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Anyone Using Bio-Rad's Blood Bank Reagents?


jhaig

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I'm going to begin a validation study on Bio-Rad's blood bank reagents and rare anti-seras and was wondering if anyone out there is currently either evaluating or using them. The pricing is what caught my eye at first, so now we're going to see how they stack up against our current company (Immucor).

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I have purchased some of their rare antisera - Jka, Jkb (kind of weak reacting and watch, the spin time is 60 seconds), K1 (works well) and N (haven't checked it yet). The pricing is nice but I'm waiting for their gel products to be available (in 2011).

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Am in the process of switching to Bio-Rad. Have validated the ABORH reagents as well as screening cells and reverse grouping cells. Also did Anti-S which reacted more strongly than Ortho's. anything we order from now on will be Bio-Rad except of course for gel reagents. It definitely is a pricing issue.

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Bio Rad is the US supplier for Biotest reagents. I have evaluated them and they seem to work as well as Immucor and Ortho. The pricing is about half the price of the others. However the drops are larger and consequently you don't necessarily get the same number of tests per bottle but it is still a cost savings. We are seriously considering switching.

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We just switched all of our reagents (except the gel cards and 0.8% screening cells and panels) to Biorad/Biotest. It was a significant cost savings, the validation went very well, and we've had no major complaints. A couple things we found:

1. The drops are slightly larger.

2. The Anti A and Anti B reagents are slightly "stickier" for lack of a better word....you have to shake just a little harder to dislodge the button from the bottom of the tube.

3. Reactions with Anti-D are about 1 grade weaker than with Immucor Anti-D.

4. The Rh antisera (C,c, etc) are much stronger than Immucor, you get nice 3-4+ reactions after only a 5 minute room temp incubation.

Our Biotest rep is awesome, overall we are very pleased. Looks like we'll be purchasing a Tango in the next few months, we'll use gel as our backup (secondary) method.

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We've been using Bio-Rad (Biotest) ABO/Rh for a while. It is just fine compared to the others (Ortho/Immucor). We're in the process of setting up our new Tango. Slowly, i am switching everything to them, save the few gel things we'll have to get from Ortho (for now, i assume those will come from Bio-Rad eventually, too). We will be doing gel as back-up. The prices are better and the reps (actually eveyone i have met associated to the company) are wonderful.

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We've switched from Immucor to Biotest for ABORh and rare anti-sera. Validation went fine, but it should be noted that anti-D is often a weaker reaction (but still clearly positive) - so unsuspecting bench techs should be warned in advance. Really like the cost savings.:)

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Just an FYI. All licensed blood grouping reagents must meet FDA requirements for potency, reactivity and specificity. In order to license these reagents they must undergo significant clinical trial testing to ensure they are giving accurate results.

It is one thing to compare or evaluate how these reagents perform against each other in your hands, but the manufacturers have performed far more testing than most end users would even think of doing. I would caution against going overboard on "validating" the use of these reagents.

As previously mentioned, pay close attention to the directions for use. Some newer monoclonals have different incubation/spin time requirements and even different saline requirements. If these are not followed, your reactions may not be what you would expect.

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I have purchased some of their rare antisera - Jka, Jkb (kind of weak reacting and watch, the spin time is 60 seconds), K1 (works well) and N (haven't checked it yet). The pricing is nice but I'm waiting for their gel products to be available (in 2011).

Could you please expand on the comment about waiting for their gel products to be available????? I am unaware of any of their plans to move into the gel market. What are they going to be offering??? I have been watching BioTest (now BioRad) since they became FDA cleared and entered the market just a couple of years ago. I have not committed to purchasing any of their reagents yet, but I'm becoming more and more convinced I need to concider switching sooner than later. Currently we are using Ortho Gel with a ProVue and have Immucor as our back up method for tube testing and antigen typing.

Also could anyone expand on the validating process? I'm hearing some do large validation comparison studies and I hear some saying not to spend much effort because the FDA has essentially validated these reagents for us? I'm not exactly sure what to do with this conflicting info. As Blood bankers, we can't simply buy new reagents and begin using them with out any sort of comparison can we???

Thanks for the help!

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I am not aware of any regulatory requirement for blood banks to validate the use of a FDA licensed reagent. The FDA does not validate reagents. They review and approve the work done by the manufacturer to ensure their claims are accurate.

