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Roseline Gonzalez posted a new Topic

Monday, Apr 13, 2026 at 3:43 PM

Hematocrit comparison acceptability criteria

Recently, I completed the biannual method-to-method comparison for hematocrit using the i‑STAT 1 (CG8+ cartridge) and the Sysmex XN‑3000 instruments. According to CAP guidelines, the acceptability criterion for this comparison is ±4%. I found it very challenging for the i‑STAT results to meet this criterion when compared to the Sysmex values.

This raised two questions for me: 1) How are others performing this method comparison? 2) What are your thoughts on CAP's ±4% acceptabili...

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Miranda Cotter posted a reply on Re: i-STAT in NICU?

Monday, Apr 13, 2026 at 3:41 PM

Said: We do not use the ISTAT in the NICU because of the capillary issue. We are moving forward with EPOC. For the time being, we use GEM.

Mary Garcia posted a reply on Re: i-STAT in NICU?

Monday, Apr 13, 2026 at 2:51 PM

Said: The latest Urgent Medical Device Correction from Abbott is below from Aug 2025.

Bob Milan has joined the group.

Monday, Apr 13, 2026 at 2:50 PM

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Adil Khan posted a reply on Re: i-STAT in NICU?

Monday, Apr 13, 2026 at 2:39 PM

Said: Hi Tersa, If this cartridge is not FDA approved for capillary samples then if you are joint commission or CAP accredited it would make it an LDT, meaning you need to do interference testing, ie full validation not verification etc. The cl...