EP Valuator
1 followers
0 Likes
Hi Guys,
I am doing the 6 month validation for BHCG on the I-STAT and I was wondering what model people use. I've done the 2 instrument comparison and the alternative. I'm just not sure which one to go with. I figured out that the Tae is 17% since that would be 3 SD from the API samples of the beckmans UniCel DxI. I am just curious what people have done. Thank you.
3 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 | 4 | 0 | 134 | ||
| Rotem Sigma Validation Help | 1 | 0 | 85 | ||
| Hemochron Sig Elite use outside of manufacturer temperature range | 1 | 0 | 137 |
Two instrument is for comparing two of the same instrument. Alternative is for comparing two different instruments.
Thank you for the clarification. Since I'm running the BhCG validation I'm trying to figure out what to validate it against. We use the Beckmans to test the levels of BHCG unlike with the i-STAT where we test to see if they are pregnant. I’m not sure how to go about validating this test.
I'm not sure I understand the question, are you saying that you do not report the quantitative result from the iSTAT? You just report Pos/Neg? If so, then you must have set a cutoff level, like <25 is Neg - then I would do a Qualitative Method Comparison and just evaluate if a pos on one method would be a pos on the other. If the other device has a different cutoff, then it can get a little tricky to compare them. You could do the Alternate quantitative using the actual number that you get from the iSTAT, and under parameters choose "Disparate Scales" so you can compare the data using the corresponding negative value for each device type.