Validation of a Real-Time PCR Assay for Fully Automated Detection of Bacillus cereus in Donor Human Milk

dc.contributor
Institut Català de la Salut
dc.contributor
[Aran G, Pleguezuelos V, Soria G] Banc de Sang i Teixits (Blood and Tissue Bank of Catalonia), Barcelona, Spain. Grup de Recerca de Medicina Transfusional, Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. [Blanco M, Garcia C, Jallow M, López M] Banc de Sang i Teixits (Blood and Tissue Bank of Catalonia), Barcelona, Spain
dc.contributor
Vall d'Hebron Barcelona Hospital Campus
dc.contributor.author
Pleguezuelos, Vanesa
dc.contributor.author
Blanco, Margarita
dc.contributor.author
Garcia-Garcia, Cristina
dc.contributor.author
Jallow Diallo, Mariama
dc.contributor.author
Lopez Montañes, Maria
dc.contributor.author
SORIA, GLORIA
dc.contributor.author
Aran , Gemma
dc.date.accessioned
2025-10-30T02:03:54Z
dc.date.available
2025-10-30T02:03:54Z
dc.date.issued
2025-10-29T12:50:22Z
dc.date.issued
2025-10-29T12:50:22Z
dc.date.issued
2025-07
dc.identifier
Aran G, Pleguezuelos V, Blanco M, Garcia C, Jallow M, López M, et al. Validation of a Real-Time PCR Assay for Fully Automated Detection of Bacillus cereus in Donor Human Milk. Microorganisms. 2025 Jul;13(7):1640.
dc.identifier
2076-2607
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http://hdl.handle.net/11351/13963
dc.identifier
10.3390/microorganisms13071640
dc.identifier
40732149
dc.identifier
001536751400001
dc.identifier.uri
http://hdl.handle.net/11351/13963
dc.description.abstract
Bacillus cereus; Donor human milk; Human milk bank
dc.description.abstract
Bacillus cereus; Leche humana de donant; Banco de leche humana
dc.description.abstract
Bacillus cereus; Llet humana de donant; Banc de llet humana
dc.description.abstract
Donor human milk (DHM) can harbor microbial contaminants that cause serious infections in premature infants. Bacillus cereus is a pathogen frequently found in DHM, capable of forming spores that can resist Holder pasteurization (62.5 °C, 30 min). Since no microbial growth is acceptable in post-pasteurized DHM, microbiological testing of pre-pasteurized DHM provides information about its contamination level to determine if it should be accepted for pasteurization. Culture is the gold standard in microbiological control but it requires 24-48 h to provide results. In this study we developed and validated a non-commercial real-time PCR assay for the detection of Bacillus cereus (BC test) in DHM specimens on a fully automated high-throughput platform, the cobas® 6800 system. The BC test showed excellent sensitivity and specificity, repeatability and linearity over an 8-log range and a low limit of detection in milk specimens, as well as good agreement with selective culture methods. BC test was then used to systematically control all milk donations (3439) over a 24-month period. Bacillus cereus was detected in 14.2% of DHM, with monthly rates ranging from 6 to 29% and a significantly higher incidence in warmer months. Incorporating this assay into our laboratory workflow improved efficiency and reduced turnaround time.
dc.format
application/pdf
dc.language
eng
dc.publisher
MDPI
dc.relation
Microorganisms;13(7)
dc.relation
https://doi.org/10.3390/microorganisms13071640
dc.rights
Attribution 4.0 International
dc.rights
http://creativecommons.org/licenses/by/4.0/
dc.rights
info:eu-repo/semantics/openAccess
dc.source
Scientia
dc.subject
Bacterièmia
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Infants prematurs
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Llet materna
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Reacció en cadena de la polimerasa
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Bancs d'espècimens biològics
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DISEASES::Bacterial Infections and Mycoses::Bacterial Infections::Bacteremia
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ANATOMY::Fluids and Secretions::Bodily Secretions::Milk, Human
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NAMED GROUPS::Persons::Age Groups::Infant::Infant, Newborn::Infant, Premature
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ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Investigative Techniques::Genetic Techniques::Nucleic Acid Amplification Techniques::Polymerase Chain Reaction::Real-Time Polymerase Chain Reaction
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HEALTH CARE::Health Care Facilities, Manpower, and Services::Health Facilities::Biological Specimen Banks::Milk Banks
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ENFERMEDADES::infecciones bacterianas y micosis::infecciones bacterianas::bacteriemia
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ANATOMÍA::líquidos y secreciones::secreciones corporales::leche humana
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DENOMINACIONES DE GRUPOS::personas::Grupos de Edad::lactante::recién nacido::recién nacido prematuro
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TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::técnicas de investigación::técnicas genéticas::técnicas de amplificación de ácidos nucleicos::reacción en cadena de la polimerasa::reacción en cadena de la polimerasa en tiempo real
dc.subject
ATENCIÓN DE SALUD::instalaciones, servicios y personal de asistencia sanitaria::centros sanitarios::bancos de muestras biológicas::bancos de leche
dc.title
Validation of a Real-Time PCR Assay for Fully Automated Detection of Bacillus cereus in Donor Human Milk
dc.type
info:eu-repo/semantics/article
dc.type
info:eu-repo/semantics/publishedVersion


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