Groundbreaking diagnostic chip allows research laboratories to generate multiple quantitative results from a single sample, may help scientists discover relationships between diseases
Whatman has announced that its multiplex protein biochip, branded CombiChip, has received CE Registration for the detection of autoimmune diseases.
This novel assay system was developed in a partnership with Privates Institut fur Immunologie und Molekulargenetik (IIM), a premier German laboratory that specialises in autoimmune and other clinical diagnostic assays.
Whatman/Schleicher and Schuell plans to make the CombiChip available to reference laboratories as a CE-marked in-vitro diagnostic kit.
"Conventional methods of autoimmune diagnosis rely on single Elisas, Immunoblots or Farr/Crithidia assays for each different analyte," explained Appelhans, general manager at IIM.
"This protein biochip for autoimmune detection will be a major step forward for our lab and others, because the ability to generate multiple results from a single sample significantly reduces the time, effort and cost of autoimmune analysis.
"After the promising results of our validation study, we plan to use this assay in our daily routine".
The biochip, which only requires a single, low volume serum sample to generate results for 14 different analytes, effectively reduces the time of analysis to two or three hours.
Additionally, in contrast to other diagnostic assays that rely on Yes/No determinations, the CombiChip uses an IgG concentration calibrator to quantitatively measure the presence of autoantibodies for each single patient's sample.
Currently, the chip identifies antibodies associated with approximately ten different collagenosis and vasculitis-related autoimmune diseases, including systemic and neonatal lupus and systemic sclerosis.
"The CE registration of our CombiChip is a major breakthrough in the field of diagnostics," said Martin Tricarico, vice president of business development.
"By analysing several diseases at once, this pioneering work offers researchers more than savings - it offers them the ability to investigate interactions and relationships between autoimmune diseases.
"In this way, researchers may discover disease groupings that they had never considered.
"We expect that this chip will open up a wealth of further application opportunities in clinical diagnostics."
