Abstract
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.
Highlights
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 falsepositive immunochemical 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 of the population for the syphilitic infection along with treponemal tests such as immunoenzyme assay (IEA) and passive hemagglutination reaction
Summary
Исследования проведены на 306 образцах сыворотки крови, полученных от пациентов с клинически установленным диагнозом сифилитической инфекции до начала проведения им специфической терапии, в том числе 49 больных с сифилисом первичным, 116 — вторичным, 72 — скрытым ранним, 22 — скрытым поздним, 47 — неуточненным как скрытый ранний или поздний (основная группа наблюдения). Дополнительную группу сравнения составили 20 образцов сыворотки крови пациентов, наблюдавшихся в научно-консультативном отделении ФГБУ «ГНЦДК» Минздравсоцразвития России по поводу биологически ложноположительных результатов исследования на сифилис (БЛПР). Для исследования образцов методом иммунохемилюминесценции применялся набор реагентов «IMMULITE® 2000 Syphilis Screen». Набор «IMMULITE® 2000 Syphilis Screen» предназначен для качественного определения в сыворотке или плазме крови человека суммарных антител (IgG и IgM) к рекомбинантному антигену Tp17 возбудителя сифилиса T. pallidum.
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
