For those of you who are using Ortho Gel reagents and equipment, specifically the MTS Centrifuge/Incubator, IgG cards, and .8% Screening/Panel Cells, are you having continuing issues with reactions seen in GEL since the contamination notification a month or so ago. and an updated version a week ago?

We are still seeing small wisps of cells throughout the GEL even after having our reagents replaced multiple times. 

 

-SB

We have not really had that much trouble recently; though we have had some issues off and on over the years.

Scott

I have submitted several complaints on this topic. The company and our rep deny, deny, deny

We had a Vision (Ortho's replacement for the Provue) installed recently.  When he was here for the training last week, we started having problems with our IgG cards on the manual bench and we have not yet been able to get the QC to pass on the Vision.  Mostly we are seeing what looks like very weak reactions.  With the most problematic lot of gel cards the reactions were clearly visible in manual testing and outright positive on the Vision.  Some other lots were okay manually but still giving questionable results on the Vision.  He said they were getting all kinds of complaints recently.  When I called to get cards replaced, they said they were back-ordered although we did get some replacement cards.  I'm wondering if live Vision users are seeing the same thing or if ours is somehow reading too closely.

I have not had any problems.......yet

Have we ever had problems! Ours has lasted for about a month and across at least four different lots of IgG cards. We were told a different company was making the beads for in the gel, and that was why we were having so many problems.

We are having a few problems, especially when the cells used on the bench get older.  On the Provue, we are having several of reaction ? reviews

We just do manual gel and haven't had any problems.  We change our cells weekly.

We are manual gel only also and have not had any problems.  We also aliquot our screen cells into tubes so there is only enough out of the refrigerator to use during a 24 hour period.  We were having issues years ago and this was instituted by the previous supervisor here.  I know this is not possible on the instruments, so maybe it is something with the onboard reagent time being longer?

 

We have experienced very weak, diffuse reactivity with Selectogen I, Lot VS981, exp: 01/03/2017.  We just began them using last week, and right out of the box, we are having repeated problems with the first screening cell.  We opened a new set, with the same results.  I called Ortho on Friday, answered questions and followed up on suggestions.  We have had problems in the past, but not with a brand new shipment.

We use only manual gel right now, but  are hoping to get a Vision soon.  This does not bode well for that encounter!

I haven't experienced any problems with the gel or the reagent red cells. I use both manual and Provue gel methods.

To say we are having problems is an understatement.  This seems to only be an issue for Vision users; the camera is very sensitive and is picking up weak reactivity that the instrument is calling "?" reactions.  Because the image is enlarged on the Vision screen, you can actually see specks in the column on reactions that should be negative (including negative QC).   Multiple reports have been filed, and we have gone through about half a dozen IgG card lots.  We are beginning to see these in our manual testing now as well (although you have to look VERY closely).  It appears that the problem is something that changed with the gel card production, although nothing official has been released by Ortho yet.  Older lots of IgG cards are fine, which proves that it is the gel cards.  Hopefully this is resolved soon...

We also have two Ortho Vision analyzers. We have been having issues with the IgG cards for a few months now. This is a nation-wide problem according to our Ortho Technician. and Account Manager.  We've tried several lot numbers of cards, some with better results than others... Thankfully, we recently upgraded the Vision software to version 4.8.0 (Mod 16) and we are now able to edit reaction grades on the QC results after reviewing the cards. Before that, the QC would fail automatically and we would be forced to repeat the QC, sometimes 3-4 times. 

 I'm surprised by some of the comments of Ortho representatives denying that there is a problem. While they don't currently have a solution to the problem, our account manager and service technician have been very forthcoming that this is a known issue with the IgG cards.

Ortho recently opened a new line for manufacturing.  Makes me wonder if they haven't gotten the bugs out yet?  We are seeing a lot of ? on B cells and SC3 regardless of lot on the Provue. You can see very tiny specks up the gel.

We're seeing a lot of question marks on screening cell 3 when it's in well 6 of the anti-IgG cards (ProVue). Manual read is clear negative. Visual inspection of reagents (which we've all done to the nth degree now) hasn't identified a problem with cards or cells. ProVue service came out and everything seems good. Frustrating situation for blood bankers.

