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March 21, 2024
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Pooled saliva testing catches asymptomatic cases of congenital CMV

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Key takeaways:

  • Around 5% of babies born in the United States have congenital cytomegalovirus.
  • Pooled saliva testing in two Israeli hospitals identified dozens of newborns with asymptomatic CMV.

Universal screening using pooled saliva PCR testing helped identify dozens of newborns with congenital cytomegalovirus at two hospitals in Israel, more than half of whom were asymptomatic, according to findings published in Nature Medicine.

According to the CDC, approximately one out of every 200 babies born in the United States has congenital cytomegalovirus (cCMV), and around 20% of them will develop symptoms or long-term health issues like hearing loss.

IDC0324Yassour_Graphic_01

CMV is the leading cause of birth defects in the country, and experts have advocated for universal newborn screening for the virus. Last February, Minnesota became the first state to require it.

Dana Wolf

“[Congenital] CMV is the most common intrauterine infection,” Dana G. Wolf, MD, director of the clinical virology unit at Hadassah Hebrew University Medical Center in Jerusalem, said in a press release. “We were driven by the unmet clinical need to identify all infants with cCMV, including those who are asymptomatic at birth, so that early treatment and monitoring could be delivered to a large proportion of infants who are otherwise not diagnosed.”

The investigation, which began during the COVID-19 pandemic, has “seamlessly extended its impact to address new medical challenges,” another author said.

“Our transformative pooled-testing approach shifts from testing around 10% of newborns to universal testing of approximately 95%,” Moran Yassour, PhD, MSc, an assistant professor of microbiology and molecular genetics at the Hebrew University of Jerusalem, said in a release.

Moran Yassour

In the longitudinal cohort study, which was conducted at two Hadassah Medical Center hospitals from April 2022 to April 2023, the researchers tested 15,805 infants, totaling 93.6% of all live newborns born at the hospitals.

In the pooled testing method, a group of samples is tested together. If the pooled sample tests negative, all infant samples are considered to be negative. If the pooled sample tests positive, then each individual test is re-tested by itself.

Pooled testing allowed the hospitals to reduce the required number of PCR tests by 83% compared with what would have been expected using the previous, non-pooled method.

“This project was facilitated by the newly available pooled diagnostic approach and the interdisciplinary collaborations that we had established during the COVID-19 pandemic, which made universal screening of cCMV possible,” Wolf said.

Overall, pooled testing identified cCMV in 54 newborns — a birth prevalence of 3.4 cases per 1,000 babies (95% CI,2.6-4.3). Among them, 55.6% were asymptomatic at birth and would not have been caught by targeted screening.

“Our findings project on the wide feasibility and benefits of saliva sample pooling to enhance universal neonatal screening for cCMV,” Wolf said. “Data derived from the implemented universal screening will serve to define the true burden of cCMV and assess future vaccines.”

The pooling setup, while extensive, can be easily integrated at any medium-to-large medical laboratory, “with an expected sixfold efficiency in populations with similar prevalence rates,” the authors said.

“While adjusting facility infrastructure may pose challenges, it's a worthwhile, one-time investment with immense benefits for all newborns and their families worldwide,” Yassour said.

References:

cCMV infection: successful implementation of pooled saliva tests. https://www.eurekalert.org/news-releases/1037331. Published Mar. 12, 2024. Accessed Mar. 20, 2024.

Merav L, et al. Nat Med. 2024;doi: 10.1038/s41591-024-02873-3.