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Ortho Workstation Validation & Temperatures


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Hello everyone,

      We have just received the OrthoWorkstation to replace our ID-MTS. What kind of validation did you use? How many positive and negatives for parallel testing? Just trying to get an idea before I get started. The manual has no recommendations as to how to validate. Also, what kind of thermometers are you using for it? I know we are going to have to get a new one to fit inside one of the gel cards. 

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A lot of folks like to run 20 of everything.  There is no regulatory requirement on the number of samples you need to use.  Whatever you feel is necessary to make you feel comfortable.  Personally, I would validate the temperature in each of the card slots (you'll need a small thermocouple, this was not well thought out by Orthoand then verify the centrifuge rpms.  The timer is digital so it needs no validation.  I don't see that you need to run patient specimens, it is not reagent, it is equipment.  Would you run specimens to verify a heat block?

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