Can anyone send me protocol or SOP telling me how to do evaluation of the anti-A, anti-A,B, anti-B, and anti-D which meet the FDA standards.

(1) Evaluation of anti-A, anti-A,B, anti-B, and anti-D before you decide to purchase the anti-sera (say a new brand or a new lot).

For example how to test the titer? Against what cells? Special cells need like anti-A and anti-A,B must react with Ax cells, anti-B not react with acquired-B, DVI not react with anti-D in immediate spin but react by IAT etc.... what else?

(2) What do you test after you receive the order (anti-sera) and before you put them in routine use?

(3) Can you send me the worksheet also, so I know how you do it?

Thanks.

CK Cheng, MSc, SBB(ASCP), CQA(ASQ)

Oct 29, 2008

For the FDA licensed antisera (anti-A,-B,-A,B,-D) . . . there is no obligation to evaluate (titrate) since they meet the FDA minimum requirements. For the anti-D reagent, you may want to read the package insert to verify how it interacts with the D ag. some reagents will not pick up DVI mosaic. I would say go with the vendor that provides the best service/pricing or whatever nebulous criteria you may desire for selection. I qc my reagents on day of use. New lots are qc'd the same way (I check them when they are put into use). In over 30 yrs of blood banking, I have never seen ABO rgnts fail qc. Rarely, an anti-D may fail, but not a new lot, only a vial that has been open for an extended time (and out of 4C storage for extended times). I use gel technology (manual) and use the Immucor corqc kit and Oneg rbcs for my qc. If you send me an email address I will forward my procedure. For my worksheet, I use photocopies of the gel cards in use and write the reactions and the lot numbers on each.

Thanks David. Do you know anyone who works or knows someone knows who works in say Ortho or Immucor that what QC do they do before release the anti-sera into the market in order to meet the standards?

CK Cheng, MSc, SBB(ASCP), CQA(ASQ)

Oct 29, 2008

I do not, but I believe they have to submit lots to the FDA for evaluation before release.

Thanks David, I just want to know how they (the manufacturer) do it. Here is my email address: chengchunkwok@yahoo.com

Can you send me protocol/procedures and worksheets on how you perform QC on blood bank reagents. Thanks.

CK Cheng, MSc, SBB(ASCP), CQA(ASQ)

Oct 29, 2008

Manufacturers of blood grouping reagents including Anti-A, -B, -AB and -D are required to meet a potency standard and must be specific. Some have reference standards and others have minimal potency requirements listed in 21 CFR 660.22. Most manufacturers are required to submit samples of product to the FDA for release. This link should take you to the FDA website and the document describing the methods recommended by FDA to evaluate performance of these reagents.

http://www.fda.gov/cber/gdlns/bldreagent.pdf

The testing manufacturers perform is very extensive and there would be no reason for end users to repeat this testing to qualify FDA licensed reagents. Performing daily QC using manufacturer recommended controls should be sufficient.

Currently we are performing QC on our reagents in house method. We are switching over to immucor's cor qc. I would appreciate if you can send me your procedures or validation what was performed going to a new method. If cor qc is FDA approved will we have to run additonal reagent test or is the manufacturer instructions sufficient to cover all reagents.

Thanks,

ESizensky MT/ASCP/BB

Hi JHH1999, thank you very much for the path. Very useful.

I tried to read the 21 CFR 660.22 printed by AABB, I did find the mininal potency requirements of most anti-sera like anti-K, -k, -Jka, etc...., but cannot find similar info regrading the minimal potency requirements and info on what cells should react and what cells should not react (like Ax, acquired-B, DVI, etc...) of anti-A, -A,B, -B, and -D. Thanks again for the path leads me to the FDA documents.

Hi, LESIZE, sorry for I do not have any info/procedures in how to do the validation on blood group reagents, that is the reason I post the thread in BBTalk and ask for help. If you have this kinda info/procedures, would like to have a copy to see. Here is my email: chengchunkwok@yahoo.com Thanks.

CK Cheng, MSc, SBB(ASCP), CQA(ASQ)

Nov 8, 2008

We changed to the use of Alba reagent anti-A, anti-B, and anti-D last May but found a problem with 3 patients in the D reaction. They reacted weakly positive with Alba but were Neg with Ortho. Unfortunately, one patient was transfused with Rh pos blood and has developed anti-D. Needless to say, we quickly changed back to Ortho, despite their ridiculously high prices.