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Definition of biometals
A group of chemical elements that are needed in minute quantities for the proper growth, development, and physiology of an organism.
The term Biometal refers to the role of metal ions in biology, biochemistry and medicine. The metals copper, zinc, iron and manganese are examples of metals that are essential for the normal functioning of the body. It is also a term used to describe a living machine.
Definition of bioceramics
An advanced ceramic used to create components suitable for use or replacement in the human body.
Biocompatible or osteoinductive (stimulating bone growth) ceramic material, such as hydroxyapatite or some other type of calcium phosphate ceramic, used for reconstructive bone surgery and dental implants.
Definition of biosemiconductor
The biosemiconductor, together with the drift of charges, ions, and radicals, may be considered as a form of "bioplasma". Bioplasma may be subject to magnetohydrodynamic (MHD) control. The EM fields emitted by trained healers may be considered as coherent, resonant biomagnetic emissions by which a less coherent EM field of the patient is "tuned" to the specific frequency and phase, and through which homeostasis can be "aligned" to induce "healing".
Definition of bioelectronics
The application of electronic theories and techniques to the problems of biology.
The use of biotechnology in electronic devices such as biosensors, molecular electronics, and neuronal interfaces; more speculatively, the use of proteins in constructing circuits.

Choosing a coating: the right surface modification technique brings benefits to patients with implants.
The importance of selecting the right coating or surface modification technique for an orthopedic implant cannot be understated. Metals and ceramics that orthopedic implants are made from are not inherently compatible with the body's tissues and organs and are prone to wear. The more wear an implant has, the shorter its lifespan in a human body will be.

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Selecting the right coating or surface modification technique can help prevent these problems. If processed properly, these methods can reduce the chances of the body having an adverse reaction to the implant and help the body accept the implant, even spurring bone to grow around it.

"The primary objective is to improve the long-term wear performance of the implant," said Gene Elwood, North America senior medical accounts manager for Ionbond LLC. IonBond deposits BioCeramic coatings through WW Medical Coating Competence Centers. IonBond's global headquarters is in Olten, Switzerland, and its North American Medical Coating Competence Center is in Rockaway, N.J. "A parallel objective is to provide a protective barrier for alloy-sensitive patients. While today no implant device lasts forever, a longer-lasting implant benefits the patient and helps to reduce healthcare costs. IonBond works closely with the device OEM to improve implant performance while satisfying each OEM's specific test and evaluation protocols," Elwood added.
As such, it is not surprising that "there's a lot of talk about reducing wear, which increases the life of an implant," said Marie Vennstrom, deputy R&D manager for Sandvik Medtech, a coatings testing company based in Sandviken, Sweden. "If you improve surface conditions, there will be less wear debris in the body. People are sensitive to metals, so the less iron released into the body, the better. And reduced wear allows for implants that stay in the body longer, which is always better for patients."

Titanium, HA Coatings

There are a number of ways these goals can be accomplished. To aid bone growth onto implants, manufacturers typically choose titanium or hydroxylapatite (HA) coatings, said Colin McCracken, Ph.D., development manager of powder products for Reading Alloys, a Robesonia, Pa.-based division of Ametek Corp., which supplies titanium-based powders used by manufacturers to coat hip, knee and dental implants. "One of the main differences between titanium-based coatings and HA coatings is that titanium-based coatings do not require any fixing agent, while HA requires a fixing agent or cement," he said. "In the short term, the recovery time is likely longer than it would be with a cemented implant. However, the non-cemented fixation normally lasts longer because it relies on bone ingrowth. HA relies on the strength of the cement to keep the implant in place."

If an implant manufacturer opts for a titanium-based coating, it can choose between one that is pure titanium and an alloy that contains 6 percent aluminum and 4 percent vanadium, called Ti-6AI-4V, McCracken said.

