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Implementation of pooled saliva tests for universal screening of cCMV infection
Lior Merav1,2,3, Noa Ofek Shlomai4,5, Esther Oiknine-Djian3,5,6
1School of Computer Science and Engineering, The Hebrew University of Jerusalem, Jerusalem, Israel.
Insights
Universal screening for congenital cytomegalovirus (cCMV) is crucial for preventing neurodevelopmental disabilities. Pooled saliva PCR testing offers an efficient, cost-effective, and sensitive method for widespread newborn screening of cCMV.
Area of Science:
- Virology
- Public Health
- Neonatal Screening
Background:
- Congenital cytomegalovirus (cCMV) is the leading cause of intrauterine infections and subsequent neurodevelopmental disabilities in newborns.
- Universal newborn screening for cCMV is increasingly recommended, but efficient testing strategies are lacking.
- Accurate and high-throughput screening methods are essential to identify all infected infants.
Purpose of the Study:
- To evaluate the feasibility and effectiveness of pooled saliva polymerase chain reaction (PCR) testing for universal congenital cytomegalovirus (cCMV) screening.
- To assess the efficiency, sensitivity, and cost-saving benefits of this pooled testing approach in a real-world setting.
- To determine the birth prevalence of cCMV and the proportion of asymptomatic cases identified through universal screening.
Main Methods:
- A prospective study was conducted in two Jerusalem hospitals from April 2022 to April 2023, screening 15,805 newborn infants.
- Pooled saliva samples were tested using PCR for cCMV, with an empirical pooling efficiency of six infants per test.
- Sensitivity was assessed by measuring PCR cycle loss compared to theoretical predictions for an eight-sample pool.
Main Results:
- The pooled saliva PCR approach successfully screened 93.6% of live newborn infants, achieving a pooling efficiency of six and reducing saliva tests by 83%.
- A minor loss of 3.05 PCR cycles in sensitivity was observed, consistent with theoretical predictions.
- cCMV was detected in 54 infants, yielding a birth prevalence of 3.4 per 1,000 live births, with 55.6% of cases being asymptomatic.
Conclusions:
- Pooled saliva PCR testing is a feasible, efficient, and cost-sparing strategy for universal newborn screening of cCMV.
- This method significantly increases the detection of cCMV, including asymptomatic cases that might otherwise be missed.
- The study supports the implementation of pooled saliva testing as a routine method for cCMV screening programs.
Abstract:
Congenital cytomegalovirus (cCMV) is the most common intrauterine infection, leading to neurodevelopmental disabilities. Universal newborn infant screening of cCMV has been increasingly advocated. In the absence of a high-throughput screening test, which can identify all infected newborn infants, the development of an accurate and efficient testing strategy has remained an ongoing challenge. Here we assessed the implementation of pooled saliva polymerase chain reaction (PCR) tests for universal screening of cCMV, in two hospitals of Jerusalem from April 2022 through April 2023. During the 13-month study period, 15,805 infants (93.6% of all live newborn infants) were screened for cCMV using the pooled approach that has since become our routine screening method. The empirical efficiency of the pooling was six (number of tested newborn infants per test), thereby sparing 83% of the saliva tests. Only a minor 3.05 PCR cycle loss of sensitivity was observed for the pooled testing, in accordance with the theoretical prediction for an eight-sample pool. cCMV was identified in 54 newborn infants, with a birth prevalence of 3.4 per 1,000; 55.6% of infants identified with cCMV were asymptomatic at birth and would not have been otherwise targeted for screening. The study demonstrates the wide feasibility and benefits of pooled saliva testing as an efficient, cost-sparing and sensitive approach for universal screening of cCMV.
