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BioArray Solutions


tmsmach4

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  • 2 weeks later...

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.

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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.

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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.

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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

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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.

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  • 3 months later...

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.

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