Changing cartridges from G3+ TO CG4+ validation i-STAT
1 followers
0 Likes
Does anybody know the method validation for implementing a new cartridge. The analytes are the same on the cartridges but we were told by joint commission to at least perform method validation. I have looked through the manual but can't find any information on the topic. We already have an IQCP in place that covers the analytes just swapping cartridges because abbott is discontinuing the G3+.
Thanks
Thanks
3 Replies
Reply
Subgroup Membership is required to post Replies
Join POCT Listserv now
Suggested Posts
| Topic | Replies | Likes | Views | Participants | Last Reply |
|---|---|---|---|---|---|
| TEG6s for Pediatrics | 3 | 0 | 267 | ||
| Affinion 2 Dropping Numbers from both Operator ID and Specimen ID When Scanning? | 2 | 0 | 221 | ||
| NovaPlus HCG Pregnancy Test Cassettes - Back order? | 1 | 0 | 210 |
The CG4 has the Lactate which will require a validation. We usually do accuracy, precision, linearity, reportable range and correlations for any new analyte. We use QC for our accuracy and precision using 15-20 datapoints (precision). I have a New Test/Methodology form that i use that someone on the listserv sent me and I can send it to you if your interested.
Yes anything you can send me will help