Open AccessAssessment of the clinical significance of the chemiluminescence immuncassay in the diagnostics of the syphilitic infection
Author(s) -
С В Ротанов,
Н В Фриго,
T YE MANUKIAN,
G.M. PODGURSKY
Publication year - 2012
Publication title -
vestnik dermatologii i venerologii
Language(s) - English
Resource type - Journals
eISSN - 2313-6294
pISSN - 0042-4609
DOI - 10.25208/vdv649
Subject(s) - medicine , chemiluminescence , syphilis , syphilis serodiagnosis , serology , immunology , antibody , population , antigen , virology , chromatography , chemistry , environmental health , human immunodeficiency virus (hiv)
The authors present the results of an assessment of the clinical efficacy of the use of the chemiluminescence immunоassay (CLIA) for determination of anti- T. pallidum antibodies in the diagnostics of the syphilitic infection with the use of IMMULITE® 2000 Syphilis Screen, a reagent kit developed on the basis of Tp17 recombinant antigen. The use of 306 samples of blood serum collected from patients suffering from different clinical forms of the syphilitic infection, 61 samples collected from active blood donors and 20 samples collected from persons with biologically false-positive immunochemical (serological) reactions for syphilis demonstrated a high clinical sensitivity (99.68%), specificity (96.30%) and reproducibility (100%) of the chemiluminescence immunоassay results. The high clinical efficacy of the study results combined with the speed of its performance and full automation of the laboratory study process are sufficient to recommend including the chemiluminescence immunоassay in regulated methods for primary examination (screening) of the population for the syphilitic infection along with treponemal tests such as immunoenzyme assay (IEA) and passive hemagglutination reaction.