ALLOURBESTNLR 30 Posted December 15, 2012 Author Share Posted December 15, 2012 I too have had 1 real positive patient recently. I have ran her, my previous CAP HBF 03 & 04, Weak D control cells, and previous lot #s of Fetal Screen kits. All have shown very good reactivity. Link to post Share on other sites
BUGGIE 11 Posted December 16, 2012 Share Posted December 16, 2012 We have validated the new kit and all my techs have run the + and - QC as training, none have had a problem. The new CAP survey was done on the old and new kit and all went well. The new kit is inuse and I do not expect any problems. We are still using NERL saline. The positive and negative controls are well defined. Link to post Share on other sites
Sandy L 113 Posted December 18, 2012 Share Posted December 18, 2012 Has anyone used the kit enough to decide if they like it? Since the latest Ortho Fetalscreen kit is showing an almost non-reactive positive control I am getting more interested in the Immucor kit.I was concerned about Mabel’s comments regarding the Ortho positive control. Has anyone else experienced this recently? We had switched to Immucor several years ago when the Ortho kit was recalled and then discontinued. When the Ortho kit was returned to the market we stuck with Immucor. Since we now needed to evaluate the new RapidScreen, we decided we should also look at the Ortho kit again. Since we are Ortho customers for our other reagents, there is a cost advantage to the Ortho kit. The techs performing the evaluation actually liked the appearance of the Ortho rosettes. They said they were a little larger than the RapidScreen rosettes and therefore easier to visualize. We had just made the decision to convert to Ortho Fetal Screen when we saw Mabel’s post. Link to post Share on other sites
kirkaw 58 Posted December 19, 2012 Share Posted December 19, 2012 I ran the validation protocol provided by Immucor and have been running the new FMH kit in tandem with the old fetal bleed screening kit. I agree with rmblack's comment about the new kit being somewhat weaker but technically correlated with the previous kit. I have seen on other forums, that several (but not a majority) people are having similar experiences. Link to post Share on other sites
lalamb 69 Posted December 19, 2012 Share Posted December 19, 2012 I noticed on my validation samples (that I prepared from the guide) that the reactions were somewhat weaker on the new kit. But technically correlated with the previous test kit.My reactions on the new FMH kit were also weaker than on the Fetal Screen Kit, but they still correlated. ?? Maybe some of the FMH clumps were bigger??The free kit expired before I could do more parallels so have ordered another kit .Attached is a "cheat sheet" for preparing the samples, from Immucor. Link to post Share on other sites
LynK 11 Posted December 20, 2012 Share Posted December 20, 2012 Perhaps there's a reference lab who can provide some pos samples for you? Also, CAP samples are good to use. Link to post Share on other sites
wellspl 10 Posted January 22, 2013 Share Posted January 22, 2013 What is the minimum number of specimens (positive and negative) we need to test for validation? Link to post Share on other sites
wellspl 10 Posted January 22, 2013 Share Posted January 22, 2013 Just mix some ABO compatible D+ cells in with D-. All you need to validate the functionality of the kit is to run a negative (D- cells) a positive(0.03mL D+ in 9.7mL D-) and a strong pos(.5mL D+ + .5mL D-) and run it in parallel with your current method.Did you use packed rbcs or whole blood? Link to post Share on other sites
carolyn swickard 232 Posted January 24, 2013 Share Posted January 24, 2013 I used the conversion protocol sent by Immucor - various dilutions - etc. I noticed that even though the number of rosettes did not seem to increase with the new kit as the dilutions increased - the rosettes were getting BIG! Seemed to correlate well and maybe that rare false positive thing will be gone too. Fast RT incubation is nice - just have to remember to wash AFTER a RT incubation - that is new. Link to post Share on other sites
Mabel Adams 1,077 Posted January 30, 2013 Share Posted January 30, 2013 We have had several times in the 2 or so years we have been using Ortho's Fetal Screen kit (really made by Alba) that the pos control is weak to negative. I know they have worked on it. It must be fine when the FDA approves the lot so it might be shipping or handling. It is usually bad as soon as we open it so it isn't deterioration or contamination from use. We can always test other positive controls and they work so we are pretty sure it is the control not the test but it is mighty annoying when it happens. But we didn't like the false positives we used to get with the Immucor one either. I really want flow cytometry. Why don't the Hem analyzers that have flow add fetal cell detection? I think there is one that offers it. Link to post Share on other sites
