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Evaluation of a laboratory developed multiplex real-time PCR assay for diagnosis of syphilis, herpes, and chancroid genital ulcers in four public health laboratories in the United States
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9 2022
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Source: Sex Transm Infect. 98(6):448-450
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Alternative Title:Sex Transm Infect
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Personal Author:
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Description:Objectives
To evaluate the field performance of a multiplex PCR (M-PCR) assay for detection of herpes simplex virus (HSV)- 1 and HSV-2, Treponema pallidum (T. pallidum), and Haemophilus ducreyi (H. ducreyi) in genital ulcer disease (GUD) specimens.
Methods
GUD M-PCR was performed on 186 remnant specimens, previously collected for HSV testing, by four public health laboratories (PHLs) and the Laboratory Reference and Research Branch (LRRB) at Centers for Disease Control and Prevention (CDC). Results from the PHLs were compared to those of LRRB, which served as the reference testing method, and percentage agreement was calculated.
Results
HSV was detected in 31/52 (59.6%), 20/40 (50%), 43/44 (97.7%), and 19/50 (38.0%) specimens from PHL1-4, respectively. The overall percent agreement between PHLs and LRRB for HSV testing was 94-100% with a kappa value of 0.922, which demonstrates high agreement. T. pallidum was identified in 7/51 (13.7%) specimens from PHL1 with 94.1% agreement and in 2/40 (5.0%) specimens from PHL2 with 100% agreement. LRRB identified three additional T. pallidum positive specimens from PHL1. The kappa value (0.849) for T. pallidum testing suggests good agreement. Consistent with the LRRB results, no T. pallidum was detected in specimens from PHL3 and PHL4, and H. ducreyi was not detected at any of the study sites.
Conclusions
The GUD M-PCR assay performed well in four independent PHLs and 12 suspected syphilis cases were identified in this study. The M-PCR assay could provide improved diagnostic options for GUD infections in state and local public health laboratories.
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Pubmed ID:34873027
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Pubmed Central ID:PMC11304264
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Volume:98
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Issue:6
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