Diagnosis of dangerous infectious diseases is often a race against time. Effective therapy is only possible when the cause of the infectious disease has been reliably identified. This usually takes a long time as patient samples need to be taken to central medical laboratories. It can be a few hours or more before results are available. Point-of-need (PON) diagnostics has the potential to change all this, as PON tests can be used directly in clinics, such as GP surgeries, where the patient sample is taken. This provides treating physicians with immediate information on the pathogen and enables them to decide on suitable treatment before the patient leaves.

“Molecular PON tests enable the identification of pathogens in less than an hour, and this enables physicians to help their patients much more quickly than they used to do,” says Dr. Jörg Schickedanz, general manager of QIAGEN Lake Constance GmbH, which manufactures PON testing devices. Early diagnosis of the pathogen that causes serious diseases or sepsis considerably improves patients’ chance of survival as well as reducing costs due to shorter hospital stays. 

“The current trend is moving towards the decentralization of diagnostics, i.e. from the hospital bed to the GP surgery, and potentially also the possibility of patients carrying out specific tests at home,” says Dr. Schickedanz. The rapid on-site diagnosis is made possible by miniaturized, mobile test devices that are easy to handle. In order to become a sensible addition to the work of central laboratories, PON systems not only need to provide rapid results, but also be able to provide reliable diagnostic information. “The test systems are basically pocket-sized laboratories,” explains Schickedanz. Such mobile devices are not only of great importance in medical diagnostics and PON applications, they are also gaining in importance in so-called applied test methods. Amongst other things, they can be used for the rapid identification of food contaminations, the identification of diseases in livestock and for providing evidence of illegal drug use in schools. 

QIAGEN Lake Constance has been active in the field of mobile diagnostics for many years. The company develops optical measurement devices and specialises in the miniaturization of test systems. “The major aim is to reduce the size of the detection unit, which is the core part of test systems used for highly sensitive measurements,” explains Schickedanz. The detection unit can be used for applications in the field of molecular biology, immunology and chemistry. The company develops and manufactures the compact detection units and integrates them into test systems. “Measurement of the parameters is thus coupled with data analysis and the transmission of data to hospital or laboratory information systems, so enabling effective documentation, storage and central surveillance of PON data,” says Schickedanz explaining the principle of the PON testing systems. 

Before the mobile devices can be used for PON diagnostics applications, they need to be adapted to the test for which they will be used. “In the development phase, we work closely with our clients who will then place the device on the market along with their proprietary diagnostic testing agents and testing systems,” says Dr. Schickedanz. The company attaches great importance not only to the assay performed with a specific device, but also increasingly to integrating the sample processing step into the device with the aim of manufacturing devices that enable users to carry out all steps from sample processing to analysis and data processing with one device. As part of the BMBF-funded project “ResCheck”, QIAGEN Lake Constance has already developed an integrated system for the diagnosis of diseases of the respiratory system (see article entitled “QIAGEN Lake Constance: a “disk player” for rapid diagnoses”; see link on the right-hand side).

QIAGEN Lake Constance GmbH’s current product portfolio includes devices for two different diagnostic POC testing methods, including isothermal nucleic acid amplification tests that enable pathogens to be identified much more quickly than with standard PCR-based methods, and devices for so-called lateral flow tests that are used for the quantitative detection of target molecules in body fluids. “Such systems enable the cost-efficient determination of the quantity of faecal calprotectin, a protein that enables the differential diagnosis of chronic bowel diseases,” says Dr. Schickedanz.

In order to keep expanding its range of products and remain at the forefront of technology, QIAGEN Lake Constance is involved in research projects in which it provides access to diagnostic platforms. “We are currently involved in two projects funded by the German Federal Ministry of Education and Research and one project funded by the Bill and Melinda Gates Foundation,” says Schickedanz. All projects are aimed at building accurate PON testing systems for the rapid detection of infectious pathogens. The focus of the three projects is the diagnosis of sepsis, respiratory diseases and active tuberculosis infections. 

QIAGEN Lake Constance GmbH was founded in 2010 following the acquisition of the Stockach-based company Embedded System Engineering GmbH (ESE) by QIAGEN, a global provider of molecular sample and assay technologies with its operative headquarters in Hilden, Germany. Back then, ESE was a recognised expert in the development of small, highly sensitive detection systems for use at the point of need rather than central laboratories and QIAGEN had identified the trend towards point-of-need diagnostics. “As QIAGEN’s ‘Competence Center for Optical Detection’, we have been able to maintain a large degree of independence that allows us to take advantage of ESE’s flexibility and speed, two characteristics that are typical of small independent companies,” explains Dr. Schickedanz. Since the acquisition, the company’s sales figures have increased considerably, enabling it to hire new staff. QIAGEN Lake Constance GmbH currently has an interdisciplinary team of 54 people. In addition to carrying out contract work for other companies, QIAGEN plans to combine the parent company’s products with the technologies and products of QIAGEN Lake Constance in order to market integrated solutions along with specific molecular, immunological and other tests.

Further information:
QIAGEN Lake Constance GmbH
Dr. Jörg Schickedanz
Senior Director Head of PON Instrumentation
Jacques-Schiesser-Str. 3
78333 Stockach
Tel.: +49 7771 9166 260
Fax: +49 7771 9166 760
E-mail: Joerg.Schickedanz(at)qiagen.com