Sheryl Kochman 14 Posted January 30, 2013 Share Posted January 30, 2013 FMH kits are NOT subject to lot release by FDA and therefore FDA does not approve each lot. So you should not assume that "it is fine". You need to file a complaint(s) with the manufacturer or distirbutor if what you are getting is not meeting the performance characteristics and claims. Link to post Share on other sites
ALLOURBESTNLR 30 Posted January 30, 2013 Author Share Posted January 30, 2013 I have never had a false positive with the Immucor kit. I have had patients who turned out to be weak D positive that reacted with it but that's not a problem with the kit. A flow test sounds nice but it would probably be more expensive. I'm glad I don't use Ortho products right now. Johnson & Johnson is trying to sell that part of their corporation and the Blood Bank division had sales down 4% last year...which means no R&D etc for those products. Link to post Share on other sites
ALLOURBESTNLR 30 Posted January 30, 2013 Author Share Posted January 30, 2013 By the way, Immucor sent out a Technical Communication this morning regarding interpreting the new kit. Lots of color photos to put with the manual. Link to post Share on other sites
Mary** 39 Posted January 30, 2013 Share Posted January 30, 2013 How did you get that? Link to post Share on other sites
ALLOURBESTNLR 30 Posted January 30, 2013 Author Share Posted January 30, 2013 It was emailed to me by them. Each account number is supposed to receive technical advisories this way. Check with your sales rep or call Immucor I guess. Link to post Share on other sites
Mabel Adams 1,077 Posted January 31, 2013 Share Posted January 31, 2013 I didn't realize FMH kits had different FDA rules. Good to know. I assure they hear from us loud and clear each time it happens. There was a kafuffle a few years back when some people failed proficiency testing due to false pos results on the Immucor kit. At that time, we found some false positives--screen pos, Kleihauer neg. Link to post Share on other sites
lalamb 69 Posted January 31, 2013 Share Posted January 31, 2013 Regarding how many specimens to test : our reference lab made 1 set of the dilutions in duplicate (Immucors dilution protocol) and had multiple techs read the tubes.A large university hosp had up 15 positives and 5 neg's and had different tech read the tubes.I went nuts and made Immucors dilution protocol 2x. and read them all myself : was kinda freaking out that my # of rosettes didn't appear to have a linear relationship w/my dilutions !! but I also thought to rosettes looked bigger.Then found out the Technical Manual had a recipe and I did that 3x - the recipe was actually easier to prepare, although I still chose R2r cells, as recommended by Immucor.Took this opportunity to revamp our fetal screen procedure - old one was accurate but clunky and vague. [ATTACH]688[/ATTACH][ATTACH]689[/ATTACH]It and the quiz are attached if anyones needs on--they are simple...we're all generalists Link to post Share on other sites
lalamb 69 Posted February 1, 2013 Share Posted February 1, 2013 See attached immucor bullitin w/pics Link to post Share on other sites
DianeMartin 10 Posted February 4, 2013 Share Posted February 4, 2013 LaLamb, I was told you had a nice procedure attached to one of your posts but I can't seem to find it---Would you care to post it again???Or if easier, could e-mail it to me Diane_Martin@chs.net Link to post Share on other sites
PAWHITTECAR 89 Posted February 6, 2013 Share Posted February 6, 2013 LaLamb I would love it too. patricia.whittecar@salinememorial.org Link to post Share on other sites
lalamb 69 Posted February 6, 2013 Share Posted February 6, 2013 I emailied it to you...will try again to post itpolicy...quiz...Immucor Interp aidLaLamb, I was told you had a nice procedure attached to one of your posts but I can't seem to find it---Would you care to post it again???Or if easier, could e-mail it to me Diane_Martin@chs.net Link to post Share on other sites
PAWHITTECAR 89 Posted February 6, 2013 Share Posted February 6, 2013 Thanks.. Link to post Share on other sites
kate murphy 176 Posted February 7, 2013 Share Posted February 7, 2013 Lalamb - Very nice!! Particulary liked the competency! Thank you for sharing! Link to post Share on other sites
Mabel Adams 1,077 Posted February 27, 2013 Share Posted February 27, 2013 Is everyone using phosphate buffered saline with this kit as recommended or are you just using regular blood bank saline? Link to post Share on other sites
L106 271 Posted February 27, 2013 Share Posted February 27, 2013 We use phosphate buffered saline.Donna Link to post Share on other sites
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