High Sensitivity Troponin on iSTAT

We are also looking at bringing on the i-STAT hs-troponin. We have Telcor, and I don't think we have any issues with the build. My question is about how everyone is handling the protocol for interpreting results. We have Roche hs-troponin T on our lab instrumentation, and i-STAT is hs-troponin I. We are working on what we will use for our cutoffs for results--rule in or rule out. There isn't any literature out there yet, since this is so new. Does anyone have this set up yet? Any ideas are welcome.
kathleen.david@tricore.org

You could do a clinical concordance study.   Test acute chest-pain specimens simultaneously on the i-STAT hs-cTnI and Roche hs-cTnT assays. Then compare each result to its assay-specific 99th-percentile cutoff and calculate the positive and negative agreement. 

Has anyone gone live with the hs-Troponin i-STAT cartridge? If so how have you integrated the test in the patient work-up?

With those of you who have successfully completed the validation process, would you be willing to share any of your process to those of us who are just starting? I ordered a bulk supply of the cTnI cartridges to tide us over until we wrapped up with a previous project, so we're in the beginning phase of validations. Thank you in advance to those who would be willing to lend any support. 

we are currently verifying our i-STAT hsTroponin cartridges if i can help. I do need assistance with precision criteria but happy to help with the rest. 

NPE-6017.1_Guidance_on_Saving_hs-TnI_Samples.pdf

NPE-5942.2_Method_Eval_i-STAT_hs-TnI_Cartridge.pdf

We are also validating it now. Two of our sister hospitals have already gone live. I found these documents on the Abbott website. The documents have a few good suggestions about the validation process and correlation suggestions. This is the process that our sister hospitals used with a few tweeks to match lab and regulatory requirements. The only way to do a patient correlation is a concordance study because the methods are not comparable. Abbott has suggested gender cut offs. The combined cut off they suggest is 21 ng/L. So we chose 0-21 ng/L as our reference range with a "critical" value of 100 ng/L. I'm not sure where the 100 came from. Criteria for diagnosing an MI includes more than the Troponin testing. Physician education will definitely be required. Serial testing will need to stay with the same method or a new baseline will need to be done with the new method. I haven't moved farther than a meeting with the ED medical director as we have just begun our validation.