"Both are engineered to spur bone ingrowth," he said. "The Ti-6AI-4V has higher strength than pure titanium but does cost more. The market is about 50-50. Both go back a long way. Which gets used often depends on which material the orthopedics company started with, which was grandfathered in. Companies generally don't change those kinds of preferences."

New technologies are being developed that will do an even better job at promoting bone ingrowth, McCracken added. This in turn is prompting firms such as Reading Alloys to develop new powders that are more compatible with these processes.

"Several medical companies are developing new porous coatings for implants that promote and increase bone ingrowth and reduce bone shielding effects by the use of titanium-based foams or scaffolds," he explained. "Today's technology works by plasmaspraying the powder onto the implant. New technologies will not require plasma spraying. They will result in a higher level of porosity. And that will make the implants much closer to the strength of the bone and reduce the amount of bone shielding that occurs. If you can reduce bone shielding, the life of the implant increases. The scaffolding technology requires a finer particle size distinction. So we are developing new powders to aid those developments." Also, he noted, "metal injection molding is being used for very small dental implants. Putting Sintering titanium hydride powder in another form through the sintering process also allows the implant to achieve higher density, which leads to improved strength."

Similarly, the device industry is looking into biologics to help promote bone ingrowth, said Elwood. "The device industry is evaluating biologic growth surfaces to enhance cell attachment and promote bone ingrowth. IonBond's patented TST [titanium surface technology] is at the forefront of enhanced bone cell attachment," he said.

Elwood also sees two other developments for metal- and ceramic-based coatings coming to the forefront in the near future.

"Primary deposition technologies are PVD, PaCVD and CVD with PVD being currently used to deposit TiN (titanium nitride) on implants for patients with alloy sensitivity issues, currently used widely in Europe. A more recent introduction is a device coated with a multilayer coating, top layer being ZrN (zirconium nitride); addresses both wear and alloy sensitivity," he said.

Advances in BioCeramic coatings for spine implant applications also will have a major impact to improve wear and eliminate current issues for MRI imaging that are produced by alloys such as CoCr, he said. "Ti (titanium is an excellent alternative biomaterial, but its wear properties are poor; hence, the need for a BioCeramic coating. The unique properties of IonBond's exclusive Medthin-Diamond (ADLC) has demonstrated positive performance results with cervical discs, for example."
The Application OF Bioceramics IN Medical Implants
The development of bioceramics fulfils a unique function as biomedical materials and built-up techniques that has broaden the diversity of medical implants application within the human body.

