Diagnostic kit

Recent developments in Europe mean that reference materials included in diagnostic kits are covered by the recent directive controlling the production and use of in vitro diagnostic devices, and must be licensed before use. 

Chemical-based products cover a broad spectrum of materials and forms, ranging from molecules to appliances. Table 16.1-1 shows the various product functional forms, along with examples in major application areas. Examples highlighted in italic are those discussed in this book. Most small molecules such as BTX (benzene-toluene-xyxlene) are sold to chemical and allied products industries while a limited number such as refrigerants and solvents are for sale in the consumer market. In contrast, multicomponent liquid mixtures such as liquid shampoo, semi-solids such as cream and paste, and structured solids such as controlled release herbicide are often sold directly to the consumers. Business-to-consumer sale is even more prevalent for ready-to-use devices and appliances such as diagnostic kits, drinking water filters and air cleaners. 

Richardson also devised many novel reagents and chromogenic substances that are now used in various diagnostic kits of value for the rapid and accurate visual detection of human disease, as well as for the identification of pathogenic organisms associated with disease. For chemical posterity, it is therefore considered important to present a detailed account of Richardson s numerous research contributions. 

The fact that his work in carbohydrate chemistry had led to many useful and important commercial products, such as TGS and his various diagnostic kits, also gave him great scientific fulfillment. The same can be said of the valuable synthetic protocols and intermediates that he published throughout his days in chemical research. 

Apart from academic organizations, the NCI (National Cancer Institute) and FDA (Food and Drug Administration) have initiated a collaboration to focus on using proteomic technologies to develop more targeted treatments and more reliable diagnostic kits for early detection of cancer. In mid-2001, researchers analyzed a series of tumor cells from different patients and came up with a roster of proteins present in cancer cells. These are distinct molecules not found in normal cells. In early 2002, scientists involved in this program reported that it is possible to compare... 

Identification of disease-related markers (biosensors, diagnostic kits)... 

Several recent examples demonstrate that when there is sufficient political concern, money and innovation will flow. The SARS outbreak in 2003 led to unprecedented international cooperation and a tremendous marshaling of resources to cope with this new threat. In a matter of weeks, scientists had sequenced the virus, and through successful public and private cooperation, a diagnostic kit was rapidly developed and deployed. Similarly, the anthrax scare in the U.S. in 2001 led biodefense research spending at the U.S. NIH to increase from US 53 million in 2001 to US 1.6 billion in 2004. 

Jalloh A, Tantular IS, Pusarawati S, et al. Rapid epidemiologic assessment of glucose-6-phosphate dehydrogenase deficiency in malaria-endemic areas in Southeast Asia using a novel diagnostic kit. Trap Med Int Health. 2004 9 615-623. 

Zhou et al. [175] described the determination of severe acute respiratory syndrome (SARS) coronavirus by a microfluidic chip system. The unit included an LIF microfluidic chip analyzer, a glass microchip for both PCR and capillary electrophoresis, a chip thermal cycler based on dual Peltier thermoelectric elements, a reverse transcription-polymerase chain reaction (RT-PCR) SARS diagnostic kit, and a DNA electrophoretic sizing kit. According to the authors, the system allowed efficient DNA amplification of the SARS coronavirus followed by electrophoretic sizing and detection on the same chip. 

This requirement should be adhered to not only by the diagnostic kit manufacturers but most importantly... 

An advantage of the ASO method is that it can be used to simultaneously test samples for several different mutations by the use of multiple probes bound to a solid matrix. In practice, the success of this method relies on precisely establishing conditions for optimal oligonucleotide hybridization in order to ensure specific probe hybridization, and so multiplex ASO assays can be difficult to develop. Molecular diagnostic kits for use in genetic disorders based on ASO methods are available (14). 

Alcohol oxidase. We have chosen to use alcohol oxidase from Hansenula polv-morpha (2) in our research. The enzyme has eight sub-units, all of which must be associated for the enzyme to exhibit activity. It is a large enzyme Mn 600,000 and has poor stability upon freeze drying. This factor combined with an almost flat activity response to pH between 6 and 10 and a maximum temperature activity at 40-50°C made the enzyme an ideal candidate for the study of enzyme stabilization in the dry state, especially as we wished to prepare diagnostic kits for ethanol and solid phase enzyme based sensors. 

Several FDA-approved predictive IHC assays contain cell line controls as part of the diagnostic kit or are sold separately. These are specifically developed to monitor staining of the antigen of interest, and should be included in all stain runs as an additional protocol control. 

Co57 272 d Estimate organ size and for diagnostic kits... 

The results of measurements of urinary NTx and CTx are normalized on the concentration of creatinine in urine (U-NTx/Cr, U-CTx/Cr). The fact that the diagnostic kits for CTx measuring are produced almost only by Osteometer Biotech (Denmark), while the diagnostic sets for NTx measurement are the domain of Osteomark, Ostex Int. (USA), may help the comparability of the results of the measurements. 

BALP (BIO, K5, P3) is stable for at least 100 days at -20°C when using the diagnostic kits Alkphase-B-Metra and Beckman Tandem-MP-Ostase. With the use of the Beckman Tandem-R-Ostase kit, the stability at —20°C is supposed to be unchanged even for 48 months. Cross-reactivity of different isoforms of BALP is shown in Table 4. 

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