ISCUSFlex Microdialysis POC instrument

Considering these points, the ISCUSflex could potentially fall under either Point-of-Care (POC) or a different department's purview, depending on various factors:

Rachel you may want to consider the following when making your decision:

Thank you, Steven, for those considerations. I did read about the CLIA software and we will have to refer to our regulating bodies to get further guidance.

We have a POC steering committee that ultimately decides on the usage and approval of new POC testing, so I will be sure to bring up these thoughtful points to them.

Since the ISCUS flex microdialysis analyzer is categorized as moderate complexity by CLIA, technical and scientific oversight would fall under the lab. I only saw glutamic acid and glycerol listed though, so you'll need to talk with your accrediting agency for guidance. I agree with Steven, coordinate with Neurology department on this. I'm curious about the actual specimen. Is it blood or CSF or something else? I've never seen this instrument so I'm curious what you decide to do.

I just looked up this instrument online and the sample is a microdialysate which is not a true body fluid. There may not be any normal reference ranges for this type of sample and proficiency testing might be a challenge, but it does look like a near-patient POC instrument used for corollary (not diagnostic) patient care.  

@Karen, yes, for neuro critical care, it samples microdialysate of the brain, so something akin to, but not quite, CSF. The microdialysate is retrieved by inserting a probe into whichever tissue they want to sample, so it is a very invasive procedure. I believe it has only been used for mostly research at this point and definitely not yet a standard of care anywhere. However, it can be used for trending analytes to determine patient outcomes following brain injuries. Some analytes that I have seen listed included glucose, lactate, and pyruvate.

Hi all.  We attempted in 2018 to implement the ISCUSflex as a clinical program under our CAP accreditation (mod complex).  Oversight was conducted by POC and nurses in neuro ICU were delegated to run device.  The program was ultimately not successful.  
ISCUS tests 5 analytes (glucose, lactate, pyruvate, glycerol, glutamate).  A bolt catheter is inserted into the brain with a permeable membrane that allows the extraction of microdialysate.  The catheter can stay inserted for a maximum of 5 days.  The guidance from manufacturer suggests collection once per hour for the 5 day period, to be run on the device.

Some things of note:
Software is proprietary from manufacturer (ICU Pilot).  When we adopted, it could not be interfaced, but I think now it can send in unidirectional interface with middleware.
Reagents require assembly and mixing (liquid vial + solid lyophilized reagent for each analyte).  A membrane stays on each mixed reagent vial, probe passes through membrane.
Proficiency - manufacturer provides PT kits.  You run, send back captured data to them, report is issued.

Hi Brian,

Thank you so much for that info. It sounds like a complicated setup, and I doubt my CLIA director would approve. We have a hard enough time getting RNs etc to pass QC on our other moderately complex instruments, so I can just imagine the issues one might have with such a critical and invasive procedure.

-Rachel