POC Waived Devices for checking Creatnine and GFR

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Does anyone have any suggestions for a waived device for checking Creatinine and GFR other than the Nova Stat Sensor.


Thanks,


Marcia

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I'm about to implement the i-Stat in Radiology.  It doesn't calculate eGFR, however.

We also use the I-stat device, keep in mind the sample must be from a green top tube to be considered waived with this device.

We had StatSensor for quite a few years and were never very happy with it. We switched to Alere EPOC and love it.


 

They specifically want a device that will give both the Creatinine and GFR.  Thanks for your suggestion.


Marcia

Thanks, Although I am not familiar with this meter, I will definitely check it out.

Having to actually draw a tube of blood was another mark against the I-Stat.  You know they want very accurate results, but simple and fast for them.Surprised


Thanks,


Marcia

Our radiology department uses the iSTAT and the team uses an on-line tool to calculate the GFR so it was never an issue for us.


Our X-ray and Imaging Center use an adapter to the IV line ( that they use to inject dye)  to  collect a green top tube.


They use a sample dispenser like Safe- Evac to dispense sample to the i-STAT cartridge.


They were using a syringe before and I have to explain that it is moderate complexity if they dispense directly from the syringe to the cartridge.


WE decided that it is easier and cheaper in the long run to keep the Certificate of Waiver and draw sample in green top tubes.


We use the i-STAT, and collect the sample via syringe as we start the IV for contrast adminstration.  Upon uploading the i-STAT, the Conworx interface calculates the GFR and releases it with the creatinine result.  We have done this for years, and it has worked well for us. 

Correct me if I'm wrong but I think the only two waived devices are the I-Stat and Abaxis Picolo (mind the spelling). We use the I-Stat here and despite Abbott being a difficult company to work with, it does everything that's advertised. Very useful in an ED or Radiology setting.


 


EDIT: Forgot to mention, to get the eGFR we have a rule built into Cerner that will auto calculate the GFR for us.


 


 


 


 

We are in the process of implementing the Abaxis Piccolo into our Express Care.  Easy to use, but does require a venipuncture. I have used the I-Stat for minimal testing, but the Piccolo we will utilize for a CMP. They are both really easy to use and we also have the eGFR calculated by our LIS.


NOVA  has a creatinine meter  that is waived.


The Nova StatSensor is actually moderately complex if that's the one you were thinking of.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Detail.cfm?ID=25347


 

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Marcia Britt
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