Grifols Erytra

[MaryPDX]

7 hours ago, MOBB said:

How does the Eflexis vary from the wadiana or eytra? Is it just missing the middle module with the gel cards?

From the pictures I saw, it's like a mini Erytra. You can load and unload samples and gel cards while it's still actively running (just like the Erytra). It just doesn't hold as many samples or as many gel cards. It has 2 centrifuges, like the Erytra, but the solutions and the waste (liquid and gel cards) is more like the Wadiana.

Although the picure I posted above is still on Diba Studios Facebook page, the hyperlink they have associated with the Eflexis no longer works. If I find any other info, I will post it.

[carolyn swickard]

Quote "All in all.....a good purchase.  My only outstanding concern is some missed weak antibodies (which we will continue to watch for.....for now, every questionable antibody screen will be repeated by Tube PeG). "

 

Wait - are you saying that some weak antibodies that you already knew about or suspect from weak reactions, are not being detected at all by the new analyzer?  Is PEG finding them and allowing you to identify them or is it mostly trash?

 

[MaryPDX]

From Grifols LinkedIn site:

[Guest]

On ‎12‎/‎8‎/‎2016 at 0:09 PM, GinaG said:

Hi, Brenda - I work a UCSF.  We just purchased two Erytras that are going to be delivered soon.  I'm going to be writing the IQ/OQ validation plan (someone else will be writing the PQ), and would like to know if you could share your experience with Grifols regarding their installation/ operational plans.  Did you go to their training before creating your validation plan?  Did you incorporate Grifols IQ/OQ plans into your validation and get that approved prior to the company coming in and performing the IQ/OQ?  I've validated a lot of equipment, just never an analyzer, so any help regarding the best way to proceed with this would be really valuable. 
Thank you

Sorry, just getting back to this website.  Yes, I know you purchased the Erytras as I used to work at UCSF years ago (Reference Specialist) and stay in contact with Dr. Nambiar!  Small world.  They will supply you with a template validation plan.  I used that and just "institutionalized" it by adding some steps and coming up with my own number of samples (tested more than the plan stated).  I did start the validation plan prior to training (since they provided the template) but obviously  made a number of changes once I actually knew what I was doing!   Grifols performed the IQ and some OQ while I was at training....then we performed additional OQ, plus PQ once we returned.  But again, we just worked with their templates and made modifications as necessary.  And I am right there with you.....have validated a lot of things but never an analyzer.  It is a lot of work....and you have 2! 

Sorry this was so late.....you may be well on your way by now.

Brenda

[Guest]

Just wanted to add something to a previous post of mine on this topic.  I had mentioned our "idea" to use single-layer racks in hopes of preventing any issues with the gripper crashing into cards that were not seated well when placed on machine.  At one point, we were experiencing problems like "undetectable volume."  It can occur from splashing on the sides of the wells.  I started wondering if perhaps our "handling" of that upper layer of cards to move them to an empty rack, may have been creating problems for ourselves (more opportunity to affect the liquid in the wells and/or even add dust or lint).  So, we decided to go back to the double-layer racks to see if it made any difference.  That was several weeks ago but we do not seem to be having that problem anymore.  I can't say for certain that was the reason, but just wanted to throw that out there in case any of you read my post and thought to go in that same direction.

Brenda

[Guest]

On ‎12‎/‎23‎/‎2016 at 4:24 PM, MOBB said:

Congrats on your go live! We had a bumpy start and a possessed analyzer, we also had a rough start.....some hardware some software.....but we seem to be doing ok right now (they initially connected us to an external drain...but after training and learning the decontamination process, I had them reconfigure it to go to waste bottles.....would recommend that unless you are a high throughput Institution, but that is just my personal preference) but it's much better now. I really like the analyzer and I really like our TAS and FSE. They do feel like an immature company in that they are newer in the US and seemed to struggle with supporting their staff as they've grown, BUT they seem to hear us and resolve our issues. We've been working with them a long time and I've seen dramatic improvements and growth, I don't think other hospitals or systems would experience the same rockiness.

