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  Topic Data Needs
HIV Performance of HIV Nucleic Acid Tests in Diagnostic Algorithms Performance of HIV-1 or HIV-2 qualitative or quantitative nucleic acid (DNA and/or RNA) tests in diagnostic algorithms. Performance with whole blood, serum or plasma. Specify use and context as 1st, 2nd or 3rd test in a testing algorithm. Cost analyses are encouraged.
HIV Performance of HIV Tests in CLIA-Waived Settings Studies of the performance of rapid HIV screening tests and rapid test algorithms in CLIA-waived settings.  Abstracts on newer rapid HIV tests, self-tests, performance comparisons of multiple CLIA-waived tests, and cost analyses are encouraged.
HIV Performance of HIV Screening Tests in the Laboratory Setting Studies of the performance of CLIA Moderate and High Complexity HIV screening tests FDA-approved in 2015 or later, including performance by specimen type.  Abstracts on newer tests, performance comparisons of multiple CLIA-Moderate/High complexity tests, performance of Ag/Ab tests that distinguish between analytes, and cost analyses are encouraged.
HIV CDC/APHL Laboratory Testing Algorithm Performance of newer Ag/Ab immunoassays, including Ag/Ab rapid tests, HIV-1/HIV-2 differentiation tests, and nucleic acid tests in the context of the algorithm. Reports on implementation of the recommended algorithm, including policies, program changes and cost data are encouraged.
HIV, STI Diagnostic Challenges Diagnostic challenges associated with PEP, PrEP, acute infection, vaccine use, antiretroviral therapy use or elite controllers. Data on testing in the context of bloodborne pathogen exposures. Data on testing special populations (e.g., pregnant women, infants and children) can also be included. Data on testing for STIs in the context of PrEP.
HIV Research & Development of New Tests for Diagnosis and Clinical Monitoring Research and development of new tests for diagnosis and monitoring of HIV infection, including methods applicable to resource poor settings. Evaluations of rapid test readers are encouraged. Abstracts on tests that have been or will be submitted for FDA approval or have a CE mark are encouraged.
HIV, STI, HCV Integrated Testing for Multiple Pathogens Studies on the performance of rapid and laboratory-based tests using integrated testing platforms for HIV in conjunction with STIs or HCV.  Abstracts on tests that have been or will be submitted for FDA approval are encouraged.
HIV, HCV Oral Fluid and Dried Blood Spots Performance of HIV or HCV tests using oral fluid, including comparisons with blood for antibody concentration or seroconversion performance. Studies of the performance and feasibility of using dried blood spots or oral fluid for HIV or HCV testing.

 

STI Syphilis Studies on the development, performance and usage outcomes of rapid and laboratory-based tests and algorithms for syphilis diagnosis, including serological (treponemal and non-treponemal) and molecular tests. Abstracts on tests that have recently obtained FDA approval, or have been or will be submitted for FDA approval, have a CE mark, or are pre-qualified by WHO with applicability to the US market are encouraged.
STI Antibiotic resistance of STIs, emerging STIs, and novel testing formats Research & development of new tests for diagnosis and/ or monitoring of antibiotic resistance (N. gonorrhoeae, others) and/ or emerging STIs (e.g., Mycoplasma genitalium); as well as novel STI point-of-care tests. Abstracts on tests that have been or will be submitted for FDA approval, have a CE mark, or are pre-qualified by WHO with applicability to the US market are encouraged.
HCV Hepatitis C virus Performance, development, and application of HCV point of care nucleic acid tests and rapid screening assays, particularly in a field setting or in the context of HIV coinfections.
HIV, STI, HCV Optimizing Testing in a Variety of Settings Evaluations of methods and programmatic best practices to streamline time to test result receipt and linkage to care in a variety of clinical and non-clinical settings, including implementation of new policies and procedures to improve turnaround time. Reports on novel methods for delivery of test results are encouraged. Evaluations of cloud-based solutions to improve the quality and efficiency of linkage to care are encouraged..

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Note:  The CDC HIV Case Surveillance Branch (HICSB) will provide an update on HIV surveillance and reporting.