BIOSENSOR &

diagnostic products

Mr. Nitesh D. Bhele(B.Pharm, PGDM)

Content• Introduction• Characteristics of Biosensor• Types of Biosensors• Examples• Application of Biosensor• Diagnostic Products• Diagnostic Market In India• Examples• References

Sensitive biological element : biologically derived material or biomimetic component that interacts (binds or recognizes) the analyte under study e.g. tissue, microorganisms, organelles, NA.

Transducer or the detector element:  that transforms the signal resulting from the interaction of the analyte with the biological element into another signal (i.e., transduces) that can be more easily measured and quantified.

Biosensor reader device: It is the associated electronics or signal processors that are primarily responsible for the display of the results in a user-friendly way.

A biosensor is an analytical device, used for the detection of an analyte, that combines a biological component with a physicochemical detector.

Prof. Leland C Clark Jnr (1918–2005)

Characteristics of Biosensor

LINEARITY SENSITIVITY

SELECTIVITY RESPONSE TIME

Types of Biosensors

1. Calorimetric Biosensor

2. Potentiometric Biosensor

3. Electrochemical Biosensor

4. Optical Biosensor

5. Piezo-electric Biosensor

Examples

Glucose monitoring device (for diabetes patients) Monitors the glucose level in the blood.

Pregnancy test Detects the hCG protein in urine. Infectous

disease biosensor from RBS

Application of Biosensor

• Glucose monitoring in diabetes patients.• Environmental applications e.g. the

detection of pesticides and river water contaminants such as heavy metal ions.

• Remote sensing of airborne bacteria e.g. in counter-bioterrorist activities

• Detection of pathogens.

• Determining levels of toxic substances before and after bioremediation

• Routine analytical measurement of folic acid, biotin, vitamin B12and pantothenic acid as an alternative to microbiological assay

• Drug discovery and evaluation of biological activity of new compounds.

• Detection of toxic metabolites such as mycotoxins.

Diagnostic Products

Diagnostic product refers to the device used in investigation and identification of disease.

Types: 1. In vitro diagnostics 2. In vivo diagnostics

Diagnostic Market Overview

• Globally, Molecular Diagnostics market is expected to  reach  $ 15 Billion by 2014 

• Infectious disease testing dominates the molecular diagnostics market with more than 21% market share in 2010 

• Domestic market: $ 500 million • CAGR : 20%• Its 2.5 % of the overall healthcare delivery

market• 40,000 independent path labs in the

country and the industry is highly competitive and price-driven 

• Around 70 % of treatment decisions in the country are based on lab results.

Examples

SD BIOLINE HIV Ag/Ab Combo

The SD BIOLINE HIV Ag/Ab Combo Rapid test kit is a rapid, qualitative test for the detection of HIV p24 antigen and antibodies to all isotypes (IgG, IgM and IgA) specific to HIV-1 including subtype-O and/or HIV-2 simultaneously in human serum, plasma or whole blood.

References • WHO list of prequalified

diagnostic products• http://www.novartis.com/products/dia

gnostics.shtml• www.expresshealthcaremgmt.com• http://www.abbott.com/global/url/con

tent/en_US/product/product_category/Product

• www.wikipedia.com