用于检测人血浆中生长停滞特异性蛋白6（GAS6）的酶联免疫吸附测定（ELISA）方法的开发与验证
Development and validation of an ELISA method for detection of growth arrest specific 6 (GAS6) protein in human plasma.
作者信息
Alciato Federica, Sainaghi Pier Paolo, Castello Luigi, Bergamasco Luca, Carnieletto Stefania, Avanzi Gian Carlo
机构信息
Department of Clinical and Experimental Medicine, Università del Piemonte Orientale, Novara, Italy.
出版信息
J Immunoassay Immunochem. 2008;29(2):167-80. doi: 10.1080/15321810801888480.
Gas6 protein is possibly involved in human diseases, but a validated plasma assay is lacking. So, we developed a sandwich enzyme-linked immunosorbent assay (ELISA) method using commercially available reagents. An appropriate plasma-based matrix was prepared to optimize the assay. The ELISA method showed inter- and intra-assay coefficients of variation lower than 15%. Recoveries all fell within 15% of expected values. Plasma Gas6 concentration in 61 healthy donors was 20.3+/-3.8 ng/mL. Our assay meets FDA requirements for precision and accuracy for the validation of bioanalytical methods and it is suitable for research or diagnostic purposes.
Gas6蛋白可能与人类疾病有关，但目前缺乏经过验证的血浆检测方法。因此，我们使用市售试剂开发了一种夹心酶联免疫吸附测定（ELISA）方法。制备了合适的血浆基质以优化该检测方法。ELISA方法的批间和批内变异系数均低于15%。回收率均在预期值的15%以内。61名健康供体的血浆Gas6浓度为20.3±3.8 ng/mL。我们的检测方法符合美国食品药品监督管理局（FDA）对生物分析方法验证的精密度和准确性要求，适用于研究或诊断目的。
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