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α-Gal syndrome results from sensitization to the carbohydrate epitope galactose-α-1,3-galactose (α‑gal). The allergen occurs in mammalian meat and innards, but also in other foods and medical products of animal origin. Allergic reactions generally occur delayed after allergen intake with a latency period, depending on the individual tolerance threshold and the influence of cofactors. Details in the patient's medical history can help to establish the suspected diagnosis of α‑gal syndrome. Confirmation of the diagnosis requires the expertise of specialists, experienced with the implementation and interpretation of in vitro and in vivo diagnostic tests. Whereas skin prick testing with commercial whole-meat extracts often does not provide reliable results, allergen-specific IgE (α-gal) is generally detectable in affected patients. Cell-based tests such as the basophil activation test are currently only employed in an experimental setting. To evaluate, whether a sensitization is clinically relevant, an in-patient oral food challenge should be performed, using for example cooked pork or porcine kidney in addition to suspected cofactors.

Not only therapeutic procedures, but also diagnostic procedures, have to demonstrate their patient-relevant benefits if they are to be reimbursed by public health insurance. Randomized trials comparing two diagnostic procedures allow us to assess these benefits directly if appropriate outcomes are used. However, owing to the widespread lack of such studies, it is now necessary to use the "linked evidence" approach as well, trying to predict the patient-relevant benefits from the results of comparative accuracy studies. Such a prediction is based on explicitly specifying our expectations with regard to the consequences of a change in diagnosis at the level of a single patient. We discuss the basic properties of these two approaches, which are relevant to the understanding of their possible role in the benefit assessment of diagnostic procedures. We try to predict the future roles of the two approaches and outline some of the issues on which a consensus is required to allow their successful use in benefit assessment. Furthermore, we indicate some of the developments related to the paradigm of individualized care that may influence the use of benefit assessments for diagnostic studies in the future.

This article analyses the effects that the increasing amount of medical information available today can have on risk assessment, using examples taken from the fields of serological laboratory diagnosis (HIV, Hepatitis C) and sonographic and molecular genetic examination methods. In general, it can be said that new methods of diagnosis help achieve a more exact and refined prognosis, although their results cannot always be implemented consistently, especially in so-called borderline cases. The second section provides a detailed analysis of access to and availability of medical information in proposal forms, drawing on experience gained from the most important markets.

The number of characterized monogenic and polygenic diseases is rising each year. In consequence, molecular diagnostics is faced with an ever increasing number of patient samples and with more and more heterogeneous genetic defects. The fusion of microelectronics and molecular biology has created a new technology (microelectronic miniaturization), which provides a rapid, efficient, and cost-effective tool in molecular diagnostics at a high-sample throughput. The biochip has recently been selected as one of the ten scientific highlights in the year 1998. The application of microelectronics ranges from the polymerase chain reaction (PCR), nucleotide sequence analysis via DNA-chips or capillary electrophoresis-chips to gene expression analysis. These microchips are suited for integration into fully automated systems, thus providing the basis for automation of molecular diagnostics. The present article summarizes important trends in molecular diagnostics and provides a glimpse on future technologies.