Abbott Istat and capillary samples

Hi Adonica,
Thanks for the heads up on this. I was unaware of this change. Do you know when the new cartridges will be released for use?

Hi Colette, there are no new cartridges that I am aware of.  You just won't be able to use capillary samples on the ones you have for K, iCa or Lactate.

Hi Adonica, I did misunderstand that. It's an FDA clearance issue with the current product. I just got off the phone with our Abbott Rep. It sounds like that Abbott had to reapply for FDA clearance because it's been a long time since the system was evaluated. There was not enough data for clearance for these analytes with capillary samples. My thought is to configure our NICU i-stats in the DE server to not report K and iCa since they are the only unit collecting that sample type. I'm not sure if it can be done. I have a call into Abbott.

We also had a meeting with our Abbott Rep this morning, and while they said they're working on gathering data to get the capillary approval back, they were unable to give any sort of timeline. Also, I remember them saying something similar when the same thing happened with their Chem8+ cartridges back in 2020. So.

The problem we're running into is with our high-level NICUs who run both capillary and non-capillary samples on their CG8 cartridges. You can't suppress the K/Caion results at the instrument level by sample type, it's all-or-nothing. We really don't want our frontline workers seeing results on the instrument screen that aren't valid, so we're going to just have to have the conversation with our NICU docs to see what we can come up with based on patient need. I'll definitely be watching this space for ideas!

Michelle, that's exactly where we're at.  I'm thinking about adding the G3 as that would give some type of capillary blood gas even if they don't get the chemistries.  I'll keep you posted lol.

We’re still in the brainstorming phase and working out the best approach. Currently, we're planning to create a location in RALS called Capillary Only, since the i-STAT DE does not allow more than one profile per location. This location will be assigned to specific i-STAT devices designated for capillary specimens only.

For these designated devices:

Other i-STAT devices on the units will function as usual, except that the “capillary” sample type will be disabled for them.

Important: You will need to manually update each i-STAT device to ensure the correct sample types are available.

To all, 
We are going to give the NICU docs the following 3 choices. We will then set this within DE if there are any changes needed. Our RT areas can be set differently for customization through DE due to our middleware. 

       2. Remove the EG7 cartridge from the NICU areas- Do the blood gas on the G3 cartridge by whatever sample type they choose and send the Lytes and other items on the cartridge to the lab using whatever sample they decide upon. 

 
3.     Block the K and the ICA on the EG7 and let them use the EG7 with the capillary sample type.  Once configured, the K and the ICA results would be blocked for all sample types. 

The major change in this will be at the bedside. Who draws this? Nursing or RT? Does that change per sample type? (I.E.: RT does ART, RN does Venous, either can do capillary?) 

I have told the RT areas to watch their cartridge inventory. I think that the volumes will go way down for the EG7. 

Another Abbott body slam..

 

Adonica,
Thank you so much for letting us know about the FDA clearance issue for the capillary samples on the iSTAT. We just switched our NICU to the white CG4+ because they were FDA cleared for capillary samples.
I am having our IT department suppress the lactate, iCa and K results if the user chooses a capillary sample as a quick fix so at least these results will not go into the electronic record. I really like Shea's idea of creating a capillary location in RALS because I also do not like results to appear on the screen that are not valid. Also still trying to think of a good plan since it's also a Friday. I will reach out to RALS as well.

Adonica, 
Thank you for the update, how did you find this out so quickly if it was published on 8/21/25?  Are the G3+ cartridges still available?  I thought Abbott was going to phase that cartridge out?

Hi,
We decided to remove the capillary source from the EDTC iSTATs but allow Arterial or Venous samples.  If they need to collect a capillary sample, that will get sent to the main lab to be run on the ABL.  They can either collect the capillary sample themselves or wait for the phlebotomist.  
For our remote hospital NICU, we are suppressing the K+ on their EG6+ cartridge.  The vast majority of their samples are capillary.

Shea Woodard,
Were you able to program your iSTATs to remove the capillary source from the iSTATs that you allow venous and arterial samples?  Also were you able to remove the arterial and venous sources from the iSTAT you designate as capillary only?  We also have RALS and even though we deleted the capillary source on the DE server, that still shows up as a choice on the iSTAT itself.

Hi Reine,  We use iSTAT DE but to customize the sample type selection on the meter you will have to touch each device. You can email me or call if you have other questions. My email is woodwars@musc.edu or 843-792-4007.                                                                                                                                         Customize Sample Types

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Hi,
Thank you Shea.  That was very helpful.

Hi everyone,
What kind of feedback did everyone get from the NICU docs when you told them they need to send specimens to the lab for the lactate, i CA and K?
Our NICU providers are giving us pushback for drawing extra blood on the babes  and want to change to a different device such as the GEM 5000? UGH.

We are getting the GEM7000 for our offsite NICU department. They liked the idea of running TBILs in house instead of sending to the main lab every time and getting a true hemoglobin rather than a calculated one. Abbott sent us a loaner iStat in the meantime until they can get the FDA clearance. But I'll send it back earlier once our new analyzer is live.