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Development of a syphilis serum bank to support research, development, and evaluation of syphilis diagnostic tests in the United States
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October 24 2019
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Source: Diagn Microbiol Infect Dis. 96(1):114913
[PDF-85.52 KB]
Details:
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Alternative Title:Diagn Microbiol Infect Dis
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Personal Author:
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Description: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.
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Pubmed ID:31699543
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Pubmed Central ID:PMC6906239
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Volume:96
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Issue:1
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