They are new in this country and you are correct that they are working hard to increase staff to meet the increased orders for the analyzer.  Their staff work really hard.  We have had a number of different engineers here (just depends on who is available at a given time) and a number of TAS's and there is no one I would say that we do not want to come back (as I also experienced above, we had kind of a rocky start but everything seems to have settled down....and I think some of it was due to our own inexperience and self-inflicted problems).  Some of them are on a little bit of a learning curve themselves and I can accept that.  They will get there....

We had a few learning curves too. I'm happy to share, if it helps anyone else avoid some of our self-induced problems.

1. People kept throwing away the service racks when emptied-not understanding they were service racks. The Erytra would dump the cards ok in the service rack space, but when it went to get one, it couldn't find them. 

2. If it freezes on you, DON'T hard reboot by pushing the start button. Use a mouse to right click, click global settings-not to use the global settings but to access the windows start menu and shut it down that way. Interesting that you brought up it "freezing" on you.  We had that happen a number of times in a short period of time......but has not occurred for awhile now.  Was primarily occurring when we did a shutdown (which initially we were doing twice a day because that is what we used to do on the ProVue; but since changing to once a day only, we have not been having the screen freeze on us).  But we were being instructed by Service when we called it in initially, to perform that hard shutdown you are referring to (which I know is not good....but that was how we were directed.....so just glad we have not encountered this problem for awhile)

3. You'll save yourself a lot of headaches if you turn it off every night instead of letting it go to sleep for 20 minutes for your daily maintenance. That is what we do; shutdown from touchscreen each night; shutdown also with power button in back of machine, once a week.

4. GENTLY shut the doors. We had to slam our Provue shut-so gentle touches have been difficult. Not being gentle can cause reagent splashing and possibly even splashing in gel cards too.Not only splashing to think about....my concern (and the reason I initially made the 2 tiered racks into single tiers) is that when you close the drawers too roughly, you can jostle that top layer of cards which not only causes splashing, but can also result in a gripper crash....that is what I wanted to avoid.

5. Don't let the Wash bottles get too low. We'll easily go through a full wash A container/day. Staff would get busy and not realize it would get super low or empty and start to cause issues. I ordered back up bottles and always have one ready to go on so they swap them when needed and clean and refill the container at their leisure. Grifols has a template Form for maintenance but I modified it quite a bit.  One thing I did was to have both the Day Shift (at the end of the shift) and the Night Shift (when they do shutdown and Daily QC), to check the levels of the Reagent bottles.  Since each can hold 8 liters, the Form states that if either bottle has <6.1L, to add 2 L (since you make 2L at a time).  With our workload, that results in us never having to add solution at intermittent intervals or while a specimen is running.  We also have an extra set of bottles.  And while it can hold a lot of cards, I also wanted a guideline so staff didn't just peek in the glass window and think "oh, it looks like there is enough."  Enough of "what?"  So at those same 2 intervals (when solution levels are checked), they also have to check the status of Cards and make sure there is a minimum of 36 of each type of card on the machine (that is just a number I picked based on our workload; so 72 of each type of cards per day which again allows us to not have to add them during a run)

6. Make sure your staff knows if there is a red triangle that they need to investigate and resolve the issue, not modify or accept. We allow some hemolysis as long as the gel card isn't more hemolyzed than the original sample. ANY other red triangle means there an issue and the test MUST be repeated. So I instructed staff to check their specimens before centrifugation for clots (just tilting the tube and looking for obvious clots); then after centrifugation (before placing on machine) to look for hemolysis (so they know ahead of time whether it is an acceptable level of hemolysis; thus would know they will accept it if they get the icon); fibrin "appearance" in which case they should ream it out and re-centrifuge; bubbles are bad so should be removed prior to placing specimen on analyzer; lipemia; volume; and making sure no labels are tucked underneath the specimen tubes.

 

I'm sure there lots more that I'm not thinking of at the moment. If you have any questions, I'm happy to answer and share our experiences.

Hope you don't mind if I just tag along with your post......see blue above

[goodchild]

Very useful posts. Thanks for sharing.

