Optimizing congenital cytomegalovirus detection by pool testing in saliva by a rapid molecular test.
Eur J Pediatr
; 182(11): 5131-5136, 2023 Nov.
Article
em En
| MEDLINE
| ID: mdl-37684486
ABSTRACT
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%.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Infecções por Citomegalovirus
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Citomegalovirus
Tipo de estudo:
Diagnostic_studies
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Guideline
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Prognostic_studies
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Risk_factors_studies
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Screening_studies
Limite:
Humans
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Infant
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Newborn
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article