Anotace:
The 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.