In vitro diagnostics involves the removal samples of tissue such as blood, saliva, biopsy samples from a living organism for examination in the laboratory setting, whereas in vivo diagnostics involves observing and testing tissue and function in a living organism—techniques such as medical imaging (x-rays, magnetic resonance, computed tomography, etc.) and monitoring like electrocardiography, electroencephalography, etc.).
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
A biosensor is an analytical device, used for the detection of an analyte, that combines a biological Prof. Leland C Clark Jnr component with a (1918–2005)physicochemical detector. 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.
Characteristics of Biosensor LINEARITY SENSITIVITY RESPONSE SELECTIVITY TIME
ExamplesGlucose monitoringdevice (for diabetespatients)Monitors the glucoselevel 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
Diagnostic Products Diagnostic product refers to thedevice used in investigation andidentification 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
SD BIOLINE HIV Ag/Ab ComboThe SD BIOLINE HIV Ag/Ab Combo Rapidtest kit is a rapid, qualitative test for thedetection of HIV p24 antigen and antibodiesto all isotypes (IgG, IgM and IgA) specific toHIV-1 including subtype-O and/or HIV-2simultaneously in human serum, plasma orwhole blood.
References• WHO list of prequalified diagnostic products• http://www.novartis.com/products/diagnosti cs.shtml• www.expresshealthcaremgmt.com• http://www.abbott.com/global/url/content/e n_US/product/product_category/Product• www.wikipedia.com