SCREENING AND DIAGNOSTIC POSSIBILITIES OF THE PASSIVE HEMAGLUTINATION REACTION IN EXAMINATION FOR SYPHILIS USING THE DOMESTIC MANUFACTURER’S TEST SYSTEM

About the author:	Kutova V.V., Bondarenko G.M., Khoroshun E.M., Bіlokon O.M., 
Dehtiar T.V., Nikitenko I.M., Huriev A.S.	
Heading	ORIGINAL RESEARCHES	
Type of article	Scientific Article	
Annotation	The purpose. Study of the diagnostic possibilities of the erythrocyte diagnostic
 test RPGA for the detection of specific antibodies to T. pallidum of the domestic 
manufacturer «DIA®-RPGA-Trep» PrJSC «NVK «DIAPROF-MED», Ukraine, as a 
screening and confirmatory test for the diagnosis of syphilis, taking into account the 
capabilities of the laboratory service in Ukraine.
Materials and methods. 1357 serum samples during the routine examination of 
syphilis patients with various forms of pathology and 98 collection positive control 
serum samples were studied. RPGA method – passive hemagglutination reaction 
(erythrocyte diagnostic to detect specific antibodies to Treponema pallidum) 
DIA®-RPGA-Trep PrJSC «DIAPROF-MED»; ELISA – enzyme immunoassay
reaction (EQUI anti-Treponema pallidum) LLC Equitestlab, Ukraine.
Results. The sensitivity of this test is high, it is similar to the sensitivity of the ELISA 
antibody test in various forms of syphilis, and can even be used in patients who have 
received treatment to monitor cure. The specificity of the reaction is high, as 
demonstrated by examination of sera in patients with a negative history and negative
 clinical examination together with negative results of treponemal tests and in patients
 with nonspecific seropositivity of nontreponemal tests.
Conclusions. For serological screening of the population for syphilis, it may be 
sufficient to carry out the RPGA test of a domestic manufacturer in a high-quality 
setting. As a confirmatory test, this method should also be used in a semi-quantitative 
setting in combination with other treponemal tests.	
Tags	diagnosis of syphilis; serological diagnosis; treponemal test; passive 
hemagglutination reactions (RPHA); Treponema pallidum.	
Bibliography	1. Order of the Ministry of Health of Ukraine dated April 18, 2023 No. 743 
Standard of medical care. Syphilis.
2. Kutasevych Ya.F., Kutovaya V. V., Bilokon O. M., Bondarenko H. M., 
Nikytenko I. M., Shcherbakova Yu. V. Prakticheskie aspekty serologicheskoj 
diagnostiki sifilisa na sovremennom etape [Practical aspects of serological 
diagnosis of syphilis at the current stage]. Granddaughter Dermatology and 
venereology. 2020; 1(87): 39–43.
3. Bondarenko H. M., Unuchko S. V., Nikytenko I. N., Gubenko T. V.,
 Kutova V. V. Sifilis: sovremennoe sostoyanie problemy [Syphilis: the current 
state of the problem]. Dermatology and venereology. 2018; 1(79): 8–12.
4. Bondarenko H. M., Unuchko S. V., Nikytenko I. N., Shcherbakova Yu. V.
 Modern features of the pathomorphosis of syphilis (review). Georgian medical 
news. 2019; 3 (288):105–110.
5. Kutasevych Ya.F., Litus O. I., Kutova V. V. et al. Udoskonalennia 
laboratornoi diahnostyky syfylysu v Ukraini (metodychni rekomendatsii 
[Improvement of laboratory diagnosis of syphilis in Ukraine (methodological 
recommendations)]. Kyiv. 2019: 28 p
6. CDC. Sexually transmitted disease surveillance 2022 [Internet]. Atlanta, GA: 
US Department of Health and Human Services, CDC; 2023. https://www.cdc.gov/std/statistics/2021/default.htm
7. Shinohara K, Furubayashi K, Kojima Y, Mori H, Komano J, Kawahata T J 
Clinical perspectives of Treponema pallidum subsp. Endemicum infection in 
adults, particularly men who have sex with men in the Kansai area, Japan: 
A case series. Infect Chemother 2022;28:444–50. PMID:34836779 
https://doi.org/10.1016/j. jiac.2021.11.012
8. O’Byrne P, MacPherson P. Syphilis. BMJ 2019; 365: l4159. 
doi:10.1136/bmj.l4159
9. Satyaputra F, Hendry S., Braddick M., Sivabalan R., Norton R. The 
Laboratory Diagnosis of Syphilis. J. Clin. Microbiol. 2021; Sep. 20;59(10): 
e0010021. doi: 10.1128/JCM.00100–21.
10. World Health Organization. Report on global sexually transmitted infection
 surveillance. Geneva, Switzerland: World Health Organization; 2018. 
https://www.who.int/publications/i/
item/9789241565691	
Publication of the article	«DERMATOLOGY AND VENEREOLOGY» №1(103), 2024 year, 18-22 pages,
	
DOI	10.33743/2308-1066-2024-1-18-22