“They are active materials. Once implanted in the patient, they interact with the surrounding fluids, and while they are being gradually absorbed by the body, they promote bone regeneration, acting only as an initial scaffold for the new bone.” Andres (2007:26) quotes Dr Karin Hing once saying which is a researcher at the London-based Interdisciplinary Research Centre in Biomedical Materials. Consequently our world now is facing a different kind of traumatic events particularly in car accidents which we doesn’t expect and to think critically it can cause people to the different bone damages in their body like in the knee, hips and other bone fracture. The most crucial of all is can lead to the death of a person which made their lives very short in the world we are living. Moreover several studies were made by the different scientist who have determination to get up this kind of idea which is a material that suitable as a replacement of different bone damages or fracture that can’t affect once health when it will undergo this kind of medical implant and the people who are responsible for this is what we called the doctors. That’s why the field of medicine is continually evolving for many years in its different area only to discover knew things for our present and future good. Pursuing further, they found out the applications of bioceramics is one of the greatest help in our today’s generation and to the future in medical implants for its potentially suitable for a wide range important applications specifically in different bone damages and because of this it’s have been publicized in early times and until now in our modern world for its biocompatibility. According to Hench and Ethridge in 1982 that was quoted by Heimann which says that the inorganic compounds are designed to replace a part or a function of the human body in a safe , reliable, economic, and physiologically and aesthetically acceptable manner. Currently ceramics materials are extensively used for medical application and it’s having been successfully within the human body for many years. In the definition of Larry L. Hench, the ceramics material which used for repair and reconstruction of disease or damaged parts of musculo-skeletal system that may be bionert, resorbable, bioactive or porous for tissue in growth is known as bioceramics. On the other hand, Cristina Jimenez-Andres said that bioceramic provides the right environment for the new bone to grow into and it has a special chemical composition that allows a type of cell called osteoblasts which is responsible for bone production to attach to the ceramic’s surface, and start generating new bone. Also the interconnected tiny holes within the bioceramic structure facilitate the proliferation of the cell network, and the growth of the bone, within the synthetic scaffold and the calcium content of the bioceramic provides the inorganic component that new bone requires to develop its mineral-like structure. General speaking my study focuses on the similar properties of bioceramics is a good substitute for replacing bone damages which aims to know the what are the comparable properties of bioceramics to the bone and how does interact in the human body. In addition, it also aims how it bioceramics discover or shall we say its past history until know. However, to make this study effective you need at least 10 sources whether in books, magazine, newspaper, and in the online sources which what I’m doing it. Indeed I came to this generalization it’s because
II. Body History of Bioceramics 1983: March 27, bioceramic engineers and medical scientists are working together to develop medical devices from ceramic materials that have chemical. 1986: November 7, the Advanced Structural Ceramics specifically bioceramics in medical has Business Communications. In December 1 2005, there is a hip replacement cost $1520.00 in North America. 1988: April 26, the first international symposium on bioceramics was held in Kyoto Japan and the current status of ceramics is now commonly used in medical fields as dental and bone implants. The Artificial teeth and bones are relatively commonplace 1989: April 5, auto and construction industry are shape and found growing application in the auto, IT, and household goods sectors the advanced structural ceramics specificall bioceramics, medical and dental has Business Communications. 1990: January 1, there is CERAMICS: Workshop focuses on ceramics in biomedical applications Biomedical Materials on November 1, 1993 at the Institute of Bioceramics at the New York State College of Ceramics. 1991: October 1, the physiological response of tissue to implant bioceramics and described new developments and research in both fields in biomedical and combinational materials science. 1992: May 1, the Institute will be dedicated to the research of bioceramic materials as well as new materials for medical and dental applications. Work under way includes research into calcium phosphate ceramics such as hydroxyapatite, bioresorbable glasses and orthopaedic implants. 1993: March 1, Microwaves: Industrial, Scientific and Medical Applications.Find Microwave Journal articles. This reference book describes current commercial applications of microwaves in fields as diverse as industrial. July 1, Article: PUBLICATIONS: Proceedings from bioceramics meeting now available Biomedical Materia. The proceedings from the 6th International Symposium on Ceramics in Medicine held in Philadelphia, USA, in November 1992. October 1, Zirconia is gaining on alumina in popularity for use in bioceramics because of its superior mechanical properties. The French company Rhodia Inc will acquire certain assets of US company Applied Silicone Corp's healthcare and medical application businesses. December 1, Publications: Proceedings from bioceramics meeting is available and different articles will be published about bioceramics. Expected to appeal to researchers and students in material science, medical engineering and clinical implant. 