CHEM8 and CG4 Blue cartridge

Just have to say this has been the most stressful week of my career! Way more stressful than inspection. Yesterday I was told that ABBOTT can not guarantee the availability of ANY cartridge, it was also emphasized that the letter says a DIFFERENT methodology, Which means not istat period. Freaking out just a little! I have a feeling this is just going to get worse! 

Our facility has already gotten a quote for the Nova lactate meter, but I thought you could use capillary since they market it with lancets. 

We are also in the process to purchase nova lactate devices for the ER. Does anyone in the group already use the nova lactate? How does the methodology compares with lab?

Thank you

Sent via Groupsite Mobile.

The 510k states fresh venous and arterial whole blood and capillary.

Sent via Groupsite Mobile.

Ops...Send message before finishing the sentence. Capillary is not acceptable.

Sent via Groupsite Mobile.

Do any of you oversee transport teams using istat? What are you considering as an option for them since I don’t see how they could go without a device. I’m down to CG8s only but my large order I placed last week is already late!

Have you pulled all in house testing into the main lab and will reserve stock for transport, etc?

Sent via Groupsite Mobile.

I use Nova lactate meters, along with glucose meters.  I like the lactate meters except use CAN NOT use capillary blood.   You must use either a green to, Heparin, or fresh whole blood.  So the patient must have a venipuncture and not a finger stick.  Nova lactate is also a moderate complex test, not waived.  Nova lactate did correlate well with our Beckman AU instruments.  Over all I like the meters and I'm not disappointed I went with them.  I just wish I could use cap blood.

Hi David, I am I the process of validating the Nova Lactate meters and my correlations with the ABL90 are not totally satisfactory. Basically the Nova meters show a negative bias, however, this bias is corrected by adding an offset value to the meters recommended by Nova. Our medical directors are studying the possibility of using the Nova Lactate meter with this offset value.

 In regard to the correlations of the Nova Lactate meter with the Beckman AU, did you observe a bias, if so, was it on he lower or upper ranges? Will you be able to share a copy of your validation data?

Thanks!

We use CG8+ and they have worked well.

It will work great if they have any in stock. We put in an order and they will only 500 cartridges. Vs the 5000 we ordered to meet our demand

Sent via Groupsite Mobile.

Is anyone, doing the full validation on CHEM8+ as a LDT? If so, do you have a platform on how to do the sensitivity and specificity of all the analytes in the CHEM8+ cartridges?

A LDT would make it a high-complexity test and RNs are not allowed to perform high-complexity tests in California.

Kathleen, we are considering an LDT validation of Lactate. We will not be considering that for CHEM8+. In Colorado we follow CLIA, so a Nursing degree does qualify someone for High Complexity as long as proper training and competency assessment takes place. The training and competency requirements are the same for Moderate and High Complexity, so we would not need to do anything additional as far as that goes. The tough part will be in deciding how many iSTAT's to validate as High Complexity analyzers, as that is a lot more work. No longer would we be able to use a subset of devices every 6 months, but would have to do a full semi-annual validation on each handheld that we decide can run Lactate. Also, doing the sensitivity and specificity studies are a challenge. It will be at least 60 cartridge runs to do just the LoD study. I am not sure if CAP would expect that on each handheld or for the "test system".

Pedro,

Would you please share your SOP for ABL 90?

I am considering using ABL 90 to run lactate in our ER.

Here is my email

Elhamb@aol.com

Sent via Groupsite Mobile.

Pedro,

I did have a slight negative bias on Nova Lactate, but it wasn't enough to invalidate the test.  I have it on a different CAP number so we don't have to do 6 month correlations. We only use it for sepsis screening.