If you follow the manufacturer's instructions and run the necessary controls daily, you should be able to put them into use without any further testing. Any additional work would be in my opinion a waste of time and valuable reagent.

As far as the gel thing, I have heard something about the patent on that technology ending allowing others to start making gel system supplies to compete with Ortho.

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BioRad also bought DiaMed awhile back. DiaMed is the company who sells Gel reagent in the rest of the world and currently has something (?agreement, contract, license?) with Ortho that allows them the exclusive right to sell and distrubute in the U.S. until I think 2012 (maybe late 2011?). After that I believe BioRad will be able to sell DiaMed reagents in the U.S.

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We used Biotest at my previous employer. The panel reacted very nicely. Never used the ABO reagents. We thought the Jka, Jkb and K reacted slightly weaker than Immucor/Ortho, even with the correct spin times. Lea reacted well; however, didn't like suspending the cells in PBS prior to testing. M and N reacted strongly. P1 & S reacted well, these were made with albumin & we were told if the patient had a positive DAT, the results of these 2 reagents may be invalid.

I am preparing to validate the Biotest panel at my current location to use for rule outs.

Overall, I was pleased with the products I used.

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In terms of validation, I would recommend that you do some level of parallel testing to ensure that you are getting the results you expect to get. You want to look at extremes (weak antibodies and subgroups, for example) and routines. You want to look at return on investment (the drop size issue). Then you want to document your decision.

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BioRad also bought DiaMed awhile back. DiaMed is the company who sells Gel reagent in the rest of the world and currently has something (?agreement, contract, license?) with Ortho that allows them the exclusive right to sell and distrubute in the U.S. until I think 2012 (maybe late 2011?). After that I believe BioRad will be able to sell DiaMed reagents in the U.S.

DIamed licensed the technology to MTS in the US. MTS was subsiquently purchased by Ortho. The exclusive rights MTS has to the method expires in 2012 according to my Biorad rep. At that point Biorad will jump into the gel market here in the US. Looking forward to it as Biorad has a good reputation and consistancy of the products we use in Chemistry and Hematology / Coagulation.

I agree with adiescast about parallel testing to assure the reagents perform similar to the reagents you are currently using. It allows for a chance to see if there are differences in performance and results as compared to what a facility is accustomed to using. This adds a comfort level (an added bonus) for less frequent users prior to "going live" with a new vendor. Just my opinion :)

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We just switched all of our reagents (except the gel cards and 0.8% screening cells and panels) to Biorad/Biotest. It was a significant cost savings, the validation went very well, and we've had no major complaints. A couple things we found:

1. The drops are slightly larger.

2. The Anti A and Anti B reagents are slightly "stickier" for lack of a better word....you have to shake just a little harder to dislodge the button from the bottom of the tube.

3. Reactions with Anti-D are about 1 grade weaker than with Immucor Anti-D.

4. The Rh antisera (C,c, etc) are much stronger than Immucor, you get nice 3-4+ reactions after only a 5 minute room temp incubation.

Our Biotest rep is awesome, overall we are very pleased. Looks like we'll be purchasing a Tango in the next few months, we'll use gel as our backup (secondary) method.

I may do the same thing. I want to keep the gel cards and the 0.8% Ortho panels (I think the BioRad panel is a 3%?). I've validated all of the anti-sera, but I'm still considering the Biotestcell screening cells. What obstacles would there be if I switched to Biotest screening cells but kept the Ortho 0.8% ID panels?

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The way i understood it, BioRad actually owns the gel patent. BioRad's contracts with Ortho will or already have expired and since BioRad aquired BioTest, they are not going to allow a competing company (Ortho) sell "their" products...

Nevermind, i see too late that it was already better explained above!

Edited by SusanM
typed before reading entire thread.
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  • 1 month later...
I have purchased some of their rare antisera - Jka, Jkb (kind of weak reacting and watch, the spin time is 60 seconds), K1 (works well) and N (haven't checked it yet). The pricing is nice but I'm waiting for their gel products to be available (in 2011).

Is that a monoclonal K1? We primarily use Ortho (utilize the Gel system), with Immucor being our 2nd provider. However, a group of Hospital Consultants that came in to assist in "cutting costs," is trying to get us to look at this company as our 2nd provider. I do not want 3 providers so I would want to know that Biotest could supply the reagents we currently receive from Immucor (i.e. C3 Control Cells; Monoclonal K1, et al) and that the reagents from this company work well (as I do not personally know of anyone using them yet).

