Report of an international collaborative study to establish the suitability of using modified ATP assay for viable count of BCG vaccine
| Autor(a) principal: | |
|---|---|
| Data de Publicação: | 2008 |
| Outros Autores: | , , , , , , , , |
| Tipo de documento: | Artigo |
| Idioma: | eng |
| Título da fonte: | Repositório Institucional da FIOCRUZ (ARCA) |
| Texto Completo: | https://www.arca.fiocruz.br/handle/icict/32336 |
Resumo: | Bacteriology Division. NIBSC. South Mimms.Potters Bar. Hertfordshire EN6 3QG, UK. |
| id |
CRUZ_a738fa0a02ca36c0cee78cf097b0474f |
|---|---|
| oai_identifier_str |
oai:www.arca.fiocruz.br:icict/32336 |
| network_acronym_str |
CRUZ |
| network_name_str |
Repositório Institucional da FIOCRUZ (ARCA) |
| repository_id_str |
2135 |
| spelling |
Ho, Mei M.Markey, KevinRigsby, PeterJensen, Sten E.Gairola, SunilSeki, MasaakiCastello-Branco, Luiz R.López-Vidal, YolandaKnezevic, IvanaCorbel, Michael J.2019-04-02T17:33:27Z2019-04-02T17:33:27Z2008HO, Mei M. et al. Report of an international collaborative study to establish the suitability of using modified ATP assay for viable count of BCG vaccine.Vaccine, v. 26, p.4754-4757, June 2008.0264-410Xhttps://www.arca.fiocruz.br/handle/icict/3233610.1016/j.vaccine.2008.06.026engElsevierBCGatpViabilidadeVacinasBCGATPViabilityVaccineReport of an international collaborative study to establish the suitability of using modified ATP assay for viable count of BCG vaccineinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleBacteriology Division. NIBSC. South Mimms.Potters Bar. Hertfordshire EN6 3QG, UK.Bacteriology Division. NIBSC. South Mimms.Potters Bar. Hertfordshire EN6 3QG, UK.BioStatistics, NIBSC. South Mimms. Potters Bar. Hertfordshire EN6 3QG, UK.Statens Serum Institut, Artillerivej 5, DK-2300, Copenhagen, Denmark.Serum Institute of India Ltd.. 212/2, Hadaspar, Pune-411028, India.Japan BCG Laboratory, 3-1-5, Matsuyama, Kiyose City, Tokyo 204-0022, Japan.Fundação Ataulpho de Paiva. Rio de Janeiro, RJ, Brasil / Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Rio de Janeiro, RJ, Brasil.Universidad Nacional Autónoma de México. Facultad de Medicina. Departamento de Microbiología y Parasitología, Facultad de Medicina. Mexico.Quality, Safety and Standards Team. WHO, Geneva 27, Switzerland.Bacteriology Division. NIBSC. South Mimms.Potters Bar. Hertfordshire EN6 3QG, UK.As part of the World Health Organisation (WHO) initiative to update the current requirements for BCG vaccine a collaborative study was carried out to establish the robustness, reproducibility and the suitability of the modified ATP assay. This assay was developed by Statens Serum Institut, Denmark, as a potential replacement of the method for detection of viable counts of BCG vaccine which is routinely used as a quality control test for lot release. Two BCG preparations, of same strain but different production methods, were tested. For each preparation, two different storage conditions of -20 or 37 degrees C were used in order to establish the suitability of this assay for testing heat-treated BCG vaccine as in the temperature stability test. The lyophilised BCG samples were tested using the ATP reagents from the same source and same principle of testing but some procedural modifications were allowed to accommodate different equipment and resource availability in different laboratories. Data from four laboratories showed that the heat-treated BCG samples contained significantly lower ATP content per sample than the untreated control stored at -20 degrees C. Three laboratories gave consistent mean ATP contents, especially for control samples, even with variations in testing protocol. The present study showed that this modified ATP assay is very robust and can be reproducible. Once the correlation of cultural viable count and ATP content of a BCG vaccine product has been established, this rapid alternative assay may be used to monitor BCG viable count. Due to the fact that this study was small, further investigation is planned. A collaborative study will be carried out using this modified ATP assay in parallel with the cultural viable count method in the establishment of the replacement of the WHO International Reference Preparation of BCG vaccine.info:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-82991https://www.arca.fiocruz.br/bitstream/icict/32336/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALLuizR_CasteloBranco_etal_IOC_2008.pdfLuizR_CasteloBranco_etal_IOC_2008.pdfapplication/pdf160158https://www.arca.fiocruz.br/bitstream/icict/32336/2/LuizR_CasteloBranco_etal_IOC_2008.pdf09284362e95c8d29b71754fa30eb886aMD52TEXTLuizR_CasteloBranco_etal_IOC_2008.pdf.txtLuizR_CasteloBranco_etal_IOC_2008.pdf.txtExtracted texttext/plain20432https://www.arca.fiocruz.br/bitstream/icict/32336/3/LuizR_CasteloBranco_etal_IOC_2008.pdf.txta6e1c9e4f84026b1940acaac8f93ef56MD53icict/323362023-09-05 10:26:15.809oai:www.arca.fiocruz.br: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ório InstitucionalPUBhttps://www.arca.fiocruz.br/oai/requestrepositorio.arca@fiocruz.bropendoar:21352023-09-05T13:26:15Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)false |
