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New Fetal Screen Kit/ FMH Screen


ALLOURBESTNLR
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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.

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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.

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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.

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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.

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  • 1 month later...
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?

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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.

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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.

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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.

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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.

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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.

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Regarding how many specimens to test :

  1. our reference lab made 1 set of the dilutions in duplicate (Immucors dilution protocol) and had multiple techs read the tubes.
  2. 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

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  • 3 weeks later...

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