Application of Domestic Express-Test in Diagnosis of Syphilis by RPR Method

Abstract

The objective. Study of the effectiveness of the domestic «Non-treponemal rapid test for the diagnosis of syphilis RPR (Express-test RPR)» produced by JSC «BIOLIK» for screening diagnosis of syphilis by RPR. Materials and methods. Diagnostic test system «Non-treponemal rapid test for the diagnosis of syphilis RPR (Express-test RPR)» JSC «BIOLIK»; RPR-Carbon-DAC (DAC-SpectroMed s.r.l.), «DSU-LEWIS-TEST» (set 2) LLC DSU, a collection of control sera, serum of patients undergoing examination for syphilis in the State Institution «IDV of NAMS of Ukraine». Results. A new domestic test-system «Express-test RPR» (JSC «BIOLIK») was developed based on the determination of syphilis-associated reagin antibodies in serum (plasma) samples of human blood. In the presented work, the diagnostic significance of the diagnostic «Express-test RPR» (JSC «BIOLIK») was evaluated in the format of a screening test. In the study, the test-system showed absolute (100%) sensitivity and specificity in relation to seropositive (n = 87) and seronegative (n = 13) control samples, as well as up to 100 samples obtained during the examination of patients with various forms of pathology in which the presence or absence of cardiolipin antibodies to T. Spallidum was established by other RPR tests. Conclusions. It is recommended to use the «RPR non-treponemal rapid test for the diagnosis of syphilis (RPR rapid test)» produced by BIOLIK JSC as a macroscopic non-treponemal rapid screening test for syphilis.