Abstract Details
8/22/2022 | 4:05 PM - 4:30 PM | Governor General III
The Use of Saliva Samples to Test for Congenital Cytomegalovirus (cCMV) Infection in Newborns
A large-scale universal screening research study in five hospitals is being conducted to identify the clinical sensitivity of PCR testing on newborn dried blood spot (DBS) versus saliva specimens for diagnosis of cCMV. Any positive saliva or blood result is reported to the primary care provider for follow-up. Objective: To document the prevalence of false positive saliva PCR results and the potential association with donor milk. Methods: Frequency of positive saliva results, true (TP) and false positive (FP) status from clinical confirmation was documented. Frequency of donor milk use was compared for TP and FP cases. PCR testing was conducted on seven different batches of donor milk from the hospital with the highest FP rate (none of these batches were consumed by study participants). Results: Of 22,079 participants tested from February 2016 through May 2022, 96 had positive saliva results. After clinical investigation, 15 were determined to be FPs and 79 were TPs. Two were excluded from analysis for incomplete clinical workup. Donor milk use in the feeding of the newborn was identified for 18 (19.8%) of all positive saliva screens. Among the 15 FPs, 11 (73.33%) consumed donor milk compared to 7 of the 79 TPs (8.8%). Among all positive saliva cases, donor milk was associated with increased odds of FP results (OR 28.29, 95% CI (7.0971-112.7342, p < 0.001). PCR testing of unrelated donor milk samples was positive for three of the seven batches (67, 174, and 205 copies of CMV DNA /mL).
- Describe a large, multi-site, universal screening research study with saliva specimen testing for congenital cytomegalovirus (cCMV) infection
- Understand the potential impact of donor milk on saliva PCR results
- Describe the prevalence of false positive saliva PCR results
Presentation:
This presentation has not yet been uploaded.
Handouts:
No handouts have been uploaded.
Nelmary Hernandez-Alvarado (Co-Presenter), hernande@umn.edu;
Ms. Hernandez-Alvarado is a molecular biology and Director of a CLIA-certified CMV diagnostic laboratory at the University of Minnesota. She has considerable expertise in detection of CMV and in the clinical manifestations of congenital and neonatal CMV infections.
|
ASHA DISCLOSURE: Financial - No relevant financial relationship exists. Nonfinancial - No relevant nonfinancial relationship exists. |
|
AAA DISCLOSURE: Financial - No relevant financial relationship exists. |
Whitney Wunderlich (Co-Presenter), whitney.wunderlich@allina.com;
Whitney Wunderlich is a Project Manager for Clinical Research at Allina Health in Minneapolis, Minnesota. She has worked in research at Allina since 2016 and in health care research for ten years for both Allina and Duke Health. Her current role supports the Mother Baby Clinical Service Line as well as other research program agendas within the Care Delivery Research Department. Whitney has a Masters in Clinical Psychology and a Bachelors degree in both Psychology and Human Services. She has substantial experience working directly with study management, patient recruitment and biospecimen collection for cCMV research.
|
ASHA DISCLOSURE: Financial - No relevant financial relationship exists. Nonfinancial - No relevant nonfinancial relationship exists. |
|
AAA DISCLOSURE: Financial - No relevant financial relationship exists. |