[Guest]

On ‎1‎/‎23‎/‎2017 at 4:27 PM, cswickard said:

Quote "All in all.....a good purchase.  My only outstanding concern is some missed weak antibodies (which we will continue to watch for.....for now, every questionable antibody screen will be repeated by Tube PeG). "

 

Wait - are you saying that some weak antibodies that you already knew about or suspect from weak reactions, are not being detected at all by the new analyzer?  Is PEG finding them and allowing you to identify them or is it mostly trash?

 

In my experience, this can be an issue with any type of automation (whether solid phase or gel.....I have seen it more with solid phase though); that weakly reactive antibodies may give a negative reaction.  Most of them are Passive D (which I had already heard about and am ok with).  Some cold, warm, or non-specific antibodies.  But yes, a couple of weak significant antibodies.  Sometimes the Erytra reports it as an NRD.....so based on our correlation studies, we pursue those (using PeG and/or Grifols panel).  Grifols explained that the machine is set up for specific algorithms such that sometimes, it is a matter of the pattern of cells in the gel, not being seen as a positive reaction by the Erytra.  They work on those as they are made aware of them and have said the new software version coming out later this year should resolve much of that.  But I can honestly say we have had NO problems with missed antibodies and patient harm....and no patients that developed a positive DAT after transfusion because an antibody was missed on the Erytra. Since our correlation studies are over, we would only know about these if it is a patient with a previously positive reaction that is now negative; or a patient with a new antibody and a positive DAT (or a new antibody but we still have the previous specimen so we could go back and test it by a different method and see if the Erytra missed something.....but have not had any such scenarios).  So for now, we will continue to observe.

[goodchild]

Brenda, I have one question in relationship to the sensitivity of the camera on the analyzer. Do you occasionally see specs towards the bottom (i.e. no clean delineation of the unagglutinated pellet at the bottom of the well) and have your techs expressed concerns regarding manual interpretation using the image on the screen versus the card in hand?

I've heard of issues with the new analyzers and their high definition cameras.

Edited February 21, 2017 by goodchild

[Guest]

On ‎12‎/‎27‎/‎2016 at 7:25 PM, JRA said:

 

You are correct, it is a large machine and is geared more towards hospitals with a high throughput (which we are NOT).  That was also my first impression when I saw it at a hospital.  I am a die-hard gel fan so that narrowed down the instrumentation right there.  We had ProVue's, but between being unhappy with the customer service we received for repairs, plus the loudness of the Vision, we took a look at the Erytra.  While it is "more machine" than what we need, it just has a lot of good features.  Also, the size means duplicity of some of the parts which is useful to any size hospital in the event 1 part breaks down (i.e. 2 probes so if one crashes or gets bent or clogged, you can still keep working with the other one; 2 centrifuges, so if one has a problem, you still have the other one to work with; 4 incubators, so extras there also; if draining externally, you also have 2 drawers for Solution A and 2 for Solution B....so if a drawer were to get stuck, you could still get to the other one).  Now you might be thinking about now....but how often do those things occur?  So we started validations late Sept. and went LIVE mid-Dec.  In that time:

1. Problems with 1 agitator rack drawer but we could use the other one until the 1st one was fixed

2.  One Solution Drawer got stuck, but we still had another one for that same solution

3. 1 probe disabled

4. A problem with a card stuck in one of the centrifuges so we disabled that one and only the  other one was used until service came

So you start to see where the extra features can also be useful to smaller Institutions just as well as larger.  Of course the Erytra is much more expensive than a Vision, so that has to be considered.  I have heard that there are problems with the Vision being too sensitive and calling false positives.....but we have run into some issues with the Erytra having problems catching very weak reactions (actually, the card may look positive, but it is more a function of the algorithms of the analyzer at this point in time).  So Pros and Cons for both.  Just a personal preference (unless money is a major factor.....).

As far as space, we moved into a new hospital in 2013 and have quite a bit of space in the Blood Bank.  We had 2 ProVues (just exchanged them for 1 Erytra; which you can do since the Erytra has multiples of many parts) which sat on benches with wheels.  So we just removed 1 of the benches with the ProVue and the Erytra fit in that spot against the wall.