| dc.title.pt_BR.fl_str_mv |
Report of an international collaborative study to establish the suitability of using modified ATP assay for viable count of BCG vaccine |
| title |
Report of an international collaborative study to establish the suitability of using modified ATP assay for viable count of BCG vaccine |
| spellingShingle |
Report of an international collaborative study to establish the suitability of using modified ATP assay for viable count of BCG vaccine Ho, Mei M. BCG atp Viabilidade Vacinas BCG ATP Viability Vaccine |
| title_short |
Report of an international collaborative study to establish the suitability of using modified ATP assay for viable count of BCG vaccine |
| title_full |
Report of an international collaborative study to establish the suitability of using modified ATP assay for viable count of BCG vaccine |
| title_fullStr |
Report of an international collaborative study to establish the suitability of using modified ATP assay for viable count of BCG vaccine |
| title_full_unstemmed |
Report of an international collaborative study to establish the suitability of using modified ATP assay for viable count of BCG vaccine |
| title_sort |
Report of an international collaborative study to establish the suitability of using modified ATP assay for viable count of BCG vaccine |
| author |
Ho, Mei M. |
| author_facet |
Ho, Mei M. Markey, Kevin Rigsby, Peter Jensen, Sten E. Gairola, Sunil Seki, Masaaki Castello-Branco, Luiz R. López-Vidal, Yolanda Knezevic, Ivana Corbel, Michael J. |
| author_role |
author |
| author2 |
Markey, Kevin Rigsby, Peter Jensen, Sten E. Gairola, Sunil Seki, Masaaki Castello-Branco, Luiz R. López-Vidal, Yolanda Knezevic, Ivana Corbel, Michael J. |
| author2_role |
author author author author author author author author author |
| dc.contributor.author.fl_str_mv |
Ho, Mei M. Markey, Kevin Rigsby, Peter Jensen, Sten E. Gairola, Sunil Seki, Masaaki Castello-Branco, Luiz R. López-Vidal, Yolanda Knezevic, Ivana Corbel, Michael J. |
| dc.subject.other.pt_BR.fl_str_mv |
BCG atp Viabilidade Vacinas |
| topic |
BCG atp Viabilidade Vacinas BCG ATP Viability Vaccine |
| dc.subject.en.pt_BR.fl_str_mv |
BCG ATP Viability Vaccine |
| description |
Bacteriology Division. NIBSC. South Mimms.Potters Bar. Hertfordshire EN6 3QG, UK. |
| publishDate |
2008 |
| dc.date.issued.fl_str_mv |
2008 |
| dc.date.accessioned.fl_str_mv |
2019-04-02T17:33:27Z |
| dc.date.available.fl_str_mv |
2019-04-02T17:33:27Z |
| dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
| dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
| format |
article |
| status_str |
publishedVersion |
| dc.identifier.citation.fl_str_mv |
HO, Mei M. et al. Report of an international collaborative study to establish the suitability of using modified ATP assay for viable count of BCG vaccine.Vaccine, v. 26, p.4754-4757, June 2008. |
| dc.identifier.uri.fl_str_mv |
https://www.arca.fiocruz.br/handle/icict/32336 |
| dc.identifier.issn.pt_BR.fl_str_mv |
0264-410X |
| dc.identifier.doi.none.fl_str_mv |
10.1016/j.vaccine.2008.06.026 |
| identifier_str_mv |
HO, Mei M. et al. Report of an international collaborative study to establish the suitability of using modified ATP assay for viable count of BCG vaccine.Vaccine, v. 26, p.4754-4757, June 2008. 0264-410X 10.1016/j.vaccine.2008.06.026 |
| url |
https://www.arca.fiocruz.br/handle/icict/32336 |
| dc.language.iso.fl_str_mv |
eng |
| language |
eng |
| dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
| eu_rights_str_mv |
openAccess |
| dc.publisher.none.fl_str_mv |
Elsevier |
| publisher.none.fl_str_mv |
Elsevier |
| dc.source.none.fl_str_mv |
reponame:Repositório Institucional da FIOCRUZ (ARCA) instname:Fundação Oswaldo Cruz (FIOCRUZ) instacron:FIOCRUZ |
| instname_str |
Fundação Oswaldo Cruz (FIOCRUZ) |
| instacron_str |
FIOCRUZ |
| institution |
FIOCRUZ |
| reponame_str |
Repositório Institucional da FIOCRUZ (ARCA) |
| collection |
Repositório Institucional da FIOCRUZ (ARCA) |
| bitstream.url.fl_str_mv |
https://www.arca.fiocruz.br/bitstream/icict/32336/1/license.txt https://www.arca.fiocruz.br/bitstream/icict/32336/2/LuizR_CasteloBranco_etal_IOC_2008.pdf https://www.arca.fiocruz.br/bitstream/icict/32336/3/LuizR_CasteloBranco_etal_IOC_2008.pdf.txt |
| bitstream.checksum.fl_str_mv |
5a560609d32a3863062d77ff32785d58 09284362e95c8d29b71754fa30eb886a a6e1c9e4f84026b1940acaac8f93ef56 |
| bitstream.checksumAlgorithm.fl_str_mv |
MD5 MD5 MD5 |
| repository.name.fl_str_mv |
Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ) |
| repository.mail.fl_str_mv |
repositorio.arca@fiocruz.br |
| _version_ |
1798325029752012800 |