Skip to main content

Project INSPECT

We have developed a CMOS biochip with which the prostate-specific antigen can be quantitatively detected. The chip achieves the specifications required for clinical PSA tests according to Rili-BÄK for early cancer detection.

The goal: rapid, precise testing for prostate cancer diagnosis

During diagnosis and care of prostate cancer, PSA concentration (prostate-specific antigen) is determined at all stages: early recognition, exploratory investigation, treatment monitoring and follow-up care. Even a few nanograms PSA per millilitre blood (ng/ml) are an indication of whether and which further tests and treatment are needed. Higher PSA concentrations may be a sign of cancer or its return. The physician takes blood and sends it away for analysis. The PSA test results usually take a few days to come back. Not only for PSA concentrations, science has been working on one new point-of-care (PoC) testing system after another which may obviate costly, time-consuming lab tests carried out on huge, complex apparatus and reduce to a minimum the usually very worrying wait for the patient.

In many cases, such solutions involve test strips which change colour enabling the doctor to assess concentrations in the consultation room. The colour changes vary in intensity and are caused by biochemical reaction. There has been a move in recent years towards using PoC devices with photodetectors or a camera for concentration testing.

Apparatus of this kind still labours under the disadvantage of inaccuracy in comparison with laboratory testing. In the case of PSA detection, the ”Rili-BÄK“ (the guidelines published by the German Medical Association (Bundesärztekammer) for quality assurance in medical laboratory tests) prescribe a lower detection limit of 0.2 ng/ml and a range up to 50 ng/ml. Confidence in the results depends on a coefficient of variation (CV) which is at most 15.5%. Measurements taken with a PoC reader and PSA test strip combination developed for reference purposes in the current research project, however, failed to reach these standards. 

Chip-based prototype detects and measures PSA at less than one nanogram per millilitre

In the INSPECT project, IMMS designed and developed a photometer as a portable reader in combination with a replaceable opto-electronic CMOS biochip and produced a demonstration model. Instead of the test strip employed to date in certain PoC systems with camera, the new version measures the biochemical reaction without a gap between photometer and sample, which is placed directly onto a microelectronic chip. IMMS’ partner in the project, the company Senova Gesellschaft für Biowissenschaft und Technik mbH, undertook the tasks firstly of providing the chip surface with its biochemical functions using immobilised prostate-specific antibodies and secondly of using the prototype to measure samples with various PSA concentration levels. If the sample contains PSA, this is shown by biochemical reactions which darken the sample to an extent that varies with the concentration and with photometry and electronics the differences in brightness are measured. It is a world first for the Senova and IMMS partnership that the presence of PSA on a CMOS biochip can be proven with a lower detection limit of 0.1 ng/ml. This degree of accuracy fulfils the requirements for clinical PSA tests set by ”Rili-BÄK“. The total time required for the test with the CMOS biochip is 14 minutes, there is digital output of the results and these can be processed on a computer connected to the diagnostic device.

For the test and characterisation of the developed integrated circuits, we used and further developed our modular and mobile test systems.

Acronym / Name:

INSPECT / Microelectronic diagnostic platforms for personalised cancer research and micro-bioreactors

Duration:2016 – 2019

Application:

Life Sciences|cancer screenings| point-of-care systems (POC)| in-vitro diagnostics (IVD)

Research field:Integrated sensor systems


Related content

Reference

Dr. Friedrich Scholz, Senova

“IMMS demonstrated great commitment in responding to the huge challenges on the development of the point-of-care test. Our experience demonstrates that IMMS application-oriented analyses, understands and models the biochemical processes. Furthermore, the colleagues implement the specifications with their integrated system design and are flexible in adapting the systems as necessary.”
Reference
All publicationsINSPECT

Event,

MEDICA 2018

IMMS will exhibit at the joint booth of DiagnostikNet-BB: Hall 3 / Booth G60.

Event,

19. Heiligenstädter Kolloquium

„Technische Systeme für die Lebenswissenschaften“

Event,

IEEE SSD 2018

The 15th International Multi-Conference on Systems, Signals and Devices 2018

Event,

RIS3

IMMS mit Vortrag und Poster zum Projekt INSPECT dabei auf der „Entdeckungsreise durch das Innovationsland Thüringen“

Press release,

Mobile rapid tests for prostate and colon cancer – microelectronics measures antigen concentration

IMMS demonstrates functional model at MEDICA trade fair, Nov 13th – 16th, hall 3/G60

Press release,

IMMS presents three developments at MEDICA 2017

Nov 13th – Nov 16th 2017, Düsseldorf (Germany), joint booth DiagnostikNet BB, hall 3/G60

Press release,

Informieren, Probieren, Mitmachen: das war die Lange Nacht der Wissenschaften in Erfurt

Vorträge, Mitmachexponate und jede Menge Angebote für Praktika, Bachelor- und Master-Arbeiten am IMMS

Press release,

MEDICA 2016: IMMS setzt Mikroelektronik für die Vor-Ort-Diagnostik ein

Testaufbau mit Live-Demo für die individualisierte Krebsfrüherkennung in Halle 3 / Stand G60


Contact

Contact

Eric Schäfer, M. Sc.

Head of Microelectronics / Branch Office Erfurt

eric.schaefer(at)imms.de+49 (0) 361 663 25 35

Eric Schäfer and his team research Integrated sensor systems, especially CMOS-based biosensors, ULP sensor systems and AI-based design and test automation. The results are being incorporated into research on the lead applications Sensor systems for in-vitro diagnostics and RFID sensor technology. It will assist you with services for the development of Integrated circuits and with IC design methods.


Funding

The INSPECT project was funded by the “Land” of Thüringen and the European Union under the reference 2015 FE 9159.


This might also be interesting for you

Core topic

CMOS-based biosensors

We are researching CMOS-integrated transducers and their interaction with biological receptors. They offer the potential for precise, digital and cost-effective point-of-care tests and allow properties to be recorded on a molecular scale.

Service for R&D

Integrated Circuits

We offer the design and realisation of application-specific integrated circuits (ASICs) in CMOS, BiCMOS and SOI technologies. We achieve well-performing ASICs with our first runs (first-time right silicon).

Research field

Integrated sensor systems

Here we investigate miniaturised systems manufactured in semiconductor technology consisting of microelectronic components for sensors applications, as well as methods to design these highly complex systems efficiently and safely.

Lead application

Sensor systems for in-vitro diagnostics

Here we are developing sensor systems for in-vitro diagnostics that enable individual, decentralised health monitoring for all with electronic rapid tests.

Back