Nachweis einer Infektion mit Humanem Immundefizienzvirus (HIV): Serologisches Screening mit nachfolgender Bestätigungsdiagnostik durch Antikörper-basierte Testsysteme und/oder durch HIV-Nukleinsäure-Nachweis

Abstract

Grundlage einer gesicherten Diagnose einer HIV-Infektion und damit Basis für die Mitteilung an den betroffenen Patienten und die Meldung im Rahmen der nicht-namentlichen Meldepflicht (IfSG § 7, Absatz 3) an das Robert Koch-Institut (RKI) ist eine Stufendiagnostik.

Human Immunodeficiency Virus (HIV)

“…Reactive screening test results must be followed by a serologic confirmation test or a NAT assay. An additional second blood sample has to be investigated for confirmation of an HIV infection (see 1.4) [116]. Until the results are clarified, the donation is separated and should be preserved for additional investigations.…”

“…A positive p24 antigen test result must also be confirmed. Appropriate tests are blocking/neutralisation tests or preferably NAT [116]. Most of the HIV-1 p24 antigen tests react also with the HIV-2 p25 antigen, but in some systems with reduced sensitivity.…”

“…HIV-infected donors should be counselled and referred to a general practitioner or a specialised centre for further care. The counselling should include information about the HIV transmission routes and the possibility of antiretroviral therapy [116,153] (see also 3.4). The information given should also include the fact that they are no longer suitable as a blood, plasma or organ donor in Germany.…”

“…In the same sample the amount of viral genomes (viral load) should also be determined using NAT in order to identify the need for antiviral treatment [116,117]. …”

“…Only if the criteria for a positive Immunoblot/Western blot are fulfilled can the HIV infection be considered as confirmed [116]. But if an antibody test is reactive and a positive result for the specimen is obtained in the NAT with a sensitivity of >1,000 HIV genome copies/ml, the confirmatory immunoblot can be omitted and the HIV-infected individual be informed about the antibody and NAT results, advising the patient to seek specific medical attendance and treatment [116].…”