Does anyone have any experience with the BioArray Solutions instrument for molecular red blood cell antigen typing, especially the validation aspects of it. Thanks in advance. Tom:)

I used to work for them prior to their being bought by Immucor/Gamma. I might be able to answer some questions for you. The issue is how many instances of an antigen you feel that you need to identify. The system was pretty robust so getting a good result should not be the problem it is identifying the right strategy and collecting the appropriate samples for running the validation. Email me if you like.

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.

Thanks for answering my thread. I will email you by Friday with my questions as I am out of the office. I look forward to talking to you.

Tom

We currently use the BioArray system for HEA genotyping and have had success. The only caveat is their pricing strategy, they have increased their prices dramatically within the past year and, it appears, require a standing order before they will ship their new 1.2 kits.

Thank you for replying to my thread. I am out of the office today and will return tomorrow. I will email you some questions that I have. I see that you are fairly new too. This really is a special site for blood bankers. Thanks again. Tom

AABB has published the first standards for molecular testing: Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens. Transfusion also published a supplement about molecular testing about 2 years ago. Most of that information is also on the FDA website.

Thank you for the information Marilyn. I will look into the Transfusion Medicine article as well as the Standards. Would it be ok to ask you questions in the future? Again, thanks! Tom

Does anyone know, if Bioarray has a working system in Europe? I have only seen Progenika BLOODchip around so far

If I recall correctly they have at least one system in Europe. I believe it is in Switzerland. Sorry I can't be more specific. They do have CE mark, but previously lacked the sales & marketing muscle to do much outside the US. Perhaps now that Immucor owns them they will expand.

BioArray now has systems at INTS in Paris, Policlinico in Milan and Red Cross in Madrid.

For those of you using BioArray for patient typings: Are you charging the patient? Are you getting reimbursed? What are the CPT codes?

Does anyone use the BioArray system for HLA typing? I was wondering if it was a viable method that gave accurate results. Thanks.

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.