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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 USA
  1. Munegowda Koralur1,2,
  2. Cheng Y Chen1,
  3. Allan Pillay1,
  4. Brunie White1,
  5. Kevin Pettus1,
  6. Kai-Hua Chi1,
  7. Joey Stringer3,
  8. Chukwuemika Aroh3,
  9. Trivikram Dasu4,
  10. Sanjib Bhattacharyya4,
  11. Keith Perkins5,
  12. Jenny Chen5,
  13. Diana Riner6,
  14. Marty Soehnlen6,
  15. Weiping Cao1,
  16. Anne M Gaynor7,
  17. Ellen N Kersh1
  1. 1Division of STD Prevention, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA
  2. 2Oak Ridge Institute for Science and Education, Oak Ridge, Tennessee, USA
  3. 3Dallas County Health and Human Services, Dallas, Texas, USA
  4. 4City of Milwaukee Health Department Laboratory, Milwaukee, Wisconsin, USA
  5. 5Maryland Department of Health, Baltimore, Maryland, USA
  6. 6Michigan Department of Health and Human Services Bureau of Laboratories, Lansing, Michigan, USA
  7. 7Association of Public Health Laboratories, Silver Spring, Maryland, USA
  1. Correspondence to Dr Munegowda Koralur, Centers for Disease Control and Prevention, Atlanta, GA 30329-4018, USA; mgowdakc{at}gmail.com

Abstract

Objective 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 the Centers for Disease Control and Prevention. The results from the PHLs were compared with those of LRRB, which served as the reference testing method, and percentage agreement was calculated.

Results HSV was detected in 31 of 52 (59.6%), 20 of 40 (50%), 43 of 44 (97.7%) and 19 of 50 (38.0%) specimens from PHL1, PHL2, PHL3 and PHL4, respectively. There were seven discrepant results for HSV, and the overall percent agreement between the PHLs and the LRRB was 94%–100%, with a kappa value of 0.922, which demonstrates high agreement. T. pallidum was identified in 7 of 51 (13.7%) specimens from PHL1 with 94.1% agreement and in 2 of 40 (5.0%) specimens from PHL2 with 100% agreement. The 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 PHLs.

  • diagnosis
  • female
  • genital diseases
  • male
  • syphilis
  • herpes simplex

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Footnotes

  • Handling editor Nigel Field

  • Twitter @sanjibusa

  • Contributors MK, CYC, BW, AP, AMG and EK participated in test concept design and implementation. MK, BW, KPet, K-HC, JS, SB, CA, TD, KPer, JC, DR and MS participated in specimen testing, validation and data analysis. MK, AP, WC and EK contributed to manuscript writing. All authors read and approved the final manuscript.

  • Funding The study was funded by the CDC (Atlanta, Georgia, USA) and in part by an appointment (MK) to the Research Participation Program at the CDC, administered by the Oak Ridge Institute for Science and Education through an interagency agreement between the US Department of Energy and CDC.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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