We had one lot of IgG cards that was giving a lot of false positives in manual gel.  That lot was reacting 1+ on the Vision with negative samples.  The other lots are just giving ? on the Vision.  So some lots are worse than others apparently.  Our trainer told us it was a known problem and to phone in a report to Customer Service.  The person who took the call seemed like she had never heard of it before.

In this case, what are you guys doing for reporting patient testing? Are you going back to tube with enhancement ?

We are using manual gel, seeing false positive reactions with negative QC and patients, Ortho is supposed to send us a new lot # of IgG cards.

  We have not had any problems with either the ProVue or manual gel.

On 12/8/2016 at 10:12 PM, Mabel Adams said:

We had a Vision (Ortho's replacement for the Provue) installed recently.  When he was here for the training last week, we started having problems with our IgG cards on the manual bench and we have not yet been able to get the QC to pass on the Vision.  Mostly we are seeing what looks like very weak reactions.  With the most problematic lot of gel cards the reactions were clearly visible in manual testing and outright positive on the Vision.  Some other lots were okay manually but still giving questionable results on the Vision.  He said they were getting all kinds of complaints recently.  When I called to get cards replaced, they said they were back-ordered although we did get some replacement cards.  I'm wondering if live Vision users are seeing the same thing or if ours is somehow reading too closely.

We have had the Ortho Vision installed in May and went live in September. We have had nothing but problems with ? results for the IgG cards since install. We have used different lots and can see the small "dots" or "wisps" near the bottom. The camera amplifies this and visually the cards are negative. If you over-read using an optical aid, you can detect what the camera is picking up. No resolution from support after numerous complaints. Also, since QC wouldn't pass, including previously negative patients, your only solution is installing the software upgrade. This allowed us to edit QC results just to pass QC. We should have kept the Provue made by Grifols !

I will attempt to attach an image of the sort of reaction that is giving a question mark on our Vision.  Remember that these are magnified and you can't really see the dots with the naked eye.

false pos IgG card image.docx

We are currently using Ortho gel card lot 090616001-15 and are seeing some random, very slight stuff like this.  We only do manual gel reading here.  It really looks to me like it would be an issue with the cells forming random clumps rather than defective gell cards, but I know that recently there has been a shortage of cards due to an Ortho recall.

Scott

On 12/12/2016 at 9:24 AM, mawyant said:

We have experienced very weak, diffuse reactivity with Selectogen I, Lot VS981, exp: 01/03/2017.  We just began them using last week, and right out of the box, we are having repeated problems with the first screening cell.  We opened a new set, with the same results.  I called Ortho on Friday, answered questions and followed up on suggestions.  We have had problems in the past, but not with a brand new shipment.

We use only manual gel right now, but  are hoping to get a Vision soon.  This does not bode well for that encounter!

I recommend you hold off on your Vision until either the current issues with the IgG cards gets resolved! Almost all our patients require editing of the antibody cell screen results on the Vision due to weak false positive reactions. The camera is very sensitive and picks up the small clumps near the bottom the reaction wells. Consider looking at the Biorad  analyzer (just received FDA approval) and the Grifols is pending FDA approval - both gel systems!

On 12/8/2016 at 0:55 PM, SEBaker said:

For those of you who are using Ortho Gel reagents and equipment, specifically the MTS Centrifuge/Incubator, IgG cards, and .8% Screening/Panel Cells, are you having continuing issues with reactions seen in GEL since the contamination notification a month or so ago. and an updated version a week ago?

We are still seeing small wisps of cells throughout the GEL even after having our reagents replaced multiple times. 

 

-SB

I recommend you hold off on your Vision until either the current issues with the IgG cards gets resolved! Almost all our patients require editing of the antibody cell screen results on the Vision due to weak false positive reactions. The camera is very sensitive and picks up the small clumps near the bottom the reaction wells. Consider looking at the Biorad  analyzer (just received FDA approval) and the Grifols is pending FDA approval - both gel systems!

I recommend you hold off on your Vision until either the current issues with the IgG cards gets resolved or the sensitivity on the Vison can be adjusted! Almost all our patients require editing of the antibody cell screen results on the Vision due to weak false positive reactions. The camera is very sensitive and picks up the "small grainy clumps near the bottom of the reaction wells. Also, consider looking at the Biorad analyzer (just received FDA approval) and the Grifols benchtop which is pending FDA approval - both gel systems!

Grifols Erytra is already FDA approved. It was approved before the Vision was.