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Complement QC with Poly IgG


ejani
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I am sorry if this has been discussed previous... I searched and didn't find anything.  Quick question...

We are transfusion service that performs DAT's using poly-clonal IgG... if it is positive, we run the mono-clonal IgG, however, we do not run the C3d.    How many of you would and/or do run the complement control cells for DAT QC in addition to Check Cells?  

 

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With a positive poly on a DAT, we only run the anti-IgG here.  But we send the specimen out to a nearby lab for the Compliment.  We do not do the anti-compliment as we do not want to pay for the QC material that we would have to buy (and mostly waste when it outdates).

Scott

 

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TRM.40200 DAT Controls Phase II
When performing an antiglobulin test with anti-IgG or polyspecific antiglobulin reagents, IgG-coated red blood cells are used as a control in all negative antiglobulin tests. NOTE: IgG-coated red blood cells must be used to confirm all negative antiglobulin test results when the antiglobulin reagent used for testing has anti-IgG reactivity. Tests found negative by tube methodology must be verified by obtaining a positive test result after adding IgGcoated (control) red blood cells. If a licensed blood typing system is used that does not require
verification of negative test results using IgG-coated red blood cells, an appropriate quality control procedure must be followed, as recommended by the manufacturer.
Evidence of Compliance:
✓ Records of testing that include control results confirming negative antiglobulin tests

TRM.40210 DAT Phase II
When performing an antiglobulin test with anti-C3 antiglobulin reagents, C3-coated red
blood cells are used as a control in all negative antiglobulin tests.
NOTE: Complement-coated red blood cells must be used to confirm all negative antiglobulin
test results when the antiglobulin reagent used for testing has anti-C3 reactivity. Tests found
negative by tube methodology must be verified by obtaining a positive test result after adding C3-
coated (control) red blood cells.
If a licensed blood typing system is used that does not require
verification of negative test results using C3-coated red blood cells, an appropriate quality control
procedure must be followed, as recommended by the manufacturer. If a polyspecific antiglobulin
reagent is used, refer to checklist item TRM.40200.
Evidence of Compliance:
✓ Records of testing that include control results confirming negative antiglobulin tests

**********************************************************************************************************************************************

I was cited for this years ago. I called CAP and was told that because poly AHG has anti-C3 reactivity as well as anti-IgG reactivity, both had to be confirmed. In addition to this std, she also referred me to the all common checklist which requires that we perform QC on reagents every day of use. So unless the manufacturer of our reagent had some other recommended QC procedure for C3 reactivity, we were required to use the complement coated cells. I put a standing order in for C3 coated cells that day, sent the confirmation email to CAP and my citation was considered corrected on site. I would assume that AABB would view this in a similar way, not to mention CLIA.

When we do a DAT, we are looking for both anti-IgG and anti-C3 activity.  If the DAT is positive with poly and anti-IgG, that doesn't preclude anti-C3 activity. If you aren't doing QC for the anti-C3 activity of your poly AHG, how can you demonstrate that your reagent is reacting properly? If you send all DATs out to check for C3 activity, then you would only have to QC the anti-IgG activity and your reference lab would be responsible for the C3 activity. 

Having said all that.....have I ever seen a failure with the C3 activity? Nope and I don't expect to. I've given students anti-C3b, -C3d reagent that's outdated by years and it still works just fine. But that's irrelevant and not how the game is played. We don't do very many DATs, but that's also irrelevant. So, I stock the C3 coated cells. Cost of doing business. I find ways to save in other areas.

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I have never seen that interp for polyahg requiring IgG and C3 sensitized cells.  It seems to me that the final sentence of referring to TRM.40200 allows the use of the IgG sensitized cells to document the reactivity of your poly reagent.  I know I am not the only one who interprets this.  I will f/u w CAP on this.

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Regardless of a particular regulatory requirement concerning DAT QC,  I believe that one must at the least follow manufacturer's recommendations for a particular system.  For our Ortho BioClone polyspecific, the procedure requires both types of sensitized cells for positive controls.  This makes sense to me.  And besides showing that the cell-washer is working properly, one has to prove that the reagent can give a positive with both compliment- and IgG-sensitized cells.