For me personally, the Grifols cards seem a little more difficult to interpret, but I think you have to keep in mind:

1.  They are slightly different than the Ortho cards so you are just used to one over the other...doesn't make one better or worse.

2. With the algorithm issues of the Erytra, it can be confusing trying to learn to interpret their cards because what seems positive by you, may be called negative by the Erytra (and sometimes it is....and sometimes it is not).  So it is a little bit of a tough learning curve in that respect.

Good Luck with whatever you choose.

Brenda

[Guest]

3 hours ago, goodchild said:

Brenda, I have one question in relationship to the sensitivity of the camera on the analyzer. Do you occasionally see specs towards the bottom (i.e. no clean delineation of the unagglutinated pellet at the bottom of the well) and have your techs expressed concerns regarding manual interpretation using the image on the screen versus the card in hand?

I've heard of issues with the new analyzers and their high definition cameras.

When we first saw the Erytra (at another Hospital) and they showed the enlarged gel card picture, I thought "uh oh, this is not going to be good."  I could see every little red speck in there and wanted to call it Positive, but the TSA said it was Negative.  So, I try not to look at those enlarged pictures.  If I need a close-up on something questionable, I will pull the card out and look at it.

Brenda

[goodchild]

17 hours ago, Brenda Hutson said:

When we first saw the Erytra (at another Hospital) and they showed the enlarged gel card picture, I thought "uh oh, this is not going to be good."  I could see every little red speck in there and wanted to call it Positive, but the TSA said it was Negative.  So, I try not to look at those enlarged pictures.  If I need a close-up on something questionable, I will pull the card out and look at it.

Brenda

That was my exact reaction when I saw them. Thanks for the quick reply!

[TypeO4life]

Our Erytra is going to be delivered in the next week! Would anyone be willing to share their validation plan? Also, any words of advice for the validation process? Was the TAS helpful for the validation and training?

[MaryPDX]

Grifols TAS people were onsite to go through their validation of our Erytras. This is simply just making sure that the instrument is functioning properly (hardware and software). They had a book with the scripts they follow while our technical coordinator did the actual button pushing.  As far as training goes, 2 of our people went to Grifols for training.  They were responsible for completing the correlation studies and training the rest of the techs  

Correlation takes longer and may involve your medical director (or the primary person responsible at your facility that makes the decision as to how many specimens need to be run make a test method valid. 

[goodchild]

We'll hopefully be getting our Erytra within a month!

[MeganPLT]

On 12/23/2016 at 11:28 AM, Brenda Hutson said:

......

All in all.....a good purchase.  My only outstanding concern is some missed weak antibodies (which we will continue to watch for.....for now, every questionable antibody screen will be repeated by Tube PeG).

Brenda Hutson, MT(ASCP)SBB

Great Post All! Just one concern - Brenda, your last post mentioned missing weak antibodies and I know no one method is perfect (it's my mantra), but can you give us an example of which ones are weak/missed that are showing in PeG? And when you say questionable screen - do you repeat screens that have a history of antibody or just when they give you an equivocal result?? I've seen where others have done that during a transition period between switching methods - until they get use to it!

And just since no one has mentioned it yet - we got a chance to look at the echo Lumena and have been fairly impressed with footprint and new and improve specificity (an issue solid phase has dealt with but seems to be getting better and hopefully much better on the Lumena!) and sensitivity has never been an issue for us with Echo.

PS - @MaryPDX Thanks for the heads up on the Eflexis, I hadn't heard about that analyzer yet; but just keep in mind anything available in Europe usually takes 2-4 additional years for US to approve (from what I've seen in the past) so I wouldn't wait around for it! 

[Guest]

18 hours ago, MeganPLT said:

Great Post All! Just one concern - Brenda, your last post mentioned missing weak antibodies and I know no one method is perfect (it's my mantra), but can you give us an example of which ones are weak/missed that are showing in PeG? And when you say questionable screen - do you repeat screens that have a history of antibody or just when they give you an equivocal result?? I've seen where others have done that during a transition period between switching methods - until they get use to it!

