Using our proven and well-qualified antibodies and reagents in a biosensor platform still presents your lab with significant challenges in re-qualifying and optimizing the reagents. Before considering adapting our reagents to an automated system, you are encouraged to contact our Technical Service Department for guidance on how to approach assay development, qualification, and validation. These systems include automated microtiter plate instruments and other liquid handling systems as well as several “biosensor” platforms. Cygnus Technologies has much experience with various automation platforms. Many of our customers have expressed an interest in automating our ELISAs to improve throughput and assay performance. Thus, in duplicate analysis we suggest repeating any sample that yields a %CV greater than 20%. In the case of duplicate analysis, we do not allow for editing of any apparent outliers since there is no statistical basis for establishing which of the duplicates is inappropriate. Numbers of Replicates - When precision is very good (average replicate %CV on ODs are less than 5%) we feel duplicate analysis is adequate and the most effective approach. Contact our Technical Services Department for advice on how to make and establish controls specific to your needs. Use of such parameters in the absence of true analyte controls, will frequently yield erroneous results. Curve fit parameters such as R square, slope, y-intercept, and upper and lower asymptotes are not sensitive or specific enough to reliably detect assay problems. Do not rely on curve fit parameters as quality control specifications in the absence of true analyte controls. Once you have statistically established a range for these samples, they will become your most sensitive and specific tool to assure quality control of the assay. Controls should be made in bulk, aliquoted for single use, and frozen at -80☌ until stability studies indicate some other storage conditions are adequate. Use of laboratory-specific controls is the only way to assure total quality control of the assay for your needs. For more information on MAC– (F465R) or advice on how to make and establish controls specific to your needs please contact technical support. MAC™ is designed to serve as a set of controls that span the analytical range of four popular Cygnus assays, and can also be used to trend the performance of each of these four assays over time. coli HCP ELISA (F410) and Protein A Mix-N-Go ELISA (F610). Cygnus offers Multi-Analyte Controls (MAC™) this set of low, medium and high controls is compatible with CHO 3G HCP ELISA (F550), HEK 293 HCP ELISA (F650R), E. By using your source of analyte in your sample matrices, you will be best able to identify any problems within the run or between runs and kit lots. Furthermore, the controls should be in the same matrix as your critical samples or after dilution to MRD for your final drug substance. Ideally, these controls should be made using your source of analyte (e.g. We recommend 3 controls, a low control in the range of about 2 to 4 times the assay Limit of Quantitation (LOQ), a medium control, and a high control. The routine run-to-run quality control of ELISA is best accomplished by assaying control samples across the important analytical range of the assay. However, for generic kits, Cygnus performs QC on a limited range of parameters that may or may not be sensitive to your product specific issues. ![]() We manufacture our kits for lot-to-lot consistency and restrict and evaluate changes in any components or procedures that could impact accuracy in the customers' laboratory.
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