The Robert Koch Institute (RKI): main building in Berlin. more
Germany’s Public Health institute RKI monitors the population’s health and wellbeing. more
The Robert Koch Institute is the German government's central institution for the identification, surveillance and prevention of infectious diseases in the Portfolio of the German Ministry of Health. more
Heads: Dr. Kirsten Hanke & Dr. Karolin Meixenberger
Since there can be an unknown period, often several years, between the time of HIV infection and the HIV diagnosis, no statements can be made about the current course of infection using the HIV registration data according to the Infection Protection Act (IfSG). Various serological methods have existed for a number of years to distinguish between recently acquired (approx. < 6 months) and long-standing HIV infections in the context of epidemiological investigations. These serological tests are carried out as part of the InzSurv-HIV study with serum or plasma samples from people who have a new HIV diagnosis that is notifiable according to section 7 IfSG. By continuously recording the proportion of recent new HIV diagnoses, risk populations and regions can be identified and prevention messages can be adapted. Furthermore, by continuously determining recently acquired HIV infections, temporal trends in different risk groups can be observed. For this purpose, the serological data are linked to the epidemiological data (link to FG34).
The BED capture enzyme immunoassay was used for the investigation until the end of 2018. Since the sensitivity (81.7%) and specificity (89.1%) of the test are too low for diagnostic purposes, its application is limited to epidemiological studies and it cannot be used for individual diagnostics. In the test, new HIV diagnoses that are presumably recently discovered and for which there is information about a clinically diagnosed AIDS-defining disease (CDC stage C) are counted among the longer-standing infections. The modified GenScreen HIV-1/-2 avidity test has been used since 2019 because the BED-CEIA is no longer manufactured. With a sensitivity of 81.9% and a specificity of 90.3%, this test is also not suitable for individual diagnostics. As part of the Integrated Genomic Surveillance (IGS-HIV), which is also based on the InzSurv-HIV sample material, the extent to which the duration of the infection can be estimated using Next Generation Sequencing (NGS) data is currently being evaluated.
Information for submitters of the InzSurv-HIV & IGS-HIV
In order to fulfill our mandate formulated in the Infection Protection Act in the best possible way, we use modern molecular processes. Viral RNA is isolated from serum/plasma and then amplified and sequenced. We process both regular serum/plasma samples and filter cards onto which serum or plasma has been dripped (DSS/DPS). In the case of the latter, the higher fragmentation and degradation of the viral RNA is proving to be increasingly problematic. Since July 1st, 2020, we have therefore been gradually switching from filter cards to sending in regular serum/plasma samples.
For a successful HIV sequencing we need at least 500 µl serum/plasma and the sample material should be damaged as little as possible by storage or freeze-thaw cycles.
In the course of a pilot phase, it has been shown that a weekly or event-related direct mailing is logistically advantageous for many senders.
If you are interested in switching from DSS/DPS to serum/plasma or have not yet sent any samples to the RKI but would like to send us samples in the future, please feel free to contact us.
A quick guide to sending serum/plasma samples by post can be found here:
You will receive the shipping material for serum/plasma samples from us free of charge. Sample transport by courier or post is also free of charge for you.
Shipping management
Sabrina Neumann
Telephone +49 (0)30-18754-2243
Fax: +49 (0)30-18754-2605
Email: Molsurv-HIV [at] rki.de
Heads of InzSurv-HIV & IGS-HIV
Dr. Kirsten Hanke
Telephone +49 (0)30-18754-2639
Fax: +49 (0)30-18754-2605
Email: Molsurv-HIV [at] rki.de
Dr. Karolin Meixenberger
Telephone +49 (0)30-18754-2277
Fax: +49 (0)30-18754-2605
Email: Molsurv-HIV [at] rki.de
Date: 22.01.2024
