Hemochron ACT Signature Elite Validation

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Hello everyone, 

I am reaching out to see if anyone had a procedure for validating Hemochron. We received a new instrument and I have seen that 20 samples should be run, but its hard to find samples for this instrument since it is for clotting. Any help is appreciated!

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We just received 5 new Hemochrons last year for our Cath Lab. Our Cath Lab ran 20 samples on each over a period of a week, during Cath procedures,  comparing to the "old" Hemochrons we were replacing. I'm sure that several of the specimens were from the same patient, at different points during a procedure. One of the tips the Werfen rep gave was to have both Hemochrons set in the 5 minute mode prior to sample collection, and perform the test immediately after collection on both instruments. He also mentioned that we evaluate the results based on Total Allowable Error (20%) rather than typical slope and correlation coefficient statistics, due to the nature of whole blood coagulation testing. Hope that helps!

We got a new replacement Sig Elite to replace our 15 year old device. Following the recommendations of the Werfen rep, we ran 10 normal and abnormal QC. We also had our cath lab run a 5 patient parallel. We only validated this device for ACT-LR, but the same would need to be done for other tests performed. So if we later want to run, say, citrated INRs or ACT+, we'd have to do the QC precision and parallel for that test as well. Also, once you validate one device, you can use that device as your reference device to validate others. 
@ Patricia Rauchholz-- did you get the 'new' New Hemochrons-- the 100s? If so, how do you like them? I made a budget request for those, I'm hoping to find out for myself, soon! 

@Gloria MacLean: no, we did not get the new ones. I wasn't even aware of them! Maybe next time we need a replacement!

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