Methods of identification of human immunodeficiency virus (HIV) infections in Polish blood donors (2005–2022)

Abstract

The human immunodeficiency virus (HIV) attacks the immune system to cause a lifelong severe illness called AIDS (acquired immunodeficiency syndrome). The HIV infection is a serious condition associated with high costs of therapy and care. Since the beginning of the AIDS/HIV epidemic the number of HIV infected people worldwide has exceeded 84 million, and about 40 million have already died of AIDS. Transfusion of blood and blood components is one of the transmission routes for HIV infection. The risk of transmission of infection by this route has been significantly reduced e.g. by introducing mandatory screening tests for blood donors. There are still however reports of sporadic cases of transfusion transmitted infections related to the so-called diagnostic window and virus polymorphism. In Poland, mandatory testing of anti-HIV were introduced for all blood donors in 1987, and HIV RNA in 2005. Enzyme immunoassays (EIA) have gradually been improved and currently all Polish Blood Transfusion Centers (BTCs) analyze both IgG and IgM antibodies as well as p24 antigen (IV generation tests) in donors. HIV RNA is tested in individual donations (IDT) or in mini pools (MP); the sensitivity expressed as 95% limit of detection [95% LOD] is 45-18 IU/mL and 1469 IU/mL -302 IU/mL, respectively. Verification tests were always performed at the Department of Virology of the Institute of Hematology and Transfusion Medicine (IHTM) with Western blot (WB) and molecular biology methods: transcription mediated amplification (TMA) and real-time polymerase chain reaction (RT-PCR).This publication presents detailed strategy and methodology for conducting screening and verification tests for HIV in Polish blood donors in the years 2005-2022. The study is an extension and update of a part of the author's doctoral dissertation and initiates a discussion on the donor qualification process and the effectiveness of screening studies.