1994: April 1, the composite biomaterials: properties and chemistry; biomaterials and tissue interactions; clinical applications; and complications and adverse reactions. July 1, the proceedings of the 7th International and the proceedings will feature the following sections: bioactive ceramics; theory and clinical applications; preparation of bioceramics. November 1, the Ceramics known as bioceramics for medical application had been developed 20 years ago. 1995: April 1, Bioceramics: Materials and Applications, (order number: ACS 152; list price: GBP 71, but GBP 57 to members of the American Ceramic Society [ACS]), contains contributions from medical practitioners, component manufacturers and material scientists. August 1, Research being carried out into the development and applications of ceramics in the medical field is covered in `Bioceramics, Volume 7', the proceedings of the 7th International Symposium on Ceramics in Medicine, held in July 1994 in Turku, Finland. December 1, find Advanced Ceramics Report articles. Affairs Law to manufacture and market its artificial bone graft medical devices. An artificial bone graft is a product used for medical.Comparative study of the osteoinductive properties of bioceramic, coral and processed bone graff substitutes. 1996: May 1, Science and technology in composite materials - application of bioceramics composite materials to artificial bones/joints. June 1, a book combining the proceedings from two distinct meetings on ceramics presents a broad, multidisciplinary perspective on bioceramic materials, according to its publisher American Technical Publishers Ltd. Bioceramics: Materials and Applications contains contributions from medical. August 1, most medical-grade zircon as have similar properties, so the scientists mconclude that tests with these materials from other manufacturers will produce the same results. September 1, BIOCERAMICS: Computer-based approach to ceramic dental inlays. October 8, the 10th Bioceramics volume reports on the meeting held in Paris from 5th to 8th October 1997 and Bioceramics in Medicine has become one of the major fields. 1998: June 1, BIOCERAMICS: Ceramics offer potential treatment for diabetes. 1999: December 1, today's medical-grade alumina is hot isostatic pressed (HIP), laser engraved and 100% proof-tested. Other bioceramics, such as Y-TZP zirconia (yttrium oxide tetragonal stabilized [ZrO.sub.2]) and hydroxyapatite (HA), are currently being tested for use in medical applications. 2000: June 8, Pacific Aerospace & Electronics Reaches Milestones With Bioceramic Implantable Medical Components. October 18, with a few medical research projects like building wrist bones or the teeny bones in the ear out of bioceramic matter thrown in February 1, Article: CERAMICS: Workshop focuses on ceramics in biomedical applications. The Institute of Bioceramics at the New York State College of Ceramics at Alfred University has an event on 8-10 June 1994, in Alfred, New York, USA. December 19, Bio-Ceramic products when worn externally react to the body temperature and reportedly emit far infrared rays. The common medical use of such products are T-shirts for asthma patients, socks and knee braces for patients with arthritic problems, ankle and shin braces for minor sprains. 2003: May 13,Cortek is currently preparing for an IDE application in pursuit of a PMA and CE mark for the Replace Lumbar IBF Device ten years of research, have been designed by a team of bioceramic and medical polymer specialists with a combined experience of more than fifty years. 2004: May 1, Ceramics for Medical Implant. High Tech Ceramics News on May, 2004. Morgan Advanced Ceramics (MAC), provides ceramic and coating material solutions for medical applications. 2005: January 1, Extends the benefits of its ceramic materials to a wide range of medical applications, including joint replacement surgery. June 8, the first of these two patents applications, "BioPolymer-Bioceramic Composite Coatings and Process for making the same September 2, though a specialist in industrial applications of ceramics, he was familiar with medical applications too. Two decades earlier, while a researcher and lecturer at the University of Pretoria, he had worked in the emerging field of alumina ceramics, with bioceramics as one of the areas. 2006: January 1, the choice of material is dependent on the application. HTCN: As bioceramics has taken over as the largest segment within the advanced structural ceramics area. March 23, Bioceramics are ceramics that are used in biomedical applications ranging from medical implants to biomedical pumps. April 1, the total market for medical ceramics (excluding dental) was pegged at $57 million in 2005 by Advanced Glasses & Glass Ceramics: Materials, Processing, New Developments-GB-094U from BCC Research. July 20, Niobium and Tantalum Propel Electronic Ceramics Market Material technology advancements have resulted. The growing application of smart ceramics and bioceramics, the medical technology field is portending bountiful growth. August 15, The annual conference will concentrate on new challenges being faced in the bioceramics industry from the progress of modern medicine 2007: January 3, bring the proven bio-compatibility and long term durability benefits of ceramic materials to an increasingly wide range of medical applications July 3, this approach is being explored in the development of a new generation of nanobioceramics with a widened range of medical applications. 