The development of uniform conditions for the standard operating procedure (SOP), namely enzyme immunoassay, aimed at ensuring quality conditions for the performance of syphilis research in all clinical and diagnostic institutions of the Ministry of Health of Ukraine, as the most informative, which corresponds to the modern conditions of the standardized description of this method.

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.

The objective of the work is to identify systemic and random errors in the formulation of controlled methods and to achieve comparative results obtained by laboratories participating in external quality control of laboratory tests for syphilis. Materials and methods. Laboratories of three levels took part in the activities of external quality control of serological diagnostics of syphilis: clinical diagnostic laboratories (CDL) of medical institutions of scientific research institutes of the NAMS of Ukraine, serological departments as part of the CDL of the dermatovenerological profile of the RDVD, CDVD. Results. The quality of serological tests for syphilis in 21 CDL (serological departments) was assessed using the following methods: RMP, RPR, Rapid-test, TPHA, FTA-abs, ELISA in three control serum samples according to formal and essential characteristics. The most significant differences in the results were revealed in the study of control serum samples with a low content of antibodies and those without antibodies to the causative agent of syphilis in the non-treponemal RMP test and the treponemal FTA-abs test. Conclusions. The conducted studies have shown the high efficiency of the practical application of the developed system of external quality control of laboratory methods for diagnosing syphilis.