And just since no one has mentioned it yet - we got a chance to look at the echo Lumena and have been fairly impressed with footprint and new and improve specificity (an issue solid phase has dealt with but seems to be getting better and hopefully much better on the Lumena!) and sensitivity has never been an issue for us with Echo.

PS - @MaryPDX Thanks for the heads up on the Eflexis, I hadn't heard about that analyzer yet; but just keep in mind anything available in Europe usually takes 2-4 additional years for US to approve (from what I've seen in the past) so I wouldn't wait around for it! 

I will have to go back to my validation binder to get the specifics for you.....plus am a little hesitant in that I do not want to make a definitive negative statement concerning Grifols testing (as I myself have not come to a negative conclusion).  For the most part, it is working as expected.  But I can answer some of the other issues you raised.  So when the Erytra is questioning whether or not a Screen is Positive (calls it an NRD), then you have to make a decision. You can look at the card (or picture....but as stated previously, I tend to shy away from those giant pictures); and perhaps you decide to change the NRD to Negative....or you can do further work.  At least at this moment, we choose to do further work based on both our validation results and on our admitted need to become more used to how we interpret the Grifols Cards , but also just the fact that it is new and I want to kind of continue correlation studies a little longer.  So we would not interpret that questionable reaction just based on looking at the card.  We would perform a panel (Grifols; or Immucor) and/or PeG testing. 

As far as other screens we have pursued further....if we run a patient on the Erytra who has known antibodies (and was reactive when last tested) and it is Negative, we will either perform a PeG Screen, or run some Immucor cells in Ortho IgG (which is better as far as comparison studies than using PeG).  So I guess we are still just "learning" about the Erytra (and I am feeling better about it the more we use it...AND, the more I do these comparison studies).  Another thing to keep in mind is that when we did our initial comparison studies, a lot of those were frozen known antibody specimens, so perhaps those just didn't run as well on the Erytra as other techniques....because as I stated, it is getting better.

Hope that helps a little....sorry for not being more specific on antibodies but don't know how much could be due to being new users and/or using older, frozen specimens....so would not want to make too many associations with the Erytra at this point in time. But will keep you guys posted should I become more concerned....just wanted to throw it out initially so you would all also do due diligence when doing your comparison studies.

Thanks

Brenda

[MaryPDX]

19 hours ago, MeganPLT said:

Great Post All! Just one concern - Brenda, your last post mentioned missing weak antibodies and I know no one method is perfect (it's my mantra), but can you give us an example of which ones are weak/missed that are showing in PeG? And when you say questionable screen - do you repeat screens that have a history of antibody or just when they give you an equivocal result?? I've seen where others have done that during a transition period between switching methods - until they get use to it!

And just since no one has mentioned it yet - we got a chance to look at the echo Lumena and have been fairly impressed with footprint and new and improve specificity (an issue solid phase has dealt with but seems to be getting better and hopefully much better on the Lumena!) and sensitivity has never been an issue for us with Echo.

PS - @MaryPDX Thanks for the heads up on the Eflexis, I hadn't heard about that analyzer yet; but just keep in mind anything available in Europe usually takes 2-4 additional years for US to approve (from what I've seen in the past) so I wouldn't wait around for it! 

We didn't.  We now have 2 Erytras.  Had the first for about 1 1/2 years, the second we just got.

 

[MeganPLT]

@Brenda Hutson No that all makes perfect sense! I don't want you to have to dive into the antibody details if not needed; I appreciate you giving a well rounded review of the Erytra. (and I feel frozen/thawed samples have to be looked at with extra consideration as well!)  About shying away from the big pictures - that is similar to what we do with the echos - we don't "blow it images up" because sometimes you can actually "over read" or start to question the reaction which is not good either - but it took us some time to get there and understanding it too has a camera algorithm to abide to! And as we have gained experience with the reaction images, it is easier to make that determination - sometimes going to the panel and sometimes knowing it is "safe" to call the screen image negative and feeling confident. Thanks for the additional details as it help me understand how the different instruments/methodologies work and gives an example of decision making for interpretation (since with any instrument, you will have to have that).