2008: June 16, Britannica online encyclopedia article on bioceramics, ceramic products or components employed in medical and dental applications, mainly as implants and replacements. 2009: January 1, Breakthrough nanomaterial for implantable medical devices in bioceramics. (Cited from http://www.nytimes.com) The Different bioceramics in bone replacement and its properties * Hydroxyapatite has been recognized as an important bioceramics because of its excellent biocompatible due to similar chemical composition to the human bone. However, HAp cannot be used as implant in a heavy load bearin parts like artificial teeth or hip joints due to its low inherent low mechanical properties particularly low fracture toughness compared to human bone. Many studies have been reported on the improvement of fracture toughness of HAp ceramics by the addition of a second phase including particles whiskers or fibers and metallic coating or dispersion etc. One important to improve mechanical property without dispensing the excellent biocompability of Hap and this fact limits the choice of second phase to modify. HAp ceramic matrix Al2O3 and ZrO2 are two common properties although bio-inert in nature. (Taek, Lez, Sarkar, & Song, 2009) In addition, HAp also known have a high biological affinity for example good osteoconductivity. Therefore it is widely used as an artificial substitute in the repair of bone tissues because its protein adsorption characteristics, another popular application is in culomn packaging for liquid chromatography. (Watanabe, Ogata, Kamitakahara, & Ohtsuki, 2009) Nevertheless, Tetracalcium Phosphate (Ca4P2O9) > Amorphous calcium Phosphate > alpha-Tricalcium Phosphate (Ca3(PO4)2) > beta-Tricalcium Phosphate (Ca3(PO4) 2) >> Hydroxyapatite (Ca10(PO4)6(OH)2)Unlike the other calcium phosphates, hydroxyapatite does not break down under physiological conditions. In fact, it is thermodynamically stable at physiological pH and actively takes part in bone bonding, forming strong chemical bonds with surrounding bone. This property has been exploited for rapid bone repair after major trauma or surgery. While its mechanical properties have been found to be unsuitable for load-bearing applications such as orthopaedics, it is used as a coating on materials such as titanium and titanium alloys, where it can contribute its 'bioactive' properties, while the metallic component bears the load. Such coatings are applied by plasma spraying. However, careful control of processing parameters is necessary to prevent thermal decomposition of hydroxyapatite into other soluble calcium phosphates due to the high processing temperatures.(Gross,2002) *Alumina and Zirconia are known for their general chemical inertness and hardness. These properties are exploited for implant purposes, where it is used as an articulating surface in hip and knee joints. Its ability to be polished to a high surface finish make it an ideal candidate for this wear application, where it operates against materials such as ultra high molecular weight polyethylene (UHMWPE).Porous alumina has also been used as a bone spacer, where sections of bone have had to be removed due to disease. In this application, it acts as a scaffold for bone ingrowth. Single crystal alumina or sapphire has also been used in dental applications, although its use in this application is declining with the advent of more advanced materials such as resin-based composites. *Titanium ant its alloy have been widely applied as artificial dental implant and hip joint due to their good bio-compability and mechanical properties. However, Ti would take more than three months to integrate with bone. In particular Ti, must be kept with bones without applying mechanical force during the fixation period. It is known that the regeneration of apatite on Ti substrates can be promoted by bio-ceramic coating such as hydroxyapatite, tricalcium phosphate,and calcium titanate.(Sato, Tu, Goto, Euda & Narushima, 2009) Examples of Medical Application in Orthopaedics Joint Replacement: The use of ceramic components in surgery began in the 1970’s with the introduction of first generation alumina products for joint replacement, when ceramic’s superior resistance to wear in comparison to more traditional metal and polyethylene materials became apparent. Advances in material quality and processing techniques and a better understanding of ceramic design led to the introduction of second generation alumina components in the 1980’s that offered even better performance than early systems. (n.a, 2000) CERAMIC FEMORAL HEAD (Hip Joint Ball): Replacing broken and worn out body parts is not a new idea. In fact, the first orthopedic institute was established in 1780 to treat skeletal deformities in children. Professor Themistocles Gluck (1853 -1942) as inventor of artificial biomaterials. Prof Gluck, pupil of professor von Langenbeck, renowned practitioner of the Berlin’s Surgical Clinic, changed concept of contemporary surgery “from being the destructive art to become the reconstructive art”. He developed artificial total joints, fabricated from ivory and implanted them in many patients. In the early 1960s, the first artificial hip joint, a stainless steel stem and cup invented, by the English surgeon Sir John Charnley, was implanted. Charnley’s design, although simple, was virtually unchanged for three decades, even though