Comparative evaluation of the 4th generation ELISA/CLIA assays used for the diagnosis of HIV infection in the Russian Federation [СРАВНИТЕЛЬНАЯ ОЦЕНКА ТЕСТ-СИСТЕМ ИФА/ИХЛА 4-го ПОКОЛЕНИЯ, ПРИМЕНЯЕМЫХ В РОССИЙСКОЙ ФЕДЕРАЦИИ ДЛЯ ДИАГНОСТИКИ ВИЧ-ИНФЕКЦИИ]

The aim of the work was to compare the five most widely used ELISA diagnostic kits on the territory of the Russian Federation, which are used for screening for HIV infection. Materials and methods. 5442 samples from visitors of diagnostic centers who came for blood donation for non-infectious analyses, cohorts with a high risk of HIV infection, as well as patients with potentially interfering conditions were used as a material for the study. Additionally, seroconversion panels and a panel of viral diversity were used to evaluate the analytical characteristics. The following test systems were compared: Architect HIV Ag/Ab Combo (Abbott), Genscreen Ultra HIV Ag-Ab (Bio-Rad), CombiBest HIV-1,2 AG/AT (Vector-Best), DS-ELISA-HIVAGAT- SCREEN (Diagnostic Systems), HIV-1,2-AG/AT (Medical-Biological Union). Conclusion. The diagnostic sensitivity of all tests was 100% with the exception of one (Medical-Biological Union), in which it turned out to be 99,54%. Diagnostic specificity ranged from 99,58% to 99,89%, but unexpectedly strongly depended on the test population, decreasing on a group with a high risk of HIV infection to 93,26% (Vector-Best). The convergence between initial and repeat reactive samples ranged from 100% (Abbott) to 89,51% (Vector-Best). The results of the analysis of seroconversion panels showed that the tests differed slightly from each other, receiving positive results from 22,12% (Diagnostic Systems) to 27,88% (Abbott) samples. When testing the panel of viral diversity, diagnostic tests from foreign manufacturers showed better results, revealing 100% (Abbott) and 85,9% (Bio-Rad). The smallest number of panel samples was detected by the kit of the Medical-Biological Union (52,1%). This work is the only study where the 4th generation ELISA kits, widely used in the Russian Federation for screening for HIV infection, were compared in an extensive sampling. The results obtained make it possible to evaluate the effectiveness of the use of the listed kits in routine diagnostic practice. © 2019.

Kireev D.E. 1 , Shipulin G.A.2 , Semenov A.V. 3, 6 , Tivanova E.V.1 , Chulanov V.P.1 , Kolyasnikova N.M.1 , Zueva E.B.3 , Galli C.4 , Pokrovsky V.V. 1, 5
Baltic Medical Educational Center
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  • 1 Central Research Institute of Epidemiology of Rospotrebnadzor, Moscow, Russian Federation
  • 2 Center of Strategical Planning and Biomedical Health Risks Management, Moscow, Russian Federation
  • 3 Saint-Petersburg Pasteur Institute, Saint-Petersburg, Russian Federation
  • 4 Abbott Diagnostics, Rome, Italy
  • 5 Peoples' Friendship University of Russia, Moscow, Russian Federation
  • 6 North-Western State Medical University named after I.I.Mechnikov, Saint-Petersburg, Russian Federation
CLIA; Diagnostic tests; Efficiency; ELISA; HIV; Immunoblot; Screening; Sensitivity; Seroconversion panels; Specificity
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