Assay specificity

Ethylene oxide is sold as a high purity chemical, with typical specifications shown ia Table 14. This purity is so high that only impurities are specified. There is normally no assay specification. Proper sampling techniques are critical to avoid personal exposure and prevent contamination of the sample with trace levels of water. A complete review and description of analytical methods for pure ethylene oxide is given ia Reference 228. 

Can an assay specification of not less than 99.0% pure be upheld ... 

Specific IgE Assay. Two radioimmunoassays are available in France using a quaternary ammonium compoimd coupled to Sepharose [30, 31]. The sensitivity of these tests was equivalent at 88%, the specificity reaches 90%. A morphine-based immunoassay has been proposed in Australia [14]. More recently, Ebo et al. [32] investigated a rocuronium ImmimoCAP and set the sensitivity at 85%, the specificity being absolute, provided an assay-specific decision threshold is applied. An ImmimoCAP (Phadia A) is available. 

The second experiment was carried out with the same RNA isolated from mycelia growing on presence of glucose and apple pectin. cDNAs were obtained from those RNA by reverse trancription and used as template for PCR assays. Specific oligonucleotide primers for PG gene were used in the amplification reaction. The Fig-5 shows the results of this amplification experiment. 

FIG. 4. Scatchard analysis of specific 3H-LSD binding to crude homogenates of cortex from rats treated with either 200 9 intraventricular 5,7-DHT, 20 mg/kg i.p. PCA, or saline 45 days prior to assay. Specific binding of 3H-LSD (final concentrations from 1-100 nm) was defined as the difference between 3H-LSD binding in the absence and presence of 10 jim 5-HT. Each point represents the mean of three rats. The dissociation constants (KD) of 5,7-DHT- and saline-treated rats were significantly different (p < 0.05 f-test). (From ref. 16, with the permission of ANKO International Inc. for Neuroscience and Biobehavioral Reviews.)... 

Mineral Formula Assays (%) Specific gravity Hardness... 

Compositional determinations Assays Specific determinations Qualitative Quantitative Understand the chemistry responsible for proper/improper product performance Provide technical leads for new developments Assure product quality Correct product problem Understand competitor s products Regulatory compliance Develop new products... 

To assay specifically the afferent arm of the DTH response, the proliferation of the popliteal lymph node cells to SRBCs can also be measured (White et al., 1985). As described, mice treated with the test article are sensitized to SRBCs by inoculation of SRBCs into the hind footpad. However, 1.5 h later they are challenged intraperitoneally with FUdR and 2h later they are administered [125I]IUdR intravenously (instead of 125I-labeled HSA). Mice are sacrificed 24 h after challenge and both popliteal lymph nodes are removed and counted in a gamma counter. 

In this case study the assay specification limits for this EU product were set at 95.0-105.0% and therefore the transfer acceptance criteria will be, Q =3.0% and B =2.5% (see Table 1). 

Enzyme assayed Specific activity [nmol min (mg protein)... 

Bitton, G. Jung, K. Koopman, B. Evaluation of a microplate assay specific for heavy metal toxicity. Arch. Environ. Con. Tox. 1994, 27, 25-28. 

Eollow-up for positive results in reporter assays specifically developed for profiling screening would by default be in vivo MNT, though additional information might... 

The general safety profile from CEREP including 155 in vitro assays specifically designed to identify potential side effects of drug candidates (not in a specific pathology). 

Fig. 21. Principles of ELISA. A In a direct ELISA the unlabeled antigen is attached to the solid phase. Enzyme-conjugated antibody is then added, followed by the enzyme substrate solution and color is allowed to develop. B ELISA with unlabeled antibody attached to the solid support. A variable amount of antigen is then added. A secondary antibody labeled with enzyme, followed by substrate solution, is added to all wells. The amount of color produced is proportional to the amount of antigen present. C Sandwich ELISA assay with the antigen sandwiched between an immobilized, antigen-specific primary antibody and an antigen- or species-specific secondary antibody. An enzyme-labeled tertiary antibody increases the assay specificity and sensitivity...

Assay-specific acceptance and rejection criteria for a standard curve and QCs... 

Another issue of relevant importance to the interpretation of analytical results is the analytical specificity of the test, particularly when in an immunobased assay. Specificity is exquisite in immunochemical assays but, at the same time, it can be exquisitely troublesome. For example, when an immunochemical assay for the penicilloyl group is used to monitor the pharmacokinetics of penicillin elimination from the serum of treated animals, the measured levels remain high for at least several weeks, although the antibacterial activity was all eliminated from bovine serum within 24 h after injection. This is because the immunochemical assay measured not only the free drug but also the penicilloyl groups covalently bound to proteins in serum. The half-life of these bound residues is roughly equal to the half-life of the proteins in the circulation. 

All purification procedures require a method for quantifying or assaying the protein of interest in the presence of other proteins. Purification can be monitored by assaying specific activity. 

As is often the case in multidisciplinary research, a number of different assays have been developed to monitor the inhibition of hemozoin aggregation (Table 1). Consequently, a great deal of confusion has arisen in the literature concerning the exact efficacy of a particular hemozoin inhibitor. For this reason, it is worthwhile to discuss the principal assays employed in the evaluation of antimalarial compounds and those assays specifically designed to evaluate heme aggregation inhibition. 

Rotational speed of the inner and outer sweep blades during processing Total time required to increase the batch temperature to 65 °C Time required to achieve batch cool-down (65-35°C) Appearance pH Assay Specific gravity Penetrometer reading Microbial contents... 

Lee, N., H.L. Beasley, and J.H. Skerritt. 1998. Development of immunoassays for type II synthetic pyrethroids. 2. Assay specificity and application to water, soil, and grain. J. Agric. Food Chem. 46 535-546. 

There have been improvements to the ASO assay, specifically by development of a multiplex allele-specific diagnostic assay (MASDA) in which the ASO technique is adapted to a solid support and multiple regions are probed simultaneously. This has been achieved by altering probe... 

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