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Noninvasive Determination of CMV Serostatus From Dried Buccal Swab Samples: Assay Development, Validation, and Application to 1.2 Million Samples

BACKGROUND: Buccal swab sampling constitutes an attractive noninvasive alternative to blood drawings for antibody serostatus assays. Here we describe a method to determine the cytomegalovirus immunoglobulin G (CMV IgG) serostatus from dried buccal swab samples. METHODS: Upon solubilization, CMV IgG...

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Autores principales: Behrens, Geoffrey A, Brehm, Michael, Groß, Rita, Heider, Jana, Sauter, Jürgen, Baier, Daniel M, Wehde, Tatjana, Castriciano, Santina, Schmidt, Alexander H, Lange, Vinzenz
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8514182/
https://www.ncbi.nlm.nih.gov/pubmed/32052845
http://dx.doi.org/10.1093/infdis/jiaa067
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author Behrens, Geoffrey A
Brehm, Michael
Groß, Rita
Heider, Jana
Sauter, Jürgen
Baier, Daniel M
Wehde, Tatjana
Castriciano, Santina
Schmidt, Alexander H
Lange, Vinzenz
author_facet Behrens, Geoffrey A
Brehm, Michael
Groß, Rita
Heider, Jana
Sauter, Jürgen
Baier, Daniel M
Wehde, Tatjana
Castriciano, Santina
Schmidt, Alexander H
Lange, Vinzenz
author_sort Behrens, Geoffrey A
collection PubMed
description BACKGROUND: Buccal swab sampling constitutes an attractive noninvasive alternative to blood drawings for antibody serostatus assays. Here we describe a method to determine the cytomegalovirus immunoglobulin G (CMV IgG) serostatus from dried buccal swab samples. METHODS: Upon solubilization, CMV IgG is determined by an ELISA assay specifically adapted to cope with low IgG concentrations. The derived CMV titer is normalized against the total protein concentration to adjust for incorrectly or less efficiently sampled buccal swabs. Assay parameters were optimized on a set of 713 samples. RESULTS: Validation with 1784 samples revealed distinct results for > 80% of samples with 98.6% specificity and 99.1% sensitivity. Based on the analysis of 1.2 million samples we derived age- and sex-stratified CMV prevalence statistics for Germany, Poland, United Kingdom, and Chile. To confirm accuracy of the assay in routine operation, the CMV status of 6518 donors was reassessed by independent laboratories based on conventional blood samples revealing 96.9% specificity and 97.4% sensitivity. CONCLUSIONS: The assay accurately delivers the CMV IgG serostatus from dried buccal swab samples for > 80% of the participants. Thereby it provides a noninvasive alternative to plasma-based CMV monitoring for nondiagnostic purposes such as hematopoietic stem cell transplantation donor screening or population studies.
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spelling pubmed-85141822021-10-14 Noninvasive Determination of CMV Serostatus From Dried Buccal Swab Samples: Assay Development, Validation, and Application to 1.2 Million Samples Behrens, Geoffrey A Brehm, Michael Groß, Rita Heider, Jana Sauter, Jürgen Baier, Daniel M Wehde, Tatjana Castriciano, Santina Schmidt, Alexander H Lange, Vinzenz J Infect Dis Major Articles and Brief Reports BACKGROUND: Buccal swab sampling constitutes an attractive noninvasive alternative to blood drawings for antibody serostatus assays. Here we describe a method to determine the cytomegalovirus immunoglobulin G (CMV IgG) serostatus from dried buccal swab samples. METHODS: Upon solubilization, CMV IgG is determined by an ELISA assay specifically adapted to cope with low IgG concentrations. The derived CMV titer is normalized against the total protein concentration to adjust for incorrectly or less efficiently sampled buccal swabs. Assay parameters were optimized on a set of 713 samples. RESULTS: Validation with 1784 samples revealed distinct results for > 80% of samples with 98.6% specificity and 99.1% sensitivity. Based on the analysis of 1.2 million samples we derived age- and sex-stratified CMV prevalence statistics for Germany, Poland, United Kingdom, and Chile. To confirm accuracy of the assay in routine operation, the CMV status of 6518 donors was reassessed by independent laboratories based on conventional blood samples revealing 96.9% specificity and 97.4% sensitivity. CONCLUSIONS: The assay accurately delivers the CMV IgG serostatus from dried buccal swab samples for > 80% of the participants. Thereby it provides a noninvasive alternative to plasma-based CMV monitoring for nondiagnostic purposes such as hematopoietic stem cell transplantation donor screening or population studies. Oxford University Press 2020-02-13 /pmc/articles/PMC8514182/ /pubmed/32052845 http://dx.doi.org/10.1093/infdis/jiaa067 Text en © The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Major Articles and Brief Reports
Behrens, Geoffrey A
Brehm, Michael
Groß, Rita
Heider, Jana
Sauter, Jürgen
Baier, Daniel M
Wehde, Tatjana
Castriciano, Santina
Schmidt, Alexander H
Lange, Vinzenz
Noninvasive Determination of CMV Serostatus From Dried Buccal Swab Samples: Assay Development, Validation, and Application to 1.2 Million Samples
title Noninvasive Determination of CMV Serostatus From Dried Buccal Swab Samples: Assay Development, Validation, and Application to 1.2 Million Samples
title_full Noninvasive Determination of CMV Serostatus From Dried Buccal Swab Samples: Assay Development, Validation, and Application to 1.2 Million Samples
title_fullStr Noninvasive Determination of CMV Serostatus From Dried Buccal Swab Samples: Assay Development, Validation, and Application to 1.2 Million Samples
title_full_unstemmed Noninvasive Determination of CMV Serostatus From Dried Buccal Swab Samples: Assay Development, Validation, and Application to 1.2 Million Samples
title_short Noninvasive Determination of CMV Serostatus From Dried Buccal Swab Samples: Assay Development, Validation, and Application to 1.2 Million Samples
title_sort noninvasive determination of cmv serostatus from dried buccal swab samples: assay development, validation, and application to 1.2 million samples
topic Major Articles and Brief Reports
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8514182/
https://www.ncbi.nlm.nih.gov/pubmed/32052845
http://dx.doi.org/10.1093/infdis/jiaa067
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