Abstract
Background: Congenital cytomegalovirus (cCMV) infection is a prominent global public health concern due to its association with enduring neurological sequelae and sensorineural hearing impairments. Despite the recommendation for universal cCMV screening, its implementation remains limited. Consequently, alternative targeted testing strategies have been explored to augment detection rates. This study aimed to assess the efficacy of a targeted strategy for screening for cCMV utilizing CMV-IgM antibody screening followed by DNA diagnosis.
Methods: A retrospective analysis was conducted, utilizing data collected between January 2013 and December 2022, encompassing all infants who underwent early cCMV testing. The testing protocol entailed an initial screening of CMV-IgM antibodies, subsequently confirmed through the detection of CMV-DNA in urine, blood, or both, to ascertain cCMV infection. Comprehensive data pertaining to infant presentation, test modalities, and outcomes were recorded for subsequent analysis.
Results: Of the total 60,950 infants subjected to CMV-IgM testing, 816 progressed to CMV-DNA diagnostic testing. Indications for CMV-DNA testing encompassed clinical symptoms (84.31%), maternal HIV infection (8.09%), maternal CMV infection (7.23%), and fetal CMV infection (0.37%). Among the tested population, 95 infants received a diagnosis of cCMV infection, accounting for 0.16% of all screened infants, 11.64% of those who underwent CMV-DNA testing, and 94.74% of symptomatic infants. Fifteen different symptoms were identified, with the highest detection rates for cCMV being hepatitis (38.46%, 5/13), intestinal intussusception (33.33%, 2/6), abnormal CNS imaging (25%, 3/12), jaundice (16.24%, 57/351), sepsis (16.13%, 15/95), and pneumonitis (14.29%, 37/259). The sensitivity and specificity of CMV-IgM screening for cCMV, based on CMV-DNA diagnosis, were determined to be 69.47% and 94.59%, respectively.
Conclusions: The targeted testing strategy utilizing CMV-IgM antibody screening followed by DNA diagnosis exhibits promising potential in substantially enhancing the detection rate of infants affected by cCMV who might otherwise remain undiagnosed. Further investigation is warranted to validate and optimize this approach, as well as assess its feasibility, implementation, and cost-effectiveness in diverse clinical settings.