The complexity of IVD Certification in the Case of Disruptive Technology Combining Kit + Instrument + Software

The contribution of MALDI mass spectrometry in the field of bacteriology has been well established.

For several years now, Biomaneo has demonstrated through NeoSickle® solution the capacity of MALDI to meet the needs of large-scale screening when combined with automated data processing and interpretation IT solutions. The NeoSickle® solution enables the neonatal screening for sickle cell disease to be performed simply, quickly and with the same sensitivity as reference methods and cheaper.

NeoSickle solution is used to screen for sickle cell disease. In this context NeoSickle is an IVDDM which is placed on the market under the responsibility of its manufacturer, the company Biomaneo, after having affixed the CE mark, which is evidence of conformity to the essential health and safety requirements laid down by European directives.
The Neosickle solution is composed of :
- a kit with different reagents, two configurations are produced: NS540 (for automats with high throughput analysis) and NS96 (low throughput)
- a MALDI-MS, today three instruments are validated, Microflex (Bruker), and AXIMA (VITEK-MS Biomérieux) and 8020 Shimadzu. 
- a LIMS (Laboratory Information Management System) NeoScreening® to create a link between the different instruments and allow good traceability, A software e-NeoSickle®, which processes the raw data and interprets the results. 

The complexity of IVD certification in the case of our NeoSickle application comes from the link between the different elements. The quality controls used to validate the sensitivity of the method are qualified by the instrument and the software, which must themselves be qualified. In order to certify the entire NeoSickle solution, Biomaneo had to qualify the kit and the software in combination. Biomaneo was inspected by the ANSM Medication Safety Agency, which certified the CE marking and the technical file for the NeoSickle global solution.