Immuncor is coming out with a new Fetal Screen kit next year ( FMH RapidScreen) . It is replacing the current kit. Any thoughts on doing validation studies when we get maybe 1 positive patient a year???

Thanks in advance.

You can make up some positive samples with different concentration of FMH.

If you are currently using the Immucor fetal screen kit that they are discontinuing, they are providing a free validation kit to make the transition to the new kit. There is a form from Immucor to fill out requesting the validation kit and selecting when you would like to receive your shipment.

We intend to parallel test patients with the current kit and the new rapid kit, as well as creating some weak positives that we will also test with both kits.

I am curious--why validate? aren't the pos and neg controls provided enough?

You must prove that the kit functions as intended. This is standard practice for any new reagent used in the lab. Ref to CFR42.493.1253b1i

ok--didn't know--thanks for the CFR regulation.

Doesn't the positive and negative control prove that the kit functions as intended.

Hello! Feel free to e-mail me (ESims@Immucor.com) if you need any assistance on acquiring your FMH kit.

((I hope this doesn't count as solicitation!!!))

If you are currently using the Immucor fetal screen kit that they are discontinuing, they are providing a free validation kit to make the transition to the new kit. There is a form from Immucor to fill out requesting the validation kit and selecting when you would like to receive your shipment.

How do you get the form for the validation kit? If it's from the website, where can you access it? I have trouble navigating the site.

Immuncor is coming out with a new Fetal Screen kit next year ( FMH RapidScreen) . It is replacing the current kit. Any thoughts on doing validation studies when we get maybe 1 positive patient a year???

Thanks in advance.

I just received an email from my Immucor Business Manager with instsructions for how to create appropriate postive specimens. The document is titled FMH Conversion Protocol. Evidently they have been receiving a lot requests for guidance from their customers. If you have not received this you should contact your Immucor Business Manager.

Shout out to Immucor: I have to find out from here that a validation kit will exist from you all and then find out from here that some Business Managers are taking care of their customers with a Conversion Protocol. How about full information to your customers so they don't have to go to BLOG sites ( great as this one is ) to find out what's going on with your product.

All Immucor Blood Bank Business Managers and Blood Bank Technical Specialists have been reaching out to their customers to make this process as quick and easy as possible. If you need assistance, please e-mail me with your name, location, and best method of contact so that we can get you your free validation kit and any additional information!

Thank you!

Elyse

ELYSE SIMS

...................................

Immucor, Inc.

esims@immucor.com

free validation kit may be a misnomer. As of now all we have received are instructions on how to make master cell suspensions. Kit implies more than instructions.

Later

Tony

I just validated my new kit . . . interestingly I have an employee who is a variant D . . . she did not react with the anti-D in the kit (she hardly reacts with any anti-D).

free validation kit may be a misnomer. As of now all we have received are instructions on how to make master cell suspensions. Kit implies more than instructions.

Later

Tony

Tony--

You need to request the free validation kit. If you have not received the request info from your Business Manager contact them or contact Immucor Customer Service directly and they will help you. I'm not sure how your facility is set up but at mine it frequently happens that this type of info ends up going to the purchasing department and not directly to me. Purchasing then forgets to tell me about the new stuff .

If you haven't signed up with Immucor for electronic notifications I highly recommend it, that way you are much less likely to miss new/important information that they are sending out. You can sign up on their website.

Doesn't the positive and negative control prove that the kit functions as intended.

I understand your comment and thought process, RWOOD57. (That was my first thought about the "validation" concept when it finally entered the Blood Bank realm; before that most of us used to do "quality control" and "calibration", but not "validation".)

Here's the way I explain it: OK, the Pos and Neg Controls prove that the test works "correctly", but validation proves whether the test is really testing for what it is supposed to be testing for.

Donna

I just validated my new kit . . . interestingly I have an employee who is a variant D . . . she did not react with the anti-D in the kit (she hardly reacts with any anti-D).

Wow, great sample for student torture ... I mean, education!

Anyone have example validation protocols written they would like to share? I have spoken with Immucor and have somewhat of a plan, but before I write a protocol from scratch, I was hoping someone may have one written that they may share with us all. Thanks!

In relation to making up a pos control when you rarely see an FMH positive test - This is a rosetting screen test based on the presence of D+ cells in a D- mom. You do not need fetal Hb to make up a control. 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. You can use a weak pos that will represent less than a 30mL bleed but be prepared to see some rosettes.

Immucor will provide your first FMH RS kit at no charge so you are not paying for the validation material. The dilutions provided in the guide they provided are fine but a little more complicated than the volumes I've listed above using whole blood. It doesn't matter what version you use. Plus - the new kit is positive IF you see 5 rosettes total after viewing 5 fields. NOT 5 per field.

as you can tell, I've been tearing my hair out with this one but I'm sure I've figured it all out now

I got lucky a couple of weeks ago running parallel testing on the new kit vs the old kit. I actually had a patient with a positive fetal screen. We only see a positive once every year or two with the number of tests that we perform. Talk about perfect timing!

Attached (I hope) is the Conversion Protocol.

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've been doing my correlations and I've only had the one lot number kit but so far I think the reactions are easy to read. My POS control is consistently strong with multiple (5-10) agglutinates PER FIELD.

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.