Hemochron Sig. Elite LR 6 month correlations
3 followers
0 Likes
How is everyone performing their 6 month correlations for the Hemochron Signature Elites (LR)? How are you performing linearity? Do you use a kit or draw fresh samples? Is anyone using control material? Thanks in advance.
13 Replies
Reply
Subgroup Membership is required to post Replies
Join POCT Listserv now
Suggested Posts
| Topic | Replies | Likes | Views | Participants | Last Reply |
|---|---|---|---|---|---|
| iSTAT in NICU -chem 8, CG4 | 5 | 0 | 256 | ||
| Rotem Sigma Validation Help | 1 | 0 | 103 | ||
| Hemochron Sig Elite use outside of manufacturer temperature range | 2 | 0 | 171 |
Correlation: We use CAP's ACT Quality Cross Check.
Linearity: Not applicable as this is a coagulation test.
Thank you!
Does anyone just use QC material for correlation?
Yes, we do. We have QC monthly, and we use those values to compare all the Hemochrons to each other. It's been working for us for a few years. It means we don't have to collect all the devices to compare them to each other.
Awesome! thanks so much!
Hi Gayle, we also use QC material in a process similar to Kathleen’s. We use the same QC vial for the handhelds that we are comparing. We document each month and sign off at year end.
Sent via Groupsite Mobile.
Kathleen or Ruth- would you be able to send me your process? We currently do 6 month sample comparisons on all 27 of our Hemochrons and it's a pain to round up all of those analyzers!
We do the same as Kathleen. The units do the QC every month and we also do the QC on our Lab spare Elites. Since everyone downloads them to QML, we just pull the results every 6 months and use the lab instrument as the reference result. I put them in EP evaluator and it crunches the numbers for me.
What do you use as limits of acceptability for agreement between the lab instrument and all others?
I use proficiency testing acceptable limits. If you use QC, then it would be the QC acceptable ranges.
I use 20% for ACT-LR and 15% for ACT+.
I didn't think you could use Quality control for Instrument comparisons unless:
COM 04250
Quality control data may be used for this comparison for tests performed on the same instrument platform, with both control materials and reagents of the same manufacturer and lot number.
I remember calling CAP about this and they said if the control ranges were specific to the lot number of reagent it could be used. Like ISTAT qc is reagent lot specific.
Am I reading this wrong?
Since there is no commercially available product for this, I spike donor (usually mine) blood in glass tubes across the heparin sensitivity range for the assay (we have both ACT+ and ACT-LR, so I perform two studies with separate sample sets, each with different heparin concentrations). We use the AAB guideline of 20% for acceptability, which appears to be close to the acceptable ranges I see used on CAP surveys for ACT+.
I usually can't get all seven of our Hemochrons at once, even on a weekend due to the near-constant cardiac procedures. When a device is omitted due to an OR case I make sure to include it next time; omitting another device if necessary. If I did this study during the week I could probably only get half my Hemochrons at most.
We use the CAP quality cross check, CT2Q. That works beautifully for me.