VALIDATION OF THE ENZYME-LINKED IMMUNOSORBENT ASSAY FOR EMIQUANTITATIVE DETERMINATION OF IgM ANTIBODIES AGAINST CHLAMYDIA TRACHOMATIS

The object of the following study is representation scientific and methodical foundation procedure validation means serum in vitro diagnosis basing on sample ELISA for semiquantification specific Chlamydia trachomatis IgM-antibodies. Validation characteristics (precision, diagnostic analytic specificity, sensitivity, relative linearity) were defined both at beginning release set expiration date (as element stability study). values sensitivity via in-process serums (20 positive 50 negative) comprised 100%. presence other classes antibodies samples didn’t influence results IgM antibodies. Linearity method was sufficient. intra-assay variation between 3.1% to 6.4%, precision from 1.5% 8.4%, staying acceptable (≤ 10%) moment during date. validated, kit regarded as stable 1 year.