Optimizing congenital cytomegalovirus detection by pool testing in saliva by a rapid molecular test
© 2023. The Author(s)..
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%.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:182 |
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| Enthalten in: |
European journal of pediatrics - 182(2023), 11 vom: 08. Nov., Seite 5131-5136 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Izquierdo, Giannina [VerfasserIn] |
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| Links: |
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| Themen: |
Congenital cytomegalovirus |
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| Anmerkungen: |
Date Completed 13.11.2023 Date Revised 04.04.2024 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1007/s00431-023-05183-x |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM361819781 |
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| 245 | 1 | 0 | |a Optimizing congenital cytomegalovirus detection by pool testing in saliva by a rapid molecular test |
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| 500 | |a Date Revised 04.04.2024 | ||
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| 520 | |a © 2023. The Author(s). | ||
| 520 | |a 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% | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Congenital cytomegalovirus | |
| 650 | 4 | |a Loop-mediated isothermal amplification (LAMP) | |
| 650 | 4 | |a Pool-testing | |
| 650 | 4 | |a Saliva | |
| 650 | 4 | |a Screening | |
| 700 | 1 | |a Farfan, Mauricio J |e verfasserin |4 aut | |
| 700 | 1 | |a Villavicencio, Leonel |e verfasserin |4 aut | |
| 700 | 1 | |a Montecinos, Luisa |e verfasserin |4 aut | |
| 700 | 1 | |a Tarque, Felipe |e verfasserin |4 aut | |
| 700 | 1 | |a Acevedo, William |e verfasserin |4 aut | |
| 700 | 1 | |a Reyes, Roberto |e verfasserin |4 aut | |
| 700 | 1 | |a Guerra, Carolina |e verfasserin |4 aut | |
| 700 | 1 | |a Araya, Leslie |e verfasserin |4 aut | |
| 700 | 1 | |a Sepúlveda, Belén |e verfasserin |4 aut | |
| 700 | 1 | |a Cabrera, Camila |e verfasserin |4 aut | |
| 700 | 1 | |a Medina, Pamela |e verfasserin |4 aut | |
| 700 | 1 | |a Mendez, Jocelyn |e verfasserin |4 aut | |
| 700 | 1 | |a Mardones, Elieder |e verfasserin |4 aut | |
| 700 | 1 | |a Torres, Juan P |e verfasserin |4 aut | |
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