INVICTA Medical Diagnostic Laboratory is accredited according to ISO 9001:2008 and ISO 14001:2004. Invicta Laboratory operates based on the principles of best laboratory practice. Protocols and procedures are followed to standardize the workflows, including performance of PGS-NGS 360°™. The protocols describe in details the laboratory processes and are constantly updated and monitored. They include step-by-step instructions for handing the materials and reagents. Additionally for our PGS procedure, our experts developed a system of internal and external quality control to ensure the maximal level of security and reliability. Both systems of quality control are used to monitor and estimate potential errors in the laboratory. The internal controls give security in our daily work, while the external gives us a reference point in relation to other users, and to assess the comparability of our results.
Quality control is an essential part of dailywork of INVICTA laboratory. Not only it is a legal requirement, but also an essential element of the quality management system. It provides assurance that we are able to estimate and detect potential errors. In the case of an occurrence of any errors we develop and implement corrective actions thus helping to prevent their recurrence.
There are several specific control points in each of the stages of our PGS procedure. One of them applies to labelling and identification of samples before they enter the PGS-NGS 360°™ workflow. Strict control of this phase includes confirmation that the cell identification matches the labelling on the tube. Sample barcoding during the library preparation stage enables matching of the cell diagnostic result with the embryo from which that cell was biopsied.
Another important aspects of quality control during the INVICTA PGS procedure is using an intra assay control materials. For each embryonic cell analysed, a cell-free wash negative control is analysed in parallel. Blank containing medium, run for every biopsy allows us to eliminate the potential contamination during cell collection. Additional reagent negative control (no DNA) is processed during library preparation and sequencing run to assess contamination within the reagents. In order to ensure that the assay is working on the day of the test we use reference sample of normal DNA that was previously screened to be negative for chromosomal aneuploidy. Only correct score for the reference sample together with required results of control sequencing run parameters such astest fragment, indicates that the test was performed correctly and the results can be released to patients.
In addition to maintaining strict internal quality protocols we submit to external quality assessment. External Quality Assessment (EQA) evaluates the accuracy and reliability of the procedure by testing sampless upplied by the external organizer. Those samples are tested prior to the assessment but the results are not known by the laboratory being assessed. This type of assessment provides the ability to compare of results between laboratories and between techniques therefore it allows us to maintain a high standard of INVICTA PGS-NGS 360°™.