Scott

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I have heard from CAP on this question - and I quote:

" Mr. Saikin

If you are using polyspecific reagent, you are only required to confirm negative results with IgG-coated red cells.  C3-coated red cells are only required with anti-C3 reagents are used (sic).  The last sentence in the note for TRM.40210 states that if polyspecific reagent is used, the TRM.40200 applies.  I hope this helps.

Regards,

Sarah Fabian, MLS(ASCP)"

If you use polyahg, you only need to run IgG check cells to confirm negatives.

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My interpretation: Users of POLYSPECIFIC antiglobulin reagents are obliged to verify performance each day of use, i.e., QC should involve use of IgG-coated cells AND Complement-coated cells. This gives the user confidence that the reagent is performing as expected.

During routine testing, addition of IgG-coated cells to negative tests is sufficient to verify that the IAT was performed correctly - correct/effective washing, the antiglobulin reagent was added and is reactive, etc.

If it were a requirement to add IgG-coated cells and complement-coated cells to every negative IAT using polyspecific antiglobulin, it would be necessary to run everything in duplicate - one set would get IgG-coated cells and the other set would get complement-coated cells. I don't think that is the case.

Edited by exlimey
Typo
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The wording on this one has changed several times since it first appeared in the standards - I'm sure they are seeking to  clarify the intent. And every time they change the standard it just brings another angle to the debate about what they mean. That's why we all love the checklist  :cries:(not!).

Reading back through the thread, I think if we talk about this as 2 different topics, it would help.

  1. Confirmation of negative patient results with poly - David, thanks for inquiring on TRM 40200 and 40210. The package insert for the poly I use does not require the use of complement coated cells to confirm negative reactions for patient testing. IgG coated red cells are sufficient. Matches the response that David received from CAP. The package insert for the Anti-C3b, - C3d I use requires the use of complement coated cells to confirm negative reagents for patient testing. Also matches the response from CAP. Pretty straight forward.
  2. QC  - the All Common checklist requires QC  with a positive and negative control for every reagent, every day of use or following manufacturer recommendations . The package insert for the poly and anti-C3b, -C3d reagent I use does state that complement coated cells should be used to confirm that the reagents have sufficient anti-C3 reactivity - once a day.

So, my interpretation of the standards for QC and the standards for patient testing are:

  • If you are using a reagent with anti-C3 reactivity, you will need complement coated cells for QC. This would include poly and anti-C3. Performed once daily, when used.
  • If you are confirming a negative patient test and you have used poly, you must use IgG coated cells, but complement coated cells are not required.
  • If you are confirming a negative patient test and you have used anti-C3, you must use complement coated cells.

 

So ejani should use complement control cells as part of daily QC for the poly AHG used for patient testing, but only needs to use IgG coated cells to confirm negative patient test results.

 

 

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I use a Poly reagent by Immucor that states you must perform QC using the IgG coated as well as complement coated check cells.  We QC the poly reagent with both cells once per day of use and then when we perform patient testing we only us the IgG coated cells to QC the negative results.  

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On 7/27/2018 at 11:12 AM, mld123 said:

I use a Poly reagent by Immucor that states you must perform QC using the IgG coated as well as complement coated check cells.  We QC the poly reagent with both cells once per day of use and then when we perform patient testing we only us the IgG coated cells to QC the negative results.  

We do the same with the BioRad Poly. I also include a negative cell with QC (A1 cell), just to say it reacts with IgG coated cells and Complement coated cells but not with non-coated cells. 

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  • 2 years later...

We run complement cells with the daily QC, against the AHG. 

For patient testing if we get a positive DAT and the patient is an adult, we break it down between IgG and C3. The reason we do this is if the C3 is positive and the IgG  is negative the BB is done with their testing and any follow up. If the IgG is positive and the patient has been transfused in the last 14 days we perform an eluate

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