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- W2982159968 abstract "The Centers for Disease Control and Prevention’s (CDC) Division of STD Prevention, in collaboration with the Association of Public Health Laboratories (APHL), is developing a nationally available syphilis serum repository for research of Food and Drug Administration (FDA)-cleared or investigational syphilis diagnostic assays in the United States. State and local public health laboratories (PHL) submitted de-identified residual sera with information on collection date, volume, storage conditions, freeze-thaw cycles, PHL serology results, reported syphilis stage and demographic details if available. Previous test results were blinded and sera (N = 152 reported syphilis stage, N = 131 unknown status) were tested at CDC using five FDA-cleared and one investigational syphilis tests. Treponemal and nontreponemal test sensitivity ranged from 76.3–100% and 63.2–100%, respectively, among staged specimens. The conventional treponemal assays showed high concordance of 95.4%. By providing syphilis stage and comprehensive serological test data, developed repository may serve as a valuable resource for diagnostic test validation studies." @default.
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- W2982159968 date "2020-01-01" @default.
- W2982159968 modified "2023-10-17" @default.
- W2982159968 title "Development of a syphilis serum bank to support research, development, and evaluation of syphilis diagnostic tests in the United States" @default.
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- W2982159968 doi "https://doi.org/10.1016/j.diagmicrobio.2019.114913" @default.
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