surgeons and researchers alike knew there were problems with using metal in the human body. These included corrosion, wear, and loss of bone. Yet, until the 1990s, there was no alternatives that could match metals implant lifespan of 10 to 15 years. Hence, many orthopedics manufacturers began experimenting with ceramics, which are being used extensively in orthopedic implants, particularly hips. Ceramics offer some inherent advantages over metal. They are biologically inert, produce nearly no wear debris, and can be designed to more closely match the material properties of natural bone. Again metal has such high stiffness, the bone surrounding an implant no longer bears the load; the implant carries the entire load. As bone is a living tissue, it begins to resorb when it ceases to carry the load, allowing the implant to loosen and eventually require replacement. Ceramics can now also be formulated to allow bone to grow within their porous structures, or scaffolds. They can completely incorporate the scaffold with natural bone within five to seven months. For the articulating surfaces on hip, knee, and shoulder implants, two ceramics are most commonly used, alumina and zirconia. These materials are much harder than metal, cannot be scratched, and can be used on both the ball and socket components of an implant, such as the femoral head and the acetabular cup of a hip implant. The ceramic hip prosthesis gives much higher life than metallic prosthesis, formation foreign debris is also much lower thereby reducing side effects and is suited for all patients especially relatively younger people who may have to opt for HIP replacement surgery. More than 0.5 million Hip replacement surgeries are being performed per year globally. Hip replacement surgery is done for a case of necessity and needs lots of precautions and post operative measures. Patients who experience unbearable pain due to Osteoarthritis or have broken hips due to accidents undergo such an operation. This coupled with increased life expectancy has triggered multi-directional research activity to identify ideal materials for such implants to give the desired longevity and comfort. Property requirement of alumina based femoral head as per international standard. (Yuan, Drujin ,& Zhary, 2001) Impact of Bioceramics as replacement of bone damages The most significant demand for biomaterials has emerged as a consequence of the need to provide clinical treatment to a large number of patients. The key factors and driving forces are the increase in life expectancy and the aim to provide a minimum quality of life to an aging population. In particular, said increase in life expectancy has increased considerably the number of patients with osteoporosis. According to Prof. M. Vallet- Regi, if we take also into account the continuous increase in the number of motor vehicles, with its associated social penalty in terms of traffic accidents, the incidence of bone pathologies is increasing at an alarming rate in recent years. The search for potential solutions in this field produces a large demand for materials suitable for bone repair or replacement. Calcium phosphates, bio-glasses, bio-glass ceramics and ordered silica mesoporous materials, among other types of materials, will be reviewed and studied from the point of view of their potential applications as replacement materials in bone repair and regeneration, as potential substrates in tissue engineering, and also as drug delivery systems. The ability of functionalizing the material surfaces with various molecules of different nature and shape will allow actuating selectively on the biological environment. An overview on the present achievements, but also on the missing links will be presented. In the next century as a better understanding of the interactions of artificial bone with organic components is achieved on the molecular level it will be possible to tailor the physical and chemical properties of the material with the specific biological and metabolic requirements of bone tissues or disease states. Since the population is continuing to grow older, artificial bone will play an even more important role in improving the health of many people around the world. (Sheppard, 2000) III. Conclusion Over the last 20 years, ceramic materials have been refined and there is now a range of ceramic and engineered solutions optimized for medical applications including surgical tooling, ultrasound and implants. Now, manufacturers of ceramic materials are concentrating their efforts on development of manufacturing processes to address specific medical needs. As a result of this research and development medical device manufacturers, doctors and their patients are all benefiting from the ability to precision engineer very high reliability components in commercial quantities. Indeed the bioceramics materials is a good substitute for bone damages because of its similar properties of the bones which potentially act to as a natural bone replacement inside the body that capable to interact with the bone tissues and in fact it really helps a lot of people who go through this kind of implant. Its revolutionary changes and has occurred in reconstructive surgery which people benefited in the improvement of the quality of their life that is the increase of their life expectancy or shall we say they will live longer in the world. As year passed bioceramics it will meet a highly demand and continue to be successful of these materials and also the opening of new avenues for many reconstructive surgeries to lead a damage free, pain free, maintenance free stable for a longer time.

