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Analytical and Clinical Performance of a Real-time Screening PCR Assay Identifying Congenital CMV Infection

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      Abstract

      Background

      Congenital CMV infection (cCMV) is the most common identifiable cause of mental retardation in the United States but requires early diagnosis to define the infection and to institute effective antiviral therapy. Traditional identification strategies including hearing screens and physical exams likely miss many patients with cCMV. We therefore developed and evaluated the performance of a PCR assay optimized for low cost, specimen collection at time of dried blood spot collection, and detection thresholds below the salivary CMV concentrations known to occur in cCMV patients.

      Methods

      We utilized a real-time CMV PCR assay (Simplexa TM CMV)(DiaSorin, Cypress CA) amplifying the UL83 gene and the 3M Integrated Cycler. Saliva was collected from volunteers (Copan swab), and spiked with known concentrations of CMV culture supernatant quantified by COBAS Ampliprep TM. (Roche Diagnostics). Additionally, saliva was collected by copan swab from all births within a single multi-hospital system from 3/21/16 – 5/4/17. Newborns who were initial screen PCR positive were subsequently evaluated by urine CMV PCR by an outside laboratory for confirmation of cCMV.

      Results

      Analytical threshold of detection was well below 4 log copies/ML, with 100% of samples testing positive at 3.5 log copies/ML (Fig 1). 6127 newborn saliva samples were evaluated and 61 were PCR positive (£40 CT). 47 of these tests were confirmed by urine PCR (Fig 2) (PPV 0.9792, NPV 0.9988, Sens 0.8704, Spec 0.9998). Screen positive tests which were not confirmed by urine PCR had CT values £36. Adjusting the definition of a positive to CT £36 further improved the performance (PPV >0.9999, NPV 0.9997, Sens 0.9592, Spec >0.9999).

      Conclusion

      We demonstrate good performance of a congenital CMV methodology thus facilitating an effective universal newborn screening program

      Disclosures

      J. P. Devincenzo, AstraZeneca/MedImmune: Investigator, Research support

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      Author and article information

      Affiliations
      [1 ] Children’s Foundation Research Institute, Le Bonheur Children’s Hospital , Memphis, Tennessee
      [2 ] Molecular Diagnostics Laboratory, Le Bonheur Children’s Hospital , Memphis, Tennessee
      [3 ] Department of Pediatrics, University of Tennessee School of Medicine , Memphis, Tennessee
      [4 ] Department of Microbiology, Immunology, and Molecular Biology, University of Tennessee School of Medicine , Memphis, Tennessee
      Author notes

      Session: 145. Diagnostics: Viral

      Friday, October 6, 2017: 12:30 PM

      Journal
      Open Forum Infect Dis
      Open Forum Infect Dis
      ofid
      Open Forum Infectious Diseases
      Oxford University Press (US )
      2328-8957
      Fall 2017
      04 October 2017
      04 October 2017
      : 4
      : Suppl 1 , ID Week 2017 Abstracts
      : S356
      5631887 10.1093/ofid/ofx163.861 ofx163.861
      © The Author 2017. Published by Oxford University Press on behalf of Infectious Diseases Society of America.

      This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence ( http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

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