Immunoassay biomedical analysis

General books [213-217], chapters [218], and reviews were published in the 1980s reporting the suitability of CL and BL in chemical analysis [219-222], the specific analytical applications of BL [223], the CL detection systems in the gas phase [224], in chromatography [225, 226], the use of different chemiluminescent tags in immunoassay, and applications in clinical chemistry [227-232] as well as the applications of CL reactions in biomedical analysis [233]. 

Geng, D., Shankar, G., Schantz, A., Rajadhyaksha, M., Davis, H., and Wagner, C. 2005. Validation of immunoassays used to assess immunogenicity to therapeutic monoclonal antibodies. Journal of Pharmaceutical and Biomedical Analysis 39, 364-375. 

Weiner, R.S., Srinivas, N.R., Calore, J.D., Fadrowski, C.G., Shyu, W.C., and Tay, L.K. (1997) A sensitive enzyme immunoassay for the quantitation of human CTLA4Ig fusion protein in mouse serum pharmacokinetic application to optimizing cell line selection. Journal of Pharmaceutical and Biomedical Analysis, 15, 571 579. 

Shankar, G., Devnarayan, V., Amaravadi, L., Barrett, Y.C., Bowsher, R., Finco Kent, D., Fiscella, M., Gorovits, B., Kirschner, S., Moxness, M., Parish, T., Quarmby, V., Smith, H., Smith, W., Zukerman, L.A., and Koren, E. (2008) Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. Journal of Pharmaceutical and Biomedical Analysis, doi 10.1016/j.jpba.2008.09.020. 

Sukovaty, R.L., Lee,J.W., Fox,J., Toney, K., Papac, D.I., Thomas, A., Grover, T.A., and Wells, D.S. (2006) Quantification of recombinant human parathyroid hormone (rhPTH(l 84)) in human plasma by immunoassay commercial kit evaluation and validation to support pharmacokinetic studies. Journal ofPharmaceutical and Biomedical Analysis, 42, 261 271. 

Horninger, D., Eirikis, E., Pendley, C., Giles Komar, J., Davis, H.M., and Miller, B.E. (2005) A one step, competitive electrochemiluminescence based immunoassay method for the quantification of a fully human anti TNFa antibody in human serum. Journal of Pharmaceutical and Biomedical Analysis, 38, 703 708. 

Grimshaw, C., Gleason, C., Chojnicki, E., and Young, J. (1997) Development of an equilibrium immunoassay using electrochemiluminescent detection for a novel recom binant protein product and its application to pre clinical product development. Journal of Pharmaceutical and Biomedical Analysis, 16, 605 612. 

Findlay JWA, et al. Validation of Immunoassays for Bioanalysis A Pharmaceutical Industry Perspective. Journal of Pharmaceutical and Biomedical Analysis 2000 21,1249-1273. 

Abelian, R., Ventura, R., Palmi, I., et al. (2008) Immunoassays for the measurement of IGF-II, IGFBP-2 and -3, and ICTP as indirect biomarkers of recombinant human growth hormone misuse in sport values in selected population of athletes./owma/ of Pharmaceutical and Biomedical Analysis, DOI 10.1016/j.pba.2008.1005.1037. 

Most immunoassays currently employed in the biomedical field are either radioimmunoassays, enzyme immunoassays, or luminescence immunoassays (including fluorescence immunoassays [FIA] and chemiluminescence immunoassays). Although radioimmunoassay is currently the most sensitive of these (10 -10 M concentrations are often detectable), due to the problems inherent to dealing with radioactive materials, such as licensing, radiation hazard, short shelf-life of expensive radioisotopes, the expense of the counting equipment, and the tedium associated with heterogeneous immunoassay, it has fallen, in popularity, behind the non-isotopic methods of analysis. 

In addition to commercially production, a great deal of research and development work on biochips has been going on both in industry and in academia. Genomic analysis of DNA and RNA continues to be the focus of interest, but more and more effort is being spent on proteomic analysis of proteins and peptides. Several enzyme assays and immunoassays designed based on microarray-based systems with simple microfluidic control are close to commercialization. They can be a vital tool in clinic diagnostics, drug discovery, and biomedical research. 

Wujian Miao illustrated a time line of various events in the development of ECL till 2002 (Fig. 1.3) [1]. As the time went on, this field attracted bulk of people to do research on ECL basic theory, emitters, mechanisms, applications, etc. Hence, advancements in the area of ECL increased exponentially over more than 45 years. After a long journey of almost half a century, ECL has now grown to be an incredibly potent analytical technique and been extensively used in many areas, such as criminology, forensic, environment, biomedical, biowarfare agent detection immunoassay [3], etc. This technique has also been effectively employed as a detector of flow injection analysis (FIA), high-performance liquid chromatography (HPLC), capillary electrophoresis (CE), and micro total analysis (pTAS) [13]. 

Silicone rubber has been widely used in biomedical applications due to its biocompatibility, nontoxicity and biodurability. Therefore, attempts have been made to further improve the properties of SR by reinforcing it with various inorganic nanofillers [46,189-193]. Zhang eta/. [189] introduced gold nanoparticles in PDMS microfluidic chips and studied its applications in enzyme reactors, immunoassays and biochemical analysis. Recent studies have shown that PDMS-Ag composite exhibits good antibacterial properties... 

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