Digital immunodiagnostic rapid test

Rapid immunoassay chip with integrated  power supply, transducer readout and display. It is based on sandwich immunoassay using superparamagnetic nanoparticles as labels  and designed to detect semi-quantitatively analyte concentration and will be demonstrated to measure hCG (human chorionic gonadotrophin), a hormone released by the placenta right after the embryo begins implanting into the uterine lining. The hormone is released in a pregnant woman's urine.

Relevance of the technology

Since its initial development in the 1980s, the technology of Lateral Flow Immunoassay (LFIA) has gained wide acceptance.  The main reason for its popularity is the simplicity of the test design.

Exemplary applications

Detection of e.g.:

Hepatitis B, HIV, Malaria, Syphilis, Allergy, Anemia, Cardiac Marker, Chagas Disease, Chlamydia, Cholera, Dengue, DIC Marker, coli, Fertility, Filiariasis, Group A Streptococcus, Group B Streptococcus, Hantavirus, Hepatitis C, Influenza A, Leishmaniasis, Leptospirosis, Listeria, Peptic ulcer, Rheumatoid Factor, Rickettsia, Salmonella, Thyroid Marker, Tuberculosis, Tumor Marker…

State of the art

Test read out is typically made by visual inspection and is subjective interpretation of the test result and is influenced by. e.g., illumination conditions, and vitality condition of the inspector. Recently separate reader devices based on photometry or even detection of magnetic particles has been developed. There are integrated devices with read out, processing and display integrated into a single device, e.g. ClearBlue.  They are still rather expensive and have to be manufactured in cheap labor countries. So, there is a clear need to have lower cost rapid tests with objective, digital and quantitative test result and higher sensitivity without any external instruments.

Benefit of the ML2 lab-on-chip in comparison to state of the art solutions

The integrated design allows for the production of cheap quick tests which provide semi quantitative information on analyte concentration in a sample within 2 minutes. It also digitises information and displays it alpahanumerically and prevents thus wrong interpretation of test results. The production approach of ML2 will enable cost efficient manufacturing of tests.

MultiLayer MicroLab