Bioelectronics
A discipline in which biotechnology and electronics are joined in at least three areas of research and development: biosensors, molecular electronics, and neuronal interfaces. Some workers in the field include so-called biochips and biocomputers in this area of carbon-based information technology. They suggest that biological molecules might be incorporated into self-structuring bioinformatic systems which display novel information processing and pattern recognition capabilities, but these applications—although technically possible—are speculative.
Of the three disciplines—biosensors, molecular electronics, and neuronal interfaces—the most mature is the burgeoning area of biosensors. The term biosensor is used to describe two sometimes very different classes of analytical devices—those that measure biological analytes and those that exploit biological recognition as part of the sensing mechanism—although it is the latter concept which truly captures the spirit of bioelectronics. Molecular electronics is a term coined to describe the exploitation of biological molecules in the fabrication of electronic materials with novel electronic, optical, or magnetic properties. Finally, and more speculatively, bioelectronics incorporates the development of functional neuronal interfaces which permit contiguity between neural tissue and conventional solid-state and computing technology in order to achieve applications such as aural and visual prostheses, the restoration of movement to the paralyzed, and even expansion of the human faculties of memory and intelligence. The common feature of all of this research activity is the close juxtaposition of biologically active molecules, cells, and tissues with conventional electronic systems for advanced applications in analytical science, electronic materials, device fabrication, and neural prostheses.
Bioelectronic sensor technology for detection of cystic fibrosis and hereditary hemochromatosis mutations.
CONTEXT: Bioelectronic sensors, which combine microchip and biological components, are an emerging technology in clinical diagnostic testing. An electronic detection platform using DNA biochip technology (eSensor) is under development for molecular diagnostic applications. Owing to the novelty of these devices, demonstrations of their successful use in practical diagnostic applications are limited. OBJECTIVE: To assess the performance of the eSensor bioelectronic method in the validation of 6 Epstein-Barr virus-transformed blood lymphocyte cell lines with clinically important mutations for use as sources of genetic material for positive controls in clinical molecular genetic testing. Two cell lines carry mutations in the CFTR gene (cystic fibrosis), and 4 carry mutations in the HFE gene (hereditary hemochromatosis). DESIGN: Samples from each cell line were sent for genotype determination to 6 different molecular genetic testing facilities, including the laboratory developing the DNA biochips. In addition to the bioelectronic method, at least 3 different molecular diagnostic methods were used in the analysis of each cell line. Detailed data were collected from the DNA biochip output, and the genetic results were compared with those obtained using the more established methods. RESULTS: We report the successful use of 2 applications of the bioelectronic platform, one for detection of CFTR mutations and the other for detection of HFE mutations. In all cases, the results obtained with the DNA biochip were in concordance with those reported for the other methods. Electronic signal output from the DNA biochips clearly differentiated between mutated and wild-type alleles. This is the first report of the use of the cystic fibrosis detection platform. CONCLUSIONS: Bioelectronic sensors for the detection of disease-causing mutations performed well when used in a "real-life" situation, in this case, a validation study of positive control blood lymphocyte cell lines with mutations of public health importance. This study illustrates the practical potential of emerging bioelectronic DNA detection technologies for use in current molecular diagnostic applications.

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