Hi, I am a technical marketing representative (TMR) for BioArray Solutions and will try my best to answer your question. Validation of the system typically consists of 3 parts: installation, operation and performance. A TMR will perform the installation qualification (IQ), while the qualified user that was trained to perform the system runs the operation and performance qualification (OQ/PQ). The OQ/PQ is typically performed with assistance and supervision from the TMR to ensure proper technique and protocol is maintained after training. The performance portion is to confirm that all BioArray BeadChip™antigen typing results are concordant with serology results. Please feel free to contact me for more details or further inquiries.
Yes, there are a few sites in the US that are currently using the HLA-A and HLA-B BeadChip products with successful results. It is a viable method for low resolution HLA results.