Study lead Unit 18: Dr. Kirsten Hanke & Dr. Karolin Meixenberger

Study lead Unit 34: Dr. Uwe Koppe

Tasks

Since the period between the time of HIV infection and the time of HIV diagnosis can be of unknown length, often several years, the HIV notification data according to the Infection Protection Act (IfSG) do not allow any statements to be made about recent events of infection. For several years, various serological methods have existed to distinguish between recently (ca. < 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 using serum or plasma samples from people who have a new HIV diagnosis that is notifiable according to § 7 of the German Infection Protection Act (IfSG). By continuously recording the proportion of recent new HIV diagnoses, populations at risk and regions with recent transmission can be identified and prevention messages can be adapted. Furthermore, the continuous determination of recently acquired HIV infections allows the observation of temporal trends in different risk groups. For this purpose, the serological data are linked to the epidemiological data.

The main study objectives are

• Nationwide determination of the proportion of recent HIV new diagnoses, e.g. by sex, transmission groups, age groups, origin
• Identification of trends in the occurrence of infection over time
• Deriving targeted prevention strategies, focusing ongoing prevention measures

Methods

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 use is limited to epidemiological investigations and it cannot be used for individual diagnostics. HIV new diagnoses that were presumably identified as recent and for which a clinically diagnosed AIDS-defining disease was reported (CDC stage C) are counted as chronic infections. Since 2019, the modified GenScreen HIV-1/2 avidity test has been used 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. The Integrated Genomic Surveillance (IGS-HIV), which is also based on the sample material of the InzSurv-HIV, is currently evaluating the extent to which the duration of infection can be estimated using next-generation sequencing (NGS) data.

Sociodemographic (sex, age, region of residence, region of origin, transmission route) and clinical data (viral load, CD4 cell count) are collected from the non-named HIV report (Section 7 (3) IfSG) in Unit 34 of the RKI. Test results are assigned to the statutory HIV reports via the report form number for further analysis.

Notes for participants of the InzSurv-HIV & IGS-HIV

In order to fulfill our duties as formulated in the Infection Protection Act in the best possible way, we use modern molecular methods. Viral RNA is isolated from serum/plasma and then amplified and sequenced. We process both regular serum/plasma samples and filter cards on which serum or plasma has been dropped (DSS/DPS). In the case of the latter, the higher fragmentation and degradation of viral RNA is increasingly proving to be a problem. Therefore, since July 1, 2020, we have been gradually switching from filter cards to regular serum/plasma samples.

For successful HIV sequencing, we require at least 500 µl serum/plasma and the sample material should be as unaffected as possible by longer storage or freeze-thaw cycles.

During a pilot phase, it has been shown that weekly or event-driven direct shipment by mail is logistically advantageous for many senders.

If you are interested in switching from DSS/DPS to serum/plasma or have not yet sent samples to the RKI but would like to send samples to us in the future, please feel free to contact us.

See also the Quick guide for sending serum/plasma samples by post for the integrated genomic surveillance of new HIV diagnoses [PDF, 305KB, File does not meet accessibility standards].

We will provide you with the shipping material for serum/plasma samples free of charge. Sample transport by courier or post is also free of charge for you.

Contact details

Shipping management (Unit 18)

Sabrina Neumann
Phone: +49 (0)30-18754-2243
E-mail: Molsurv-HIV [at] rki.de

Documentation (Unit 34)

Sami Marzougui
Phone: +49 (0)30-18754-2042
E-mail: InzSurv.HIV [at] rki.de

Head of Studies Unit 18 (Molecular Epidemiology)

Dr. Kirsten Hanke
Phone: +49 (0)30-18754-2639
E-mail: Molsurv-HIV [at] rki.de

Dr. Karolin Meixenberger
Phone: +49 (0)30-18754-2277
E-mail: Molsurv-HIV [at] rki.de

Head of Studies Unit 34 (Epidemiology)

Dr. Uwe Koppe
Phone: +49 (0)30-18754-2262
E-mail: InzSurv.HIV [at] rki.de