Optimizing congenital cytomegalovirus detection by pool testing in saliva by a rapid molecular test

• Published in: European journal of pediatrics Vol. 182; no. 11; pp. 5131 - 5136
• Main Authors: Izquierdo, Giannina, Farfan, Mauricio J, Villavicencio, Leonel, Montecinos, Luisa, Tarque, Felipe, Acevedo, William, Reyes, Roberto, Guerra, Carolina, Araya, Leslie, Sepúlveda, Belén, Cabrera, Camila, Medina, Pamela, Mendez, Jocelyn, Mardones, Elieder, Torres, Juan P
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01.11.2023; Springer Nature B.V
• Subjects: Congenital infection; Cost analysis; Cytomegalovirus; Cytomegalovirus - genetics; Cytomegalovirus Infections - diagnosis; Hearing loss; Humans; Infant; Infant, Newborn; Medicine; Medicine & Public Health; Neonatal Screening - methods; Neonates; Pediatrics; Polymerase chain reaction; Real-Time Polymerase Chain Reaction - methods; Saliva; Urine; Congenital cytomegalovirus; Screening; Loop-mediated isothermal amplification (LAMP); Saliva; Pool-testing
• ISSN: 1432-1076; 0340-6199; 1432-1076
• DOI: 10.1007/s00431-023-05183-x

Universal congenital cytomegalovirus (cCMV) screening in saliva is increasingly recommended. The aim of our study was to correlate the performance of a point-of-care rapid molecular test with CMV real time PCR (CMV RT-PCR) detection, using saliva pool-testing in newborns under a universal screening strategy. Saliva swabs were prospectively collected from newborns < 21 days old and tested by Alethia-LAMP-CMV assay in pools of 5 samples. In positive pools, subjects were tested individually and by saliva and urine CMV RT-PCR. A subset of negative pools were studied with both techniques and viral loads in whole blood were determined in positive patients. From 1,642 newborns included in 328 pools, 8 were confirmed by urine CMV RT-PCR, (cCMV prevalence 0,49%). The PPA and NNA of the pooled saliva Alethia-LAMP-CMV testing were 87,5% and 99,8% with a negative and positive predictive value of 99,9% and 77,7%, respectively. Two false positives were detected (0,12%). A subset of 17 negative pools (85 samples), studied by saliva CMV RT-PCR, showed 100% concordance.   Conclusion : CMV pool-testing using a rapid molecular test in saliva proved feasible when compared to PCR gold standards. This strategy could improve cost-effectiveness for cCMV universal neonatal screening, based on the low prevalence of the infection and could be a more affordable approach in less developed regions with reduced detection capacity. What is Known: • cCMV is the most frequent congenital infection and a leading nongenetic cause of sensorineural hearing loss and brain disease. • Universal screening could allow early detection of congenitally infected infants, improving clinical outcome. • Saliva PCR is the preferred and non-invasive test for newborn cCMV screening. What is New: • The feasibility of a universal cCMV screening by pool-testing in saliva using a rapid test in pools of 5 samples. • PPA and NPA were 87,5 and 99,8% compared to CMV PCR in urine. • This strategy could be relevant specially in LMIC where detection capacity is reduced and could improve cost-effectiveness. • cCMV prevalence in our center was 0,49%.