Limit of Detection Analysis Medical Devices

Challenge

Mycoplasmas are very small, self-replicating bacteria that are the cause of various, sometimes severe, diseases in human and veterinary medicine. They can only be cultured on special media; the biotechnical method used for this is called polymerase chain reaction (PCR). Quantitative real-time PCR (qPCR) provides much faster results and is therefore the preferred analysis method. The devices used for this have different detection limits depending on the model, up to which mycoplasmas can still be detected.

Approach

In an experimental setup, different batches of a sample matrix (cell culture) were contaminated with various bacterial strains in three different concentrations. The contamination was detected using a cultivation method. Multiple repetitions (per matrix and batch) were conducted for each concentration. The experimental setup was performed using different devices. Statistical methods were used to compare the detection limits of the different devices, and the findings were compiled into a report.

Result

The statistical analysis revealed that all devices tested for validation met the guidelines of the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), fulfilling all minimum requirements.