Immunological Assays1890 Behring and Kitasato --> Discovery of Abs

1975 Kohler and Milstein ---> hybridoma technique

1. Precipitation

2. Agglutination

3. Radioimmunoassay

4. Enzyme-linked Immunosorbent Assay (ELISA)

5. Flow Cytometry and Fluorescence

6. Immunochromatographic strip test (POCT)

Slides kindly provide by Prof. Chatchai Tayapiwatana, CMU

Biosensors

• NycoCard™• >18,000 instruments installed • 4 rapid tests :

• CRP (viral/bacterial infection)• HbA1c (diabetes-monitoring)• D-dimer (deep vein thrombosis)• Urine albumin (diabetes-

monitoring)• Distributed in 70 countries

• AFINION™ roll-out started• Advanced, fully automated multi-

assay instrument • Tailor-made for the US market

Optical sensor

AFINION™ Pipeline Short Term

MARKER PoC TEST VOLUMES

Million tests

END USER PRICE

US$

TOTAL PoC

MARKETUS$M

USE COMMENTS

HbA1cLaunched Europe and USA

20-25 6-8 120 Monitors glycaemic control in diabetic patients.

Market leader is Bayer with A-S (NycoCard™) no. 2.

CRPLaunched Europe

10 3-4 30 Distinguishes between viral and bacterial infection.

A-S NycoCard™market leader with Orion no. 2. Not introduced in US yet.

Immunochromatographic strip test•First generation POCT•Qualitative

Optical density measurement

Immunofluorescent Detector

© Copyright 2009 by the American Association for Clinical Chemistry

© Copyright 2009 by the American Association for Clinical Chemistry

© Copyright 2009 by the American Association for Clinical Chemistry

© Copyright 2009 by the American Association for Clinical Chemistry

BioMEMS• Microelectromechanical system_MEMS• MEMS is being applied to biomedical applications and has

become a new field of research unto itself.• The interface between biology and microtechnology

encompasses many diverse areas and levels of biological complexity.

• Include: DNA arrays (genes), immmunoassays (proteins), miniaturized lab-on-a-chips (genes, proteins, and sensors), and finally the integration of live cells (bacterial and mammalian) with semiconductor materials and components.

Microfluidics Applications