establish ranges for iSTAT CG8+ on babies NICU

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How do you validate or establish the ranges for iSTAT CG8+ on babies in NICU? Those samples seems like unable for me to get to perform validation or correlation.


I'm looking for any input, suggestions on this matter since don't know where to get help. I'm  new to POC & new to this group as well. Thank you for any advice.

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Are you referring to reference ranges that you need to established?  You can use ranges from literature, then verify them by using results from 20 babies whom appear to be healthy and not on any medication.  If 18 out of 20 are within the literature range, it is considered established.


For correlation and validation, you can use adult blood.  What you are looking for is how well the iSTAT in NICU correlate to your Gold Standard or your core lab.   

Don- thank you so much for your respond. I'm so glad I got your help.


So for Reference range: i can get it from Abbott (which is also our Ref range for adult here at other dept), and then run at least 20 samples from healthy babies to verify until I can get 18 of them within range. please correct me if i don't get it right.


What about Reportable range? How can I establish it? do you have a policy or reporting results you can share?


I've been calling several hospitals in town but unfortunately they don't use CG8/blood gas iSTAT in NICU. I used to be a general tech & now by myself on POC.


I appreciate your help! thank you!

Kim, no problem. 


Ref range:  Correct, if 18 out of the 20 are within that range, you can use it.


Reportable range:  Should be in the package insert or operator's manual.  If not, contact Abbott for it.  Purchase linearity kits from Abbott or other manufacturers to verify it.  Usually the kits consist of 3-5 samples.  Follow the kit instruction and run each sample at least 2x.  If results are within each acceptable range and the low and high end are close to the manufacturer range, it is considered verified. 


If don't use iSTAT, so I can't share the reportable range with you. 

wonderful! very clear!


thank you so much Don. I appreciate your help!

What are you doing if you have fewer than 18 out of 20?
Are you testing until you achieve 90% 
OR are you widening the range to hit 18 out of 20  (this doesn't seem wise)?
Thank you all!
Shannon Walden

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Kim Ng
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