Validation of the enzyme-linked immunosorbent assay for emiquantitative determination of IgM antibodies against Chlamydia trachomatis

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dc.contributor.authorBesarab, Alexander
dc.contributor.authorMotronenko, Valentyna
dc.contributor.authorBespalova, Elena
dc.contributor.authorNastenko, Ievgen
dc.date.accessioned2021-10-04T13:08:49Z
dc.date.available2021-10-04T13:08:49Z
dc.date.issued2021
dc.description.abstractenThe object of the following study is representation of the scientific and methodical foundation of the procedure of validation of means of serum in vitro diagnosis basing on the sample of ELISA for semiquantification of specific Chlamydia trachomatis IgM-antibodies. Validation characteristics (precision, diagnostic and analytic specificity, diagnostic sensitivity, relative linearity) were defined both at the beginning of the release of diagnostic set and the expiration date (as the element of stability study). The values of diagnostic sensitivity and specificity, defined via the in-process set of serums (20 positive and 50 negative) comprised 100%. The presence of other classes of Chlamydia antibodies in samples didn’t influence the results of ELISA for specific IgM antibodies. Linearity of the method was sufficient. The intra-assay variation of results is between 3.1% to 6.4%, and intra-assay precision was from 1.5% to 8.4%, staying acceptable (≤ 10%) both at the moment of release and during expiration date. The ELISA method is validated, and the diagnostic kit is regarded as stable during 1 year.uk
dc.format.pagerangee2313uk
dc.identifier.citationValidation of the enzyme-linked immunosorbent assay for emiquantitative determination of IgM antibodies against Chlamydia trachomatis / Alexander Besarab, Valentyna Motronenko, Elena Bespalova, Ievgen Nastenko // Journal of Microbiology, Biotechnology and Food Sciences. – 2021. – Vol. 10 No. 5. – e2313.uk
dc.identifier.doihttps://doi.org/10.15414/jmbfs.2313
dc.identifier.urihttps://ela.kpi.ua/handle/123456789/44081
dc.language.isoenuk
dc.publisherSlovak University of Agriculture in Nitrauk
dc.publisher.placeNitra, Slovakiauk
dc.rights.urihttps://creativecommons.org/licenses/by-nd/4.0/en
dc.sourceJournal of Microbiology, Biotechnology and Food Sciences, 2021, Vol. 10 No. 5uk
dc.subjectELISAuk
dc.subjectvalidationuk
dc.subjectantibodiesuk
dc.subjectChlamydia trachomatisuk
dc.titleValidation of the enzyme-linked immunosorbent assay for emiquantitative determination of IgM antibodies against Chlamydia trachomatisuk
dc.typeArticleuk

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