integration with software for HIV surveillance. Public Health Impact:  Public health programs will benefit from the data available for planning for treatment and care services as well as additional epidemiologic data for describing the spectrum of HIV infection in infected individuals in the U.S., and estimating HIV in states and nationally. Coordination: Agencies for Response: Dr. Jeffrey P. Koplan, MD, MPH Director Centers for Disease Control and Prevention 1600 Clifton Road, NE Mailstop D-14 Atlanta, GA 30333 Author: Guthrie Birkhead, MD, MPH Director, AIDS Institute New York State Department of Health Room 1483 Corning Tower, ESP Albany, NY 12237 Phone: 518-402-5382 Gsb02@health.state.ny.us References: None