Thanks

Brenda Hutson, CLS(ASCP)SBB

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Could you please expand on the comment about waiting for their gel products to be available????? I am unaware of any of their plans to move into the gel market. What are they going to be offering??? I have been watching BioTest (now BioRad) since they became FDA cleared and entered the market just a couple of years ago. I have not committed to purchasing any of their reagents yet, but I'm becoming more and more convinced I need to concider switching sooner than later. Currently we are using Ortho Gel with a ProVue and have Immucor as our back up method for tube testing and antigen typing.

Also could anyone expand on the validating process? I'm hearing some do large validation comparison studies and I hear some saying not to spend much effort because the FDA has essentially validated these reagents for us? I'm not exactly sure what to do with this conflicting info. As Blood bankers, we can't simply buy new reagents and begin using them with out any sort of comparison can we???

Thanks for the help!

I agree with the idea that you do not need to perform validations; the company has performed them.

One example of a scenario where I performed validations (or comparision studies) at a previous Institution was that we wanted to switch from receiving Cord Blood specimens in red top "clot" tubes to EDTA tubes. So I did parallel testing. I think these types of studies are much more common in Chemistry and Hematology than in Blood Banking (however, I am speaking from a manual point of view; might be other considerations when your process is automated).

Just my thoughts...

Brenda Hutson, CLS(ASCP)SBB

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I am not aware of any regulatory requirement for blood banks to validate the use of a FDA licensed reagent. The FDA does not validate reagents. They review and approve the work done by the manufacturer to ensure their claims are accurate.

If you follow the manufacturer's instructions and run the necessary controls daily, you should be able to put them into use without any further testing. Any additional work would be in my opinion a waste of time and valuable reagent.

As far as the gel thing, I have heard something about the patent on that technology ending allowing others to start making gel system supplies to compete with Ortho.

It will be interesting to see where that goes. I have proposed to more than 1 Immucor Rep. that it would be helpful (and increase their business) if in addition to offering the 3% Panels, that they would also offer them in 0.8%. They always tell me that this would be a conflict of interest (be supporting another company's technology). I guess I am looking at it from the point of view that people who use GEL, use GEL; they are not going to switch just because Immucor does not make a 0.8% Panel; so it would be more revenue for Immucor. At least that is my perspective...

Brenda Hutson

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  • 1 month later...

We have currently switched all of our ABO typing and antisera's to Biotest. I find no real difference in performance. I did, however, find that the poly AHG did not react as well with complement as I would expect. There is not a room temperature incubation after the immediate spin read so I am not sure if that may be weaking the reactions. We will probably not be using the poly reagent. We did a comparison of 20 patients (we are a small rural hospital) for the ABO reagents and only one for each antisera (due to high cost of reagent).

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My two cents on validation: if they are FDA approved, you really don't have to do an extensive validation. And as stated above, you probably don't really have to do any at all, just normal QC. However, I also agree that I want to see how they work in my lab before I make the committment to switch. So I do a limited validation just so that I get a sense of how they work, how they compare to the previous brand, etc. And it sure helps to have something available if an inspector asks to see it; yes, you could argue that it's not necessary, but the less arguments with inspectors, the better.

:bonk:

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I agree about the validation. Running a few cells in parallel with your other manufacturer is still a good idea, though, to check relative reactivities and procedural issues. My gripe with Bio-Test (which I thought I might have previously stated here but it seems to have been on another thread) is with their outdates. Our first vial of anti-M arrived outdated! Their outdates seem to be in the 6-12 month range, not a problem for the heavy hitters like anti-E or -K but a definate problem for the ones we don't use as frequently. Immucor routinely gives you 18-24 months or so.

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  • 6 months later...
  • 3 weeks later...

Good observation Beth. Will let our folks know. Had my lab partly switch over to BioRad/Biotest and so far so good. We use their ABO/Rh reagents for quick types in emergencies and to retype units.

We still have Ortho gel (not automated/no provue); however, we use BioRad antisera in gel for phenotyping patients and units with great success.

I did speak with our BioRad salesman recently about getting a 0.8% panel from them to supplement our panel A from Ortho (hey it's a small lab folks), but he seems to think that won't be anytime soon (maybe 2013). Just in case someone wanted to know about availability. :cries:

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