Many professional applications of qPCR technology require appropriate validation of the method based on this technology. This applies in particular to diagnostic methods and analytical methods used in industry, e.g., in the quality control process of specific products (food, cosmetics, pharmaceuticals, etc.). The purpose of method validation is to determine the parameters that define its properties. Examples of parameters include the detection limit, the limit of quantification, the repeatability and reproducibility of the method, the linearity range, the efficiency of the qPCR reaction, the diagnostic sensitivity and specificity, the resistance of the method to various factors (e.g., PCR inhibitors), etc. Performing method validation requires knowledge that goes far beyond the ability to routinely use a given method. Knowledge of statistical methods, advanced processing of experimental results, and the ability to prepare a validation protocol and validation report are necessary.
Using RIVBIO’s services gives you access to know-how in the field of professional validation of diagnostic and analytical methods based on qPCR technology. We are able to carry out the validation process in a comprehensive manner: prepare a validation protocol, collect or prepare the required reagents (including, for example, calibrators), carry out the validation process, and then compile the results and prepare a validation report with the relevant documentation. We are the only company in Poland with the relevant expertise and providing services of this type. Working with us gives you access to unique and hard-to-find knowledge and enables you to implement a diagnostic/analytical method in accordance with the requirements of various quality control systems.
First, we try to thoroughly understand the purpose of the validated method. This allows us to determine the scope of validation and define the parameters that should be set in the validation process. After determining the scope of the tests, we prepare a validation cost estimate, and after its approval, we move on to the implementation phase. We begin by preparing a validation protocol, which we send to the customer for approval. Then we collect the necessary reagents and perform the experimental part. In the final phase, we compile the collected results and prepare a validation report with additional documentation, which we send to the customer.
We are a leading company in Poland with the ability to validate analytical/diagnostic methods based on nucleic acid analysis using qPCR. Our team members have previously participated in the validation of analytical methods for pharmaceutical products and diagnostic kits intended for the veterinary and medical markets. They are capable of performing qPCR method validation for various applications of the validated method.
