Hemochron Elite validation

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Hi, our Cath Lab purchased the Hemochron Elite for POCT, and now the lab has to validate it. How do you perform validation? we are having issue finding 20 heparinized donors. Thanks

7 Replies

Ashlee Fells

Wed Aug 30, 2023 at 9:55AM

Hi Vivian! We had an applications specialist from Werfen perform our validation. Reach out to them and have them validate it for you. Fortunately, we have a robust outpatient operation and did not have any issues with finding heparinized donors. Hope that helps.

Vivian Morales

Wed Aug 30, 2023 at 9:59AM

Hi Ashlee, thanks. We had them do partial validation using the QC. Unfortunately, our population is very limited as a research facility. Thanks

Lois Schultz

Wed Aug 30, 2023 at 12:09PM

Hi Vivian,
Have you asked them about spiking samples with heparin? I believe they have a protocol.

Mary Garcia

Wed Aug 30, 2023 at 2:24PM

714547-00H i-STAT ACT Heparin Linearity Procedure.pdf

Hello Vivian,

The protocol for spiking samples is attached.

Mary

Candy Beasley

Wed Aug 30, 2023 at 2:46PM

Hiya Vivian, another suggestion from my previous POCC is: if you have access to Coagulation specimens, run 1mL Blue Top Whole blood + 0.5 CaCl at RT; good luck!

Ken C

Sat Sep 02, 2023 at 2:48PM

I wouldn't use the iSTAT instructions; you don't use the Calcium for the Hemochrons. Werfen validated our new Hemochrons, but my biannual verification is completed using spiked samples. I get heparin from pharmacy (get the same kind used in your cardiac ORs) and spike donor blood across the therapeutic range after mathing it out.

Vivian Morales

Tue Sep 05, 2023 at 6:20AM

Appreciate all the responses. Thanks

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Hemochron Elite validation