POC Intraoperative PTH testing

We are using Future Diagnostics:  https://www.future-diagnostics.com/

The method is Chemiluminescence - all manual.  Not happy with the results, from lot to lot, but it has the shortest incubation time (5 min). 

Each day of testing, you need to run a 6-point calibration and 2 QCs.  Then you can use the same calibration curve for patient samples for the day. 

If it is up to me, I probably would go with Tosoh or Roche.  The incubation time is twice as long, but results are much more consistent. 

In another life, we did our intra-operative PTH testing in the main lab on an Immulite 2500. Setting up anything POC was going to be cost prohibitive in equipment and manpower for both the Lab and the OR. What was required was an out-of-the-box thinking, highly cooperative efforts involving the laboratory, OR, the surgeon, and the anesthesiologist. Typically, an order would be placed in the HIS/LIS (Meditech), but for this testing, the Lab would place the orders from a paper requisition while the specimen was centrifuged using a Stat-Spin. The results were electronically uploaded to the OR as well as a printed report shown to the appropriate staff in the OR. The FS was performed by the Pathologist and assisting Laboratory personnel.

This will not work everywhere. It requires a highly coordinated and an all-hands-on-deck approach with all stakeholders fully invested. Anything short of that will result in disappointment.

I have attached a copy of the protocol and the requisition we used.

  PTH protocol.xlsx

Forgot to mention that it is done by lab personnel, not RN or OR staff.  This test is too complicated for non-lab personnel.

We have been using the Future Diagnostic test for the last 5 years.  Our physician is very pleased with it.  We keep the instrument in the operating area but a tech does run the test.  Each day you run a standard curve with a high and low QC.  Patients are run all day using that curve.  Our physician uses the theory of a 50% drop in results.  For example, if the baseline was 150, he wants it be 75 or lower post removal of the parathyroid.  It is great because we are right there and he gets the results as soon as they are completed.  From the time the specimen is given to the tech to the time the results are complete takes about 9 minutes. 

It is definitely a test that a lab person needs to run.  We have several employees who are trained on it and we rotate.  We will run it 2-3 days a week and I have asked the surgeon to schedule at least 2 surgeries for the day.  The kits are expensive and doesn't really make sense to only run one patient for all the work you put in to setting it up.

We were testing on the Tosoh AIA360 in a small lab near the OR.  Given this set-up, it was probably not technically POCT.  Our case load dropped to the point that it was very inefficient.  We were using more supplies and time to calibrate than we were to actually test patients.  We recently switched to a similar set up to Andreis.  Our POCT team runs samples from the OR to the main lab and manages the sample through the processing/centrifugation steps to speed up the results.  It has probably added 5-10 minutes to the TAT.  Most of our surgeons are understanding of why we made the change.