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Background: The value of the widely applied maternal cytomegalovirus (CMV) serological testing approach in predicting intrauterine transmission in highly seroprevalent regions remains unknown., Methods: A nested case-control study was conducted based on a maternal-child cohort study. Newborns with congenital CMV (cCMV) infection were included, and each of them was matched to 3 newborns without cCMV infection. Retrospective samples were tested for immunoglobulin G (IgG) avidity and immunoglobulin M (IgM) antibodies in maternal serum and CMV DNA in maternal blood and urine to analyze their associations with cCMV infection., Results: Forty-eight newborns with cCMV infection and 144 matched newborns without infection were included in the study. Maternal IgM antibodies and IgG avidity during pregnancy were not statistically associated with intrauterine transmission. The presence of CMV DNAemia indicated a higher risk of cCMV infection, with odds ratio values of 5.7, 6.5, and 13.0 in early, middle, and late pregnancy, respectively. However, the difference in CMV shedding rates in transmitters and nontransmitters was not significant in urine., Conclusions: The value of current maternal CMV serological testing in regions with high seropositivity rates is very limited and should be reconsidered. The detection of DNAemia would be helpful in assessing the risk of intrauterine transmission., Competing Interests: Potential conflicts of interest. All authors: No reported conflicts of interest. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Population screening of asymptomatic persons with Epstein-Barr virus (EBV) DNA or antibodies has improved the diagnosis of nasopharyngeal carcinoma and survival among affected persons. However, the positive predictive value of current screening strategies is unsatisfactory even in areas where nasopharyngeal carcinoma is endemic., Methods: We designed a peptide library representing highly ranked B-cell epitopes of EBV coding sequences to identify novel serologic biomarkers for nasopharyngeal carcinoma. After a retrospective case-control study, the performance of the novel biomarker anti-BNLF2b total antibody (P85-Ab) was validated through a large-scale prospective screening program and compared with that of the standard two-antibody-based screening method (EBV nuclear antigen 1 [EBNA1]-IgA and EBV-specific viral capsid antigen [VCA]-IgA)., Results: P85-Ab was the most promising biomarker for nasopharyngeal carcinoma screening, with high sensitivity (94.4%; 95% confidence interval [CI], 86.4 to 97.8) and specificity (99.6%; 95% CI, 97.8 to 99.9) in the retrospective case-control study. Among the 24,852 eligible participants in the prospective cohort, 47 cases of nasopharyngeal carcinoma (38 at an early stage) were identified. P85-Ab showed higher sensitivity than the two-antibody method (97.9% vs. 72.3%; ratio, 1.4 [95% CI, 1.1 to 1.6]), higher specificity (98.3% vs. 97.0%; ratio, 1.01 [95% CI, 1.01 to 1.02]), and a higher positive predictive value (10.0% vs. 4.3%; ratio, 2.3 [95% CI, 1.8 to 2.8]). The combination of P85-Ab and the two-antibody method markedly increased the positive predictive value to 44.6% (95% CI, 33.8 to 55.9), with sensitivity of 70.2% (95% CI, 56.0 to 81.4)., Conclusions: Our results suggest that P85-Ab is a promising novel biomarker for nasopharyngeal carcinoma screening, with higher sensitivity, specificity, and positive predictive value than the standard two-antibody method. (Funded by the National Key Research and Development Program of China and others; ClinicalTrials.gov number, NCT04085900.)., (Copyright © 2023 Massachusetts Medical Society.)

Background Congenital human cytomegalovirus (CMV) infection remains largely unrecognized and underemphasized in medical practice. This study aimed to describe the maternal CMV seroprevalence rate in early gestation and congenital CMV infection in a Chinese population. Methods This prospective cohort study was conducted in three hospitals in China from 2015 through 2018. Pregnant women were enrolled in early gestation and followed up in middle and late gestation with serological testing. CMV serostatus was determined by IgG testing in serum during early gestation. Their newborns were screened for cCMV infection by PCR testing in both saliva and urine at two time points. The cCMV prevalence, maternal seroprevalence and associated factors were analyzed. Results In China, the CMV seroprevalence was 98.11% (6602/6729, 95% CI: 97.76%-98.41%), and the cCMV prevalence was 1.32% (84/6350, 95% CI: 1.07%-1.64%). Over 98% of cCMV-positive newborns were from pregnant women who were seropositive in early gestation in China. The prevalence of cCMV infection in newborns from seropositive and seronegative pregnant women was similar (crude prevalence: 1.33% vs 0.82%, P  = 1.00; estimated prevalence: 1.27% vs 1.05%, P  = 0.32). Pregnant women who were under 25 years old or primiparous had a lower seroprevalence. Newborns from pregnant women under 25 years old or from twin pregnancies had a higher prevalence of cCMV infection. Conclusion in China, the cCMV prevalence was high, and the rates were similar in newborns from pregnant women who were seropositive and seronegative in early gestation. The vast majority of cCMV newborns were from seropositive mothers. Trial registration: ClinicalTrials.gov identifier: NCT02645396..