Seelva is a software dedicated to the validation of immunoassays method such as ELISA, RIA where non linear statistical calibration model are necessary
Seelva allows you to assess the trueness, the precision and the accuracy of your analytical method. Seelva generates Accuracy Profiles that are the keys to take a decision on one hand about the way for calibrating (which regression model) and about the validity of your method.
- Seelva is the validation software for your laboratory that guarantees that your methods will be compliant to regulatory documents.
- Seelva is a statistical software using SAS for the computation of your data
- Seelva will also generate a stand-alone report. In a couple of minutes you get the final report of your validation
- Seelva is based on the Total Error approach.
- Seelva is a decision tool: one graph = one decision.
- Seelva makes the statistic easy to understand and to interpret; Accuracy Profile is summarising all the information you need to know.
- Seelva proposes you 10 statistical models to compute your calibration data. A ranking will be proposed to help you in the decision (Accuracy Index)
- Seelva will help you to manage your RISK. Through the β-expectation Tolerance Interval, you simulate how your method will behave in routine.
- Seelva is an Internet based application on a secured website (https://). No installation and maintenance cost. Always the latest version available.
Calibration models available?
Unweighted Four Parameter Logistic Regression
Weighted (POM) Four Parameter Logistic Regression
Unweighted Five Parameter Logistic Regression
Weighted (POM) Five Parameter Logistic Regression
Unweighted Log-Log Regression
Unweighted Quadratic Regression
Weighted (1/X) Quadratic Regression
Weighted (1/X²) Quadratic Regression
Unweighted Power Regression
Weighted (POM) Power Regression
What is an immunoassay?
Immunoassays are analytical methods based on signal responses generated as a consequence of an antibody-antigen reaction. The response signal is generated from a label (e.g. enzymatic, fluorescence, luminescent or radioisotopic) attached to either the analyte (antigen) or antibody, or from a secondary, high affinity binding reaction, usually involving another labelled antibody or the well-characterized biotin-avidin system.
The concentration of unlabelled analyte in a test sample can be calculated by interpolation from a calibration (standard) curve. Immunoassays are capable of quantifying a variety of compounds, ranging from traditional small molecule xenobiotic drugs to large macromolecules.
Antibody assays also provide the basis for assessing the pharmacokinetics of antibody-based therapeutics and the immunogenicity of candidate macromolecular drugs. (Findlay and Smith (JPBA 21, 1249-1273))
How will you benefit from Seelva?
- Seelva meet ICH, FDA, Washington Conference and ISO requirements in Validation of Analytical methods
- Seelva adequately analyze the data of the validation phase of your analytical methods to ensure perfect conformity to requirements such as for example linearity, precision, trueness, accuracy, limits of quantitation and detection, quality of fit, residuals,...
- Seelva have been developed and validated in strict accordance with requirement in software validation such as 21CFRpart11, GxP, ISO.
- Seelva is not only a statistical tool but also a report generator. In 20 minutes, you will have not only the statistical calculation of your data but also a fully stand alone pdf report which will contain all the information you have to report for the validation of your method.
- Computations and delivery are performed using SAS system, the definitive reference of quality in number processing.
- Risk Management: through β-expectation Tolerance interval, you are able to predict the results your method will produce in routine analysis.
Screenshots & Technical sheets of Seelva: English - Français - Chinese
If you want to try it for 1 month, just fill the application form
