Sensitivity of Dried Blood Spot Testing for Detection of Congenital Cytomegalovirus Infection Article Swipe
YOU?
·
· 2021
· Open Access
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· DOI: https://doi.org/10.1001/jamapediatrics.2020.5441
IMPORTANCE: The sensitivity of dried blood spots (DBS) to identify newborns with congenital cytomegalovirus (cCMV) infection has not been evaluated in screening studies using the current, higher-sensitivity methods for DBS processing. OBJECTIVE: To assess the sensitivity of DBS polymerase chain reaction (PCR) for newborn screening for cCMV infection using saliva as the reference standard for screening, followed by collection of a urine sample for confirmation of congenital infection. DESIGN, SETTING, AND PARTICIPANTS: This population-based cohort study took place at 5 newborn nurseries and 3 neonatal intensive care units in the Minneapolis/Saint Paul area in Minnesota from April 2016 to June 2019. Newborns enrolled with parental consent were screened for cCMV using DBS obtained for routine newborn screening and saliva collected 1 to 2 days after birth. Dried blood spots were tested for CMV DNA by PCR at both the University of Minnesota (UMN) and the US Centers for Disease Control and Prevention (CDC). Saliva swabs were tested by CMV DNA PCR at the UMN laboratory only. Newborns who screened positive by saliva or DBS had a diagnostic urine sample obtained by primary care professionals, tested by PCR within 3 weeks of birth. Analysis began July 2019. EXPOSURES: Detection of CMV from a saliva swab using a PCR assay. MAIN OUTCOMES AND MEASURES: Number of children with urine-confirmed cCMV and the proportion of them who were CMV positive through DBS screening. RESULTS: Of 12 554 individuals enrolled through June 2019 (of 25 000 projected enrollment), 56 newborns were confirmed to have cCMV (4.5 per 1000 [95% CI, 3.3-5.7]). Combined DBS results from either UMN or CDC had a sensitivity of 85.7% (48 of 56; 95% CI, 74.3%-92.6%), specificity of 100.0% (95% CI, 100.0%-100.0%), positive predictive value (PPV) of 98.0% (95% CI, 89.3%-99.6%), and negative predictive value (NPV) of 99.9% (95% CI, 99.9%-100.0%). Dried blood spot results from UMN had a sensitivity of 73.2% (95% CI, 60.4%-83.0%), specificity of 100.0% (100.0%-100.0%), PPV of 100.0% (95% CI, 91.4%-100.0%), and NPV of 99.9% (95% CI, 99.8%-99.9%). Dried blood spot results from CDC had a sensitivity of 76.8% (95% CI, 64.2%-85.9%), specificity of 100.0% (95% CI, 100.0%-100.0%), PPV of 97.7% (95% CI, 88.2%-99.6%), and NPV of 99.9% (95% CI, 99.8%-99.9%). Saliva swab results had a sensitivity of 92.9% (52 of 56; 95% CI, 83.0%-97.2%), specificity of 99.9% (95% CI, 99.9%-100.0%), PPV of 86.7% (95% CI, 75.8%-93.1%), and NPV of 100.0% (95% CI, 99.9%-100.0%). CONCLUSIONS AND RELEVANCE: This study demonstrates relatively high analytical sensitivity for DBS compared with previous studies that performed population-based screening. As more sensitive DNA extraction and PCR methods continue to emerge, DBS-based testing should remain under investigation as a potential low-cost, high-throughput option for cCMV screening.
Related Topics
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1001/jamapediatrics.2020.5441
- https://jamanetwork.com/journals/jamapediatrics/articlepdf/2775873/jamapediatrics_dollard_2021_oi_200086_1613507662.52056.pdf
- OA Status
- hybrid
- Cited By
- 127
- References
- 30
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W3128189023
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W3128189023Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1001/jamapediatrics.2020.5441Digital Object Identifier
- Title
-
Sensitivity of Dried Blood Spot Testing for Detection of Congenital Cytomegalovirus InfectionWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2021Year of publication
- Publication date
-
2021-02-02Full publication date if available
- Authors
-
Sheila C. Dollard, Maggie Dreon, Nelmary Hernandez-Alvarado, Minal M. Amin, Phili Wong, Tatiana M. Lanzieri, Erin Osterholm, Abbey Sidebottom, Sondra D. Rosendahl, Mark McCann, Mark R. SchleissList of authors in order
- Landing page
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https://doi.org/10.1001/jamapediatrics.2020.5441Publisher landing page
- PDF URL
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https://jamanetwork.com/journals/jamapediatrics/articlepdf/2775873/jamapediatrics_dollard_2021_oi_200086_1613507662.52056.pdfDirect link to full text PDF
- Open access
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YesWhether a free full text is available
- OA status
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hybridOpen access status per OpenAlex
- OA URL
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https://jamanetwork.com/journals/jamapediatrics/articlepdf/2775873/jamapediatrics_dollard_2021_oi_200086_1613507662.52056.pdfDirect OA link when available
- Concepts
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Medicine, Saliva, Dried blood spot, Dried blood, Cytomegalovirus, Population, Urine, Newborn screening, Pediatrics, Immunology, Internal medicine, Viral disease, Herpesviridae, Virus, Chemistry, Chromatography, Biology, Genetics, Environmental healthTop concepts (fields/topics) attached by OpenAlex
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127Total citation count in OpenAlex
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2025: 25, 2024: 40, 2023: 27, 2022: 23, 2021: 12Per-year citation counts (last 5 years)
- References (count)
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30Number of works referenced by this work
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10Other works algorithmically related by OpenAlex
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