 

[Guest]

On ‎3‎/‎6‎/‎2017 at 9:58 AM, MeganPLT said:

@Brenda Hutson No that all makes perfect sense! I don't want you to have to dive into the antibody details if not needed; I appreciate you giving a well rounded review of the Erytra. (and I feel frozen/thawed samples have to be looked at with extra consideration as well!)  About shying away from the big pictures - that is similar to what we do with the echos - we don't "blow it images up" because sometimes you can actually "over read" or start to question the reaction which is not good either - but it took us some time to get there and understanding it too has a camera algorithm to abide to! And as we have gained experience with the reaction images, it is easier to make that determination - sometimes going to the panel and sometimes knowing it is "safe" to call the screen image negative and feeling confident. Thanks for the additional details as it help me understand how the different instruments/methodologies work and gives an example of decision making for interpretation (since with any instrument, you will have to have that).

 

You are welcome....

[gmenfl]

The Vision is NOT the successor to the Provue by manufacturer. Provue was manufactured by Grifols and the Vision is manufactured by a different company (Swiss). Ortho contracted out the production of their analyzers. The Vision has a lot of issues with camera over-sensitivity creating a lot of indeterminate results for antibody screens (? results). Either manual review or verification is required. Our particular Vision has had several repair and software issues in 6 months. The random access is great, as is having two centrifuges. QC was a nightmare until November since you did not have the ability to edit results which locked you out of using the analyzer. I would definitely recommend taking a look at the Biorad and Grifols automated analyzers (both Gel methods).

[Mabel Adams]

Does the Grifols gel have as much of a tendency as Ortho's to have reagent cell lots that give tons of false positive antibody screens, especially as the cells age or you get to the dregs of the vials? We had done some testing of Grifols gel and felt that it might not pick up those false positives so much.  We ended up with a Vision because of $ but I am interested in the experience of long-term Grifols users in this regard.  Our last lot of Ortho screen cells was terrible for false positives.

[MaryPDX]

On 4/7/2017 at 8:28 PM, Mabel Adams said:

Does the Grifols gel have as much of a tendency as Ortho's to have reagent cell lots that give tons of false positive antibody screens, especially as the cells age or you get to the dregs of the vials? We had done some testing of Grifols gel and felt that it might not pick up those false positives so much.  We ended up with a Vision because of $ but I am interested in the experience of long-term Grifols users in this regard.  Our last lot of Ortho screen cells was terrible for false positives.

We don't get the false positives with Grifols like we did with Ortho. IMHO

[illinoisbloodbanker]

To all the Erytra users out there I am wondering what you are using for your source of water. The Chemistry department in my lab will not allow me access to the Millipore system because it is plumbed directly to the Architects.  With my volume of testing it looks like I may need 6L of DI water per day.  Is anyone purchasing water for their Erytra? How is that process going?

[Guest]

On ‎2‎/‎21‎/‎2017 at 9:29 AM, Brenda Hutson said:

Just wanted to add something to a previous post of mine on this topic.  I had mentioned our "idea" to use single-layer racks in hopes of preventing any issues with the gripper crashing into cards that were not seated well when placed on machine.  At one point, we were experiencing problems like "undetectable volume."  It can occur from splashing on the sides of the wells.  I started wondering if perhaps our "handling" of that upper layer of cards to move them to an empty rack, may have been creating problems for ourselves (more opportunity to affect the liquid in the wells and/or even add dust or lint).  So, we decided to go back to the double-layer racks to see if it made any difference.  That was several weeks ago but we do not seem to be having that problem anymore.  I can't say for certain that was the reason, but just wanted to throw that out there in case any of you read my post and thought to go in that same direction.

Brenda

Note:  Undetected volume turned out to be a problem with analyzer; not our handling of the cards (they are now going to install a new version next week to fix the volume issues).  But we did have a crash not longer after going to double-layer racks so we are back to single-layer.  We don't need the volume the double-layer provides and it just isn't worth having the gripper crash into a card where a corner is slightly sticking up.....but that was just our personal decision.

Brenda