COM.40605 Reference Intervals for Avoximeter 1000E

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Hi,

I just finished validating the Avoximeter 1000E devices for my facility's Cath Lab. I am curious how other sites using these devices are meeting the reference interval verification requirement. A formal reference interval study does not seem practical, and I am having trouble finding published reference interval data. I would love to hear how others have approached this.

Thanks!

3 Replies

Erika Deaton-Mohney BS, MT(ASCP), CPP

Mon Jun 01, 2026 at 9:56AM

Hi Sarah! One option for completing the reference intervals for your AVOX is to use the correlation data, if you used patient samples. That would work if you had enough data that covered the reference range enough for your director. Did you need to correlate to another blood gas instrument?

Sarah Spaulding

Mon Jun 01, 2026 at 11:14AM

Hi Erika! Thanks for the quick response! We compared to the Oxicom 3000s. My facility has had the Oxicom devices for many years, and I have not been able to find any documentation showing that an initial reference interval verification was ever performed on them. Because of that, I am wondering if comparison to the Oxicoms would really count as evidence of reference interval verification if I can't demonstrate that the original reference intervals were verified in the first place. Am I thinking about that correctly?

Erika Deaton-Mohney BS, MT(ASCP), CPP

Tue Jun 02, 2026 at 7:31AM

I see. Please do understand that if the method you are using is not fully verified, you should finish to completion. Yes, even if you are going away from it. I recently had a CMS verification surveyor who looked at a device that had been retired. When I inquired about it, she stated if anything had not been completed that we would need to follow up. I suppose that is one reason why we need to keep those materials for two years after retiring them. I do not know what accreditation you are, but please do verify with your policies and accreditation standards. See below for my advice. Note: I am CAP and tend to understand those regulations best.

For this I needed to go to one of my favorite references, "The New Poor Lab's Guide to the Regulations" by Sharon S. Ehrmeyer, Ph.D. This is a great one if you don't have it! On page 70:
Reference Range: (decide on ,but typically not establish, the expected Normal range for healthy patients)

A Laboratory should follow its policy for verification of performance specifications and the laboratory director must approve the collected data prior to implementing the method of reporting patient results.
For a method in long-standing use, the combination of (a) proficiency testing data, (b) routine QC data., (c) calibration data (at least three points, spanning the range of reported test results), and (d) sa sign-off by the director, will fulfill these requirements.

Notes that may apply:

For CAP, a laboratory may use data from manufacturer information or published reports, but the laboratory must verify [in-house] accuracy, precision and reportable range.

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COM.40605 Reference Intervals for Avoximeter 1000E